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A Study of Pertuzumab in Addition to Chemotherapy and Trastuzumab as Adjuvant Therapy in Participants With Human Epidermal Growth Receptor 2 (HER2)-Positive Primary Breast Cancer (APHINITY)

Primary Purpose

Breast Cancer

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
5-Fluorouracil
Carboplatin
Cyclophosphamide
Docetaxel
Doxorubicin
Epirubicin
Paclitaxel
Pertuzumab
Placebo
Trastuzumab
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Non-metastatic operable primary invasive HER2-positive carcinoma of the breast that is histologically confirmed, and adequately excised
  • Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to (</=) 1
  • Known hormone receptor status (estrogen receptor and progesterone receptor)
  • The interval between definitive surgery for breast cancer and the first dose of chemotherapy must be no more than 8 weeks (56 days). The first cycle of chemotherapy must be administered within 7 days of randomization or on Day 56, whichever occurs first
  • Baseline left ventricular ejection fraction (LVEF) greater than or equal to (>/=) 55 percent (%) measured by echocardiogram (ECHO) or Multiple-Gated Acquisition (MUGA) Scan
  • Confirmed HER2 positive status
  • Completion of all necessary baseline laboratory and radiologic investigations prior to randomization
  • Women of childbearing potential and male participants with partners of childbearing potential must agree to use effective contraception (as defined by the protocol) by the participant and/or partner for the duration of the study treatment and for at least 7 months after the last dose of study drug

Exclusion Criteria:

  • History of any prior (ipsi- and/or contralateral) invasive breast cancer
  • History of non-breast malignancies within the 5 years prior to study entry, except for carcinoma in situ of the cervix, carcinoma in situ of the colon, melanoma in situ, and basal cell and squamous cell carcinomas of the skin
  • Any "clinical" T4 tumor as defined by primary tumor/regional lymph nodes/distant metastasis (TNM), including inflammatory breast cancer
  • Any node-negative tumor
  • Any previous systemic chemotherapy for cancer or radiotherapy for cancer
  • Prior use of anti-HER2 therapy for any reason or other prior biologic or immunotherapy for cancer
  • Concurrent anti-cancer treatment in another investigational trial
  • Serious cardiac or cardiovascular disease or condition
  • Other concurrent serious diseases that may interfere with planned treatment including severe pulmonary conditions/illness
  • Abnormal laboratory tests immediately prior to randomization
  • Pregnant or lactating women
  • Sensitivity to any of the study medications or any of the ingredients or excipients of these medications

Sites / Locations

  • HonorHealth Research Institute ? Bisgrove
  • Providence Regional Medical Center
  • Marin Cancer Care Inc
  • Kaiser Permanente - Hayward
  • UCSD Moores Cancer Center
  • Cedars-Sinai Medical Center
  • Kaiser Permanente - Oakland
  • Kaiser Permanente - Roseville
  • Sutter Cancer Center
  • Kaiser Permanente Sacramento Medical Center
  • Southern California Kaiser Permanente
  • K. Permanente - San Fransisco
  • K. Permanente - San Jose
  • K. Permanente - Santa Clara
  • K. Permanente - S. San Fran
  • Kaiser Permanente; Oncology Clinical Trials
  • K. Permanente - Walnut Creek
  • Rocky Mountain Cancer Center - Denver
  • Lutheran Hematology &Oncology
  • Eastern Ct Hema/Onco Assoc; Dept of Oncology
  • Washington Cancer Institute at MedStar Washington Hospital Center.
  • Georgetown U; Lombardi Comp Can
  • Florida Cancer Specialists; SCRI
  • Memorial Cancer Institute
  • Mayo Clinic-Jacksonville
  • Cancer Specialists; North Florida ;Jacksonville (AC Skinner Pkwy)
  • Ocala Oncology Center
  • Memorial Breast Cancer Center
  • Hematology Oncology Associates of the Treasure Coast
  • Florida Cancer Specialists; Saint Petersburg
  • Florida Cancer Specialists, Research Department
  • Phoebe Putney Memorial Hospital
  • Georgia Cancer Specialists
  • Northwest Georgia Oncology Centers PC - Marietta
  • Kootenai Cancer Center
  • Rush University Medical Center
  • Uni of Chicago
  • Ingalls Memorial Hospital
  • Loyola University Med Center
  • Edward Cancer Center Naperville
  • Illinois Cancer Care
  • Edward Cancer Center Plainfield
  • Quincy Medical Group; Canc Ctr at Blessing Hosp
  • Carle Foundation
  • University of Iowa
  • Cancer Center of Kansas
  • Cancer Center of Acadiana at Lafayette General
  • Cancer Care of Maine
  • New England Cancer Specialists
  • Mercy Medical Center
  • Weinberg CA Inst Franklin Sq
  • Maryland Oncology & Hematology, PA
  • Boston Medical Center
  • Dana Farber Cancer Institute at Faulkner Hospital
  • Beth Israel Deac Med Ctr; East Campus Rsch Pharmacy
  • Dana Farber Can Ins
  • Massachusetts General Hospital.
  • Berkshire Hematology, Oncology Pc
  • Grand Rapids Clinical Oncology Program
  • West Michigan Cancer Center
  • Southdale Cancer Clinic
  • Coborn Cancer Center
  • Metro-Minnesota Community Oncology Research Consortium
  • Jackson Oncology Associates, PLLC
  • University of Missouri-Columbia; Ellis Fischel Cancer Center
  • Washington University School of Medicine
  • Heartland CCOP/Missouri Baptist Medical Center
  • Cancer Alliance of Nebraska
  • Cancer Alliance of Nebraska
  • Dartmouth Hitchcock Med Center
  • Saint Barnabas Medical Center
  • New York Oncology Hematology, P.C.
  • Montefiore Medical Center
  • Roswell Park Cancer Inst.
  • Mount Sinai Beth Israel Medical Center
  • Mount Sinai Beth Israel Comprehensive Cancer Center
  • Mount Sinai West
  • Memorial Sloan Kettering Cancer Center
  • SUNY Upstate Medical University
  • University of North Carolina-Chapel Hill
  • Carolina Oncology Specialists, PA - Hickory
  • Dayton Clinical Oncology Prog
  • Oncology Hematology Care Inc
  • The Mark H. Zangmeister Ctr; Mid Ohio Onc/Hem Inc.
  • Toledo Clinic Cancer Center-Oregon
  • Northwest Cancer Specialists - Portland (NE Hoyt St)
  • Abramson Cancer Center; Univ of Pennsylvania
  • Albert Einstein Healthcare Network ; Cancer Center
  • Magee Womens Hospital
  • Charleston Oncology, P .A
  • Roper Bon Secours St. Francis Cancer Center
  • South Carolina Oncology Associates - SCRI
  • Cancer Centers of the Carolina; Eastside Medical Center
  • Sanford USD School of Medicine
  • Tennessee Oncology Chattanooga
  • Tennessee Onc., PLLC - SCRI
  • Vanderbilt Breast Center at One Hundred Oaks
  • Texas Oncology-Medical City Dallas
  • Texas Oncology - Dallas Presbyterian Hospital
  • Texas Oncology-Baylor Sammons Cancer Center
  • Texas Oncology-El Paso Cancer Treatment Center Grandview
  • Texas Oncology, P.A. - Fort Worth
  • The Center for Cancer and Blood Disorders - Fort Worth
  • Texas Oncology, P.A. - Garland
  • Texas Oncology - Houston (Gessner)
  • Texas Oncology-Tyler
  • Cancer Care Centers of South Texas-HOAST - San Antonio
  • Texas Oncology-Plano East
  • Community Cancer Trials of Utah
  • Wellmonth Physician Services
  • Virginia Cancer Institute
  • Providence St. Mary Regional Cancer Center
  • West Virginia University Hospitals Inc
  • Green Bay Oncology/St. Mary?s Hospital
  • Marshfield Clinic
  • Centro Medico San Roque
  • Isis Centro Especializado de Luces; Oncology
  • Lismore Base Hospital; Cancer Care & Haematology Unit
  • Mater Misericordiae Hospital; Chemotherapy Cottage
  • Newcastle Mater Misericordiae Hospital; Oncology
  • Westmead Hospital; Medical Oncology and Pallative Care
  • Wesley Medical Centre; Clinic For Haematology and Oncology
  • Mater Hospital; Oncology
  • Royal Adelaide Hospital; Oncology
  • Royal Hobart Hospital; Medical Oncology
  • Monash Medical Centre; Oncology
  • Geelong Hospital; Andrew Love Cancer Centre
  • Austin Hospital; Medical Oncology
  • Peter Maccallum Cancer Institute; Medical Oncology
  • Sir Charles Gairdner Hospital; Medical Oncology
  • Lkh-Univ. Klinikum Graz; Klinik Für Innere Medizin I
  • Tiroler Landeskrankenanstalten Ges.M.B.H.; Abt. Für Gynäkologie
  • Ordensklinikum Linz Barmherzige Schwestern; Abt. fur Innere Medizin 1
  • Lhk Feldkirch; Interne Medizin Abt.
  • Lkh Salzburg - Univ. Klinikum Salzburg; Iii. Medizinische Abt.
  • A. Ö. Krankenhaus Der Barmherzigen Brüder; Interne Abt.
  • Lkh Vöcklabruck; I. Abt. Für Innere Medizin
  • Klinikum Kreuzschwestern Wels; Iii. Interne Abt.
  • Medizinische Universität Wien; Univ.Klinik für Frauenheilkunde - Klinik für Gynäkologie
  • Medizinische Universität Wien; Univ.Klinik für Innere Medizin I - Abt. für Onkologie
  • Krankenhaus Der Stadt Wien-Hietzing; Abt. Für Gynäkologie U. Geburtshilfe
  • Institut Jules Bordet
  • GHdC Site Notre Dame
  • UZ Antwerpen
  • Jessa Zkh (Campus Virga Jesse)
  • AZ Groeninge
  • UZ Leuven Gasthuisberg
  • CHU Sart-Tilman
  • Clinique Ste-Elisabeth
  • Sint Augustinus Wilrijk
  • UMHAT Tsaritsa Yoanna - ISUL; Clinic of Oncotherapy
  • SHATO - Sofia
  • SHATOD Dr. Marko Antonov Markov-Varna, EOOD
  • Tom Baker Cancer Centre; Dept of Medicine
  • Cross Can Inst
  • BC Cancer Agency, CSI
  • BC Cancer ? Surrey
  • BCCA-Vancouver Cancer Centre
  • Bcca - Vancouver Island Cancer Centre; Oncology
  • CancerCare Manitoba; Neuro-Oncology
  • Atlantic Health Science Corporation; Saint John Regional Hospital Facility
  • Queen Elizabeth II Health Sciences Centre; Oncology
  • Hamilton Health Sciences - Juravinski Cancer Centre
  • Cancer Centre of Southeastern Ontario; Kingston General Hospital
  • London Health Sciences Centre
  • Credit Valley Hospital/Carlo Fidani Peel Regional Cancer Centre
  • Southlake Regional Health Center
  • Ottawa Regional Cancer Centre
  • Niagara Health Systems - St. Catherines General Site; Niagara Health System-St. Catharines Site
  • Northeastern Ontario; Regional Cancer Centre
  • Sunnybrook Odette Cancer Centre
  • Mount Sinai Hospital
  • Princess Margaret Cancer Center
  • Hopital Maisonneuve- Rosemont; Oncology
  • Chum Hopital Notre Dame; Centre D'Oncologie
  • Hopital Sacre-Coeur Research Centre
  • Hopital du Saint Sacrement
  • Allan Blair Cancer Centre
  • INTOP
  • Fundacion Arturo Lopez Perez
  • Cancer Hospital Chinese Academy of Medical Sciences.
  • The Affiliated Hospital of Military Medical Sciences(The 307th Hospital of Chinese PLA)
  • the First Hospital of Jilin University
  • Jilin Cancer Hospital
  • Hu Nan Provincial Cancer Hospital
  • Sichuan Provincial People's Hospital
  • Fujian Medical University Union Hospital
  • The 900th Hospital of PLA joint service support force
  • Sun Yet-sen University Cancer Center
  • Guangdong General Hospital
  • The First Affiliated Hospital of College of Medicine, Zhejiang University
  • Harbin Medical University Cancer Hospital
  • The 1st Affiliated Hospital of Nanchang Unversity
  • Fudan University Shanghai Cancer Center
  • Shanghai Jiao Tong University School of Medicine (SJTUSM) - Ruijin Hospital (GuangCi Hospital)
  • Shanghai First People's Hospital
  • Changhai Hospital of Shanghai
  • Hebei Medical University Fourth Hospital;(Tumor Hospital of Hebei Province)
  • Xiehe Hospital, Tongji Medical College Huazhong University of Science & Technology
  • Tongji Hosp, Tongji Med. Col, Huazhong Univ. of Sci. & Tech
  • Hubei Cancer Hospital
  • Inst. Nacional de Cancerologia; Clinica de Seno
  • Fundacion Cardioinfantil
  • Hospital Pablo Tobon Uribe
  • Oncomedica S.A.
  • Uni Hospital Split; Oncology & Radiotherapy
  • General Hospital Varazdin
  • Clinical Hospital Centre Zagreb
  • Masarykuv onkologicky ustav
  • Fakultni Nemocnice Hradec Kralove; Dept of Radiotherapy & Oncology
  • Fakultni nemocnice Olomouc; Onkologicka klinika
  • MULTISCAN, s.r.o., Radiologicke centrum Pardubice
  • Aalborg Universitetshospital; Klinik Kirurgi-Kræft, Onkologisk afd.
  • Sydvestjysk Sygehus Esbjerg; Onkologisk afdeling
  • Herlev Hospital; Afdeling for Kræftbehandling
  • Nordsjællands Hospital, Hillerød, Onkologisk Afdeling
  • Rigshospitalet; Onkologisk Klinik
  • Sjællands Universitetshospital, Næstved; Onkologisk Afdeling
  • Odense Universitetshospital, Onkologisk Afdeling R
  • Sygehus Syd Roskilde; Onkologisk/haematologisk ambulatorium
  • Vejle Sygehus; Onkologisk Afdeling
  • Hospital Oncologia; Oncology
  • Hospital Diagnostico Escalón
  • Clinique De L Europe; Pmsi
  • ICO Paul Papin; Oncologie Medicale.
  • HOP Prive Arras Les Bonnettes; Chimiotherapie
  • Institut Sainte Catherine
  • ICONE
  • Institut Bergonie; Oncologie
  • Polyclinique Bordeaux Nord
  • Hopital Augustin Morvan; Federation De Cancerologie
  • Centre Francois Baclesse; Recherche Clinique
  • Centre Jean Perrin; Hopital De Jour
  • Centre Leonard De Vinci;Chimiotherapie
  • Centre Georges-François Lecler; Ctr de Lutte Contre le Canc
  • Institut Daniel Hollard
  • Centre Hospitalier Departemental Les Oudairies
  • Clinique des Ormeaux; Oncologie
  • Centre Oscar Lambret; Cancerologie Gynecologique
  • Hopital Dupuytren; Oncologie Medicale
  • Centre Leon Berard; Departement Oncologie Medicale
  • Institut Paoli Calmettes; Oncologie Medicale
  • Institut régional du Cancer Montpellier
  • Polyclinique De Gentilly; Hemodialyse
  • Centre Antoine Lacassagne; Hopital De Jour A2
  • Institut de cancerologie du Gard
  • Institut Curie; Oncologie Medicale
  • Ch Pitie Salpetriere; Cmrr Ile De France Salpetriere
  • Polyclinique Francheville; MED CHIMIOTHERAPIE RADIOTHERAPIE
  • Clinique Armoricaine Radiologie; Hopital de Jour
  • Chu De Poitiers; Chu La Miletrie
  • Institut Jean Godinot; Hopital De Jour
  • Centre Eugene Marquis; Unite Huguenin
  • Centre Henri Becquerel; Oncologie Medicale
  • Ico Rene Gauducheau; Oncologie
  • ICL; Hematologie
  • Centre Rene Huguenin; CONSULT SPECIALISEES
  • Institut d'oncologie de l'Orangerie; Chimiotherapie
  • Hopital Hautepierre; Hematologie Oncologie
  • Institut Claudius Regaud; Departement Oncologie Medicale
  • Clinique Pasteur; Pneumologie
  • Centre Alexis Vautrin; Oncologie Medicale
  • Institut Gustave Roussy; Oncologie Medicale
  • Gesundheitszentrum St. Marien GmbH; Med. II, Hämatologie/Onkologie
  • Hochwaldkrankenhaus
  • Evang. Krankenhaus Frauenklinik
  • Praxisklinik Krebsheilkunde für Frauen / Brustzentrum (Dres. Kittel/Klare)
  • Praxis Dr. Schoenegg
  • HELIOS Klinikum Berlin-Buch; Klinik für Gynäkologie und Geburtshilfe
  • Frauenarzt-Zentrum Zehlendorf an der Teltower Eiche
  • Onkologische Schwerpunktpraxis Bielefeld; Haemotologie & Internistische onkologie
  • Universitätsklinikum Bonn; Zentrum für Geburtshilfe und Frauenheilkunde
  • Praxis Dr. Ralf Lorenz
  • Hämato-Onkologie im Medicum/Home
  • Klinikum Sindelfingen-Böblingen; Frauenklinik
  • Klinikum Chemnitz gGmbH; Frauen- und Kinderklinik
  • DONAU ISAR Klinikum Deggendorf; Frauenklinik
  • St. Johannes-Hospital
  • Universitätsklinikum "Carl Gustav Carus"; Frauenheilkunde und Geburtshilfe
  • Universitätsklinikum Düsseldorf; Frauenklinik
  • Luisenkrankenhaus GmbH & Co. KG., Brustzentrum
  • Praxis für Hamatologie und Onkologie
  • Universitätsklinikum Erlangen; Frauenklinik
  • Klinikum Esslingen; Klinik für Frauenheilkunde und Geburtshilfe
  • Hämatologisch-Onkologische Gemeinschaftspraxis am Bethanien-Krankenhaus
  • Klinik Johann Wolfgang von Goethe Uni; Klinik für Frauenheilkunde und Geburtshilfe
  • Städtische Kliniken Frankfurt am Main Höchst
  • Praxis für Interdisziplinäre Onkologie und Hämatologie GbR
  • Dres.Jochen Wilke und Harald Wagner
  • Universitätsklinikum Greifswald; Klinik für Frauenheilkunde und Brustzentrum
  • Universitätsklinikum Halle (Saale); Universitätsklinik Und Poliklinik Für Gynäkologie
  • Universitätsklinikum Hamburg-Eppendorf; Frauenklinik
  • SANA Klinikum Hameln-Pyrmont; Frauenklinik / Brustzentrum
  • Gynaekologisch-Onkologische Schwerpunktpraxis Prof. Dr. med. Lueck, Dr. Schrader und Dr. Noeding
  • Diakovere Henriettenstift, Frauenklinik
  • Nationales Centrum für Tumorerkrankungen (NCT) ; Gyn. Onk. Frauenklinik; Uniklinikum Heidelberg
  • Praxisgemeinschaft; Frauenärzte am Bahnhofsplatz
  • Universitätsklinikum des Saarlandes; Klinik f. Frauenheilkunden und Geburtshilfe
  • ViDia Christliche Kliniken Karlsruhe, Vincentius-Diakonissen-Kliniken gAG; Frauenklinik
  • Elisabeth-Krankenhaus Brustzentrum
  • Klinikum Kassel GmbH; Klinik für Frauenheilkunde und Geburtshilfe
  • UNI-Klinikum Campus Kiel Klinik für Gynäkologie und Geburtshilfe
  • St. Elisabeth Krankenhaus Köln GmbH; Gynäkologie und Geburtshilfe
  • Uniklinik Köln, Klinik und Poliklinik und Geburtshilfe; Brustzentrum Köln
  • Klinikum Landshut Frauenklinik
  • Sankt Elisabeth Krankenhaus; Gynaekology
  • Evangelisches Krankenhaus; Abt. Gynäkologie und Geburtshilfe
  • Universitätsklinikum Schleswig-Holstein / Campus Lübeck; Klinik für Frauenheilkunde und Geburtshilfe
  • Universitätsmedizin Mainz; Klinik u. Poliklinik f. Geburtshilfe u. Frauenheilkunde
  • Rotkreuzklinikum München; Frauenklinik
  • Brustzentrum Rhein-Ruhr Servicegesellschaft mbH
  • Klinikum der Universität München; Frauenklinik - Onkologie II
  • Klinikum rechts der Isar der TU München; Klinik und Poliklinik für Frauenheilkunde
  • Universitätsklinikum Münster; Klinik für Frauenheilkunde und Geburtshilfe
  • Sana Klinikum Offenbach GmbH; Klinik für Gynäkologie & Geburtshilfe
  • Medizinisches Versorgungszentrum am Klinikum Oldenburg GmbH
  • Hämatologisch/Onkologische Praxis Prof. Dr. Decker, Studienzentrum
  • Oncologianova GmbH
  • RoMed Klinikum Rosenheim; Klinik für Gynäkologie und Geburtshilfe
  • Universitätsfrauen- und Poliklinik am Klinikum Suedstadt
  • MVZ für Hämatologie, Onkologie, Strahlentherapie und Palliativmedizin -; Klinik Dr. Hancken
  • Klinikum Mutterhaus der Borromaeerinnen gGmbH; Haematologie/Onkologie
  • Universitätsklinik Tübingen; Frauenklinik
  • Universitätsklinikum Ulm Am Michelsberg; Frauenklinik
  • Dres. Arnd Nusch Naser Ali-Mohammad Kalhori und Werner Langer
  • Schwarzwald-Baar Klinikum Klinik für Frauenheilkunde und Geburtshilfe
  • St. Josefs-Hospital Wiesbaden GmbH; Klinik für Frauenheilkunde und Geburtshilfe
  • Marien-Hospital Witten; Frauenklinik Brustzentrum
  • Hämatologisch-Onkologische Schwerpunktpraxis Dres. Schlag & Schöttker
  • Grupo Angeles
  • Centro Oncológico Sixtino / Centro Oncológico SA
  • Queen Mary Hospital; Surgery
  • Queen Mary Hospital; Dept of Medicine
  • Semmelweis Egyetem Onkologiai Központ
  • Orszagos Onkologiai Intezet; B Belgyogyaszati Osztaly
  • Magyar Honvedseg Egeszsegugyi Kozpont; Fázis I-es Klinikai Farmakológiai Vizsgálóhely
  • Debreceni Egyetem, Klinikai Kozpont, Onkologiai Klinika
  • Petz Aladar Megyei Oktato Korhaz; Oncoradiologia
  • Békés Megyei Pándy Kálmán Kórház; Onkologiai tanszek
  • Bács-Kiskun Vármegyei Oktatókórház
  • Szegedi Tudomanyegyetem, AOK, Szent-Gyorgyi Albert Klinikai Kozpont, Onkoterapias Klinika
  • Veszprem Megyei Csolnoky; Ferenc Korhaz
  • Cork Uni Hospital; Oncology Dept
  • Mater Misericordiae Uni Hospital; Oncology
  • Beaumont Hospital; Cancer Clinical Trials Unit
  • St Vincent'S Uni Hospital; Medical Oncology
  • St. James Hospital; Oncology
  • Galway University Hospital; Clinical Trials Department
  • University Hospital Limerick - Oncology
  • Rambam Medical Center; Oncology
  • Rabin MC; Davidof Center - Oncology Institute
  • Chaim Sheba Medical Center; Oncology Dept
  • Kaplan Medical Center; Oncology Inst.
  • Sourasky / Ichilov Hospital; Oncology Department
  • Campus Universitario S.Venuta; Centro Oncologico T.Campanella
  • AORN'S.G.Moscati; Oncologia
  • IRCCS Istituto Nazionale Tumori Fondazione Pascale; Oncologia Medica A
  • Ist. Uni Federico Ii; Divisione Di Oncologia Medica - Dpt. Di Medicina Interna
  • Azienda Ospedaliero-Universitaria S.Orsola-Malpighi; Unità Operativa Oncologia Medica
  • Ospedale Ramazzini
  • Arcispedale Santa Maria Nuova; Oncologia
  • Irccs Centro Di Riferimento Oncologico (CRO); Dipartimento Di Oncologia Medica
  • Divisione Onc Med dell'Azienda
  • Ospedale Belcolle Di Viterbo; Oncologia
  • Ente Ospedaliero Ospedali Galliera; S.C. Oncologia Medica
  • Az. Osp. Uni Ria San Martino; Cliniche Uni Rie Convenzionate U.O. Oncologia Medical
  • IRCCS Istituto Nazionale Per La Ricerca Sul Cancro (IST); Oncologia Medica A
  • ASST DEGLI SPEDALI CIVILI DI BRESCIA; Oncologia Medica
  • ASST DI LECCO; Oncologia Medica
  • Irccs Istituto Europeo Di Oncologia (IEO); Ricerca Di Senologia Medica
  • Policlinico di Monza; Istituto di Oncologia
  • IRCCS Fondazione Maugeri; Oncologia Medica I
  • IRCCS Istituto Clinico Humanitas; Oncologia
  • Az. Osp. Di Busto P.O. Di Saronno; U.O. Di Oncologia Medica
  • Ospedale S. Croce Di Fano; Servizio Oncologia
  • Fondazione Del Piemonte Per L'oncologia Ircc Di Candiolo; Dipartimento Oncologico
  • Ospedale Antonio Perrino; Oncologia Medica
  • Nuovo Ospedale di Prato S. Stefano - Azienda USL Toscana Centro
  • Ospedale Di Bolzano; Dept. Di Oncologia
  • Azienda Ospedaliera Di Perugia Ospedale s. Maria Della Misericordia; Oncologia Medica
  • Azienda Ospedaliera S. Maria - Terni; Oncologia
  • Ospedale Mater Salutis; Dept of Oncology
  • Aichi Cancer Center Hospital, Breast Oncology
  • Chiba Cancer Center; Breast Surgical Oncology
  • National Cancer Center Hospital East
  • Natl Hosp Org Shikoku; Cancer Ctr, Surgery
  • National Hospital Organization Kyushu Cancer Center;Breast Oncology
  • Gunma University Hospital; Department of Thoracic and Visceral Organ Surgery
  • Hiroshima City Hiroshima Citizens Hospital; Breast Surgery
  • Iwate Med Univ School of Med; Surgery
  • Sagara Hospital; Breast Surgery
  • St. Marianna University School of Medicine Hospital, Breast and Endocrine Surgery
  • Tokai University Hospital, Breast Surgery
  • Kumamoto City Hospital, Breast and Endocrine Surgery
  • Kumamoto Shinto General Hospital; Breast Cancer Center
  • Kyoto University Hospital; Breast Surgery
  • Niigata Cancer Ctr Hospital; Breast Surgery
  • National Hospital Organization Osaka National Hospital; Breast Surgery
  • Osaka International Cancer Institute; Breast and Endocrine Surgery
  • Saitama Medical University International Medical Center; Breast Oncology
  • Saitama Cancer Center, Breast Oncology
  • Shizuoka Cancer Center; Breast Surgery
  • Shizuoka General Hospital; Breast Surgery
  • Jichi Medical School ; Surgery
  • National Cancer Center Hospital; Medical Oncology
  • Tokyo Metropolitan; Komagome Hospital, Surgery
  • The Cancer Inst. Hosp. of JFCR; Breast Oncology Center
  • Tokyo Medical Uni. Hospital; Breast Oncology
  • Seoul National University Bundang Hospital
  • Seoul National Uni Hospital; Dept. of Internal Medicine/Hematology/Oncology
  • Yonsei University Severance Hospital; Medical Oncology
  • Kyunghee University Hospital; Endocrinology
  • Samsung Medical Centre; Division of Hematology/Oncology
  • Korea University Anam Hospital; Oncology Haemotology
  • Centro Estatal de Oncología de Campeche
  • Fundacion Rodolfo Padilla Padilla A.C.
  • Núcleo de Especialidades Oncológicas
  • Hospital Angeles Metropolitano; Room 220
  • Hospital General de México; Unidad de Oncologia
  • Centro Universitario Contra El Cancer
  • Centro de Diagnóstico y Tratamiento Integral de Mama, Hospital San José Tec de Monterrey
  • Oaxaca Site Management Organization
  • Cancerologia de Queretaro; Oncologia
  • Médicos Especialistas en Cáncer SC
  • Centro Estatal De Cancerologia De Durango; Oncology
  • Centro Regional de Enfermedades Oncológicas, S.A.
  • Medisch Centrum Alkmaar
  • Amphia ziekenhuis, locatie langendijk
  • Reinier de Graaf Gasthuis
  • Academish Ziekenhuis Maastricht (Azm); Inwendige Geneeskunde
  • Isala Klinieken
  • Waikato Hospital; Dept of Medical Oncology
  • Palmerston North Hospital; Regional Cancer Treatment Service
  • The Panama Clinic
  • Centro Oncologico America
  • Clinica Anglo Americana - Centro de Investigacion Oncologia CAA
  • Instituto Nacional de Enfermedades Neoplasicas
  • Clinica El Golf
  • Clinica Peruana Americana
  • University Of Santo Tomas; Oncology; Benavides Cancer Institute
  • Rizal Medical Center
  • Veterans Memorial Medical Ctr; Cancer Research Centre
  • Bialostockie Ctr Onkologii; Oddzial Chemioterapii Dziennej
  • Centrum Onkologii;Im. Franciszka Lukaszczyka;Onkologii
  • Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii
  • Opolskie Centrum Onkologii;Oddzial Onkologii Klinicznej
  • Narodowy Inst.Onkologii im.Sklodowskiej-Curie Panstw.Inst.Bad; Klinika Nowtw.Piersi i Chir.Rekonstr
  • NZOZ Mazowiecki Szpital Onkologiczny Uczelni Warszawskiej im. M. Sk?odowskiej-Curie
  • Emergency University Bucharest Hospital; Oncology Department
  • Prof. Dr. I. Chiricuta Institute of Oncology
  • Oncology Inst. Cluj-Napoca; Cancer Dept
  • Euroclinic Center of Oncology SRL
  • S.I. Russian Oncological Research Center n.a. N.N. Blokhin
  • State Budget Institution of Healthcare of Stavropol region Pyatigorsk Oncology Dispensary
  • Clinical Oncology Dispensary of Ministry of Health of Tatarstan
  • SBI of Healthcare Samara Regional Clinical Oncology Dispensary
  • SBI of Healthcare of Stavropol region Stavropol Regional Clinical Oncology Dispensary
  • Tula Regional Oncology Dispensary
  • Institute of Oncology Ljubljana
  • National Hospital; Oncotherapy Dept
  • Wits Donald Gordon Clinical Trial Centre; Medical Oncology
  • Steve Biko Academic Hospital; Oncology
  • Hospital General Universitario de Elche; Servicio de Oncologia
  • Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia
  • Corporacio Sanitaria Parc Tauli; Servicio de Oncologia
  • Hospital Univ Vall d'Hebron; Servicio de Oncologia
  • Hospital Universitario Marques de Valdecilla; Servicio de Oncologia
  • Hospital Provincial de Castellon; Servicio de Oncologia
  • Hospital Universitario Reina Sofia; Servicio de Oncologia
  • IInstituto Oncologico de San Sebastian, Oncologikoa; Servicio de Oncologia
  • Hospital de Donostia; Servicio de Oncologia Medica
  • Hospital Universitario Son Espases
  • Hospital Son Llatzer; Servicio de Oncologia
  • Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Oncologia
  • Hospital Universitario de Canarias;servicio de Oncologia
  • Hospital del Mar; Servicio de Oncologia
  • Hospital Clínic i Provincial; Servicio de Hematología y Oncología
  • Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia
  • Hospital Duran i Reynals; Oncologia
  • Hospital Juan Ramon Jimenez;Servicio de Oncologia
  • Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico; Servicio de Oncologia
  • Complejo Hospitalario Universitario A Coruña (CHUAC, Materno Infantil), Oncología
  • Centro Oncológico Gallego José Antonio Quiroga y Piñeiro, Servicio de Oncologia
  • Hospital Universitari Arnau de Vilanova de Lleida; Servicio de Oncologia
  • Hospital General Universitario Gregorio Marañon; Servicio de Oncologia
  • Centro Oncologico MD Anderson Internacional; Servicio de Oncologia
  • Hospital Ramon y Cajal; Servicio de Oncologia
  • Hospital Universitario Clínico San Carlos; Servicio de Oncologia
  • Hospital Universitario 12 de Octubre; Servicio de Oncologia
  • Centro Integral Oncologico Clara Campal (CIOCC); Dirección Médica
  • Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia
  • Hospital General Universitario J.M Morales Meseguer; Servicio de Oncologia
  • Hospital Clinico Universitario de Salamanca; Servicio de Oncologia
  • Hospital Universitario Virgen Macarena; Servicio de Oncologia
  • Hospital Universitario Virgen del Rocio; Servicio de Oncologia
  • Hospital Univ. Nuestra Señora de Valme; Servicio de Oncologia
  • Complejo Hospitalario de Toledo- H. Virgen de la Salud; Servicio de Oncologia
  • Instituto Valenciano Oncologia; Oncologia Medica
  • Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia
  • Hospital Arnau de Vilanova (Valencia) Servicio de Oncologia
  • Hospital Universitario la Fe; Servicio de Oncologia
  • Hospital Universitario Miguel Servet; Servicio Oncologia
  • Sahlgrenska Universitetssjukhuset; Onkology
  • Uni Hospital Linkoeping; Dept. of Oncology
  • Karolinska University Hospital; Department of General Oncology
  • Norrlands Universitetssjukhus, Umeå, Cancercentrum; Dept of Oncology
  • Akademiska sjukhuset, Onkologkliniken
  • Universitaetsspital Basel; Onkologie
  • Hôpitaux Universit. de Genève Gynécologique - Oncologie; Gynécologie
  • Luzerner Kantonsspital; Medizinische Onkologie
  • Kantonsspital St. Gallen; Onkologie/Hämatologie
  • Brust-Zentrum Zürich AG Seefeldstrasse 214 Zürich
  • Changhua Christian Hospital; Dept of Surgery
  • Kaohsiung Medical Uni Chung-Ho Hospital; Dept of Surgery
  • Taichung Veterans General Hospital; Dept of Surgery
  • National Cheng Kung Uni Hospital; Surgery
  • VETERANS GENERAL HOSPITAL; Department of General Surgery
  • National Taiwan Uni Hospital; General Surgery
  • Tri-Service General Hospital, Division of General Surgery
  • Chiang Rai Prachanukraw Hospital; Department of Pediatrics, Faculty of Medicine
  • Lopburi Cancer Hospital; Chemotherpy Unit; Chemotherapy
  • Buddhachinaraj Phitsanulok Hospital; Chemotherapy Unit ; Department of Medicine
  • Songklanagarind Hospital; Department of Surgery
  • Surat Thani Hospital
  • Cherkassy Regional Oncological Hospital
  • State Medical Academy; Oncology
  • Ivano-Frankivsk Regional Oncology Center
  • Kyiv City Clinical Oncological Center, Day Hospital Department for Oncological patients
  • Volyn Regional Oncology Dispensary
  • Lvov State Regional Oncology Medical & Diagnostic Center
  • Ternopil State Medical Academy
  • Royal Berkshire Hospital; Berkshire Cancer Centre
  • Velindre Cancer Centre; Oncology Dept
  • Cheltenham General Hospital; Gloucestershire Oncology Centre
  • Colchester General Hospital
  • Royal Cornwall Hospital; Dept of Clinical Oncology
  • University Hospital coventry; Oncology Department
  • Western General Hospital; Edinburgh Breast Unit
  • Royal Devon & Exeter Hospital; Oncology Centre
  • Ipswich Hospital; Oncology Pharmacy
  • St James Uni Hospital; Icrf Cancer Medicine Research Unit
  • St. Bartholomew'S Hospital; Dept of Medical Oncology
  • UCL Hospital NHS Trust
  • Royal Marsden Hospital; Dept of Med-Onc
  • Christie Hospital; Breast Cancer Research Office
  • Mount Vernon Hospital; Centre For Cancer Treatment
  • Nottingham City Hospital; Oncology
  • Churchill Hospital; Oxford Cancer and Haematology Centre
  • Peterborough City Hospital, Edith Cavell Campus; Oncology Department
  • Queen Alexandra Hospital; Haematology and Oncology Centre
  • Royal Preston Hosp; Rosemere Cancer Ctr
  • Weston Park Hospital; Cancer Clinical Trials Centre
  • Uni Hospital of North Staffordshire; Staffordshire Oncology Centre
  • Royal Marsden Hosp NHS Fnd; Medicine - Breast Unit
  • The Clatterbridge Cancer Ctr For Oncolgy
  • New Cross Hospital; Deansley Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Pertuzumab + Trastuzumab + Chemotherapy

Placebo + Trastuzumab + Chemotherapy

Arm Description

Participants will receive pertuzumab (840 mg loading dose, then 420 mg) and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) intravenously (IV) every 3 weeks (Q3W) for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m^2 + epirubicin 90-120 mg/m^2 or doxorubicin 50 mg/m^2 + cyclophosphamide 500-600 mg/m^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m^2 for 3 cycles, 75 mg/m^2 in first cycle and 100 mg/m^2 in subsequent cycles, or 75 mg/m^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m^2 once weekly (QW); 2) 4 cycles (Q3W) of doxorubicin 60 mg/m^2 or epirubicin 90-120 mg/m^2 + cyclophosphamide 500-600 mg/m^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m^2 + carboplatin area under the curve (AUC) 6 (up to 900 mg).

Participants will receive placebo matching to pertuzumab IV Q3W and trastuzumab (8 milligrams per kilogram [mg/kg] loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 milligrams per square meter (mg/m^2) + epirubicin 90-120 mg/m^2 or doxorubicin 50 mg/m^2 + cyclophosphamide 500-600 mg/m^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m^2 for 3 cycles, 75 mg/m^2 in first cycle and 100 mg/m^2 in subsequent cycles, or 75 mg/m^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m^2 or epirubicin 90-120 mg/m^2 + cyclophosphamide 500-600 mg/m^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m^2 + carboplatin AUC 6 (up to 900 milligrams [mg]).

Outcomes

Primary Outcome Measures

Percentage of Participants With Invasive Disease-Free Survival (IDFS) Event (Excluding Second Primary Non-Breast Cancer [SPNBC]), as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings
Percentage of participants with IDFS events (excluding SPNBC) is reported. IDFS event was defined as the first occurrence of one of the following events: Ipsilateral invasive breast tumor recurrence (that is [i.e.], an invasive breast cancer involving the same breast parenchyma as the original primary lesion); ipsilateral local-regional invasive breast cancer recurrence (i.e., an invasive breast cancer in the axilla, regional lymph nodes, chest wall, and/or skin of the ipsilateral breast); distant recurrence (i.e., evidence of breast cancer in any anatomic site - other than the two above mentioned sites); death attributable to any cause; contralateral invasive breast cancer. All SPNBCs and in situ carcinomas (including ductal carcinoma in situ [DCIS] and lobular carcinoma in situ [LCIS]) and non-melanoma skin cancer were excluded as an event.
Kaplan-Meier Estimate of the Percentage of Participants Who Were IDFS Event-Free (Excluding SPNBC) at Year 3, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings
Kaplan-Meier estimate of the percentage of participants who were IDFS event-free (excluding SPNBC) at Year 3 is reported. IDFS event was defined as the first occurrence of one of the following events: Ipsilateral invasive breast tumor recurrence (i.e., an invasive breast cancer involving the same breast parenchyma as the original primary lesion); ipsilateral local-regional invasive breast cancer recurrence (i.e., an invasive breast cancer in the axilla, regional lymph nodes, chest wall, and/or skin of the ipsilateral breast); distant recurrence (i.e., evidence of breast cancer in any anatomic site - other than the two above mentioned sites); death attributable to any cause; contralateral invasive breast cancer. All SPNBCs and in situ carcinomas (including DCIS and LCIS) and non-melanoma skin cancer were excluded as an event.

Secondary Outcome Measures

Percentage of Participants With IDFS Event (Including SPNBC), as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings
Percentage of participants with IDFS events (including SPNBC) is reported. IDFS-SPNBC event was defined as the first occurrence of one of the following events: Ipsilateral invasive breast tumor recurrence (i.e., an invasive breast cancer involving the same breast parenchyma as the original primary lesion); ipsilateral local-regional invasive breast cancer recurrence (i.e., an invasive breast cancer in the axilla, regional lymph nodes, chest wall, and/or skin of the ipsilateral breast); distant recurrence (i.e., evidence of breast cancer in any anatomic site - other than the two above mentioned sites); death attributable to any cause; contralateral invasive breast cancer; SPNBC (with the exception of non-melanoma skin cancers and in situ carcinoma of any site).
Kaplan-Meier Estimate of the Percentage of Participants Who Were IDFS Event-Free (Including SPNBC) at Year 3, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings
Kaplan-Meier estimate of the percentage of participants who were IDFS event-free (including SPNBC) at Year 3 is reported. IDFS-SPNBC was defined as the first occurrence of one of the following events: Ipsilateral invasive breast tumor recurrence (i.e., an invasive breast cancer involving the same breast parenchyma as the original primary lesion); ipsilateral local-regional invasive breast cancer recurrence (i.e., an invasive breast cancer in the axilla, regional lymph nodes, chest wall, and/or skin of the ipsilateral breast); distant recurrence (i.e., evidence of breast cancer in any anatomic site - other than the two above mentioned sites); death attributable to any cause; contralateral invasive breast cancer; SPNBC (with the exception of non-melanoma skin cancers and in situ carcinoma of any site).
Percentage of Participants With Disease-Free Survival (DFS) Event, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings
Percentage of participants with DFS event is reported. DFS event was defined as the first occurrence of one of the following events: Ipsilateral invasive breast tumor recurrence (i.e., an invasive breast cancer involving the same breast parenchyma as the original primary lesion); ipsilateral local-regional invasive breast cancer recurrence (i.e., an invasive breast cancer in the axilla, regional lymph nodes, chest wall, and/or skin of the ipsilateral breast); distant recurrence (i.e., evidence of breast cancer in any anatomic site - other than the two above mentioned sites); death attributable to any cause; contralateral invasive breast cancer; SPNBC or contralateral or ipsilateral DCIS.
Kaplan-Meier Estimate of the Percentage of Participants Who Were DFS Event-Free at Year 3, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings
Kaplan-Meier estimate of the percentage of participants who were DFS event-free at Year 3 is reported. DFS was defined as the first occurrence of one of the following events: Ipsilateral invasive breast tumor recurrence (i.e., an invasive breast cancer involving the same breast parenchyma as the original primary lesion); ipsilateral local-regional invasive breast cancer recurrence (i.e., an invasive breast cancer in the axilla, regional lymph nodes, chest wall, and/or skin of the ipsilateral breast); distant recurrence (i.e., evidence of breast cancer in any anatomic site - other than the two above mentioned sites); death attributable to any cause; contralateral invasive breast cancer; SPNBC or contralateral or ipsilateral DCIS.
Percentage of Participants Who Died
Percentage of participants who died due to any cause is reported.
Kaplan-Meier Estimate of the Percentage of Participants Who Were Alive at Year 3
The Kaplan-Meier approach was used to estimate the percentage of participants who were alive at 3 years.
Percentage of Participants With Recurrence-Free Interval (RFI) Event, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings
Percentage of participants with RFI event is reported. RFI event was defined as local, regional or distant breast cancer recurrence.
Kaplan-Meier Estimate of the Percentage of Participants Who Were RFI Event-Free at Year 3, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings
Kaplan-Meier estimate of the percentage of participants who were RFI event-free at Year 3 is reported. RFI event was defined as local, regional or distant breast cancer recurrence.
Percentage of Participants With Distant Recurrence-Free Interval (DRFI) Event, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings
Percentage of participants with DRFI event is reported. DRFI event was defined as distant breast cancer recurrence.
Kaplan-Meier Estimate of the Percentage of Participants Who Were DRFI Event-Free at Year 3, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings
Kaplan-Meier estimate of the percentage of participants who were DRFI event-free at Year 3 is reported. DRFI event was defined as distant breast cancer recurrence.
Percentage of Participants With Primary Cardiac Event
Primary cardiac event was defined as either: Heart Failure (New York Heart Association [NYHA] Class III or IV) and a drop in left ventricular ejection fraction (LVEF) of at least 10 ejection fraction (EF) points from baseline and to below 50 percent (%); or cardiac death. Cardiac death was defined as either definite cardiac death: due to heart failure, myocardial infarction, or documented primary arrhythmia; or probable cardiac death: sudden unexpected death within 24 hours of a definite or probable cardiac event (e.g., syncope, cardiac arrest, chest pain, infarction, arrhythmia) without documented etiology.
Percentage of Participants With Secondary Cardiac Event
Secondary cardiac event was defined as asymptomatic or mildly symptomatic (NYHA Class II) significant drop in LVEF (defined as an absolute decrease of at least 10 EF points from baseline and to below 50%), confirmed by a second LVEF assessment within approximately three weeks of the first significant LVEF assessment or confirmed by the Cardiac Advisory Board (CAB).
Change From Baseline in LVEF to Worst Post-Baseline Value
LVEF is the fraction of blood (in percent) pumped out of the heart's left ventricular chamber with each heart beat, and is a measure of cardiac output for the heart. Baseline LVEF value and the maximum absolute decrease (worst value) in LVEF measurement from baseline were reported. LVEF was measured by echocardiogram (ECHO) or multiple-gated acquisition (MUGA) scan.
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30) Global Health Status (GHS) Scale Score
EORTC QLQ-C30 is a cancer-specific instrument with 30 questions used to assess the overall quality of life (QOL) in cancer participants. First 28 questions used 4-point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much) for evaluating 5 functional scales (physical, role, social, cognitive, emotional), 8 symptom scales/items (diarrhea, fatigue, dyspnea, appetite loss, insomnia, nausea and vomiting [N/V], constipation, and pain) and a single item (financial difficulties). Last 2 questions represented participant's assessment of overall health and quality of life, used 7-point scale (1=very poor to 7=excellent). EORTC QLQ-C30 global scores were linearly transformed on a scale of 0 to 100, with a high score indicating better GHS/QOL. Negative change from Baseline values indicated deterioration in QOL or functioning and positive values indicated improvement.
Change From Baseline in EORTC QLQ-C30 Functioning Subscale Scores
EORTC QLQ-C30 is a cancer-specific instrument with 30 questions used to assess the overall QOL in cancer participants. First 28 questions used 4-point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much) for evaluating 5 functional scales (physical, role, social, cognitive, emotional), 8 symptom scales/items (diarrhea, fatigue, dyspnea, appetite loss, insomnia, N/V, constipation, and pain) and a single item (financial difficulties). Last 2 questions represented participant's assessment of overall health and quality of life, coded on 7-point scale (1=very poor to 7=excellent). EORTC QLQ-C30 functioning scores were linearly transformed on a scale of 0 to 100, with a high score indicating better functioning/support. Negative change from Baseline values indicated deterioration in functioning and positive values indicated improvement.
Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores
EORTC QLQ-C30 is a cancer-specific instrument with 30 questions used to assess the overall QOL in cancer participants. First 28 questions used 4-point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much) for evaluating 5 functional scales (physical, role, social, cognitive, emotional), 8 symptom scales/items (diarrhea, fatigue, dyspnea, appetite loss, insomnia, nausea and vomiting [N/V], constipation, and pain) and a single item (financial difficulties). Last 2 questions represented participant's assessment of overall health and quality of life, coded on 7-point scale (1=very poor to 7=excellent). EORTC QLQ-C30 disease/treatment-related symptom scores were linearly transformed on a scale of 0 to 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicated improvement in symptoms and positive values indicated worsening of symptoms.
Change From Baseline in EORTC QLQ-C30 Financial Difficulties Subscale Scores
EORTC QLQ-C30 is a cancer-specific instrument with 30 questions used to assess the overall QOL in cancer participants. First 28 questions used 4-point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much) for evaluating 5 functional scales (physical, role, social, cognitive, emotional), 8 symptom scales/items (diarrhea, fatigue, dyspnea, appetite loss, insomnia, N/V, constipation, and pain) and a single item (financial difficulties). Last 2 questions represented participant's assessment of overall health and quality of life, coded on 7-point scale (1=very poor to 7=excellent). EORTC QLQ-C30 financial difficulties scores were linearly transformed on a scale of 0 and 100, with a high score indicating a higher level of financial difficulties. Negative change from Baseline values indicated improvement in financial difficulties and positive values indicated worsening of financial difficulties.
Change From Baseline in European Organisation for Research and Treatment of Cancer - Breast Cancer Module Quality of Life (EORTC QLQ-BR23) Functional Scale Score
EORTC-QLQ-BR23 is a 23-item breast cancer-specific companion module to the EORTC-QLQ-C30 and consists of four functional scales (body image, sexual enjoyment, sexual functioning, future perspective [FP]) and four symptom scales (systemic side effects [SE], upset by hair loss, arm symptoms, breast symptoms). Questions used 4-point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Scores averaged and transformed to 0-100 scale. High score for functional scale indicated high/better level of functioning/healthy functioning. Negative change from Baseline indicated deterioration in QOL and positive change from Baseline indicated an improvement in QOL.
Change From Baseline in EORTC QLQ-BR23 Symptom Scale Score
EORTC-QLQ-BR23 is a 23-item breast cancer-specific companion module to the EORTC-QLQ-C30 and consists of four functional scales (body image, sexual enjoyment, sexual functioning, future perspective [FP]) and four symptom scales (systemic side effects [SE], upset by hair loss, arm symptoms, breast symptoms). Questions used 4-point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Scores averaged and transformed to 0-100 scale. High score for symptom scale indicated high level of symptomatology/problems/greater degree of symptoms. Negative change from Baseline indicated deterioration in QOL and positive change from Baseline indicated an improvement in QOL.
Percentage of Participants With Response for European Quality of Life-5 Dimensions-3 Level (EQ-5D-3L) Questionnaire: Mobility Domain
EQ-5D-3L is a descriptive system of health-related quality of life states consisting of 5 dimensions/domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and each of which has 3 levels of severity (no problems [scored as 1], some or moderate problems [scored as 2], and extreme problems [scored as 3]). Percentage of participants with each of the following responses in mobility domain was reported: I have no problems in walking about; I have some problems in walking about; and I am confined to bed. Response percentages may not add up to 100% due to data rounding.
Percentage of Participants With Response for EQ-5D-3L Questionnaire: Self-Care Domain
EQ-5D-3L is a descriptive system of health-related quality of life states consisting of 5 dimensions/domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and each of which has 3 levels of severity (no problems [scored as 1], some or moderate problems [scored as 2], and extreme problems [scored as 3]). Percentage of participants with each of the following responses in self-care domain was reported: I have no problems with self-care; I have some problems washing or dressing myself; and I am unable to wash or dress myself. Response percentages may not add up to 100% due to data rounding.
Percentage of Participants With Response for EQ-5D-3L Questionnaire: Usual Activities Domain
EQ-5D-3L is a descriptive system of health-related quality of life states consisting of 5 dimensions/domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and each of which has 3 levels of severity (no problems [scored as 1], some or moderate problems [scored as 2], and extreme problems [scored as 3]). Percentage of participants with each of the following responses in usual activities domain was reported: I have no problems with performing my usual activities; I have some problems with performing my usual activities; and I am unable to perform my usual activities. Response percentages may not add up to 100% due to data rounding.
Percentage of Participants With Response for EQ-5D-3L Questionnaire: Pain/Discomfort Domain
EQ-5D-3L is a descriptive system of health-related quality of life states consisting of 5 dimensions/domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and each of which has 3 levels of severity (no problems [scored as 1], some or moderate problems [scored as 2], and extreme problems [scored as 3]). Percentage of participants with each of the following responses in pain/discomfort domain was reported: I have no pain or discomfort; I have moderate pain or discomfort; and I have extreme pain or discomfort. Response percentages may not add up to 100% due to data rounding.
Percentage of Participants With Response for EQ-5D-3L Questionnaire: Anxiety/Depression Domain
EQ-5D-3L is a descriptive system of health-related quality of life states consisting of 5 dimensions/domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and each of which has 3 levels of severity (no problems [scored as 1], some or moderate problems [scored as 2], and extreme problems [scored as 3]). Percentage of participants with each of the following responses in anxiety/depression domain was reported: I am not anxious or depressed; I am moderately anxious or depressed; and I am extremely anxious or depressed. Response percentages may not add up to 100% due to data rounding.
Trough Serum Concentration (Cmin) of Pertuzumab
Cmin of Trastuzumab
Peak Serum Concentration (Cmax) of Pertuzumab
Cmax of Trastuzumab

Full Information

First Posted
May 20, 2011
Last Updated
October 3, 2023
Sponsor
Hoffmann-La Roche
Collaborators
Genentech, Inc., Breast International Group
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1. Study Identification

Unique Protocol Identification Number
NCT01358877
Brief Title
A Study of Pertuzumab in Addition to Chemotherapy and Trastuzumab as Adjuvant Therapy in Participants With Human Epidermal Growth Receptor 2 (HER2)-Positive Primary Breast Cancer
Acronym
APHINITY
Official Title
A Randomized Multicenter, Double-Blind, Placebo-Controlled Comparison of Chemotherapy Plus Trastuzumab Plus Placebo Versus Chemotherapy Plus Trastuzumab Plus Pertuzumab as Adjuvant Therapy in Patients With Operable HER2-Positive Primary Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 8, 2011 (Actual)
Primary Completion Date
December 19, 2016 (Actual)
Study Completion Date
November 30, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
Collaborators
Genentech, Inc., Breast International Group

4. Oversight

5. Study Description

Brief Summary
This randomized, double-blind, placebo-controlled, two-arm study will assess the safety and efficacy of pertuzumab in addition to chemotherapy plus trastuzumab as adjuvant therapy in participants with operable HER2-positive primary breast cancer. This study will be carried out in collaboration with the Breast International Group (BIG).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
4804 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pertuzumab + Trastuzumab + Chemotherapy
Arm Type
Experimental
Arm Description
Participants will receive pertuzumab (840 mg loading dose, then 420 mg) and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) intravenously (IV) every 3 weeks (Q3W) for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m^2 + epirubicin 90-120 mg/m^2 or doxorubicin 50 mg/m^2 + cyclophosphamide 500-600 mg/m^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m^2 for 3 cycles, 75 mg/m^2 in first cycle and 100 mg/m^2 in subsequent cycles, or 75 mg/m^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m^2 once weekly (QW); 2) 4 cycles (Q3W) of doxorubicin 60 mg/m^2 or epirubicin 90-120 mg/m^2 + cyclophosphamide 500-600 mg/m^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m^2 + carboplatin area under the curve (AUC) 6 (up to 900 mg).
Arm Title
Placebo + Trastuzumab + Chemotherapy
Arm Type
Placebo Comparator
Arm Description
Participants will receive placebo matching to pertuzumab IV Q3W and trastuzumab (8 milligrams per kilogram [mg/kg] loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 milligrams per square meter (mg/m^2) + epirubicin 90-120 mg/m^2 or doxorubicin 50 mg/m^2 + cyclophosphamide 500-600 mg/m^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m^2 for 3 cycles, 75 mg/m^2 in first cycle and 100 mg/m^2 in subsequent cycles, or 75 mg/m^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m^2 or epirubicin 90-120 mg/m^2 + cyclophosphamide 500-600 mg/m^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m^2 + carboplatin AUC 6 (up to 900 milligrams [mg]).
Intervention Type
Drug
Intervention Name(s)
5-Fluorouracil
Intervention Description
5-Fluorouracil will be administered as per the schedule specified in the respective arm.
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Intervention Description
Carboplatin will be administered as per the schedule specified in the respective arm.
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide
Intervention Description
Cyclophosphamide will be administered as per the schedule specified in the respective arm.
Intervention Type
Drug
Intervention Name(s)
Docetaxel
Intervention Description
Docetaxel will be administered as per the schedule specified in the respective arm.
Intervention Type
Drug
Intervention Name(s)
Doxorubicin
Intervention Description
Doxorubicin will be administered as per the schedule specified in the respective arm.
Intervention Type
Drug
Intervention Name(s)
Epirubicin
Intervention Description
Epirubicin will be administered as per the schedule specified in the respective arm.
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Intervention Description
Paclitaxel will be administered as per the schedule specified in the respective arm.
Intervention Type
Drug
Intervention Name(s)
Pertuzumab
Other Intervention Name(s)
Perjeta®
Intervention Description
Pertuzumab will be administered as per the schedule specified in the respective arm.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo will be administered as per the schedule specified in the respective arm.
Intervention Type
Drug
Intervention Name(s)
Trastuzumab
Other Intervention Name(s)
Herceptin®
Intervention Description
Trastuzumab will be administered as per the schedule specified in the respective arm.
Primary Outcome Measure Information:
Title
Percentage of Participants With Invasive Disease-Free Survival (IDFS) Event (Excluding Second Primary Non-Breast Cancer [SPNBC]), as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings
Description
Percentage of participants with IDFS events (excluding SPNBC) is reported. IDFS event was defined as the first occurrence of one of the following events: Ipsilateral invasive breast tumor recurrence (that is [i.e.], an invasive breast cancer involving the same breast parenchyma as the original primary lesion); ipsilateral local-regional invasive breast cancer recurrence (i.e., an invasive breast cancer in the axilla, regional lymph nodes, chest wall, and/or skin of the ipsilateral breast); distant recurrence (i.e., evidence of breast cancer in any anatomic site - other than the two above mentioned sites); death attributable to any cause; contralateral invasive breast cancer. All SPNBCs and in situ carcinomas (including ductal carcinoma in situ [DCIS] and lobular carcinoma in situ [LCIS]) and non-melanoma skin cancer were excluded as an event.
Time Frame
Randomization to the first occurrence of IDFS event (excluding SPNBC) (until data cut-off date 19 December 2016, up to maximum length of follow-up of 59 months)
Title
Kaplan-Meier Estimate of the Percentage of Participants Who Were IDFS Event-Free (Excluding SPNBC) at Year 3, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings
Description
Kaplan-Meier estimate of the percentage of participants who were IDFS event-free (excluding SPNBC) at Year 3 is reported. IDFS event was defined as the first occurrence of one of the following events: Ipsilateral invasive breast tumor recurrence (i.e., an invasive breast cancer involving the same breast parenchyma as the original primary lesion); ipsilateral local-regional invasive breast cancer recurrence (i.e., an invasive breast cancer in the axilla, regional lymph nodes, chest wall, and/or skin of the ipsilateral breast); distant recurrence (i.e., evidence of breast cancer in any anatomic site - other than the two above mentioned sites); death attributable to any cause; contralateral invasive breast cancer. All SPNBCs and in situ carcinomas (including DCIS and LCIS) and non-melanoma skin cancer were excluded as an event.
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Percentage of Participants With IDFS Event (Including SPNBC), as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings
Description
Percentage of participants with IDFS events (including SPNBC) is reported. IDFS-SPNBC event was defined as the first occurrence of one of the following events: Ipsilateral invasive breast tumor recurrence (i.e., an invasive breast cancer involving the same breast parenchyma as the original primary lesion); ipsilateral local-regional invasive breast cancer recurrence (i.e., an invasive breast cancer in the axilla, regional lymph nodes, chest wall, and/or skin of the ipsilateral breast); distant recurrence (i.e., evidence of breast cancer in any anatomic site - other than the two above mentioned sites); death attributable to any cause; contralateral invasive breast cancer; SPNBC (with the exception of non-melanoma skin cancers and in situ carcinoma of any site).
Time Frame
Randomization to the first occurrence of IDFS event (including SPNBC) (until data cut-off date 19 December 2016, up to maximum length of follow-up of 59 months)
Title
Kaplan-Meier Estimate of the Percentage of Participants Who Were IDFS Event-Free (Including SPNBC) at Year 3, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings
Description
Kaplan-Meier estimate of the percentage of participants who were IDFS event-free (including SPNBC) at Year 3 is reported. IDFS-SPNBC was defined as the first occurrence of one of the following events: Ipsilateral invasive breast tumor recurrence (i.e., an invasive breast cancer involving the same breast parenchyma as the original primary lesion); ipsilateral local-regional invasive breast cancer recurrence (i.e., an invasive breast cancer in the axilla, regional lymph nodes, chest wall, and/or skin of the ipsilateral breast); distant recurrence (i.e., evidence of breast cancer in any anatomic site - other than the two above mentioned sites); death attributable to any cause; contralateral invasive breast cancer; SPNBC (with the exception of non-melanoma skin cancers and in situ carcinoma of any site).
Time Frame
3 years
Title
Percentage of Participants With Disease-Free Survival (DFS) Event, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings
Description
Percentage of participants with DFS event is reported. DFS event was defined as the first occurrence of one of the following events: Ipsilateral invasive breast tumor recurrence (i.e., an invasive breast cancer involving the same breast parenchyma as the original primary lesion); ipsilateral local-regional invasive breast cancer recurrence (i.e., an invasive breast cancer in the axilla, regional lymph nodes, chest wall, and/or skin of the ipsilateral breast); distant recurrence (i.e., evidence of breast cancer in any anatomic site - other than the two above mentioned sites); death attributable to any cause; contralateral invasive breast cancer; SPNBC or contralateral or ipsilateral DCIS.
Time Frame
Randomization to the first occurrence of DFS event (until data cut-off date 19 December 2016, up to maximum length of follow-up of 59 months)
Title
Kaplan-Meier Estimate of the Percentage of Participants Who Were DFS Event-Free at Year 3, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings
Description
Kaplan-Meier estimate of the percentage of participants who were DFS event-free at Year 3 is reported. DFS was defined as the first occurrence of one of the following events: Ipsilateral invasive breast tumor recurrence (i.e., an invasive breast cancer involving the same breast parenchyma as the original primary lesion); ipsilateral local-regional invasive breast cancer recurrence (i.e., an invasive breast cancer in the axilla, regional lymph nodes, chest wall, and/or skin of the ipsilateral breast); distant recurrence (i.e., evidence of breast cancer in any anatomic site - other than the two above mentioned sites); death attributable to any cause; contralateral invasive breast cancer; SPNBC or contralateral or ipsilateral DCIS.
Time Frame
3 years
Title
Percentage of Participants Who Died
Description
Percentage of participants who died due to any cause is reported.
Time Frame
Randomization until death due to any cause (until data cut-off date 19 December 2016, up to maximum length of follow-up of 59 months)
Title
Kaplan-Meier Estimate of the Percentage of Participants Who Were Alive at Year 3
Description
The Kaplan-Meier approach was used to estimate the percentage of participants who were alive at 3 years.
Time Frame
3 years
Title
Percentage of Participants With Recurrence-Free Interval (RFI) Event, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings
Description
Percentage of participants with RFI event is reported. RFI event was defined as local, regional or distant breast cancer recurrence.
Time Frame
Randomization until local, regional or distant breast cancer recurrence (until data cut-off date 19 December 2016, up to maximum length of follow-up of 59 months)
Title
Kaplan-Meier Estimate of the Percentage of Participants Who Were RFI Event-Free at Year 3, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings
Description
Kaplan-Meier estimate of the percentage of participants who were RFI event-free at Year 3 is reported. RFI event was defined as local, regional or distant breast cancer recurrence.
Time Frame
3 years
Title
Percentage of Participants With Distant Recurrence-Free Interval (DRFI) Event, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings
Description
Percentage of participants with DRFI event is reported. DRFI event was defined as distant breast cancer recurrence.
Time Frame
Randomization until distant breast cancer recurrence (until data cut-off date 19 December 2016, up to maximum length of follow-up of 59 months)
Title
Kaplan-Meier Estimate of the Percentage of Participants Who Were DRFI Event-Free at Year 3, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings
Description
Kaplan-Meier estimate of the percentage of participants who were DRFI event-free at Year 3 is reported. DRFI event was defined as distant breast cancer recurrence.
Time Frame
3 years
Title
Percentage of Participants With Primary Cardiac Event
Description
Primary cardiac event was defined as either: Heart Failure (New York Heart Association [NYHA] Class III or IV) and a drop in left ventricular ejection fraction (LVEF) of at least 10 ejection fraction (EF) points from baseline and to below 50 percent (%); or cardiac death. Cardiac death was defined as either definite cardiac death: due to heart failure, myocardial infarction, or documented primary arrhythmia; or probable cardiac death: sudden unexpected death within 24 hours of a definite or probable cardiac event (e.g., syncope, cardiac arrest, chest pain, infarction, arrhythmia) without documented etiology.
Time Frame
Baseline until data cut-off date 19 December 2016 (up to maximum length of follow-up of 59 months)
Title
Percentage of Participants With Secondary Cardiac Event
Description
Secondary cardiac event was defined as asymptomatic or mildly symptomatic (NYHA Class II) significant drop in LVEF (defined as an absolute decrease of at least 10 EF points from baseline and to below 50%), confirmed by a second LVEF assessment within approximately three weeks of the first significant LVEF assessment or confirmed by the Cardiac Advisory Board (CAB).
Time Frame
Baseline until data cut-off date 19 December 2016 (up to maximum length of follow-up of 59 months)
Title
Change From Baseline in LVEF to Worst Post-Baseline Value
Description
LVEF is the fraction of blood (in percent) pumped out of the heart's left ventricular chamber with each heart beat, and is a measure of cardiac output for the heart. Baseline LVEF value and the maximum absolute decrease (worst value) in LVEF measurement from baseline were reported. LVEF was measured by echocardiogram (ECHO) or multiple-gated acquisition (MUGA) scan.
Time Frame
Baseline until data cut-off date 19 December 2016 (up to maximum length of follow-up of 59 months)
Title
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30) Global Health Status (GHS) Scale Score
Description
EORTC QLQ-C30 is a cancer-specific instrument with 30 questions used to assess the overall quality of life (QOL) in cancer participants. First 28 questions used 4-point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much) for evaluating 5 functional scales (physical, role, social, cognitive, emotional), 8 symptom scales/items (diarrhea, fatigue, dyspnea, appetite loss, insomnia, nausea and vomiting [N/V], constipation, and pain) and a single item (financial difficulties). Last 2 questions represented participant's assessment of overall health and quality of life, used 7-point scale (1=very poor to 7=excellent). EORTC QLQ-C30 global scores were linearly transformed on a scale of 0 to 100, with a high score indicating better GHS/QOL. Negative change from Baseline values indicated deterioration in QOL or functioning and positive values indicated improvement.
Time Frame
Baseline, Weeks 13, 25; end of treatment (EOT, 28 days after the last dose, up to Week 56); Follow-up (FU) Months 18, 24, 36
Title
Change From Baseline in EORTC QLQ-C30 Functioning Subscale Scores
Description
EORTC QLQ-C30 is a cancer-specific instrument with 30 questions used to assess the overall QOL in cancer participants. First 28 questions used 4-point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much) for evaluating 5 functional scales (physical, role, social, cognitive, emotional), 8 symptom scales/items (diarrhea, fatigue, dyspnea, appetite loss, insomnia, N/V, constipation, and pain) and a single item (financial difficulties). Last 2 questions represented participant's assessment of overall health and quality of life, coded on 7-point scale (1=very poor to 7=excellent). EORTC QLQ-C30 functioning scores were linearly transformed on a scale of 0 to 100, with a high score indicating better functioning/support. Negative change from Baseline values indicated deterioration in functioning and positive values indicated improvement.
Time Frame
Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36
Title
Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores
Description
EORTC QLQ-C30 is a cancer-specific instrument with 30 questions used to assess the overall QOL in cancer participants. First 28 questions used 4-point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much) for evaluating 5 functional scales (physical, role, social, cognitive, emotional), 8 symptom scales/items (diarrhea, fatigue, dyspnea, appetite loss, insomnia, nausea and vomiting [N/V], constipation, and pain) and a single item (financial difficulties). Last 2 questions represented participant's assessment of overall health and quality of life, coded on 7-point scale (1=very poor to 7=excellent). EORTC QLQ-C30 disease/treatment-related symptom scores were linearly transformed on a scale of 0 to 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicated improvement in symptoms and positive values indicated worsening of symptoms.
Time Frame
Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36
Title
Change From Baseline in EORTC QLQ-C30 Financial Difficulties Subscale Scores
Description
EORTC QLQ-C30 is a cancer-specific instrument with 30 questions used to assess the overall QOL in cancer participants. First 28 questions used 4-point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much) for evaluating 5 functional scales (physical, role, social, cognitive, emotional), 8 symptom scales/items (diarrhea, fatigue, dyspnea, appetite loss, insomnia, N/V, constipation, and pain) and a single item (financial difficulties). Last 2 questions represented participant's assessment of overall health and quality of life, coded on 7-point scale (1=very poor to 7=excellent). EORTC QLQ-C30 financial difficulties scores were linearly transformed on a scale of 0 and 100, with a high score indicating a higher level of financial difficulties. Negative change from Baseline values indicated improvement in financial difficulties and positive values indicated worsening of financial difficulties.
Time Frame
Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36
Title
Change From Baseline in European Organisation for Research and Treatment of Cancer - Breast Cancer Module Quality of Life (EORTC QLQ-BR23) Functional Scale Score
Description
EORTC-QLQ-BR23 is a 23-item breast cancer-specific companion module to the EORTC-QLQ-C30 and consists of four functional scales (body image, sexual enjoyment, sexual functioning, future perspective [FP]) and four symptom scales (systemic side effects [SE], upset by hair loss, arm symptoms, breast symptoms). Questions used 4-point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Scores averaged and transformed to 0-100 scale. High score for functional scale indicated high/better level of functioning/healthy functioning. Negative change from Baseline indicated deterioration in QOL and positive change from Baseline indicated an improvement in QOL.
Time Frame
Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36
Title
Change From Baseline in EORTC QLQ-BR23 Symptom Scale Score
Description
EORTC-QLQ-BR23 is a 23-item breast cancer-specific companion module to the EORTC-QLQ-C30 and consists of four functional scales (body image, sexual enjoyment, sexual functioning, future perspective [FP]) and four symptom scales (systemic side effects [SE], upset by hair loss, arm symptoms, breast symptoms). Questions used 4-point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Scores averaged and transformed to 0-100 scale. High score for symptom scale indicated high level of symptomatology/problems/greater degree of symptoms. Negative change from Baseline indicated deterioration in QOL and positive change from Baseline indicated an improvement in QOL.
Time Frame
Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36
Title
Percentage of Participants With Response for European Quality of Life-5 Dimensions-3 Level (EQ-5D-3L) Questionnaire: Mobility Domain
Description
EQ-5D-3L is a descriptive system of health-related quality of life states consisting of 5 dimensions/domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and each of which has 3 levels of severity (no problems [scored as 1], some or moderate problems [scored as 2], and extreme problems [scored as 3]). Percentage of participants with each of the following responses in mobility domain was reported: I have no problems in walking about; I have some problems in walking about; and I am confined to bed. Response percentages may not add up to 100% due to data rounding.
Time Frame
Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36
Title
Percentage of Participants With Response for EQ-5D-3L Questionnaire: Self-Care Domain
Description
EQ-5D-3L is a descriptive system of health-related quality of life states consisting of 5 dimensions/domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and each of which has 3 levels of severity (no problems [scored as 1], some or moderate problems [scored as 2], and extreme problems [scored as 3]). Percentage of participants with each of the following responses in self-care domain was reported: I have no problems with self-care; I have some problems washing or dressing myself; and I am unable to wash or dress myself. Response percentages may not add up to 100% due to data rounding.
Time Frame
Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36
Title
Percentage of Participants With Response for EQ-5D-3L Questionnaire: Usual Activities Domain
Description
EQ-5D-3L is a descriptive system of health-related quality of life states consisting of 5 dimensions/domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and each of which has 3 levels of severity (no problems [scored as 1], some or moderate problems [scored as 2], and extreme problems [scored as 3]). Percentage of participants with each of the following responses in usual activities domain was reported: I have no problems with performing my usual activities; I have some problems with performing my usual activities; and I am unable to perform my usual activities. Response percentages may not add up to 100% due to data rounding.
Time Frame
Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36
Title
Percentage of Participants With Response for EQ-5D-3L Questionnaire: Pain/Discomfort Domain
Description
EQ-5D-3L is a descriptive system of health-related quality of life states consisting of 5 dimensions/domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and each of which has 3 levels of severity (no problems [scored as 1], some or moderate problems [scored as 2], and extreme problems [scored as 3]). Percentage of participants with each of the following responses in pain/discomfort domain was reported: I have no pain or discomfort; I have moderate pain or discomfort; and I have extreme pain or discomfort. Response percentages may not add up to 100% due to data rounding.
Time Frame
Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36
Title
Percentage of Participants With Response for EQ-5D-3L Questionnaire: Anxiety/Depression Domain
Description
EQ-5D-3L is a descriptive system of health-related quality of life states consisting of 5 dimensions/domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and each of which has 3 levels of severity (no problems [scored as 1], some or moderate problems [scored as 2], and extreme problems [scored as 3]). Percentage of participants with each of the following responses in anxiety/depression domain was reported: I am not anxious or depressed; I am moderately anxious or depressed; and I am extremely anxious or depressed. Response percentages may not add up to 100% due to data rounding.
Time Frame
Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36
Title
Trough Serum Concentration (Cmin) of Pertuzumab
Time Frame
Cycles 1, 10 and 15 (Cycle length=21 days)
Title
Cmin of Trastuzumab
Time Frame
Cycles 1, 10 and 15 (Cycle length=21 days)
Title
Peak Serum Concentration (Cmax) of Pertuzumab
Time Frame
Cycles 1, 10 and 15 (Cycle length=21 days)
Title
Cmax of Trastuzumab
Time Frame
Cycles 1, 10 and 15 (Cycle length=21 days)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Non-metastatic operable primary invasive HER2-positive carcinoma of the breast that is histologically confirmed, and adequately excised Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to (</=) 1 Known hormone receptor status (estrogen receptor and progesterone receptor) The interval between definitive surgery for breast cancer and the first dose of chemotherapy must be no more than 8 weeks (56 days). The first cycle of chemotherapy must be administered within 7 days of randomization or on Day 56, whichever occurs first Baseline left ventricular ejection fraction (LVEF) greater than or equal to (>/=) 55 percent (%) measured by echocardiogram (ECHO) or Multiple-Gated Acquisition (MUGA) Scan Confirmed HER2 positive status Completion of all necessary baseline laboratory and radiologic investigations prior to randomization Women of childbearing potential and male participants with partners of childbearing potential must agree to use effective contraception (as defined by the protocol) by the participant and/or partner for the duration of the study treatment and for at least 7 months after the last dose of study drug Exclusion Criteria: History of any prior (ipsi- and/or contralateral) invasive breast cancer History of non-breast malignancies within the 5 years prior to study entry, except for carcinoma in situ of the cervix, carcinoma in situ of the colon, melanoma in situ, and basal cell and squamous cell carcinomas of the skin Any "clinical" T4 tumor as defined by primary tumor/regional lymph nodes/distant metastasis (TNM), including inflammatory breast cancer Any node-negative tumor Any previous systemic chemotherapy for cancer or radiotherapy for cancer Prior use of anti-HER2 therapy for any reason or other prior biologic or immunotherapy for cancer Concurrent anti-cancer treatment in another investigational trial Serious cardiac or cardiovascular disease or condition Other concurrent serious diseases that may interfere with planned treatment including severe pulmonary conditions/illness Abnormal laboratory tests immediately prior to randomization Pregnant or lactating women Sensitivity to any of the study medications or any of the ingredients or excipients of these medications
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
Facility Name
HonorHealth Research Institute ? Bisgrove
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85258
Country
United States
Facility Name
Providence Regional Medical Center
City
Everett
State/Province
California
ZIP/Postal Code
98208
Country
United States
Facility Name
Marin Cancer Care Inc
City
Greenbrae
State/Province
California
ZIP/Postal Code
94904
Country
United States
Facility Name
Kaiser Permanente - Hayward
City
Hayward
State/Province
California
ZIP/Postal Code
94545
Country
United States
Facility Name
UCSD Moores Cancer Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Kaiser Permanente - Oakland
City
Oakland
State/Province
California
ZIP/Postal Code
94611
Country
United States
Facility Name
Kaiser Permanente - Roseville
City
Roseville
State/Province
California
ZIP/Postal Code
95661
Country
United States
Facility Name
Sutter Cancer Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95816
Country
United States
Facility Name
Kaiser Permanente Sacramento Medical Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95825
Country
United States
Facility Name
Southern California Kaiser Permanente
City
San Diego
State/Province
California
ZIP/Postal Code
92108
Country
United States
Facility Name
K. Permanente - San Fransisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
K. Permanente - San Jose
City
San Jose
State/Province
California
ZIP/Postal Code
95119
Country
United States
Facility Name
K. Permanente - Santa Clara
City
Santa Clara
State/Province
California
ZIP/Postal Code
95051
Country
United States
Facility Name
K. Permanente - S. San Fran
City
South San Francisco
State/Province
California
ZIP/Postal Code
94080
Country
United States
Facility Name
Kaiser Permanente; Oncology Clinical Trials
City
Vallejo
State/Province
California
ZIP/Postal Code
94589
Country
United States
Facility Name
K. Permanente - Walnut Creek
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94596
Country
United States
Facility Name
Rocky Mountain Cancer Center - Denver
City
Littleton
State/Province
Colorado
ZIP/Postal Code
80120
Country
United States
Facility Name
Lutheran Hematology &Oncology
City
Wheat Ridge
State/Province
Colorado
ZIP/Postal Code
80033
Country
United States
Facility Name
Eastern Ct Hema/Onco Assoc; Dept of Oncology
City
Norwich
State/Province
Connecticut
ZIP/Postal Code
06360
Country
United States
Facility Name
Washington Cancer Institute at MedStar Washington Hospital Center.
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Georgetown U; Lombardi Comp Can
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20016-1468
Country
United States
Facility Name
Florida Cancer Specialists; SCRI
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33901
Country
United States
Facility Name
Memorial Cancer Institute
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Facility Name
Mayo Clinic-Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
Cancer Specialists; North Florida ;Jacksonville (AC Skinner Pkwy)
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
Ocala Oncology Center
City
Ocala
State/Province
Florida
ZIP/Postal Code
34471
Country
United States
Facility Name
Memorial Breast Cancer Center
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33028-1006
Country
United States
Facility Name
Hematology Oncology Associates of the Treasure Coast
City
Port Saint Lucie
State/Province
Florida
ZIP/Postal Code
34952
Country
United States
Facility Name
Florida Cancer Specialists; Saint Petersburg
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33719
Country
United States
Facility Name
Florida Cancer Specialists, Research Department
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33401
Country
United States
Facility Name
Phoebe Putney Memorial Hospital
City
Albany
State/Province
Georgia
ZIP/Postal Code
31701
Country
United States
Facility Name
Georgia Cancer Specialists
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30341
Country
United States
Facility Name
Northwest Georgia Oncology Centers PC - Marietta
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Kootenai Cancer Center
City
Post Falls
State/Province
Idaho
ZIP/Postal Code
83854
Country
United States
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Uni of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Ingalls Memorial Hospital
City
Harvey
State/Province
Illinois
ZIP/Postal Code
60426
Country
United States
Facility Name
Loyola University Med Center
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
Edward Cancer Center Naperville
City
Naperville
State/Province
Illinois
ZIP/Postal Code
60540
Country
United States
Facility Name
Illinois Cancer Care
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61615
Country
United States
Facility Name
Edward Cancer Center Plainfield
City
Plainfield
State/Province
Illinois
ZIP/Postal Code
60585
Country
United States
Facility Name
Quincy Medical Group; Canc Ctr at Blessing Hosp
City
Quincy
State/Province
Illinois
ZIP/Postal Code
62301
Country
United States
Facility Name
Carle Foundation
City
Urbana
State/Province
Illinois
ZIP/Postal Code
61801
Country
United States
Facility Name
University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Cancer Center of Kansas
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214-3728
Country
United States
Facility Name
Cancer Center of Acadiana at Lafayette General
City
Lafayette
State/Province
Louisiana
ZIP/Postal Code
70506
Country
United States
Facility Name
Cancer Care of Maine
City
Brewer
State/Province
Maine
ZIP/Postal Code
04412
Country
United States
Facility Name
New England Cancer Specialists
City
Scarborough
State/Province
Maine
ZIP/Postal Code
04074
Country
United States
Facility Name
Mercy Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21202
Country
United States
Facility Name
Weinberg CA Inst Franklin Sq
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21237
Country
United States
Facility Name
Maryland Oncology & Hematology, PA
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20817
Country
United States
Facility Name
Boston Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
Dana Farber Cancer Institute at Faulkner Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02130
Country
United States
Facility Name
Beth Israel Deac Med Ctr; East Campus Rsch Pharmacy
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Dana Farber Can Ins
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Massachusetts General Hospital.
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
2114
Country
United States
Facility Name
Berkshire Hematology, Oncology Pc
City
Pittsfield
State/Province
Massachusetts
ZIP/Postal Code
01201
Country
United States
Facility Name
Grand Rapids Clinical Oncology Program
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
West Michigan Cancer Center
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49007
Country
United States
Facility Name
Southdale Cancer Clinic
City
Edina
State/Province
Minnesota
ZIP/Postal Code
55414
Country
United States
Facility Name
Coborn Cancer Center
City
Saint Cloud
State/Province
Minnesota
ZIP/Postal Code
56303
Country
United States
Facility Name
Metro-Minnesota Community Oncology Research Consortium
City
Saint Louis Park
State/Province
Minnesota
ZIP/Postal Code
55416
Country
United States
Facility Name
Jackson Oncology Associates, PLLC
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39202
Country
United States
Facility Name
University of Missouri-Columbia; Ellis Fischel Cancer Center
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Heartland CCOP/Missouri Baptist Medical Center
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63131
Country
United States
Facility Name
Cancer Alliance of Nebraska
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68510
Country
United States
Facility Name
Cancer Alliance of Nebraska
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68106
Country
United States
Facility Name
Dartmouth Hitchcock Med Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
Saint Barnabas Medical Center
City
Livingston
State/Province
New Jersey
ZIP/Postal Code
07039
Country
United States
Facility Name
New York Oncology Hematology, P.C.
City
Albany
State/Province
New York
ZIP/Postal Code
12206
Country
United States
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
Roswell Park Cancer Inst.
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States
Facility Name
Mount Sinai Beth Israel Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
Mount Sinai Beth Israel Comprehensive Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10011
Country
United States
Facility Name
Mount Sinai West
City
New York
State/Province
New York
ZIP/Postal Code
10019
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
SUNY Upstate Medical University
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
University of North Carolina-Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Carolina Oncology Specialists, PA - Hickory
City
Hickory
State/Province
North Carolina
ZIP/Postal Code
28602
Country
United States
Facility Name
Dayton Clinical Oncology Prog
City
Centerville
State/Province
Ohio
ZIP/Postal Code
45459
Country
United States
Facility Name
Oncology Hematology Care Inc
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Facility Name
The Mark H. Zangmeister Ctr; Mid Ohio Onc/Hem Inc.
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43219
Country
United States
Facility Name
Toledo Clinic Cancer Center-Oregon
City
Oregon
State/Province
Ohio
ZIP/Postal Code
43616
Country
United States
Facility Name
Northwest Cancer Specialists - Portland (NE Hoyt St)
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
Facility Name
Abramson Cancer Center; Univ of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Albert Einstein Healthcare Network ; Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19141
Country
United States
Facility Name
Magee Womens Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Charleston Oncology, P .A
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29414
Country
United States
Facility Name
Roper Bon Secours St. Francis Cancer Center
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29414
Country
United States
Facility Name
South Carolina Oncology Associates - SCRI
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29210
Country
United States
Facility Name
Cancer Centers of the Carolina; Eastside Medical Center
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States
Facility Name
Sanford USD School of Medicine
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57104
Country
United States
Facility Name
Tennessee Oncology Chattanooga
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
Country
United States
Facility Name
Tennessee Onc., PLLC - SCRI
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Vanderbilt Breast Center at One Hundred Oaks
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37204
Country
United States
Facility Name
Texas Oncology-Medical City Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
Texas Oncology - Dallas Presbyterian Hospital
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Texas Oncology-Baylor Sammons Cancer Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Texas Oncology-El Paso Cancer Treatment Center Grandview
City
El Paso
State/Province
Texas
ZIP/Postal Code
79902
Country
United States
Facility Name
Texas Oncology, P.A. - Fort Worth
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
The Center for Cancer and Blood Disorders - Fort Worth
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Texas Oncology, P.A. - Garland
City
Garland
State/Province
Texas
ZIP/Postal Code
77060
Country
United States
Facility Name
Texas Oncology - Houston (Gessner)
City
Houston
State/Province
Texas
ZIP/Postal Code
77024
Country
United States
Facility Name
Texas Oncology-Tyler
City
Irving
State/Province
Texas
ZIP/Postal Code
75063
Country
United States
Facility Name
Cancer Care Centers of South Texas-HOAST - San Antonio
City
New Braunfels
State/Province
Texas
ZIP/Postal Code
78130
Country
United States
Facility Name
Texas Oncology-Plano East
City
Plano
State/Province
Texas
ZIP/Postal Code
75075-7787
Country
United States
Facility Name
Community Cancer Trials of Utah
City
Ogden
State/Province
Utah
ZIP/Postal Code
84405
Country
United States
Facility Name
Wellmonth Physician Services
City
Bristol
State/Province
Virginia
ZIP/Postal Code
24201
Country
United States
Facility Name
Virginia Cancer Institute
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23229
Country
United States
Facility Name
Providence St. Mary Regional Cancer Center
City
Walla Walla
State/Province
Washington
ZIP/Postal Code
99362
Country
United States
Facility Name
West Virginia University Hospitals Inc
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26056
Country
United States
Facility Name
Green Bay Oncology/St. Mary?s Hospital
City
Green Bay
State/Province
Wisconsin
ZIP/Postal Code
54301
Country
United States
Facility Name
Marshfield Clinic
City
Marshfield
State/Province
Wisconsin
ZIP/Postal Code
54449
Country
United States
Facility Name
Centro Medico San Roque
City
San Miguel de Tucuman
ZIP/Postal Code
T4000IAK
Country
Argentina
Facility Name
Isis Centro Especializado de Luces; Oncology
City
Santa Fe
ZIP/Postal Code
S3000XAE
Country
Argentina
Facility Name
Lismore Base Hospital; Cancer Care & Haematology Unit
City
Lismore
State/Province
New South Wales
ZIP/Postal Code
2480
Country
Australia
Facility Name
Mater Misericordiae Hospital; Chemotherapy Cottage
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2060
Country
Australia
Facility Name
Newcastle Mater Misericordiae Hospital; Oncology
City
Waratah
State/Province
New South Wales
ZIP/Postal Code
2298
Country
Australia
Facility Name
Westmead Hospital; Medical Oncology and Pallative Care
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Facility Name
Wesley Medical Centre; Clinic For Haematology and Oncology
City
Auchenflower
State/Province
Queensland
ZIP/Postal Code
4066
Country
Australia
Facility Name
Mater Hospital; Oncology
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
4101
Country
Australia
Facility Name
Royal Adelaide Hospital; Oncology
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Royal Hobart Hospital; Medical Oncology
City
Hobart
State/Province
Tasmania
ZIP/Postal Code
7000
Country
Australia
Facility Name
Monash Medical Centre; Oncology
City
Clayton
State/Province
Victoria
ZIP/Postal Code
3168
Country
Australia
Facility Name
Geelong Hospital; Andrew Love Cancer Centre
City
Geelong
State/Province
Victoria
ZIP/Postal Code
3220
Country
Australia
Facility Name
Austin Hospital; Medical Oncology
City
Heidelberg
State/Province
Victoria
ZIP/Postal Code
3084
Country
Australia
Facility Name
Peter Maccallum Cancer Institute; Medical Oncology
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3000
Country
Australia
Facility Name
Sir Charles Gairdner Hospital; Medical Oncology
City
Perth
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Facility Name
Lkh-Univ. Klinikum Graz; Klinik Für Innere Medizin I
City
Graz
ZIP/Postal Code
8036
Country
Austria
Facility Name
Tiroler Landeskrankenanstalten Ges.M.B.H.; Abt. Für Gynäkologie
City
Innsbruck
ZIP/Postal Code
6020
Country
Austria
Facility Name
Ordensklinikum Linz Barmherzige Schwestern; Abt. fur Innere Medizin 1
City
Linz
ZIP/Postal Code
4010
Country
Austria
Facility Name
Lhk Feldkirch; Interne Medizin Abt.
City
Rankweil
ZIP/Postal Code
6830
Country
Austria
Facility Name
Lkh Salzburg - Univ. Klinikum Salzburg; Iii. Medizinische Abt.
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
Facility Name
A. Ö. Krankenhaus Der Barmherzigen Brüder; Interne Abt.
City
St Veit An Der Glan
ZIP/Postal Code
9300
Country
Austria
Facility Name
Lkh Vöcklabruck; I. Abt. Für Innere Medizin
City
Vöcklabruck
ZIP/Postal Code
4840
Country
Austria
Facility Name
Klinikum Kreuzschwestern Wels; Iii. Interne Abt.
City
Wels
ZIP/Postal Code
4600
Country
Austria
Facility Name
Medizinische Universität Wien; Univ.Klinik für Frauenheilkunde - Klinik für Gynäkologie
City
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
Medizinische Universität Wien; Univ.Klinik für Innere Medizin I - Abt. für Onkologie
City
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
Krankenhaus Der Stadt Wien-Hietzing; Abt. Für Gynäkologie U. Geburtshilfe
City
Wien
ZIP/Postal Code
1130
Country
Austria
Facility Name
Institut Jules Bordet
City
Anderlecht
ZIP/Postal Code
1070
Country
Belgium
Facility Name
GHdC Site Notre Dame
City
Charleroi
ZIP/Postal Code
6000
Country
Belgium
Facility Name
UZ Antwerpen
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
Facility Name
Jessa Zkh (Campus Virga Jesse)
City
Hasselt
ZIP/Postal Code
3500
Country
Belgium
Facility Name
AZ Groeninge
City
Kortrijk
ZIP/Postal Code
8500
Country
Belgium
Facility Name
UZ Leuven Gasthuisberg
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
CHU Sart-Tilman
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Facility Name
Clinique Ste-Elisabeth
City
Namur
ZIP/Postal Code
5000
Country
Belgium
Facility Name
Sint Augustinus Wilrijk
City
Wilrijk
ZIP/Postal Code
2610
Country
Belgium
Facility Name
UMHAT Tsaritsa Yoanna - ISUL; Clinic of Oncotherapy
City
Sofia
ZIP/Postal Code
1527
Country
Bulgaria
Facility Name
SHATO - Sofia
City
Sofia
ZIP/Postal Code
1756
Country
Bulgaria
Facility Name
SHATOD Dr. Marko Antonov Markov-Varna, EOOD
City
Varna
ZIP/Postal Code
9010
Country
Bulgaria
Facility Name
Tom Baker Cancer Centre; Dept of Medicine
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N2
Country
Canada
Facility Name
Cross Can Inst
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
Facility Name
BC Cancer Agency, CSI
City
Kelowna
State/Province
British Columbia
ZIP/Postal Code
V1Y 5L3
Country
Canada
Facility Name
BC Cancer ? Surrey
City
Surrey
State/Province
British Columbia
ZIP/Postal Code
V3V 1Z2
Country
Canada
Facility Name
BCCA-Vancouver Cancer Centre
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 4E6
Country
Canada
Facility Name
Bcca - Vancouver Island Cancer Centre; Oncology
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8R 6V5
Country
Canada
Facility Name
CancerCare Manitoba; Neuro-Oncology
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R2H 2A6
Country
Canada
Facility Name
Atlantic Health Science Corporation; Saint John Regional Hospital Facility
City
Saint John
State/Province
New Brunswick
ZIP/Postal Code
E2L 4L2
Country
Canada
Facility Name
Queen Elizabeth II Health Sciences Centre; Oncology
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 2Y9
Country
Canada
Facility Name
Hamilton Health Sciences - Juravinski Cancer Centre
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8V 5C2
Country
Canada
Facility Name
Cancer Centre of Southeastern Ontario; Kingston General Hospital
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 5P9
Country
Canada
Facility Name
London Health Sciences Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4L6
Country
Canada
Facility Name
Credit Valley Hospital/Carlo Fidani Peel Regional Cancer Centre
City
Mississauga
State/Province
Ontario
ZIP/Postal Code
L5M 2N1
Country
Canada
Facility Name
Southlake Regional Health Center
City
Newmarket
State/Province
Ontario
ZIP/Postal Code
L3Y 2R2
Country
Canada
Facility Name
Ottawa Regional Cancer Centre
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 1C4
Country
Canada
Facility Name
Niagara Health Systems - St. Catherines General Site; Niagara Health System-St. Catharines Site
City
St. Catharines
State/Province
Ontario
ZIP/Postal Code
L2R 7C6
Country
Canada
Facility Name
Northeastern Ontario; Regional Cancer Centre
City
Sudbury
State/Province
Ontario
ZIP/Postal Code
P3E 5J1
Country
Canada
Facility Name
Sunnybrook Odette Cancer Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
Mount Sinai Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X5
Country
Canada
Facility Name
Princess Margaret Cancer Center
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1Z5
Country
Canada
Facility Name
Hopital Maisonneuve- Rosemont; Oncology
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 2M4
Country
Canada
Facility Name
Chum Hopital Notre Dame; Centre D'Oncologie
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L 4M1
Country
Canada
Facility Name
Hopital Sacre-Coeur Research Centre
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4J 1C5
Country
Canada
Facility Name
Hopital du Saint Sacrement
City
Quebec City
State/Province
Quebec
ZIP/Postal Code
G1S 4L8
Country
Canada
Facility Name
Allan Blair Cancer Centre
City
Regina
State/Province
Saskatchewan
ZIP/Postal Code
S4T 7T1
Country
Canada
Facility Name
INTOP
City
Providencia
ZIP/Postal Code
7501089
Country
Chile
Facility Name
Fundacion Arturo Lopez Perez
City
Santiago
ZIP/Postal Code
7500921
Country
Chile
Facility Name
Cancer Hospital Chinese Academy of Medical Sciences.
City
Beijing
ZIP/Postal Code
100021
Country
China
Facility Name
The Affiliated Hospital of Military Medical Sciences(The 307th Hospital of Chinese PLA)
City
Beijing
ZIP/Postal Code
100071
Country
China
Facility Name
the First Hospital of Jilin University
City
Changchun
ZIP/Postal Code
130021
Country
China
Facility Name
Jilin Cancer Hospital
City
Changchun
ZIP/Postal Code
132013
Country
China
Facility Name
Hu Nan Provincial Cancer Hospital
City
Changsha
ZIP/Postal Code
410006
Country
China
Facility Name
Sichuan Provincial People's Hospital
City
Chengdu
ZIP/Postal Code
610072
Country
China
Facility Name
Fujian Medical University Union Hospital
City
Fuzhou City
ZIP/Postal Code
350001
Country
China
Facility Name
The 900th Hospital of PLA joint service support force
City
Fuzhou
ZIP/Postal Code
110016
Country
China
Facility Name
Sun Yet-sen University Cancer Center
City
Guangzhou City
ZIP/Postal Code
510663
Country
China
Facility Name
Guangdong General Hospital
City
Guangzhou
ZIP/Postal Code
510080
Country
China
Facility Name
The First Affiliated Hospital of College of Medicine, Zhejiang University
City
Hangzhou
ZIP/Postal Code
310003
Country
China
Facility Name
Harbin Medical University Cancer Hospital
City
Harbin
ZIP/Postal Code
150081
Country
China
Facility Name
The 1st Affiliated Hospital of Nanchang Unversity
City
Nanchang
ZIP/Postal Code
330019
Country
China
Facility Name
Fudan University Shanghai Cancer Center
City
Shanghai City
ZIP/Postal Code
200120
Country
China
Facility Name
Shanghai Jiao Tong University School of Medicine (SJTUSM) - Ruijin Hospital (GuangCi Hospital)
City
Shanghai
ZIP/Postal Code
200025
Country
China
Facility Name
Shanghai First People's Hospital
City
Shanghai
ZIP/Postal Code
200080
Country
China
Facility Name
Changhai Hospital of Shanghai
City
Shanghai
ZIP/Postal Code
200433
Country
China
Facility Name
Hebei Medical University Fourth Hospital;(Tumor Hospital of Hebei Province)
City
Shijiazhuang
ZIP/Postal Code
050035
Country
China
Facility Name
Xiehe Hospital, Tongji Medical College Huazhong University of Science & Technology
City
Wuhan
ZIP/Postal Code
430022
Country
China
Facility Name
Tongji Hosp, Tongji Med. Col, Huazhong Univ. of Sci. & Tech
City
Wuhan
ZIP/Postal Code
430030
Country
China
Facility Name
Hubei Cancer Hospital
City
Wuhan
ZIP/Postal Code
430079
Country
China
Facility Name
Inst. Nacional de Cancerologia; Clinica de Seno
City
Bogota
ZIP/Postal Code
111511
Country
Colombia
Facility Name
Fundacion Cardioinfantil
City
Bogota
Country
Colombia
Facility Name
Hospital Pablo Tobon Uribe
City
Medellin
ZIP/Postal Code
050034
Country
Colombia
Facility Name
Oncomedica S.A.
City
Monteria
ZIP/Postal Code
230002
Country
Colombia
Facility Name
Uni Hospital Split; Oncology & Radiotherapy
City
Split
ZIP/Postal Code
21000
Country
Croatia
Facility Name
General Hospital Varazdin
City
Varazdin
ZIP/Postal Code
42000
Country
Croatia
Facility Name
Clinical Hospital Centre Zagreb
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
Masarykuv onkologicky ustav
City
Brno
ZIP/Postal Code
656 53
Country
Czechia
Facility Name
Fakultni Nemocnice Hradec Kralove; Dept of Radiotherapy & Oncology
City
Hradec Kralove
ZIP/Postal Code
500 05
Country
Czechia
Facility Name
Fakultni nemocnice Olomouc; Onkologicka klinika
City
Olomouc
ZIP/Postal Code
779 00
Country
Czechia
Facility Name
MULTISCAN, s.r.o., Radiologicke centrum Pardubice
City
Pardubice
ZIP/Postal Code
532 03
Country
Czechia
Facility Name
Aalborg Universitetshospital; Klinik Kirurgi-Kræft, Onkologisk afd.
City
Aalborg
ZIP/Postal Code
9000
Country
Denmark
Facility Name
Sydvestjysk Sygehus Esbjerg; Onkologisk afdeling
City
Esbjerg
ZIP/Postal Code
6700
Country
Denmark
Facility Name
Herlev Hospital; Afdeling for Kræftbehandling
City
Herlev
ZIP/Postal Code
2730
Country
Denmark
Facility Name
Nordsjællands Hospital, Hillerød, Onkologisk Afdeling
City
Hillerod
ZIP/Postal Code
3400
Country
Denmark
Facility Name
Rigshospitalet; Onkologisk Klinik
City
København Ø
ZIP/Postal Code
2100
Country
Denmark
Facility Name
Sjællands Universitetshospital, Næstved; Onkologisk Afdeling
City
Naestved
ZIP/Postal Code
4700
Country
Denmark
Facility Name
Odense Universitetshospital, Onkologisk Afdeling R
City
Odense C
ZIP/Postal Code
5000
Country
Denmark
Facility Name
Sygehus Syd Roskilde; Onkologisk/haematologisk ambulatorium
City
Roskilde
ZIP/Postal Code
4000
Country
Denmark
Facility Name
Vejle Sygehus; Onkologisk Afdeling
City
Vejle
ZIP/Postal Code
7100
Country
Denmark
Facility Name
Hospital Oncologia; Oncology
City
Salvador
ZIP/Postal Code
01101
Country
El Salvador
Facility Name
Hospital Diagnostico Escalón
City
San Salvador
ZIP/Postal Code
01101
Country
El Salvador
Facility Name
Clinique De L Europe; Pmsi
City
Amiens
ZIP/Postal Code
80090
Country
France
Facility Name
ICO Paul Papin; Oncologie Medicale.
City
Angers
ZIP/Postal Code
49055
Country
France
Facility Name
HOP Prive Arras Les Bonnettes; Chimiotherapie
City
Arras
ZIP/Postal Code
62012
Country
France
Facility Name
Institut Sainte Catherine
City
Avignon
ZIP/Postal Code
84082
Country
France
Facility Name
ICONE
City
Bezannes
ZIP/Postal Code
51430
Country
France
Facility Name
Institut Bergonie; Oncologie
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
Polyclinique Bordeaux Nord
City
Bordeaux
ZIP/Postal Code
33300
Country
France
Facility Name
Hopital Augustin Morvan; Federation De Cancerologie
City
Brest
ZIP/Postal Code
29200
Country
France
Facility Name
Centre Francois Baclesse; Recherche Clinique
City
Caen
ZIP/Postal Code
14076
Country
France
Facility Name
Centre Jean Perrin; Hopital De Jour
City
Clermont Ferrand
ZIP/Postal Code
63011
Country
France
Facility Name
Centre Leonard De Vinci;Chimiotherapie
City
Dechy
ZIP/Postal Code
59187
Country
France
Facility Name
Centre Georges-François Lecler; Ctr de Lutte Contre le Canc
City
Dijon
ZIP/Postal Code
21034
Country
France
Facility Name
Institut Daniel Hollard
City
Grenoble
ZIP/Postal Code
38000
Country
France
Facility Name
Centre Hospitalier Departemental Les Oudairies
City
La Roche Sur Yon
ZIP/Postal Code
85925
Country
France
Facility Name
Clinique des Ormeaux; Oncologie
City
Le Havre
ZIP/Postal Code
76600
Country
France
Facility Name
Centre Oscar Lambret; Cancerologie Gynecologique
City
Lille
ZIP/Postal Code
59020
Country
France
Facility Name
Hopital Dupuytren; Oncologie Medicale
City
Limoges
ZIP/Postal Code
87042
Country
France
Facility Name
Centre Leon Berard; Departement Oncologie Medicale
City
Lyon
ZIP/Postal Code
69373
Country
France
Facility Name
Institut Paoli Calmettes; Oncologie Medicale
City
Marseille
ZIP/Postal Code
13273
Country
France
Facility Name
Institut régional du Cancer Montpellier
City
Montpellier
ZIP/Postal Code
34298
Country
France
Facility Name
Polyclinique De Gentilly; Hemodialyse
City
Nancy
ZIP/Postal Code
54100
Country
France
Facility Name
Centre Antoine Lacassagne; Hopital De Jour A2
City
Nice
ZIP/Postal Code
06189
Country
France
Facility Name
Institut de cancerologie du Gard
City
Nimes
ZIP/Postal Code
30029
Country
France
Facility Name
Institut Curie; Oncologie Medicale
City
Paris
ZIP/Postal Code
75231
Country
France
Facility Name
Ch Pitie Salpetriere; Cmrr Ile De France Salpetriere
City
Paris
ZIP/Postal Code
75651
Country
France
Facility Name
Polyclinique Francheville; MED CHIMIOTHERAPIE RADIOTHERAPIE
City
Perigueux
ZIP/Postal Code
24000
Country
France
Facility Name
Clinique Armoricaine Radiologie; Hopital de Jour
City
Plerin
ZIP/Postal Code
22190
Country
France
Facility Name
Chu De Poitiers; Chu La Miletrie
City
Poitiers
ZIP/Postal Code
86021
Country
France
Facility Name
Institut Jean Godinot; Hopital De Jour
City
Reims
ZIP/Postal Code
51056
Country
France
Facility Name
Centre Eugene Marquis; Unite Huguenin
City
Rennes
ZIP/Postal Code
35042
Country
France
Facility Name
Centre Henri Becquerel; Oncologie Medicale
City
Rouen
ZIP/Postal Code
76038
Country
France
Facility Name
Ico Rene Gauducheau; Oncologie
City
Saint Herblain
ZIP/Postal Code
44805
Country
France
Facility Name
ICL; Hematologie
City
Saint-Priest en Jarez
ZIP/Postal Code
42271
Country
France
Facility Name
Centre Rene Huguenin; CONSULT SPECIALISEES
City
St Cloud
ZIP/Postal Code
92210
Country
France
Facility Name
Institut d'oncologie de l'Orangerie; Chimiotherapie
City
Strasbourg
ZIP/Postal Code
67010
Country
France
Facility Name
Hopital Hautepierre; Hematologie Oncologie
City
Strasbourg
ZIP/Postal Code
67098
Country
France
Facility Name
Institut Claudius Regaud; Departement Oncologie Medicale
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
Clinique Pasteur; Pneumologie
City
Toulouse
ZIP/Postal Code
31076
Country
France
Facility Name
Centre Alexis Vautrin; Oncologie Medicale
City
Vandoeuvre-les-nancy
ZIP/Postal Code
54519
Country
France
Facility Name
Institut Gustave Roussy; Oncologie Medicale
City
Villejuif
ZIP/Postal Code
94800
Country
France
Facility Name
Gesundheitszentrum St. Marien GmbH; Med. II, Hämatologie/Onkologie
City
Amberg
ZIP/Postal Code
92224
Country
Germany
Facility Name
Hochwaldkrankenhaus
City
Bad Nauheim
ZIP/Postal Code
61231
Country
Germany
Facility Name
Evang. Krankenhaus Frauenklinik
City
Bergisch Gladbach
ZIP/Postal Code
51465
Country
Germany
Facility Name
Praxisklinik Krebsheilkunde für Frauen / Brustzentrum (Dres. Kittel/Klare)
City
Berlin
ZIP/Postal Code
10367
Country
Germany
Facility Name
Praxis Dr. Schoenegg
City
Berlin
ZIP/Postal Code
10719
Country
Germany
Facility Name
HELIOS Klinikum Berlin-Buch; Klinik für Gynäkologie und Geburtshilfe
City
Berlin
ZIP/Postal Code
13125
Country
Germany
Facility Name
Frauenarzt-Zentrum Zehlendorf an der Teltower Eiche
City
Berlin
ZIP/Postal Code
14169
Country
Germany
Facility Name
Onkologische Schwerpunktpraxis Bielefeld; Haemotologie & Internistische onkologie
City
Bielefeld
ZIP/Postal Code
33604
Country
Germany
Facility Name
Universitätsklinikum Bonn; Zentrum für Geburtshilfe und Frauenheilkunde
City
Bonn
ZIP/Postal Code
53127
Country
Germany
Facility Name
Praxis Dr. Ralf Lorenz
City
Braunschweig
ZIP/Postal Code
38100
Country
Germany
Facility Name
Hämato-Onkologie im Medicum/Home
City
Bremen
ZIP/Postal Code
28209
Country
Germany
Facility Name
Klinikum Sindelfingen-Böblingen; Frauenklinik
City
Böblingen
ZIP/Postal Code
71032
Country
Germany
Facility Name
Klinikum Chemnitz gGmbH; Frauen- und Kinderklinik
City
Chemnitz
ZIP/Postal Code
09116
Country
Germany
Facility Name
DONAU ISAR Klinikum Deggendorf; Frauenklinik
City
Deggendorf
ZIP/Postal Code
94469
Country
Germany
Facility Name
St. Johannes-Hospital
City
Dortmund
ZIP/Postal Code
44137
Country
Germany
Facility Name
Universitätsklinikum "Carl Gustav Carus"; Frauenheilkunde und Geburtshilfe
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Universitätsklinikum Düsseldorf; Frauenklinik
City
Düsseldorf
ZIP/Postal Code
40225
Country
Germany
Facility Name
Luisenkrankenhaus GmbH & Co. KG., Brustzentrum
City
Düsseldorf
ZIP/Postal Code
40235
Country
Germany
Facility Name
Praxis für Hamatologie und Onkologie
City
Erfurt
ZIP/Postal Code
99085
Country
Germany
Facility Name
Universitätsklinikum Erlangen; Frauenklinik
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
Facility Name
Klinikum Esslingen; Klinik für Frauenheilkunde und Geburtshilfe
City
Esslingen
ZIP/Postal Code
73730
Country
Germany
Facility Name
Hämatologisch-Onkologische Gemeinschaftspraxis am Bethanien-Krankenhaus
City
Frankfurt am Main
ZIP/Postal Code
60389
Country
Germany
Facility Name
Klinik Johann Wolfgang von Goethe Uni; Klinik für Frauenheilkunde und Geburtshilfe
City
Frankfurt
ZIP/Postal Code
60596
Country
Germany
Facility Name
Städtische Kliniken Frankfurt am Main Höchst
City
Frankfurt
ZIP/Postal Code
65929
Country
Germany
Facility Name
Praxis für Interdisziplinäre Onkologie und Hämatologie GbR
City
Freiburg
ZIP/Postal Code
79110
Country
Germany
Facility Name
Dres.Jochen Wilke und Harald Wagner
City
Fürth
ZIP/Postal Code
90766
Country
Germany
Facility Name
Universitätsklinikum Greifswald; Klinik für Frauenheilkunde und Brustzentrum
City
Greifswald
ZIP/Postal Code
17475
Country
Germany
Facility Name
Universitätsklinikum Halle (Saale); Universitätsklinik Und Poliklinik Für Gynäkologie
City
Halle
ZIP/Postal Code
06120
Country
Germany
Facility Name
Universitätsklinikum Hamburg-Eppendorf; Frauenklinik
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
SANA Klinikum Hameln-Pyrmont; Frauenklinik / Brustzentrum
City
Hameln
ZIP/Postal Code
31785
Country
Germany
Facility Name
Gynaekologisch-Onkologische Schwerpunktpraxis Prof. Dr. med. Lueck, Dr. Schrader und Dr. Noeding
City
Hannover
ZIP/Postal Code
30177
Country
Germany
Facility Name
Diakovere Henriettenstift, Frauenklinik
City
Hannover
ZIP/Postal Code
30559
Country
Germany
Facility Name
Nationales Centrum für Tumorerkrankungen (NCT) ; Gyn. Onk. Frauenklinik; Uniklinikum Heidelberg
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Praxisgemeinschaft; Frauenärzte am Bahnhofsplatz
City
Hildesheim
ZIP/Postal Code
31134
Country
Germany
Facility Name
Universitätsklinikum des Saarlandes; Klinik f. Frauenheilkunden und Geburtshilfe
City
Homburg/Saar
ZIP/Postal Code
66424
Country
Germany
Facility Name
ViDia Christliche Kliniken Karlsruhe, Vincentius-Diakonissen-Kliniken gAG; Frauenklinik
City
Karlsruhe
ZIP/Postal Code
76135
Country
Germany
Facility Name
Elisabeth-Krankenhaus Brustzentrum
City
Kassel
ZIP/Postal Code
34117
Country
Germany
Facility Name
Klinikum Kassel GmbH; Klinik für Frauenheilkunde und Geburtshilfe
City
Kassel
ZIP/Postal Code
34125
Country
Germany
Facility Name
UNI-Klinikum Campus Kiel Klinik für Gynäkologie und Geburtshilfe
City
Kiel
ZIP/Postal Code
24105
Country
Germany
Facility Name
St. Elisabeth Krankenhaus Köln GmbH; Gynäkologie und Geburtshilfe
City
Koeln
ZIP/Postal Code
50935
Country
Germany
Facility Name
Uniklinik Köln, Klinik und Poliklinik und Geburtshilfe; Brustzentrum Köln
City
Köln
ZIP/Postal Code
50931
Country
Germany
Facility Name
Klinikum Landshut Frauenklinik
City
Landshut
ZIP/Postal Code
84034
Country
Germany
Facility Name
Sankt Elisabeth Krankenhaus; Gynaekology
City
Leipzig
ZIP/Postal Code
04277
Country
Germany
Facility Name
Evangelisches Krankenhaus; Abt. Gynäkologie und Geburtshilfe
City
Ludwigsfelde
ZIP/Postal Code
14974
Country
Germany
Facility Name
Universitätsklinikum Schleswig-Holstein / Campus Lübeck; Klinik für Frauenheilkunde und Geburtshilfe
City
Lübeck
ZIP/Postal Code
23538
Country
Germany
Facility Name
Universitätsmedizin Mainz; Klinik u. Poliklinik f. Geburtshilfe u. Frauenheilkunde
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Facility Name
Rotkreuzklinikum München; Frauenklinik
City
Muenchen
ZIP/Postal Code
80637
Country
Germany
Facility Name
Brustzentrum Rhein-Ruhr Servicegesellschaft mbH
City
Mönchengladbach
ZIP/Postal Code
41061
Country
Germany
Facility Name
Klinikum der Universität München; Frauenklinik - Onkologie II
City
München
ZIP/Postal Code
80336
Country
Germany
Facility Name
Klinikum rechts der Isar der TU München; Klinik und Poliklinik für Frauenheilkunde
City
München
ZIP/Postal Code
81675
Country
Germany
Facility Name
Universitätsklinikum Münster; Klinik für Frauenheilkunde und Geburtshilfe
City
Münster
ZIP/Postal Code
48149
Country
Germany
Facility Name
Sana Klinikum Offenbach GmbH; Klinik für Gynäkologie & Geburtshilfe
City
Offenbach
ZIP/Postal Code
63069
Country
Germany
Facility Name
Medizinisches Versorgungszentrum am Klinikum Oldenburg GmbH
City
Oldenburg
ZIP/Postal Code
26133
Country
Germany
Facility Name
Hämatologisch/Onkologische Praxis Prof. Dr. Decker, Studienzentrum
City
Ravensburg
ZIP/Postal Code
88212
Country
Germany
Facility Name
Oncologianova GmbH
City
Recklinghausen
ZIP/Postal Code
45659
Country
Germany
Facility Name
RoMed Klinikum Rosenheim; Klinik für Gynäkologie und Geburtshilfe
City
Rosenheim
ZIP/Postal Code
83022
Country
Germany
Facility Name
Universitätsfrauen- und Poliklinik am Klinikum Suedstadt
City
Rostock
ZIP/Postal Code
18059
Country
Germany
Facility Name
MVZ für Hämatologie, Onkologie, Strahlentherapie und Palliativmedizin -; Klinik Dr. Hancken
City
Stade
ZIP/Postal Code
21680
Country
Germany
Facility Name
Klinikum Mutterhaus der Borromaeerinnen gGmbH; Haematologie/Onkologie
City
Trier
ZIP/Postal Code
54290
Country
Germany
Facility Name
Universitätsklinik Tübingen; Frauenklinik
City
Tübingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
Universitätsklinikum Ulm Am Michelsberg; Frauenklinik
City
Ulm
ZIP/Postal Code
89075
Country
Germany
Facility Name
Dres. Arnd Nusch Naser Ali-Mohammad Kalhori und Werner Langer
City
Velbert
ZIP/Postal Code
42551
Country
Germany
Facility Name
Schwarzwald-Baar Klinikum Klinik für Frauenheilkunde und Geburtshilfe
City
Villingen-Schwenningen
ZIP/Postal Code
78052
Country
Germany
Facility Name
St. Josefs-Hospital Wiesbaden GmbH; Klinik für Frauenheilkunde und Geburtshilfe
City
Wiesbaden
ZIP/Postal Code
65189
Country
Germany
Facility Name
Marien-Hospital Witten; Frauenklinik Brustzentrum
City
Witten
ZIP/Postal Code
58452
Country
Germany
Facility Name
Hämatologisch-Onkologische Schwerpunktpraxis Dres. Schlag & Schöttker
City
Würzburg
ZIP/Postal Code
97080
Country
Germany
Facility Name
Grupo Angeles
City
Guatemala City
ZIP/Postal Code
01015
Country
Guatemala
Facility Name
Centro Oncológico Sixtino / Centro Oncológico SA
City
Guatemala
ZIP/Postal Code
01010
Country
Guatemala
Facility Name
Queen Mary Hospital; Surgery
City
Hong Kong
ZIP/Postal Code
852
Country
Hong Kong
Facility Name
Queen Mary Hospital; Dept of Medicine
City
Hong Kong
Country
Hong Kong
Facility Name
Semmelweis Egyetem Onkologiai Központ
City
Budapest
ZIP/Postal Code
1083
Country
Hungary
Facility Name
Orszagos Onkologiai Intezet; B Belgyogyaszati Osztaly
City
Budapest
ZIP/Postal Code
1122
Country
Hungary
Facility Name
Magyar Honvedseg Egeszsegugyi Kozpont; Fázis I-es Klinikai Farmakológiai Vizsgálóhely
City
Budapest
ZIP/Postal Code
H-1077
Country
Hungary
Facility Name
Debreceni Egyetem, Klinikai Kozpont, Onkologiai Klinika
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Petz Aladar Megyei Oktato Korhaz; Oncoradiologia
City
Gyor
ZIP/Postal Code
9024
Country
Hungary
Facility Name
Békés Megyei Pándy Kálmán Kórház; Onkologiai tanszek
City
Gyula
ZIP/Postal Code
5703
Country
Hungary
Facility Name
Bács-Kiskun Vármegyei Oktatókórház
City
Kecskemet
ZIP/Postal Code
6000
Country
Hungary
Facility Name
Szegedi Tudomanyegyetem, AOK, Szent-Gyorgyi Albert Klinikai Kozpont, Onkoterapias Klinika
City
Szeged
ZIP/Postal Code
6720
Country
Hungary
Facility Name
Veszprem Megyei Csolnoky; Ferenc Korhaz
City
Veszprem
ZIP/Postal Code
8200
Country
Hungary
Facility Name
Cork Uni Hospital; Oncology Dept
City
Cork
Country
Ireland
Facility Name
Mater Misericordiae Uni Hospital; Oncology
City
Dublin
ZIP/Postal Code
7
Country
Ireland
Facility Name
Beaumont Hospital; Cancer Clinical Trials Unit
City
Dublin
ZIP/Postal Code
9
Country
Ireland
Facility Name
St Vincent'S Uni Hospital; Medical Oncology
City
Dublin
ZIP/Postal Code
D04 T6F4
Country
Ireland
Facility Name
St. James Hospital; Oncology
City
Dublin
ZIP/Postal Code
D08 HNY1
Country
Ireland
Facility Name
Galway University Hospital; Clinical Trials Department
City
Galway
ZIP/Postal Code
H91YR71
Country
Ireland
Facility Name
University Hospital Limerick - Oncology
City
Limerick
Country
Ireland
Facility Name
Rambam Medical Center; Oncology
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Facility Name
Rabin MC; Davidof Center - Oncology Institute
City
Petach Tikva
ZIP/Postal Code
4941492
Country
Israel
Facility Name
Chaim Sheba Medical Center; Oncology Dept
City
Ramat Gan
ZIP/Postal Code
5262100
Country
Israel
Facility Name
Kaplan Medical Center; Oncology Inst.
City
Rehovot
ZIP/Postal Code
7610001
Country
Israel
Facility Name
Sourasky / Ichilov Hospital; Oncology Department
City
Tel Aviv
ZIP/Postal Code
64239-06
Country
Israel
Facility Name
Campus Universitario S.Venuta; Centro Oncologico T.Campanella
City
Catanzaro
State/Province
Calabria
ZIP/Postal Code
88100
Country
Italy
Facility Name
AORN'S.G.Moscati; Oncologia
City
Avellino
State/Province
Campania
ZIP/Postal Code
83100
Country
Italy
Facility Name
IRCCS Istituto Nazionale Tumori Fondazione Pascale; Oncologia Medica A
City
Napoli
State/Province
Campania
ZIP/Postal Code
80131
Country
Italy
Facility Name
Ist. Uni Federico Ii; Divisione Di Oncologia Medica - Dpt. Di Medicina Interna
City
Napoli
State/Province
Campania
ZIP/Postal Code
80131
Country
Italy
Facility Name
Azienda Ospedaliero-Universitaria S.Orsola-Malpighi; Unità Operativa Oncologia Medica
City
Bologna
State/Province
Emilia-Romagna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Ospedale Ramazzini
City
Carpi
State/Province
Emilia-Romagna
ZIP/Postal Code
41012
Country
Italy
Facility Name
Arcispedale Santa Maria Nuova; Oncologia
City
Reggio Emilia
State/Province
Emilia-Romagna
ZIP/Postal Code
42100
Country
Italy
Facility Name
Irccs Centro Di Riferimento Oncologico (CRO); Dipartimento Di Oncologia Medica
City
Aviano
State/Province
Friuli-Venezia Giulia
ZIP/Postal Code
33081
Country
Italy
Facility Name
Divisione Onc Med dell'Azienda
City
Udine
State/Province
Friuli-Venezia Giulia
ZIP/Postal Code
33100
Country
Italy
Facility Name
Ospedale Belcolle Di Viterbo; Oncologia
City
Viterbo
State/Province
Lazio
ZIP/Postal Code
01100
Country
Italy
Facility Name
Ente Ospedaliero Ospedali Galliera; S.C. Oncologia Medica
City
Genova
State/Province
Liguria
ZIP/Postal Code
16128
Country
Italy
Facility Name
Az. Osp. Uni Ria San Martino; Cliniche Uni Rie Convenzionate U.O. Oncologia Medical
City
Genova
State/Province
Liguria
ZIP/Postal Code
16132
Country
Italy
Facility Name
IRCCS Istituto Nazionale Per La Ricerca Sul Cancro (IST); Oncologia Medica A
City
Genova
State/Province
Liguria
ZIP/Postal Code
16132
Country
Italy
Facility Name
ASST DEGLI SPEDALI CIVILI DI BRESCIA; Oncologia Medica
City
Brescia
State/Province
Lombardia
ZIP/Postal Code
25123
Country
Italy
Facility Name
ASST DI LECCO; Oncologia Medica
City
Lecco
State/Province
Lombardia
ZIP/Postal Code
23900
Country
Italy
Facility Name
Irccs Istituto Europeo Di Oncologia (IEO); Ricerca Di Senologia Medica
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20141
Country
Italy
Facility Name
Policlinico di Monza; Istituto di Oncologia
City
Monza
State/Province
Lombardia
ZIP/Postal Code
20052
Country
Italy
Facility Name
IRCCS Fondazione Maugeri; Oncologia Medica I
City
Pavia
State/Province
Lombardia
ZIP/Postal Code
27100
Country
Italy
Facility Name
IRCCS Istituto Clinico Humanitas; Oncologia
City
Rozzano
State/Province
Lombardia
ZIP/Postal Code
20089
Country
Italy
Facility Name
Az. Osp. Di Busto P.O. Di Saronno; U.O. Di Oncologia Medica
City
Saronno
State/Province
Lombardia
ZIP/Postal Code
21047
Country
Italy
Facility Name
Ospedale S. Croce Di Fano; Servizio Oncologia
City
Fano
State/Province
Marche
ZIP/Postal Code
61032
Country
Italy
Facility Name
Fondazione Del Piemonte Per L'oncologia Ircc Di Candiolo; Dipartimento Oncologico
City
Candiolo
State/Province
Piemonte
ZIP/Postal Code
10060
Country
Italy
Facility Name
Ospedale Antonio Perrino; Oncologia Medica
City
Brindisi
State/Province
Puglia
ZIP/Postal Code
72100
Country
Italy
Facility Name
Nuovo Ospedale di Prato S. Stefano - Azienda USL Toscana Centro
City
Prato
State/Province
Toscana
ZIP/Postal Code
59100
Country
Italy
Facility Name
Ospedale Di Bolzano; Dept. Di Oncologia
City
Bolzano
State/Province
Trentino-Alto Adige
ZIP/Postal Code
39100
Country
Italy
Facility Name
Azienda Ospedaliera Di Perugia Ospedale s. Maria Della Misericordia; Oncologia Medica
City
Perugia
State/Province
Umbria
ZIP/Postal Code
06156
Country
Italy
Facility Name
Azienda Ospedaliera S. Maria - Terni; Oncologia
City
Terni
State/Province
Umbria
ZIP/Postal Code
05100
Country
Italy
Facility Name
Ospedale Mater Salutis; Dept of Oncology
City
Legnago
State/Province
Veneto
ZIP/Postal Code
37045
Country
Italy
Facility Name
Aichi Cancer Center Hospital, Breast Oncology
City
Aichi
ZIP/Postal Code
464-8681
Country
Japan
Facility Name
Chiba Cancer Center; Breast Surgical Oncology
City
Chiba
ZIP/Postal Code
260-8717
Country
Japan
Facility Name
National Cancer Center Hospital East
City
Chiba
ZIP/Postal Code
277-8577
Country
Japan
Facility Name
Natl Hosp Org Shikoku; Cancer Ctr, Surgery
City
Ehime
ZIP/Postal Code
791-0280
Country
Japan
Facility Name
National Hospital Organization Kyushu Cancer Center;Breast Oncology
City
Fukuoka
ZIP/Postal Code
811-1395
Country
Japan
Facility Name
Gunma University Hospital; Department of Thoracic and Visceral Organ Surgery
City
Gunma
ZIP/Postal Code
371-8511
Country
Japan
Facility Name
Hiroshima City Hiroshima Citizens Hospital; Breast Surgery
City
Hiroshima
ZIP/Postal Code
730-8518
Country
Japan
Facility Name
Iwate Med Univ School of Med; Surgery
City
Iwate
ZIP/Postal Code
028-3695
Country
Japan
Facility Name
Sagara Hospital; Breast Surgery
City
Kagoshima
ZIP/Postal Code
892-0833
Country
Japan
Facility Name
St. Marianna University School of Medicine Hospital, Breast and Endocrine Surgery
City
Kanagawa
ZIP/Postal Code
216-8511
Country
Japan
Facility Name
Tokai University Hospital, Breast Surgery
City
Kanagawa
ZIP/Postal Code
259-1193
Country
Japan
Facility Name
Kumamoto City Hospital, Breast and Endocrine Surgery
City
Kumamoto
ZIP/Postal Code
862-8505
Country
Japan
Facility Name
Kumamoto Shinto General Hospital; Breast Cancer Center
City
Kumamoto
ZIP/Postal Code
862-8655
Country
Japan
Facility Name
Kyoto University Hospital; Breast Surgery
City
Kyoto
ZIP/Postal Code
606-8507
Country
Japan
Facility Name
Niigata Cancer Ctr Hospital; Breast Surgery
City
Niigata
ZIP/Postal Code
951-8566
Country
Japan
Facility Name
National Hospital Organization Osaka National Hospital; Breast Surgery
City
Osaka
ZIP/Postal Code
540-0006
Country
Japan
Facility Name
Osaka International Cancer Institute; Breast and Endocrine Surgery
City
Osaka
ZIP/Postal Code
541-8567
Country
Japan
Facility Name
Saitama Medical University International Medical Center; Breast Oncology
City
Saitama
ZIP/Postal Code
350-1298
Country
Japan
Facility Name
Saitama Cancer Center, Breast Oncology
City
Saitama
ZIP/Postal Code
362-0806
Country
Japan
Facility Name
Shizuoka Cancer Center; Breast Surgery
City
Shizuoka
ZIP/Postal Code
411-8777
Country
Japan
Facility Name
Shizuoka General Hospital; Breast Surgery
City
Shizuoka
ZIP/Postal Code
420-8527
Country
Japan
Facility Name
Jichi Medical School ; Surgery
City
Tochigi
ZIP/Postal Code
329-0498
Country
Japan
Facility Name
National Cancer Center Hospital; Medical Oncology
City
Tokyo
ZIP/Postal Code
104-0045
Country
Japan
Facility Name
Tokyo Metropolitan; Komagome Hospital, Surgery
City
Tokyo
ZIP/Postal Code
113-8677
Country
Japan
Facility Name
The Cancer Inst. Hosp. of JFCR; Breast Oncology Center
City
Tokyo
ZIP/Postal Code
135-8550
Country
Japan
Facility Name
Tokyo Medical Uni. Hospital; Breast Oncology
City
Tokyo
ZIP/Postal Code
160-0023
Country
Japan
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si
ZIP/Postal Code
463-707
Country
Korea, Republic of
Facility Name
Seoul National Uni Hospital; Dept. of Internal Medicine/Hematology/Oncology
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Yonsei University Severance Hospital; Medical Oncology
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
Facility Name
Kyunghee University Hospital; Endocrinology
City
Seoul
ZIP/Postal Code
130-702
Country
Korea, Republic of
Facility Name
Samsung Medical Centre; Division of Hematology/Oncology
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
Facility Name
Korea University Anam Hospital; Oncology Haemotology
City
Seoul
ZIP/Postal Code
136-705
Country
Korea, Republic of
Facility Name
Centro Estatal de Oncología de Campeche
City
Campehe
State/Province
Campeche
ZIP/Postal Code
24096
Country
Mexico
Facility Name
Fundacion Rodolfo Padilla Padilla A.C.
City
León
State/Province
Guanajuato
ZIP/Postal Code
37000
Country
Mexico
Facility Name
Núcleo de Especialidades Oncológicas
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44670
Country
Mexico
Facility Name
Hospital Angeles Metropolitano; Room 220
City
Mexico City
State/Province
Mexico CITY (federal District)
ZIP/Postal Code
06760
Country
Mexico
Facility Name
Hospital General de México; Unidad de Oncologia
City
Mexico DF
State/Province
Mexico CITY (federal District)
ZIP/Postal Code
06726
Country
Mexico
Facility Name
Centro Universitario Contra El Cancer
City
Monterrey
State/Province
Nuevo LEON
ZIP/Postal Code
64020
Country
Mexico
Facility Name
Centro de Diagnóstico y Tratamiento Integral de Mama, Hospital San José Tec de Monterrey
City
Montrrey
State/Province
Nuevo LEON
ZIP/Postal Code
64710
Country
Mexico
Facility Name
Oaxaca Site Management Organization
City
Oaxaca de Juárez
State/Province
Oaxaca
ZIP/Postal Code
68000
Country
Mexico
Facility Name
Cancerologia de Queretaro; Oncologia
City
Queretaro, Queretaro
State/Province
Queretaro
ZIP/Postal Code
76090
Country
Mexico
Facility Name
Médicos Especialistas en Cáncer SC
City
Aguascalientes
ZIP/Postal Code
20230
Country
Mexico
Facility Name
Centro Estatal De Cancerologia De Durango; Oncology
City
Durango
ZIP/Postal Code
34000
Country
Mexico
Facility Name
Centro Regional de Enfermedades Oncológicas, S.A.
City
San Luis Potosi
ZIP/Postal Code
78218
Country
Mexico
Facility Name
Medisch Centrum Alkmaar
City
Alkmaar
ZIP/Postal Code
1815 JD
Country
Netherlands
Facility Name
Amphia ziekenhuis, locatie langendijk
City
Breda
ZIP/Postal Code
4818 CK
Country
Netherlands
Facility Name
Reinier de Graaf Gasthuis
City
Delft
ZIP/Postal Code
2625 AD
Country
Netherlands
Facility Name
Academish Ziekenhuis Maastricht (Azm); Inwendige Geneeskunde
City
Maastricht
ZIP/Postal Code
6229 HX
Country
Netherlands
Facility Name
Isala Klinieken
City
Zwolle
ZIP/Postal Code
8011 JW
Country
Netherlands
Facility Name
Waikato Hospital; Dept of Medical Oncology
City
Hamilton
ZIP/Postal Code
3240
Country
New Zealand
Facility Name
Palmerston North Hospital; Regional Cancer Treatment Service
City
Palmerston North
ZIP/Postal Code
4442
Country
New Zealand
Facility Name
The Panama Clinic
City
Panama
ZIP/Postal Code
0832-02723
Country
Panama
Facility Name
Centro Oncologico America
City
Panama
ZIP/Postal Code
0834-02723
Country
Panama
Facility Name
Clinica Anglo Americana - Centro de Investigacion Oncologia CAA
City
Lima
ZIP/Postal Code
L27
Country
Peru
Facility Name
Instituto Nacional de Enfermedades Neoplasicas
City
Lima
ZIP/Postal Code
Lima 34
Country
Peru
Facility Name
Clinica El Golf
City
San Isidro
ZIP/Postal Code
L27 Lima
Country
Peru
Facility Name
Clinica Peruana Americana
City
Trujillo
ZIP/Postal Code
13011
Country
Peru
Facility Name
University Of Santo Tomas; Oncology; Benavides Cancer Institute
City
Manila
ZIP/Postal Code
1008
Country
Philippines
Facility Name
Rizal Medical Center
City
Pasig City
ZIP/Postal Code
1605
Country
Philippines
Facility Name
Veterans Memorial Medical Ctr; Cancer Research Centre
City
Quezon City
ZIP/Postal Code
1101
Country
Philippines
Facility Name
Bialostockie Ctr Onkologii; Oddzial Chemioterapii Dziennej
City
Bialystok
ZIP/Postal Code
15-027
Country
Poland
Facility Name
Centrum Onkologii;Im. Franciszka Lukaszczyka;Onkologii
City
Bydgoszcz
ZIP/Postal Code
85-796
Country
Poland
Facility Name
Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii
City
Gdansk
ZIP/Postal Code
80-214
Country
Poland
Facility Name
Opolskie Centrum Onkologii;Oddzial Onkologii Klinicznej
City
Opole
ZIP/Postal Code
45-061
Country
Poland
Facility Name
Narodowy Inst.Onkologii im.Sklodowskiej-Curie Panstw.Inst.Bad; Klinika Nowtw.Piersi i Chir.Rekonstr
City
Warszawa
ZIP/Postal Code
02-781
Country
Poland
Facility Name
NZOZ Mazowiecki Szpital Onkologiczny Uczelni Warszawskiej im. M. Sk?odowskiej-Curie
City
Wieliszew
ZIP/Postal Code
05-135
Country
Poland
Facility Name
Emergency University Bucharest Hospital; Oncology Department
City
Bucharest
ZIP/Postal Code
050098
Country
Romania
Facility Name
Prof. Dr. I. Chiricuta Institute of Oncology
City
Cluj Napoca
ZIP/Postal Code
400015
Country
Romania
Facility Name
Oncology Inst. Cluj-Napoca; Cancer Dept
City
Cluj-Napoca
ZIP/Postal Code
400015
Country
Romania
Facility Name
Euroclinic Center of Oncology SRL
City
Iasi
ZIP/Postal Code
700106
Country
Romania
Facility Name
S.I. Russian Oncological Research Center n.a. N.N. Blokhin
City
Moscow
State/Province
Moskovskaja Oblast
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
State Budget Institution of Healthcare of Stavropol region Pyatigorsk Oncology Dispensary
City
Pyatigorsk
State/Province
Stavropol
ZIP/Postal Code
357502
Country
Russian Federation
Facility Name
Clinical Oncology Dispensary of Ministry of Health of Tatarstan
City
Kazan
State/Province
Tatarstan
ZIP/Postal Code
420029
Country
Russian Federation
Facility Name
SBI of Healthcare Samara Regional Clinical Oncology Dispensary
City
Samara
ZIP/Postal Code
443031
Country
Russian Federation
Facility Name
SBI of Healthcare of Stavropol region Stavropol Regional Clinical Oncology Dispensary
City
Stavropol
ZIP/Postal Code
355045
Country
Russian Federation
Facility Name
Tula Regional Oncology Dispensary
City
Tula
ZIP/Postal Code
300053
Country
Russian Federation
Facility Name
Institute of Oncology Ljubljana
City
Ljubljana
ZIP/Postal Code
1000
Country
Slovenia
Facility Name
National Hospital; Oncotherapy Dept
City
Bloemfontein
ZIP/Postal Code
9301
Country
South Africa
Facility Name
Wits Donald Gordon Clinical Trial Centre; Medical Oncology
City
Parktown, Johannesburg
ZIP/Postal Code
2193
Country
South Africa
Facility Name
Steve Biko Academic Hospital; Oncology
City
Pretoria
ZIP/Postal Code
0002
Country
South Africa
Facility Name
Hospital General Universitario de Elche; Servicio de Oncologia
City
Elche
State/Province
Alicante
ZIP/Postal Code
03203
Country
Spain
Facility Name
Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia
City
Badalona
State/Province
Barcelona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Corporacio Sanitaria Parc Tauli; Servicio de Oncologia
City
Sabadell
State/Province
Barcelona
ZIP/Postal Code
8208
Country
Spain
Facility Name
Hospital Univ Vall d'Hebron; Servicio de Oncologia
City
Sant Andreu de La Barca
State/Province
Barcelona
ZIP/Postal Code
08740
Country
Spain
Facility Name
Hospital Universitario Marques de Valdecilla; Servicio de Oncologia
City
Santander
State/Province
Cantabria
ZIP/Postal Code
39008
Country
Spain
Facility Name
Hospital Provincial de Castellon; Servicio de Oncologia
City
Castellon de La Plana
State/Province
Castellon
ZIP/Postal Code
12002
Country
Spain
Facility Name
Hospital Universitario Reina Sofia; Servicio de Oncologia
City
Córdoba
State/Province
Cordoba
ZIP/Postal Code
14004
Country
Spain
Facility Name
IInstituto Oncologico de San Sebastian, Oncologikoa; Servicio de Oncologia
City
San Sebastian
State/Province
Guipuzcoa
ZIP/Postal Code
20014
Country
Spain
Facility Name
Hospital de Donostia; Servicio de Oncologia Medica
City
San Sebastian
State/Province
Guipuzcoa
ZIP/Postal Code
20080
Country
Spain
Facility Name
Hospital Universitario Son Espases
City
Palma De Mallorca
State/Province
Islas Baleares
ZIP/Postal Code
07014
Country
Spain
Facility Name
Hospital Son Llatzer; Servicio de Oncologia
City
Palma de Mallorca
State/Province
Islas Baleares
ZIP/Postal Code
07198
Country
Spain
Facility Name
Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Oncologia
City
Santiago de Compostela
State/Province
LA Coruña
ZIP/Postal Code
15706
Country
Spain
Facility Name
Hospital Universitario de Canarias;servicio de Oncologia
City
La Laguna
State/Province
Tenerife
ZIP/Postal Code
38320
Country
Spain
Facility Name
Hospital del Mar; Servicio de Oncologia
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Facility Name
Hospital Clínic i Provincial; Servicio de Hematología y Oncología
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia
City
Barcelona
ZIP/Postal Code
08041
Country
Spain
Facility Name
Hospital Duran i Reynals; Oncologia
City
Barcelona
ZIP/Postal Code
08907
Country
Spain
Facility Name
Hospital Juan Ramon Jimenez;Servicio de Oncologia
City
Huelva
ZIP/Postal Code
21005
Country
Spain
Facility Name
Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico; Servicio de Oncologia
City
Jaen
ZIP/Postal Code
23007
Country
Spain
Facility Name
Complejo Hospitalario Universitario A Coruña (CHUAC, Materno Infantil), Oncología
City
La Coruña
ZIP/Postal Code
15006
Country
Spain
Facility Name
Centro Oncológico Gallego José Antonio Quiroga y Piñeiro, Servicio de Oncologia
City
La Coruña
ZIP/Postal Code
15009
Country
Spain
Facility Name
Hospital Universitari Arnau de Vilanova de Lleida; Servicio de Oncologia
City
Lerida
ZIP/Postal Code
25198
Country
Spain
Facility Name
Hospital General Universitario Gregorio Marañon; Servicio de Oncologia
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Centro Oncologico MD Anderson Internacional; Servicio de Oncologia
City
Madrid
ZIP/Postal Code
28033
Country
Spain
Facility Name
Hospital Ramon y Cajal; Servicio de Oncologia
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Hospital Universitario Clínico San Carlos; Servicio de Oncologia
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre; Servicio de Oncologia
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Centro Integral Oncologico Clara Campal (CIOCC); Dirección Médica
City
Madrid
ZIP/Postal Code
28050
Country
Spain
Facility Name
Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia
City
Malaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Hospital General Universitario J.M Morales Meseguer; Servicio de Oncologia
City
Murcia
ZIP/Postal Code
30008
Country
Spain
Facility Name
Hospital Clinico Universitario de Salamanca; Servicio de Oncologia
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
Facility Name
Hospital Universitario Virgen Macarena; Servicio de Oncologia
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
Facility Name
Hospital Universitario Virgen del Rocio; Servicio de Oncologia
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Hospital Univ. Nuestra Señora de Valme; Servicio de Oncologia
City
Sevilla
ZIP/Postal Code
41014
Country
Spain
Facility Name
Complejo Hospitalario de Toledo- H. Virgen de la Salud; Servicio de Oncologia
City
Toledo
ZIP/Postal Code
45004
Country
Spain
Facility Name
Instituto Valenciano Oncologia; Oncologia Medica
City
Valencia
ZIP/Postal Code
46009
Country
Spain
Facility Name
Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Facility Name
Hospital Arnau de Vilanova (Valencia) Servicio de Oncologia
City
Valencia
ZIP/Postal Code
46015
Country
Spain
Facility Name
Hospital Universitario la Fe; Servicio de Oncologia
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Hospital Universitario Miguel Servet; Servicio Oncologia
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Facility Name
Sahlgrenska Universitetssjukhuset; Onkology
City
Gothenburg
ZIP/Postal Code
41 343
Country
Sweden
Facility Name
Uni Hospital Linkoeping; Dept. of Oncology
City
Linköping
ZIP/Postal Code
58185
Country
Sweden
Facility Name
Karolinska University Hospital; Department of General Oncology
City
Stockholm
ZIP/Postal Code
11883
Country
Sweden
Facility Name
Norrlands Universitetssjukhus, Umeå, Cancercentrum; Dept of Oncology
City
Umea
ZIP/Postal Code
90185
Country
Sweden
Facility Name
Akademiska sjukhuset, Onkologkliniken
City
Uppsala
ZIP/Postal Code
751 85
Country
Sweden
Facility Name
Universitaetsspital Basel; Onkologie
City
Basel
ZIP/Postal Code
4031
Country
Switzerland
Facility Name
Hôpitaux Universit. de Genève Gynécologique - Oncologie; Gynécologie
City
Genève 14
ZIP/Postal Code
1211
Country
Switzerland
Facility Name
Luzerner Kantonsspital; Medizinische Onkologie
City
Luzern
ZIP/Postal Code
6004
Country
Switzerland
Facility Name
Kantonsspital St. Gallen; Onkologie/Hämatologie
City
St. Gallen
ZIP/Postal Code
9007
Country
Switzerland
Facility Name
Brust-Zentrum Zürich AG Seefeldstrasse 214 Zürich
City
Zürich
ZIP/Postal Code
8008
Country
Switzerland
Facility Name
Changhua Christian Hospital; Dept of Surgery
City
Changhua
ZIP/Postal Code
500
Country
Taiwan
Facility Name
Kaohsiung Medical Uni Chung-Ho Hospital; Dept of Surgery
City
Kaohsiung
ZIP/Postal Code
807
Country
Taiwan
Facility Name
Taichung Veterans General Hospital; Dept of Surgery
City
Taichung
ZIP/Postal Code
407
Country
Taiwan
Facility Name
National Cheng Kung Uni Hospital; Surgery
City
Tainan
ZIP/Postal Code
704
Country
Taiwan
Facility Name
VETERANS GENERAL HOSPITAL; Department of General Surgery
City
Taipei
ZIP/Postal Code
00112
Country
Taiwan
Facility Name
National Taiwan Uni Hospital; General Surgery
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Facility Name
Tri-Service General Hospital, Division of General Surgery
City
Taipei
ZIP/Postal Code
114
Country
Taiwan
Facility Name
Chiang Rai Prachanukraw Hospital; Department of Pediatrics, Faculty of Medicine
City
Chiang Rai
ZIP/Postal Code
57000
Country
Thailand
Facility Name
Lopburi Cancer Hospital; Chemotherpy Unit; Chemotherapy
City
Lopburi
ZIP/Postal Code
15000
Country
Thailand
Facility Name
Buddhachinaraj Phitsanulok Hospital; Chemotherapy Unit ; Department of Medicine
City
Phitsanuok
ZIP/Postal Code
65000
Country
Thailand
Facility Name
Songklanagarind Hospital; Department of Surgery
City
Songkla
ZIP/Postal Code
90110
Country
Thailand
Facility Name
Surat Thani Hospital
City
Surat Thani
ZIP/Postal Code
84000
Country
Thailand
Facility Name
Cherkassy Regional Oncological Hospital
City
Cherkassy
ZIP/Postal Code
18009
Country
Ukraine
Facility Name
State Medical Academy; Oncology
City
Dnipropetrovsk
ZIP/Postal Code
43102
Country
Ukraine
Facility Name
Ivano-Frankivsk Regional Oncology Center
City
Ivano-Frankivsk
ZIP/Postal Code
76018
Country
Ukraine
Facility Name
Kyiv City Clinical Oncological Center, Day Hospital Department for Oncological patients
City
Kiev
ZIP/Postal Code
03115
Country
Ukraine
Facility Name
Volyn Regional Oncology Dispensary
City
Lutsk
ZIP/Postal Code
43018
Country
Ukraine
Facility Name
Lvov State Regional Oncology Medical & Diagnostic Center
City
Lvov
ZIP/Postal Code
79031
Country
Ukraine
Facility Name
Ternopil State Medical Academy
City
Ternopil
ZIP/Postal Code
46023
Country
Ukraine
Facility Name
Royal Berkshire Hospital; Berkshire Cancer Centre
City
Berkshire
ZIP/Postal Code
RG1 5AN
Country
United Kingdom
Facility Name
Velindre Cancer Centre; Oncology Dept
City
Cardiff
ZIP/Postal Code
CF14 2TL
Country
United Kingdom
Facility Name
Cheltenham General Hospital; Gloucestershire Oncology Centre
City
Cheltenham
ZIP/Postal Code
GL53 7AN
Country
United Kingdom
Facility Name
Colchester General Hospital
City
Colchester, Essex
ZIP/Postal Code
CO4 5JL
Country
United Kingdom
Facility Name
Royal Cornwall Hospital; Dept of Clinical Oncology
City
Cornwall
ZIP/Postal Code
TR1 3LQ
Country
United Kingdom
Facility Name
University Hospital coventry; Oncology Department
City
Coventry
ZIP/Postal Code
CV2 2DX
Country
United Kingdom
Facility Name
Western General Hospital; Edinburgh Breast Unit
City
Edinburgh
ZIP/Postal Code
EH4 2XU
Country
United Kingdom
Facility Name
Royal Devon & Exeter Hospital; Oncology Centre
City
Exeter
ZIP/Postal Code
EX2 5DW
Country
United Kingdom
Facility Name
Ipswich Hospital; Oncology Pharmacy
City
Ipswich
ZIP/Postal Code
IP4 5PD
Country
United Kingdom
Facility Name
St James Uni Hospital; Icrf Cancer Medicine Research Unit
City
Leeds
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Facility Name
St. Bartholomew'S Hospital; Dept of Medical Oncology
City
London
ZIP/Postal Code
EC1A 7BE
Country
United Kingdom
Facility Name
UCL Hospital NHS Trust
City
London
ZIP/Postal Code
NW1 2PG
Country
United Kingdom
Facility Name
Royal Marsden Hospital; Dept of Med-Onc
City
London
ZIP/Postal Code
SW3 6JJ
Country
United Kingdom
Facility Name
Christie Hospital; Breast Cancer Research Office
City
Manchester
ZIP/Postal Code
M20 4QL
Country
United Kingdom
Facility Name
Mount Vernon Hospital; Centre For Cancer Treatment
City
Northwood
ZIP/Postal Code
HA6 2RN
Country
United Kingdom
Facility Name
Nottingham City Hospital; Oncology
City
Nottingham
ZIP/Postal Code
NG5 1PB
Country
United Kingdom
Facility Name
Churchill Hospital; Oxford Cancer and Haematology Centre
City
Oxford
ZIP/Postal Code
OX3 7LJ
Country
United Kingdom
Facility Name
Peterborough City Hospital, Edith Cavell Campus; Oncology Department
City
Peterborough
ZIP/Postal Code
PE3 9GZ
Country
United Kingdom
Facility Name
Queen Alexandra Hospital; Haematology and Oncology Centre
City
Portsmouth
ZIP/Postal Code
PO6 3LY
Country
United Kingdom
Facility Name
Royal Preston Hosp; Rosemere Cancer Ctr
City
Preston
ZIP/Postal Code
PR2 9HT
Country
United Kingdom
Facility Name
Weston Park Hospital; Cancer Clinical Trials Centre
City
Sheffield
ZIP/Postal Code
S10 2SJ
Country
United Kingdom
Facility Name
Uni Hospital of North Staffordshire; Staffordshire Oncology Centre
City
Stoke-on-Trent
ZIP/Postal Code
ST4 6QG
Country
United Kingdom
Facility Name
Royal Marsden Hosp NHS Fnd; Medicine - Breast Unit
City
Sutton
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
Facility Name
The Clatterbridge Cancer Ctr For Oncolgy
City
Wirral
ZIP/Postal Code
CH63 4JY
Country
United Kingdom
Facility Name
New Cross Hospital; Deansley Centre
City
Wolverhampton
ZIP/Postal Code
WV10 0QP
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
35313167
Citation
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PubMed Identifier
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Citation
Piccart M, Procter M, Fumagalli D, de Azambuja E, Clark E, Ewer MS, Restuccia E, Jerusalem G, Dent S, Reaby L, Bonnefoi H, Krop I, Liu TW, Pienkowski T, Toi M, Wilcken N, Andersson M, Im YH, Tseng LM, Lueck HJ, Colleoni M, Monturus E, Sicoe M, Guillaume S, Bines J, Gelber RD, Viale G, Thomssen C; APHINITY Steering Committee and Investigators. Adjuvant Pertuzumab and Trastuzumab in Early HER2-Positive Breast Cancer in the APHINITY Trial: 6 Years' Follow-Up. J Clin Oncol. 2021 May 1;39(13):1448-1457. doi: 10.1200/JCO.20.01204. Epub 2021 Feb 4.
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Bines J, Procter M, Restuccia E, Viale G, Zardavas D, Suter T, Arahmani A, Van Dooren V, Baselga J, Clark E, Eng-Wong J, Gelber RD, Piccart M, Mobus V, de Azambuja E; APHINITY Steering Committee and Investigators. Incidence and Management of Diarrhea With Adjuvant Pertuzumab and Trastuzumab in Patients With Human Epidermal Growth Factor Receptor 2-Positive Breast Cancer. Clin Breast Cancer. 2020 Apr;20(2):174-181.e3. doi: 10.1016/j.clbc.2019.06.016. Epub 2019 Sep 5.
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Citation
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Citation
Kirschbrown WP, Kagedal M, Wang B, Lindbom L, Knott A, Mack R, Monemi S, Nijem I, Girish S, Freeman C, Fumagalli D, McConnell R, Jerusalem G, Twelves C, Baselga J, von Minckwitz G, Bines J, Garg A. Pharmacokinetic and exploratory exposure-response analysis of pertuzumab in patients with operable HER2-positive early breast cancer in the APHINITY study. Cancer Chemother Pharmacol. 2019 Jun;83(6):1147-1158. doi: 10.1007/s00280-019-03826-1. Epub 2019 Apr 11.
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Results Reference
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Learn more about this trial

A Study of Pertuzumab in Addition to Chemotherapy and Trastuzumab as Adjuvant Therapy in Participants With Human Epidermal Growth Receptor 2 (HER2)-Positive Primary Breast Cancer

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