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)
Breast Cancer
About this trial
This is an interventional treatment trial for Breast Cancer
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
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
Experimental
Placebo Comparator
Pertuzumab + Trastuzumab + Chemotherapy
Placebo + Trastuzumab + Chemotherapy
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]).