A Study Comparing Atezolizumab (Anti PD-L1 Antibody) In Combination With Adjuvant Anthracycline/Taxane-Based Chemotherapy Versus Chemotherapy Alone In Patients With Operable Triple-Negative Breast Cancer (IMpassion030)
Triple Negative Breast Cancer
About this trial
This is an interventional treatment trial for Triple Negative Breast Cancer
Eligibility Criteria
Inclusion Criteria:
- Non-metastatic operable Stage II-III breast cancer
- Histologically documented TNBC (Triple Negative Breast Cancer)
- Confirmed tumor PD-L1 evaluation as documented through central testing of a representative tumor tissue specimen
- Adequately excised: Patients must have undergone either breast-conserving surgery or mastectomy/nipple- or skin-sparing mastectomy
- Adequate hematologic and end-organ function
- For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures
- For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures and agreement to refrain from donating sperm.
- No more than 8 weeks (56 days) may elapse between definitive breast surgery and randomization.
- Representative formalin-fixed, paraffin embedded (FFPE) tumor specimen from surgical resection in paraffin blocks (preferred) or at least 25 unstained slides.
Exclusion Criteria
- Prior history of invasive breast cancer
- For the currently diagnosed breast cancer, any previous systemic anti-cancer treatment (e.g., neoadjuvant or adjuvant), including, but not limited to, chemotherapy, anti-HER2 therapy.
- Previous therapy with anthracyclines or taxanes for any malignancy
- Cardiopulmonary dysfunction
- Prior malignancies within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death and treated with expected curative outcome
- Active or history of autoimmune disease or immune deficiency
- History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan
- Urinary outflow obstruction
- Active tuberculosis
- Major surgical procedure other than for diagnosis within 4 weeks prior to initiation of study treatment or anticipation of need for a major surgical procedure during study treatment or within 5 months following the last dose of Atezolizumab (for patients randomized to Atezolizumab)
- Prior allogeneic stem cell or solid organ transplant
- Treatment with systemic immunosuppressive medications within 2 weeks prior to initiation of study treatment or anticipation of need for systemic immunosuppressive medication during the study
Sites / Locations
- John Muir Health Clinical Research Center
- Cedars-Sinai Medical Center
- Martin-O?Neil Cancer Center
- Baptist - MD Anderson Cancer Center
- Advocate Illinois Masonic Outpatient Center for Advanced Care
- Des Moines Oncology Research Association
- Cancer Center of Kansas
- University of Maryland Greenebaum Comprehensive Cancer Center
- Fairview Southdale Medical Oncology Clinic
- HCA Midwest Division
- New Hampshire Hematology Oncology
- Monter Cancer Center
- Memorial Sloan Kettering Cancer Center
- Rochester General Hospital; Lipson Cancer and Blood Center
- SCRI
- Intermountain Precision Genomics Cancer Research Clinic-Dixie
- St. Mary's Medical Center
- Centro de Oncologia e; Investigacion Buenos Aires - COIBA
- INSTITUTO DE INVESTIGACIONES METABOLICAS (IDIM); Oncology
- Hospital Britanico de Buenos Aires
- Clinica Universitaria Reina Fabiola
- Fundación Ars Medica
- Centro Oncologico Riojano Integral (CORI)
- Instituto de Oncología de Rosario
- Centro Medico San Roque
- Centro de Investigacion Clinica - Clinica Viedma S.A.; Oncology Department
- St Vincent's Hospital Sydney
- Lismore Base Hospital
- Macquarie University Hospital
- Tweed Hospital
- Sydney Adventist Hospital
- Icon Cancer Care Wesley
- Icon Cancer Foundation; Icon Cancer Care Chermside
- Icon Cancer Care South Brisbane
- Mater Hospital; Cancer Services
- Icon Cancer Foundation; Icon Cancer Care Southport
- Princess Alexandra Hospital; Cancer Trials Unit
- Royal Adelaide Hospital; Cancer Centre
- Ashford Cancer Center Research
- Box Hill Hospital; Eastern Clinical Research Unit
- Monash Medical Centre
- Austin Hospital Olivia Newton John Cancer Centre
- Maroondah Hospital; Breast Clinic
- Lkh-Univ. Klinikum Graz; Klinik Für Gynäkologie
- Medical University Innsbruck; Frauenklinik Innsbruck, Dept Gyn
- Ordensklinikum Linz Barmherzige Schwestern; Interne 1 - Hämato-Onkologie
- Uniklinikum Salzburg, LKH; Univ.Klinik f. Innere Medizin III der PMU
- AKH - Medizinische Universität Wien; Department of Oncology
- General Hospital Hietzing, KLI; Dept. Obstet&Gynecol
- Salzkammergut-Klinikum Voecklabruck
- Klinikum Kreuzschwestern Wels; Iv. Interne Abt.
- Medizinische Universität Wien; Univ.Klinik für Frauenheilkunde - Klinik für Gynäkologie
- AZ KLINA
- Institut Jules Bordet
- UZ Leuven Gasthuisberg
- CHC MontLégia
- Chr de La Citadelle
- CHU Ambroise Paré
- Clinique Sainte-Elisabeth; Oncologie
- Vitaz
- Nucleo de Oncologia da Bahia - NOB
- Crio - Centro Regional Integrado de Oncologia
- Instituto Nacional de Cancer - INCa; Oncologia
- Hospital Jardim Amália
- Oncosite - Centro de Pesquisa Clinica Em Oncologia Ltda
- Hospital Moinhos de Vento
- Hospital das Clinicas - UFRGS
- Hospital Mae de Deus
- Hospital Sao Lucas - PUCRS
- Clinica de Neoplasias Litoral
- Hospital de Cancer de Barretos
- Hospital Amaral Carvalho
- Faculdade de Medicina do ABC - FMABC
- Instituto Brasileiro de Controle Do Câncer ? São Camilo Oncologia
- Instituto Do Câncer Do Estado de São Paulo Octávio Frias de Oliveira
- Peking University People's Hospital
- Beijing Hospital; Internal Medicine-Oncology
- Beijing Union Hospital
- The First Hospital of Jilin University
- Jilin Cancer Hospital
- West China Hospital, Sichuan University
- Chongqing Cancer Hospital
- Fujian Medical University Union Hospital
- The 900th Hospital of PLA joint service support force
- Sun yat-sen University Cancer Center; Internal Medicine of Oncology
- Guangdong General Hospital
- Sun Yat-Sen University Cancer Center - Huangpu Campus
- The First Affiliated Hospital of College of Medicine, Zhejiang University
- The Second Affiliated Hospital of Zhejiang University College
- Harbin Medical University Cancer Hospital
- Shandong Cancer Hospital
- Luoyang Central Hospital
- Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School
- The Affiliated Hospital of Medical College Qingdao University
- Fudan University Shanghai Cancer Center
- Shanghai Jiao Tong University School of Medicine (SJTUSM) - Ruijin Hospital (GuangCi Hospital)
- Zhongshan Hospital Fudan University
- The University of Hong Kong-Shenzhen Hospital; Local Ethic Committee
- Hebei Medical University Fourth Hospital;(Tumor Hospital of Hebei Province)
- Wuhan Union Hospital Tongji Medical College, Huazhong University of Science and Technology
- Hubei Cancer Hospital
- The First Affiliated Hospital of Xian Jiao Tong University
- Zhejiang Cancer Hospital
- Henan Cancer Hospital
- Nemocnice Horovice, NH Hospital a.s.; Oncology Department
- Fakultni Poliklinika Vseobecne Fakultni Niemocnice; Onkologicka Klinika
- Krajska nemocnice T. Bati, a.s.
- Herlev Hospital; Afdeling for Kræftbehandling
- Odense Universitetshospital, Onkologisk Afdeling, Klinisk Forsknings Enhed
- Sygehus Lillebælt, Vejle
- Centre Hospitalier Regional Metz-Thionville - Hopital de Mercy
- Institut Sainte Catherine
- CH de Beauvais
- CHU Jean Minjoz
- Clinique Tivoli; Sce Radiotherapie
- Polyclinique Bordeaux Nord Aquitaine
- Centre Hospitalier Fleyriat
- CHRU De Brest - Hopital Morvan - Institut De Cancerologie Et D'Hematologie
- CRLCC-Francois Baclesse; Oncologie Médicale
- CH de Cholet; oncologie
- Centre Hospitalier de Compiegne
- Centre Hospitalier Alpes Leman
- Centre Georges Francois Leclerc
- Centre Hospitalier Departemental de Vendee
- Clinique Chenieux; Oncology
- Centre Hospitalier Bretagne Sud
- Hopital Prive Jean Mermoz
- Hôpital Saint Joseph
- Clinique Clémentville
- Institut régional du Cancer Montpellier
- l'Hôpital privé du Confluent SAS
- Centre Antoine Lacassagne
- CH Annecy Genevois site Annecy; Oncologie
- Chi De Cornouaille; Oncologie Hospitalisation
- Institut Jean Godinot
- Institut du Cancer Coulancy Reims
- Centre Henri Becquerel
- Institut De Cancerologie Lucien Newrth
- Centre Paul Strauss
- Hopitaux Du Leman - Site Georges Pianta
- Institut Claudius Régaud
- CHU Tours - Hôpital Bretonneau
- Hopital Prive Drome Ardeche; Hopital De Jour
- Institut de Cancérologie de Lorraine
- Institut Gustave Roussy; Departement Oncologie Medicale
- Studienzentrum Berlin City
- St. Johannes-Hospital
- Onkozentrum Dres. Göhler
- BAG Freiberg-Richter, Jacobasch, Illmer, Wolf; Gemeinschaftspraxis Hämatologie-Onkologie
- Praxis für Hamatologie und Onkologie
- Onkodok GmbH
- Albertinen-Krankenhaus Klinik f.Gynäkologie und Geburtshilfe
- Ärztehaus am Bahnhofsplatz; Praxis Uleer/Pourfard
- ViDia Christliche Kliniken Karlsruhe, Vincentius-Diakonissen-Kliniken gAG; Frauenklinik
- St. Elisabeth-Krankenhaus
- Klinikum Ludwigsburg; Studiensekretariat
- St. Vincenz-Elisabeth-Hospital; Katholisches Klinikum Mainz
- Universitätsmedizin Mainz; Klinik u. Poliklinik f. Geburtshilfe u. Frauenheilkunde
- Dres. Michael Maasberg Marion Schmitz und Maria Theresia Keller
- Klinikum Memmingen; Abt.Gynäkologie
- Johannes Wesling Klinikum Minden; Hämatologie, Onkologie, Hämostaseologie und Palliativmedizin
- Brustzentrum Rhein-Ruhr Servicegesellschaft mbH
- Klinikum der Universität München; Frauenklinik - Onkologie II
- Klinikum Neumarkt; Frauenklinik
- Sana Klinikum Offenbach GmbH; Klinik für Gynäkologie & Geburtshilfe
- Johanniter Frauenklinik Stendal Germany
- Gynäkologie Kompetenzzentrum; Praxis Dr. med. Carsten Hielscher
- Universitätsklinik Tübingen; Frauenklinik
- GRN-Klinik Weinheim; Abt.Gynäkologie und Geburtshilfe
- Marien-Hospital Witten, MVZ Witten
- Klinikum Worms; Frauenklinik; Klinik für Gynäkologie und Geburtshilfe
- Pamela Youde Nethersole Eastern Hospital; Clinical Oncology
- Queen Mary Hospital
- Queen Elizabeth Hospital Department of Clinical Oncology
- National Institute of Oncology, A Dept of Internal Medicine
- Borsod-Abaúj-Zemplén Megyei Központi Kórház és Egyetemi Oktatókórház
- Pécsi Tudományegyetem; Klinikai Központ Onkoterápiás Intézet
- Mater Misecordiae University Hospital
- Beaumont Hospital; Cancer Clinical Trials Unit
- Shaare Zedek Medical Center
- Hadassah Med Org Kiryat; Oncology Institute
- Meir Medical center, Pediatrics
- Rabin MC; Davidof Center - Oncology Institute
- The Chaim Sheba Medical Center
- Azienda Ospedaliera Papa Giovanni XXIII
- Azienda Ospedaliero Universitaria Di Bologna - Policlinico S.Orsola Malpighi; UO Farmacia Clinica
- U.O Medicina Oncologica Ospedale di Carpi
- Ospedale Degli Infermi - Faenza; Oncologia Medica
- Azienda Ospedaliero - Universitaria di Modena Policlinico
- Azienda Ospedaliero Universitaria di Parma
- Ospedale degli Infermi
- A.O. Universitaria S. Maria Della Misericordia Di Udine; Oncologia
- Policlinico Universitario Campus Biomedico Di Roma
- Azienda Ospedaliero Universitaria San Martino
- ASST DI LECCO; Oncologia Medica
- Ospedale Mater Salutis
- Istituto Europeo Di Oncologia
- Fondazione Salvatore Maugeri
- Policlinico San Mattea
- Istituto Clinico Humanitas
- Azienda Ospedaliera SS. Antonio E. Biagio E. Cesare Arrigo di Alessandria
- Ospedale Degli Infermi Di Biella; Reparto Oncologia Medica
- Ospedale Santa Maria Annunziata; Oncologia
- Azienda Usl 7; Dept. Oncologico
- Nuovo Ospedale Di Prato
- Azienda Ospedaliera di Perugia Ospedale S. Maria della Misericordia
- Aichi Cancer Center Hospital
- Chiba Cancer Center
- Shikoku Cancer Center
- National Hospital Organization Kyushu Cancer Center
- Fukushima Medical University Hospital
- Hiroshima City Hiroshima Citizens Hospital
- National Hospital Organization Hokkaido Cancer Center
- Hyogo Medical University Hospital
- University of Tsukuba Hospital
- Sagara Hospital
- Kanagawa Cancer Center
- Tokai University Hospital
- Kyoto University Hospital
- Okayama University Hospital
- Naha-nishi Clinic
- National Hospital Organization Osaka National Hospital
- Osaka International Cancer Institute
- Saitama Medical University International Medical Center
- Saitama Cancer Center
- Shizuoka Cancer Center
- St. Luke's Internat. Hospital, Breast Surgical Oncology
- The Cancer Institute Hospital of JFCR
- Chungbuk National University Hospital
- Soon Chun Hyang University Cheonan Hospital
- National Cancer Center
- CHA Bundang Medical Center
- Gachon University Gil Medical Center
- Inha University Hospital
- Seoul National University Bundang Hospital
- Seoul National University Hospital
- Severance Hospital; Yonsei University Health System
- Asan Medical Center
- Gangnam Severance Hospital
- Samsung Medical Center
- Seoul St Mary's Hospital
- Ewha Womans University Mokdong Hospital
- Ajou University Hospital
- Ulsan University Hosiptal
- Wonju Christian Hospital
- Health Pharma Professional Research
- Iem-Fucam
- Instituto Nacional De Cancerologia; Oncology; Tumores Mamarios
- Centro Médico Zambrano Hellion
- Centro de Investigacion Clinica de Oaxaca
- Oncologico Potosino
- Merida | Investigacion Clinica
- CENEIT Oncologicos; DENTRO DE CONDOMINIO SAN FRANCISCO
- Centro Medico Dalinde
- Hospital Nacional Carlos Alberto Seguin Escobedo-Essalud; Oncology & Haemathology
- Oncosalud Sac; Oncología
- Instituto Nacional de Enfermedades Neoplasicas
- Instytut MSF Sp. z o.o.
- MedPolonia
- Wielkopolskie Centrum Onkologi
- Wojskowy Instytut Medyczny - Panstwowy Instytut Badawczy; Klinika Onkologii
- "Filantropia" Clinical Hospital; Gynecological Oncology
- Institutul Oncologic Prof. Dr. Ion Chiricuta Cluj Napoca; Oncologie Medicala
- Centrul de Oncologie Sfantul Nectarie
- Medsi Clinic
- Arkhangelsk Regional Clinical Oncology Dispensary
- Bashkirian Republican Clinical Oncology Dispensary
- Regional Clinical Oncology Hospital
- Oncologica Dispensary #2
- Evimed
- Mordovia State University
- Moscow Clinical Scientific Center
- FSBI Russian Oncology Research Center n.a. Blokhin of MOH RF
- P.A. Herzen Oncological Inst. ; Oncology
- Nizhny Novgorod Regional Clinical Oncology Center
- National Medical Research Center for Oncology
- S-Pb clinical scientific practical center of specialized kinds of medical care (oncological)
- FBI "Scientific Research Institute of Oncology n. a. N. N. Petrov"
- LLC Strategic Medical Systems
- EosMed LLC
- LCC Center of Palliative Medicine - Devita
- Private Healthcare Institution Clinical Hospital RZhD Medicine
- Pyatigorsky Oncologic Dispensary
- Regional Oncology Hospital
- Ivanovo Regional Oncology Dispensary
- Regional Oncology Dispensary; Dept of Chemotherapy
- BIH at Omsk Region "Clinical Oncology Dispensary", Outpatient clinic
- Multidisciplinary clinic Reaviz
- Samara Regional Oncology Dispensary
- Regional Clinical Hospital
- SHI Volgograd Regional Clinical Oncological Dispensary#1
- National University Hospital; Medical Oncology
- National Cancer Centre
- Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia
- Hospital General De Catalunya; Servicio de Oncologia
- Hospital Mutua de Terrassa; Servicio de Oncologia
- Consorci Hospitalari de Terrassa
- Hospital de Jerez
- Hospital Provincial Castellón
- Hospital Son Llatzer
- Centro Oncologico de Galicia COG; Medical Oncology
- Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Oncologia
- Hospital Universitario Puerta de Hierro - Majadahonda
- Hospital Infanta Sofia; Servico de Oncologia
- Complexo Hospitalario de Vigo. Hospital Álvaro Cunqueiro; Servicio de Oncología
- Hospital Universitari Sant Joan de Reus; Planta baja, color lila
- Hospital Universitario de Canarias;servicio de Oncologia
- Hospital Universitario de Burgos
- Hospital San Pedro De Alcantara; Servicio de Oncologia
- Complejo Hospitalario de Jaen
- Complejo Asistencial Universitario de Leon; Servicio de Oncologia
- Hospital General Universitario Gregorio Marañon; Servicio de Oncologia
- Hospital Universitario Ramón y Cajal
- Hospital Universitario 12 de Octubre; Servicio de Oncologia
- Centro Integral Oncológico Clara Campal Ensayos Clínicos START
- Hosp Univ Fundacion Alcorcon
- Hospital Universitario de Fuenlabrada; Servicio de Oncologia
- Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia
- Hospital Universitario Virgen de Arrixaca; Servicio de Oncologia
- Hospital Quirón Sagrado Corazón
- Instituto Valenciano Oncologia; Oncologia Medica
- Hospital Clinico Universitario de Valencia
- Hospital General Universitario de Valencia; Servicio de oncologia
- Hospital Clinico Universitario Lozano Blesa; Servicio de Oncologia
- Hirslanden Medical Center - Tumorzentrum
- Centre Hospitalier Universitaire Vaudois - Lausanne
- Brust-Zentrum Zürich AG Seefeldstrasse 214 Zürich
- Chunghua Christian hospital
- Kaohsiung Medical University Hospital; Chung-Ho Memorial Hospital
- E-Da Cancer Hospital; Hematology- Oncology Department
- Chi Mei Medical Center Liou Ying Campus
- National Cheng Kung University Hospital
- Taipei Veterans General Hospital
- National Taiwan University Hospital
- Mackay Memorial Hospital - Taipei Branch
- Tri-Service General Hospital
- Chang Gung Medical Foundation Linkou Branch
- Rajavithi Hospital; Division of Medical Oncology
- Ramathibodi Hospital; Medicine/Oncology
- Siriraj Hospital; Clinical Research Center, Pharmacy Department
- Songklanagarind Hospital
- Srinagarind Hospital, Khon Kaen University
- Lampang Cancer Hospital
- King Chulalongkorn Memorial Hospital; Faculty of Medicine Chulalongkorn University
- Baskent Universitesi Adana Dr. Turgut Noyan Uygulama ve Arastirma Merkezi
- Uludag Universitesi - Saglik Uygulama ve Arastirrma Merkezi
- Ege Universitesi Hastanesi (Saglik Uygulama ve Arastirma Merkezi)
- Izmir Ekonomi Universitesi Medical Park Hastanesi
- Mersin Universitesi Tip Fakultesi Hastanesi; Tibbi Onkoloji Birimi
- Medikal Park Samsun
- Yulis Medical and Diagnostic Center
- Municipal Noncommercial Institution Regional Center of Oncology
- MI "Clinical Oncological Dispensary" of Dnipro Reg Council; chemotherapy department
- Municipal Institution Odesa Regional Oncology Dispensary
- Vinnytsya Regional Clinical Oncology Dispensary
- Regional Oncology Center; Department of Mammology
- Chernivtsi Regional Clinical Oncology Dispensary
- City Clinical Hospital #4
- Municipal Institution Kirovograd Regional Oncology Dispensary
- ME Kryviy Rih Oncology Dispensary of Dnipropetrovs?k Regional Council; Chemotherapy Department
- Volyn Regional Oncology Dispensary
- Lviv State Oncological Regional Treatment and Diagnostic Center
- Municipal Institution Odesa Regional Clinical Hospital
- Sumy Reg. Clin. Oncological Dispensary; Thoracall Department
- CCCH City Oncological Center SHEI Uzhgorod NU
- Transkarpathian Regional Oncology Clinic; Chemotherapy
- Zaporizhzhia Regional Clinical Oncology Dispensary; Zaporizhzhya State Medical University
- NHS Lothian - Western General Hospital; NHS Lothian - Western General Hospital
- Calderdale and Huddersfield NHS Foundation Trust
- Leeds Teaching Hosp NHS Trust;St James's Institute of Onc
- Guys and St Thomas NHS Foundation Trust, Guys Hospital
- The Christie NHS Foundation Trust
- Nottingham University Hospitals NHS Trust - City Hospital
- University Hospitals of North Midlands NHS Trust-Royal Stoke University Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Atezolizumab + Chemotherapy
Chemotherapy
Participants will receive atezolizumab (in combination with chemotherapy as described below) every 2 weeks for 10 doses, followed by atezolizumab maintenance therapy every 3 weeks to complete 1 year of treatment from the first dose Chemotherapy will consist of paclitaxel every week for 12 weeks, followed by dose-dense doxorubicin +cyclophosphamide or dose-dense epirubicin + cyclophosphamide every 2 weeks, for 4 doses supported with Granulocyte Colony-Stimulating Factor (G-CSF) or Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF)
Chemotherapy will consist of paclitaxel every week for 12 weeks, followed by dose-dense doxorubicin +cyclophosphamide or dose-dense epirubicin + cyclophosphamide every 2 weeks, for 4 doses supported with Granulocyte Colony-Stimulating Factor (G-CSF) or Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF)