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Brief Title: A Study to Evaluate the Efficacy and Safety of Trastuzumab Emtansine in Combination With Atezolizumab or Atezolizumab-Placebo in Participants With Human Epidermal Growth Factor-2 (HER2) Positive Locally Advanced or Metastatic Breast Cancer (BC) Who Received Prior Trastuzumab and Taxane Based Therapy
Official Title: A Randomized, Multicenter, Double-Blind, Placebo-Controlled Phase II Study of the Efficacy and Safety of Trastuzumab Emtansine in Combination With Atezolizumab or Atezolizumab-Placebo in Patients With HER2-Positive Locally Advanced or Metastatic Breast Cancer Who Have Received Prior Trastuzumab and Taxane Based Therapy
Study ID: NCT02924883
Brief Summary: This Phase II, double-blind, randomized, placebo-controlled multicenter study will investigate the efficacy and safety of trastuzumab emtansine in combination with atezolizumab or atezolizumab-placebo in participants with HER2-positive locally advanced or metastatic BC who have received prior trastuzumab and taxane based therapy, either alone or in combination, and/or who have progressed within 6 months after completing adjuvant therapy.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Breastlink Med Group Inc, Orange, California, United States
University of Colorado, Aurora, Colorado, United States
MedStar Georgetown University Hospital (Lombardi Comprehensive Cancer Center), Washington, District of Columbia, United States
SCRI Florida Cancer Specialists South, Fort Myers, Florida, United States
Florida Cancer Specialists; Saint Petersburg, Saint Petersburg, Florida, United States
Northside Hospital, Atlanta, Georgia, United States
Johns Hopkins Univ Med Center, Baltimore, Maryland, United States
San Juan Oncology Associates, Farmington, New Mexico, United States
Laura and ISAAC Perlmutter Cancer Center at NYU Langone., New York, New York, United States
Ohio State Uni Medical Center, Columbus, Ohio, United States
Magee Womens Hospital, Pittsburgh, Pennsylvania, United States
Cancer Care Associates of York, York, Pennsylvania, United States
SCRI Tennessee Oncology Chattanooga, Chattanooga, Tennessee, United States
Tennessee Oncology; Sarah Cannon Research Institute, Nashville, Tennessee, United States
University of Washington, Seattle, Washington, United States
St George Hospital; Cancer Care Centre, Kogarah, New South Wales, Australia
Calvary Mater Newcastle, Waratah, New South Wales, Australia
Princess Alexandra Hospital Woolloongabba; Clinical Hematology and Medical Oncology, Woolloongabba, Queensland, Australia
Peter MacCallum Cancer Center, East Melbourne, Victoria, Australia
Peninsula and South Eastern Haematology and Oncology Group, Frankston, Victoria, Australia
Sunshine Hospital, St Albans, Victoria, Australia
St John of God Hospital; Bendat Cancer Centre, Subiaco, Western Australia, Australia
Lakeridge Health Oshawa; Oncology, Oshawa, Ontario, Canada
The Ottawa Hospital Cancer Centre; Oncology, Ottawa, Ontario, Canada
Sunnybrook Odette Cancer Centre, Toronto, Ontario, Canada
McGill University; Sir Mortimer B Davis Jewish General Hospital; Oncology, Montreal, Quebec, Canada
McGill University; Glen Site; Oncology, Montreal, Quebec, Canada
Hopital du Saint Sacrement, Quebec City, Quebec, Canada
HELIOS Klinikum Berlin-Buch; Klinik für Gynäkologie und Geburtshilfe, Berlin, , Germany
Studienzentrum Berlin City, Berlin, , Germany
Klinikum Essen-Mitte Ev. Huyssens-Stiftung / Knappschafts GmbH; Klinik für Senologie / Brustzentrum, Essen, , Germany
Praxis für Interdisziplinäre Onkologie und Hämatologie GbR, Freiburg, , Germany
Nationales Centrum für Tumorerkrankungen (NCT) ; Gyn. Onk. Frauenklinik; Uniklinikum Heidelberg, Heidelberg, , Germany
Institut für Versorgungsforschung in der Onkologie GbR Koblenz, Koblenz, , Germany
IRCCS Istituto Nazionale Tumori Fondazione Pascale; Oncologia Medica A, Napoli, Campania, Italy
A.O.U Policlinico S. Orsola Malpighi di Bologna U.O di Medicina Interna Borghi - Pad.2, Bologna, Emilia-Romagna, Italy
Ospedale Regionale Di Parma; Divisione Di Oncologia Medica, Parma, Emilia-Romagna, Italy
Centro Di Riferimento Oncologico; SOC Oncologia Medica C, Aviano, Friuli-Venezia Giulia, Italy
Centro Catanese Di Oncologia; Oncologia Medica, Catania, Sicilia, Italy
Ospedale Santo Stefano, Azienda USL Centro Prato, Prato, Toscana, Italy
National Cancer Center, Goyang-si, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
Seoul National University Hospital, Seoul, , Korea, Republic of
Severance Hospital, Yonsei University Health System, Seoul, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Hospital Universitario Reina Sofia; Servicio de Oncologia, Córdoba, Cordoba, Spain
Hospital Univ Vall d'Hebron; Servicio de Oncologia, Barcelona, , Spain
Complejo Hospitalario Universitario A Coruña (CHUAC, Materno Infantil), Oncología, La Coruña, , Spain
Hospital Ramon y Cajal; Servicio de Oncologia, Madrid, , Spain
Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia, Valencia, , Spain
Hospital Arnau de Vilanova (Valencia) Servicio de Oncologia, Valencia, , Spain
Changhua Christian Hospital; Dept of Surgery, Changhua, , Taiwan
Kaohsiung Medical Uni Chung-Ho Hospital; Dept of Surgery, Kaohsiung, , Taiwan
China Medical University Hospital; Surgery, Taichung, , Taiwan
Chi-Mei Medical Center, Tainan, , Taiwan
Koo Foundation Sun Yat-Sen Cancer Center; Hemato-Oncology, Taipei City, , Taiwan
VETERANS GENERAL HOSPITAL; Department of General Surgery, Taipei, , Taiwan
National Taiwan Uni Hospital; General Surgery, Taipei, , Taiwan
Chang Gung Memorial Hospital - Linkou, Taoyuan, , Taiwan
Royal United Hospital; Oncology Department, Bath, , United Kingdom
Beatson West of Scotland Cancer Centre, Glasgow, , United Kingdom
Royal Free Hospital; Dept of Oncology, London, , United Kingdom
Royal Marsden Hosp NHS Fnd; Breast Unit, London, , United Kingdom
Christie Hospital; Breast Cancer Research Office, Manchester, , United Kingdom
Nottingham City Hospital, Nottingham, , United Kingdom
Weston Park Hospital; Cancer Clinical Trials Centre, Sheffield, , United Kingdom
Royal Marsden Hosp NHS Fnd; Medicine - Breast Unit, Sutton, , United Kingdom
Singleton Hospital; Pharmacy, Swansea, , United Kingdom
Name: Clinical Trials
Affiliation: Hoffmann-La Roche
Role: STUDY_DIRECTOR