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Spots Global Cancer Trial Database for 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

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Trial Identification

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

Study Description

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:

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: Clinical Trials

Affiliation: Hoffmann-La Roche

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

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