Breast Cancer Clinical Trial

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

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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Archival tumor samples must be obtained from primary and/or metastatic sites
Able to submit tumor tissue that is evaluable for programmed death- ligand 1 (PD-L1) expression
HER-2 positive BC as defined by an immunohistochemistry score of 3 or gene amplified by in-situ hybridization as defined by a ratio of greater than or equal to (>=) 2.0 for the number of HER2 gene copies to the number of chromosome 17 copies
Histologically or cytologically confirmed invasive BC: incurable, unresectable, locally advanced BC previously treated with multimodality therapy or metastatic BC
Prior treatment for BC in the: adjuvant; unresectable locally advanced; or metastatic settings; which must include both, a taxane and trastuzumab (alone or in combination with another agent)
Progression must have occurred during or after most recent treatment for locally advanced/metastatic BC or within 6 months after completing adjuvant therapy
Participants must have measurable disease that is evaluable as per RECIST v1.1
Eastern Cooperative Oncology Group Performance Status of 0 or 1
Negative serum pregnancy test within 7 days of enrollment for pre-menopausal women and for women less than 12 months after the onset of menopause
Use of highly effective method of contraception as defined by the protocol

Exclusion Criteria:

Prior treatment with trastuzumab emtansine, cluster of differentiation 137 agonists, anti-programmed death-1, or anti-PD-L1 therapeutic antibody or pathway-targeting agents
Receipt of any anti-cancer drug/biologic or investigational treatment within 21 days prior to Cycle 1 Day 1 except hormone therapy, which can be given up to 7 days prior to Cycle 1 Day 1; recovery of treatment related toxicity consistent with other eligibility criteria
Radiation therapy within 2 weeks prior to Cycle 1, Day 1
History of exposure to the cumulative doses of anthracyclines
History of other malignancy within the previous 5 years, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage I uterine cancer, or participants who have undergone potentially curative therapy with no evidence of disease and are deemed by the treating physician to be at low risk for recurrence
Cardiopulmonary dysfunction, symptomatic pleural effusion, pericardial effusion, or ascites
Participants with severe infection within 4 weeks prior to randomization, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia
Current severe, uncontrolled systemic disease
Major surgical procedure or significant traumatic injury within 28 days prior to randomization or anticipation of the need for major surgery during the course of study treatment
Clinically significant history of liver disease, including cirrhosis, current alcohol abuse, autoimmune hepatic disorders, sclerosis cholangitis or active infection with human immunodeficiency virus, hepatitis B virus, or hepatitis C virus
Need for current chronic corticosteroid therapy (>=10 mg of prednisone per day or an equivalent dose of other anti-inflammatory corticosteroids)
Spinal cord compression not definitively treated with surgery and/or radiation, or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for greater than (>) 2 weeks prior to randomization
Participants with known central nervous system disease
Leptomeningeal disease
History of autoimmune disease
Prior allogeneic stem cell or solid organ transplantation
Active tuberculosis
Receipt of a live, attenuated vaccine within 4 weeks prior to randomization or anticipation that such a live, attenuated vaccine will be required during the study
Treatment with systemic immunostimulatory agents within 4 weeks or five half-lives of the drug (whichever is shorter) prior to randomization
Treatment with systemic corticosteroids or other systemic immunosuppressive medications within 2 weeks prior to randomization, or anticipated requirement for systemic immunosuppressive medications during the trial
Participants who are breastfeeding, or intending to become pregnant during the study

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

202

Study ID:

NCT02924883

Recruitment Status:

Completed

Sponsor:

Hoffmann-La Roche

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There are 68 Locations for this study

See Locations Near You

Breastlink Med Group Inc
Orange California, 92868, United States
University of Colorado
Aurora Colorado, 80045, United States
MedStar Georgetown University Hospital (Lombardi Comprehensive Cancer Center)
Washington District of Columbia, 20007, United States
SCRI Florida Cancer Specialists South
Fort Myers Florida, 33916, United States
Florida Cancer Specialists; Saint Petersburg
Saint Petersburg Florida, 33719, United States
Northside Hospital
Atlanta Georgia, 30342, United States
Johns Hopkins Univ Med Center
Baltimore Maryland, 21231, United States
San Juan Oncology Associates
Farmington New Mexico, 87401, United States
Laura and ISAAC Perlmutter Cancer Center at NYU Langone.
New York New York, 10016, United States
Ohio State Uni Medical Center
Columbus Ohio, 43210, United States
Magee Womens Hospital
Pittsburgh Pennsylvania, 15213, United States
Cancer Care Associates of York
York Pennsylvania, 17403, United States
SCRI Tennessee Oncology Chattanooga
Chattanooga Tennessee, 37404, United States
Tennessee Oncology; Sarah Cannon Research Institute
Nashville Tennessee, 37203, United States
University of Washington
Seattle Washington, 98195, United States
St George Hospital; Cancer Care Centre
Kogarah New South Wales, 2217, Australia
Calvary Mater Newcastle
Waratah New South Wales, 2298, Australia
Princess Alexandra Hospital Woolloongabba; Clinical Hematology and Medical Oncology
Woolloongabba Queensland, 4102, Australia
Peter MacCallum Cancer Center
East Melbourne Victoria, 3002, Australia
Peninsula and South Eastern Haematology and Oncology Group
Frankston Victoria, 3199, Australia
Sunshine Hospital
St Albans Victoria, 3021, Australia
St John of God Hospital; Bendat Cancer Centre
Subiaco Western Australia, 6008, Australia
Lakeridge Health Oshawa; Oncology
Oshawa Ontario, L1G 2, Canada
The Ottawa Hospital Cancer Centre; Oncology
Ottawa Ontario, K1H 8, Canada
Sunnybrook Odette Cancer Centre
Toronto Ontario, M4N 3, Canada
McGill University; Sir Mortimer B Davis Jewish General Hospital; Oncology
Montreal Quebec, H3T 1, Canada
McGill University; Glen Site; Oncology
Montreal Quebec, H4A 3, Canada
Hopital du Saint Sacrement
Quebec City Quebec, G1S 4, Canada
HELIOS Klinikum Berlin-Buch; Klinik für Gynäkologie und Geburtshilfe
Berlin , 13125, Germany
Studienzentrum Berlin City
Berlin , 14169, Germany
Klinikum Essen-Mitte Ev. Huyssens-Stiftung / Knappschafts GmbH; Klinik für Senologie / Brustzentrum
Essen , 45136, Germany
Praxis für Interdisziplinäre Onkologie und Hämatologie GbR
Freiburg , 79110, Germany
Nationales Centrum für Tumorerkrankungen (NCT) ; Gyn. Onk. Frauenklinik; Uniklinikum Heidelberg
Heidelberg , 69120, Germany
Institut für Versorgungsforschung in der Onkologie GbR Koblenz
Koblenz , 56068, Germany
IRCCS Istituto Nazionale Tumori Fondazione Pascale; Oncologia Medica A
Napoli Campania, 80131, Italy
A.O.U Policlinico S. Orsola Malpighi di Bologna U.O di Medicina Interna Borghi - Pad.2
Bologna Emilia-Romagna, 40138, Italy
Ospedale Regionale Di Parma; Divisione Di Oncologia Medica
Parma Emilia-Romagna, 43100, Italy
Centro Di Riferimento Oncologico; SOC Oncologia Medica C
Aviano Friuli-Venezia Giulia, 33081, Italy
Centro Catanese Di Oncologia; Oncologia Medica
Catania Sicilia, 95126, Italy
Ospedale Santo Stefano, Azienda USL Centro Prato
Prato Toscana, 59100, Italy
National Cancer Center
Goyang-si , 10408, Korea, Republic of
Samsung Medical Center
Seoul , (0)63, Korea, Republic of
Seoul National University Hospital
Seoul , 03080, Korea, Republic of
Severance Hospital, Yonsei University Health System
Seoul , 03722, Korea, Republic of
Asan Medical Center
Seoul , 05505, Korea, Republic of
Hospital Universitario Reina Sofia; Servicio de Oncologia
Córdoba Cordoba, 14004, Spain
Hospital Univ Vall d'Hebron; Servicio de Oncologia
Barcelona , 08035, Spain
Complejo Hospitalario Universitario A Coruña (CHUAC, Materno Infantil), Oncología
La Coruña , 15006, Spain
Hospital Ramon y Cajal; Servicio de Oncologia
Madrid , 28034, Spain
Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia
Valencia , 46010, Spain
Hospital Arnau de Vilanova (Valencia) Servicio de Oncologia
Valencia , 46015, Spain
Changhua Christian Hospital; Dept of Surgery
Changhua , 500, Taiwan
Kaohsiung Medical Uni Chung-Ho Hospital; Dept of Surgery
Kaohsiung , 807, Taiwan
China Medical University Hospital; Surgery
Taichung , 404, Taiwan
Chi-Mei Medical Center
Tainan , 736, Taiwan
Koo Foundation Sun Yat-Sen Cancer Center; Hemato-Oncology
Taipei City , 11259, Taiwan
VETERANS GENERAL HOSPITAL; Department of General Surgery
Taipei , 00112, Taiwan
National Taiwan Uni Hospital; General Surgery
Taipei , 100, Taiwan
Chang Gung Memorial Hospital - Linkou
Taoyuan , 333, Taiwan
Royal United Hospital; Oncology Department
Bath , BA1 3, United Kingdom
Beatson West of Scotland Cancer Centre
Glasgow , G12 0, United Kingdom
Royal Free Hospital; Dept of Oncology
London , NW3 2, United Kingdom
Royal Marsden Hosp NHS Fnd; Breast Unit
London , SW3 6, United Kingdom
Christie Hospital; Breast Cancer Research Office
Manchester , M20 4, United Kingdom
Nottingham City Hospital
Nottingham , NG5 1, United Kingdom
Weston Park Hospital; Cancer Clinical Trials Centre
Sheffield , S10 2, United Kingdom
Royal Marsden Hosp NHS Fnd; Medicine - Breast Unit
Sutton , SM2 5, United Kingdom
Singleton Hospital; Pharmacy
Swansea , SA2 8, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

202

Study ID:

NCT02924883

Recruitment Status:

Completed

Sponsor:


Hoffmann-La Roche

How clear is this clinincal trial information?

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