🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in India / NCT04873362
Active, not recruiting Phase 3

A Study Evaluating the Efficacy and Safety of Adjuvant Atezolizumab or Placebo and Trastuzumab Emtansine for Participants With HER2-Positive Breast Cancer at High Risk of Recurrence Following Preoperative Therapy

NCT04873362 · tracked via the Priya Life Science India tracker
Sponsor
Hoffmann-La Roche
Phase
Phase 3
Started
2021-05-04
Last updated
2026-09-03

Condition(s) studied

Breast Cancer

Investigational drug(s) / intervention(s)

AtezolizumabTrastuzumab EmtansinePlaceboTrastuzumab

Atezolizumab: Atezolizumab will be administered at a dose of 1200 mg every three weeks (Q3W) for 14 cycles.

Trastuzumab Emtansine: Trastuzumab emtansine will be administered at a dose of 3.6 mg/kg Q3W for 14 weeks.

Placebo: Placebo matched to atezolizumab will be administered at a dose of 1200 mg Q3W for 14 cycles.

Trastuzumab: Trastuzumab will be used to complete 14 cycles of study treatment if trastuzumab emtansine is discontinued for toxicity not considered to be related to the trastuzumab component of the drug.

Study summary

This is a Phase III, two-arm, randomized, double-blind placebo-controlled study in participants with HER2-positive primary breast cancer who have received preoperative chemotherapy and HER2-directed therapy, including trastuzumab followed by surgery, with a finding of residual invasive disease in the breast and/or axillary lymph nodes.

As of June 4, 2024, this study is no longer accepting any newly screened participants.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: * Histologically confirmed invasive breast carcinoma * Centrally-confirmed human epidermal growth factor receptor 2 (HER2)-positive invasive breast cancer * Centrally confirmed PD-L1 and hormone receptor status * Clinical stage at disease presentation (prior to neoadjuvant therapy): cT4/anyN/M0, any cT/N2-3/M0, or cT1-3/N0-1/M0 (participants with cT1mi/T1a/T1b/N0 are not eligible) * Completion of pre-operative systemic chemotherapy including at least 9 weeks of taxane and 9 weeks of trastuzumab (anthracycline and/or additional HER2-targeted agents are permitted) * \<=12 weeks between primary surgery and randomization * Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1 * Screening left ventricular ejection fraction (LVEF) \>= 50% and no decrease in LVEF by \>15% from the pre-chemotherapy LVEF. If no pre-chemotherapy LVEF, screening LVEF \>= 55% * Life expectancy \>= 6 months * Adequate hematologic and end organ function Exclusion Criteria: * Stage IV breast cancer * An overall response of disease progression according to the investigator at the conclusion of preoperative systemic therapy * Prior treatment with T-DM1, or atezolizumab, or other immune checkpoint inhibitors * History of exposure to various cumulative doses of anthracyclines * History of other malignancy within 5 years prior to screening, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage I uterine cancer, or ductal carcinoma in situ (DCIS) * Current grade \>=2 peripheral neuropathy * History of idiopathic pulmonary fibrosis, organizing pneumonia, or pneumonitis * History of or active autoimmune disease or immune deficiency * Treatment with immunostimulatory or immunosuppressive agents * Cardiopulmonary dysfunction * Any known active liver disease

Primary outcome measure(s)

Trial sites (238)

FacilityCityRegionStatus
Alabama Oncology Birmingham Alabama
Roy and Patricia Disney Family Cancer Center- Providence Saint Joseph Medical Center Buena California
UCLA Medical Center Santa Monica California
Innovation Clinical Research Institute Whittier California
Florida Cancer Specialists West Palm Beach Florida
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital Carrollton Georgia
University of Iowa Iowa City Iowa
New England Cancer Specialists Westbrook Maine
The Valley Hospital Paramus New Jersey
Levine Cancer Institute Charlotte North Carolina
Abramson Cancer Center; Univ of Pennsylvania; Clinical Research Unit Philadelphia Pennsylvania
The West Clinic Germantown Tennessee
Thompson Cancer Survival Center Knoxville Tennessee
Mays Cancer Center at UT Health San Antonio MD Anderson Cancer San Antonio Texas
Hematology Oncology Associates of Fredericksburg, Inc. Fredericksburg Virginia
Virginia Oncology Associates - New Port News Newport News Virginia
Virginia Oncology Associates Norfolk Virginia
Virginia Cancer Institute Richmond Virginia
Virginia Oncology Associates - Virginia Beach Virginia Beach Virginia
Providence Regional Cancer Partnership Everett Washington
Kadlec Clinic Hematology and Oncology Kennewick Washington
Northwest Medical Specialties Tacoma Washington
Macarthur Cancer Therapy Centre Campbelltown New South Wales
Royal North Shore Hospital St Leonards New South Wales
Princess Alexandra Hospital Woolloongabba Queensland
Tiroler Landeskrankenanstalten Ges.M.B.H. Innsbruck Austria
Ordensklinikum Linz Barmherzige Schwestern Linz Austria
Lkh Salzburg - Univ. Klinikum Salzburg Salzburg Austria
Cliniques Universitaires St-Luc Brussels Belgium
Jessa Zkh (Campus Virga Jesse) Hasselt Belgium
Clinique St. Elizabeth Namur Belgium
Crio - Centro Regional Integrado de Oncologia Fortaleza Ceará
Hospital Sao Rafael - HSR Salvador Estado de Bahia
Hospital Araujo Jorge Goiânia Goiás
Oncosite - Centro de Pesquisa Clinica Em Oncologia Ltda Ijuí Rio Grande do Sul
Santa Casa de Misericordia de Porto Alegre Porto Alegre Rio Grande do Sul
Hospital Sao Lucas - PUCRS Porto Alegre Rio Grande do Sul
Hospital Nossa Senhora da Conceicao Porto Alegre Rio Grande do Sul
Hospital de Base de Sao Jose do Rio Preto São José do Rio Preto São Paulo
Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda São Paulo São Paulo

+ 198 more sites — see the full list on the official registry below.

On this site

📄 Tecentriq (atezolizumab) drug profile → 📄 Herceptin (trastuzumab) drug profile →

More Hoffmann-La Roche trials in India

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04873362 on ClinicalTrials.gov ↗ ← All trials in India