Trials / Active Not Recruiting
Active Not RecruitingNCT04873362
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
A Phase III, Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Adjuvant Atezolizumab or Placebo and Trastuzumab Emtansine for HER2-Positive Breast Cancer at High Risk of Recurrence Following Preoperative Therapy
- Status
- Active Not Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 1,188 (actual)
- Sponsor
- Hoffmann-La Roche · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Atezolizumab | Atezolizumab will be administered at a dose of 1200 mg every three weeks (Q3W) for 14 cycles. |
| DRUG | Trastuzumab Emtansine | Trastuzumab emtansine will be administered at a dose of 3.6 mg/kg Q3W for 14 weeks. |
| DRUG | Placebo | Placebo matched to atezolizumab will be administered at a dose of 1200 mg Q3W for 14 cycles. |
| DRUG | 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. |
Timeline
- Start date
- 2021-05-04
- Primary completion
- 2028-08-31
- Completion
- 2034-10-02
- First posted
- 2021-05-05
- Last updated
- 2026-03-04
Locations
238 sites across 32 countries: United States, Australia, Austria, Belgium, Brazil, Bulgaria, China, Czechia, Denmark, France, Germany, Greece, Hong Kong, Hungary, India, Italy, Kenya, Mexico, New Zealand, Poland, Portugal, Romania, Russia, Singapore, South Korea, Spain, Taiwan, Thailand, Turkey (Türkiye), Uganda, Ukraine, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04873362. Inclusion in this directory is not an endorsement.