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

Conditions

• Breast Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Atezolizumab — DRUG
  Atezolizumab will be administered at a dose of 1200 mg every three weeks (Q3W) for 14 cycles.
• Trastuzumab Emtansine — DRUG
  Trastuzumab emtansine will be administered at a dose of 3.6 mg/kg Q3W for 14 weeks.
• Placebo — DRUG
  Placebo matched to atezolizumab will be administered at a dose of 1200 mg Q3W for 14 cycles.
• Trastuzumab — DRUG
  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 Details

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.

Key Dates

Start date

May 4, 2021

Status verified

Mar 2026

Primary completion

Aug 31, 2028

Completion

Oct 2, 2034

Study Design

Enrollment

1,188 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Arm A: Placebo + Trastuzumab Emtansine
  Participants will receive an intravenous (IV) infusion of placebo prior to the IV infusion of trastuzumab emtansine on Day 1 of each 21-day cycle for a total of 14 cycles.
• Experimental: Arm B: Atezolizumab + Trastuzumab Emtansine
  Participants will receive an IV infusion of atezolizumab prior to the IV infusion of trastuzumab emtansine on Day 1 of each 21-day cycle for a total of 14 cycles.

Primary Outcome Measure

Invasive Disease-free Survival (IDFS) in the Full Analysis Set (FAS) [ Time Frame: From baseline until the first occurrence of iDFS event or death, through primary analysis data cut off (approximately 7 years) ]

Locations (22)

Find similar trials in Birmingham, AL

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