A Study of Trastuzumab Emtansine in Combination With Atezolizumab or Placebo as a Treatment for Participants With Human Epidermal Growth Factor 2 (HER2)-Positive and Programmed Death-ligand 1 (PD-L1)-Positive Locally Advanced (LABC) or Metastatic Breast Cancer (MBC)

Part of paid clinical trials in Redlands, California.

Sponsor
Hoffmann-La Roche
Study ID
NCT04740918
Phase
PHASE3
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Trastuzumab Emtansine — DRUG
    Trastuzumab emtansine 3.6 mg/kg IV infusion
  • Atezolizumab — DRUG
    Atezolizumab 1200 mg IV infusion
  • Placebo — OTHER
    Placebo matched to atezolizumab

Study Details

This study will evaluate the efficacy, safety and patient-reported outcomes of trastuzumab emtansine plus atezolizumab compared with trastuzumab emtansine plus placebo in participants with HER2-positive and PD-L1-positive LABC or MBC.Participants must have progressed either during or after prior trastuzumab- (+/- pertuzumab) and taxane-based therapy for LABC/MBC; or during (or within 6 months after completing) trastuzumab- (+/-pertuzumab) and taxane-based therapy in the neoadjuvant and/or adjuvant setting.

Key Dates

Start date
Jun 7, 2021
Status verified
Jul 2025
Primary completion
Jun 19, 2024
Completion
Jun 19, 2024

Study Design

Enrollment
96 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Arm A: Trastuzumab Emtansine and Placebo
    Placebo matched to atezolizumab followed by trastuzumab emtansine 3.6 milligrams per kilogram (mg/kg) intravenous (IV) infusion on Day 1 Cycle 1 and thereafter on Day 1 of each 21-day cycle until disease progression, unmanageable toxicity, or study termination by the sponsor.
  • Experimental: Arm B: Trastuzumab Emtansine and Atezolizumab
    Atezolizumab 1200 mg IV infusion followed by trastuzumab emtansine 3.6 mg/kg IV infusion on Day 1 Cycle 1 and thereafter on Day 1 of each 21-day cycle until disease progression, unmanageable toxicity, or study termination by the Sponsor.

Primary Outcome Measure

Progression-Free Survival (PFS) as Determined by Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) [ Time Frame: Up to 28 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Emad Ibrahim, Md, IncRedlandsCalifornia92373-

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Emad Ibrahim, Md, Inc· Redlands, CA

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