CompletedPhase 3

A Study of the Efficacy and Safety of Atezolizumab Plus Chemotherapy for Patients With Early Relapsing Recurrent Triple-Negative Breast Cancer

United States595 participantsStarted 2018-01-11

Plain-language summary

This study will evaluate the efficacy and safety of atezolizumab plus chemotherapy compared with placebo plus chemotherapy in patients with inoperable recurrent triple-negative breast cancer (TNBC).

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓PD-L1-positive tumour status (assessed centrally prior to randomisation), defined as PD-L1 expression on tumour-infiltrating immune cells (IC) of 1% or greater.

Exclusion criteria

✕Hypersensitivity to platinum containing compounds or any component of carboplatin or gemcitabine drug formulations in patients selected to receive carboplatin and Gemcitabine

What they're measuring

Overall Survival (OS) in PD-L1-positive Population

Timeframe: Time from randomization to death (Up to 68 months)

OS in Modified Intent-to-treat (mITT) Population

Timeframe: Time from randomization to death (Up to 68 months)

Trial details

NCT IDNCT03371017

SponsorHoffmann-La Roche

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-10-23

Results submitted2025-10-15

View on ClinicalTrials.gov More Triple Negative Breast Neoplasms trials