CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 595 enrolled
Drug / intervention
Atezolizumab +4 moredrug
Likely dose
Atezolizumab 1200 mg IV infusion every 3 weeks (combined with gemcitabine 1000 mg/m² + carboplatin AUC 2 on days 1,8 or capecitabine 1000 mg/m² twice daily days 1-14)AI-extracted
Key inclusion· 8
  • ✓Histologically confirmed triple-negative breast cancer that is inoperable locally advanced or metastatic
  • ✓Disease progression within 12 months from last curative treatment
  • ✓Prior treatment with anthracycline and taxane for early breast cancer
  • ✓No prior chemotherapy or targeted systemic therapy for locally advanced inoperable or metastatic disease; prior radiation for recurrent disease permitted
Key exclusion· 10
  • ✕Spinal cord compression not definitively treated or untreated for <2 weeks
  • ✕Symptomatic, untreated, or actively progressing CNS metastases
  • ✕Symptomatic or rapid visceral progression
  • ✕History of leptomeningeal disease

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03371017
NCT03371017Phase 3Completed
CompareCT.gov

A Phase III, Randomised, Double-Blind, Placebo-Controlled, Multicentre Study Of The Efficacy And Safety Of Atezolizumab Plus Chemotherapy For Patients With Early Relapsing Recurrent (Inoperable Locally Advanced Or Metastatic) Triple-Negative Breast Cancer

Hoffmann-La Roche·interventional·Posted Dec 13, 2017·Updated Nov 12, 2025

In Brief

A Phase 3 clinical trial evaluating Atezolizumab, Placebo, and 3 other interventions for Triple Negative Breast Neoplasms. Completed, enrolled 595 participants across 124 sites in 28 countries.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTriple Negative Breast Neoplasms
CountriesArgentina, Bosnia and Herzegovina, Brazil, Chile, China, Cuba, Finland, France, Germany, Hungary, Italy, Kazakhstan, Mexico, Montenegro, Morocco, Panama, Peru, Poland, Portugal, Russia, Serbia, Singapore, South Africa, South Korea, Spain, Turkey (Türkiye), United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedDec 13, 2017
Enrollment StartJan 11, 2018
Primary CompletionOct 23, 2024
TodayJul 2, 2026
Enrollment to primary: 6.8 yearsPosted 8.6 years ago

Interventions

Atezolizumabdrug

Atezolizumab will be administered, 1200 mg by IV infusion with : gemcitabine 1000 mg/m2, followed by carboplatin target area under the curve (AUC) 2 mg/ml/min, both administered by IV infusion on Days 1 and 8 of each 3-week treatment cycle or with capecitabine 1000 mg/m2, twice daily orally on Days 1 to 14, followed by a 7-day rest period in each 3-week treatment cycle

Placebodrug

Placebo will be administered, 1200 mg by IV infusion with : gemcitabine 1000 mg/m2, followed by carboplatin target area under the curve (AUC) 2 mg/ml/min, both administered by IV infusion on Days 1 and 8 of each 3-week treatment cycle or with capecitabine 1000 mg/m2, twice daily orally on Days 1 to 14, followed by a 7-day rest period in each 3-week treatment cycle

Gemcitabinedrug

Gemcitabine 1000 mg/m2, followed by carboplatin target area under the curve (AUC) 2 mg/ml/min, both administered by IV infusion on Days 1 and 8 of each 3-week treatment cycle

Capecitabinedrug

Capecitabine 1000 mg/m2, twice daily orally on Days 1 to 14, followed by a 7-day rest period in each 3-week treatment cycle

Carboplatindrug

Carboplatin target area under the curve (AUC) 2 mg/ml/min, both administered by IV infusion on Days 1 and 8 of each 3-week treatment cycle