CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 242 enrolled
Drug / intervention
Atezolizumab +4 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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

Search/NCT04177108
NCT04177108Phase 3Completed
CompareCT.gov

A Phase III, Double-blind, Placebo-controlled, Randomized Study of Ipatasertib in Combination With Atezolizumab and Paclitaxel as a Treatment for Patients With Locally Advanced Unresectable or Metastatic Triple-Negative Breast Cancer

Hoffmann-La Roche·interventional·Posted Nov 26, 2019·Updated Mar 27, 2024

In Brief

A Phase 3 clinical trial evaluating Atezolizumab, Ipatasertib, and 3 other interventions for Triple-Negative Breast Cancer. Completed, enrolled 242 participants across 182 sites in 37 countries.

Detailed Summary

This study evaluated the efficacy and safety of ipatasertib in combination with atezolizumab and paclitaxel in locally advanced or metastatic Triple-Negative Breast Cancer (TNBC) previously untreated in this setting.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTriple-Negative Breast Cancer
CountriesArgentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Colombia, Costa Rica, Czechia, Denmark, Finland, France, Greece, Hong Kong, India, Israel, Italy, Japan, Mexico, New Zealand, Peru, Poland, Portugal, Romania, Russia, Singapore, South Africa, South Korea, Spain, Switzerland, Taiwan, Thailand, Turkey (Türkiye), Ukraine, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2020202120222023202420252026
First PostedNov 26, 2019
Enrollment StartNov 25, 2019
Primary CompletionFeb 28, 2023
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 6.6 years ago

Interventions

Atezolizumabdrug

Atezolizumab was administered as per the dosage regimen mentioned in arm descriptions.

Ipatasertibdrug

Ipatasertib was administered as per the dosage regimen mentioned in arm descriptions.

Paclitaxeldrug

Paclitaxel was administered as per the dosage regimen mentioned in arm descriptions.

Placebo for Atezolizumabdrug

Placebo was administered as per the dosage regimen mentioned in arm descriptions.

Placebo for Ipatasertibdrug

Placebo was administered as per the dosage regimen mentioned in arm descriptions.