Clinical Trial

Testing Experimental Treatment of Breast Cancer

Study Description

A Study Of Ipatasertib in Combination With Atezolizumab and Paclitaxel as a Treatment for Participants With Locally Advanced or Metastatic Triple-Negative Breast Cancer.

This study will evaluate 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.

Location

Locations Selected Location

Methods

Pharmaceutical medication involved Pharmaceutical medication involved
Recruiting patients only Recruiting patients only

Drug - Atezolizumab

Atezolizumab will be administered to participants by intravenous (IV) infusion at a fixed dose of 840 mg on Days 1 and 15 of each 28-day cycle until unacceptable toxicity.

Drug - Ipatasertib

Ipatasertib will be administered to participants at a starting dose of 400 mg QD PO (one tablet a day orally) for 21 days of each 28-day cycle on Days 1 - 21 unless held for management of adverse events.

Drug - Paclitaxel

Paclitaxel will be administered to participants at a starting dose of 80 mg/m^2 by IV infusion for 3 of 4 weeks on Days 1, 8, and 15 of each 28-day cycle unless deferred to Day 22 because of an adverse event.

Drug - Placebo for Atezolizumab

Placebo will be administered to participants at a fixed dose of 840 mg IV infusion for Atezolizumab on Days 1 and 15 of each 28-day cycle until unacceptable toxicity.

Drug - Placebo for Ipatasertib

Placebo will be administered to participants at a starting dose of 400 mg QD PO (one tablet a day orally) for Ipatasertib for 21 days of each 28-day cycle on Days 1 - 21 unless held for management of adverse events.

Additional Information

Official Study Title

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

Clinical Trial ID

NCT04177108

ParticipAid ID

aAD3Be