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

Official 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.

Summary:

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.

Trial Description

Primary Outcome:

• Investigator-assessed Progression Free Survival (PFS)
• Overall Survival (OS)

Secondary Outcome:

• Overall Response Rate (ORR)
• Duration of Response (DOR)
• Clinical Benefit Rate (CBR)
• Mean and mean changes from baseline score in participant-reported function (role, physical)
• Mean and mean changes from baseline score in function in participant-reported Global Health Status (GHS)/Quality of Life (QoL) by assessment timepoint and between treatment arms
• Progression Free Survival (PFS) for participants with Programmed Death-Ligand 1 (PD-L1)-non-positive tumours
• Overall Survival (OS) for participants with PD-L1-non-positive tumours
• Overall Response Rate (ORR) for participants with PD-L1-non-positive tumours
• Progression Free Survival (PFS) for participants with PIK3CA/AKT1/PTEN-altered tumours
• Overall Survival (OS) for participants with PIK3CA/AKT1/PTEN-altered tumours
• Overall Response Rate (ORR) for participants with PIK3CA/AKT1/PTEN-altered tumours
• Duration of Response (DOR) for participants with PIK3CA/AKT1/PTEN-altered tumours
• Number of Participants with Adverse Events (AEs)
• Plasma concentration of ipatasertib and its metabolite (G037720) (ng/mL) at specified timepoints
• Serum concentration of atezolizumab (µg/mL) at specified timepoints
• Level of Anti-Drug Antibodies (ADAs) (%) to Atezolizumab

This study will evaluate the efficacy, safety and pharmacokinetics of ipatasertib in combination with atezolizumab and paclitaxel in locally advanced unresectable or metastatic triple-negative breast cancer (TNBC) previously untreated in this setting. Participants with Programmed Death-Ligand 1 (PD-L1) non-positive and PD-L1 positive tumours will be independently enrolled in Cohorts 1 and 2, respectively. The combination of ipatasertib, atezolizumab and paclitaxel will be evaluated in Cohorts 1 and 2 and the combination of ipatasertib and paclitaxel will be evaluated in Cohort 1.

View this trial on ClinicalTrials.gov