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

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.

Timeline

Start

2019-11-25

Primary completion

2023-02-28

Completion

2023-02-28

Outcome

Mixed primary results

registry Cohort 1 Arm A: Ipatasertib + Atezolizumab + Paclitaxel vs Cohort 1 Arm C: Ipatasertib Matching Placebo + Atezolizumab Matching Placebo + Paclitaxel; p = 0.0098; Hazard Ratio (HR) 0.49 (95% CI 0.28 to 0.85) NCT04177108 ↗

registry Cohort 1 Arm A: Ipatasertib + Atezolizumab + Paclitaxel vs Cohort 1 Arm C: Ipatasertib Matching Placebo + Atezolizumab Matching Placebo + Paclitaxel; p = 0.6805; Hazard Ratio (HR) 1.17 (95% CI 0.55 to 2.51) NCT04177108 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Atezolizumab	Monoclonal antibody	840 mg	Intravenous
Subject	Ipatasertib	Small molecule	400 mg	Oral
Background	Paclitaxel	Small molecule	80 mg/m2	Intravenous

Indications