A Study of Ipatasertib in Combination With Paclitaxel as a Treatment for Participants With PIK3CA/AKT1/PTEN-Altered, Locally Advanced or Metastatic, Triple-Negative Breast Cancer or Hormone Receptor-Positive, HER2-Negative Breast Cancer

Summary

This study will evaluate the efficacy of ipatasertib + paclitaxel versus placebo + paclitaxel in participants with histologically confirmed, locally advanced or metastatic triple-negative breast cancer (TNBC) and in participants with locally advanced or metastatic hormone receptor positive (HR+)/ human epidermal growth factor receptor 2 negative (HER2-) breast adenocarcinoma who are not suitable for endocrine therapy.

Timeline

Start

2018-01-06

Primary completion

2023-01-04

Completion

2023-01-04

Outcome

Missed primary endpoint

registry analysis (superiority test); Cohort A: Placebo + Paclitaxel vs Cohort A: Ipatasertib + Paclitaxel; p = 0.9237; Stratified Hazard Ratio 1.02 (95% CI 0.71 to 1.45); Log Rank NCT03337724 ↗

registry analysis (superiority test); Cohort B: Placebo + Paclitaxel vs Cohort B: Ipatasertib + Paclitaxel; p = 0.9965; Stratified Hazard Ratio 1.00 (95% CI 0.71 to 1.40); Log Rank NCT03337724 ↗

paper Adding ipatasertib to paclitaxel did not improve efficacy in PIK3CA/AKT1/PTEN-altered HR+ HER2-negative aBC. PMID 34860318 ↗

Publications

• Turner N, Dent RA, O'Shaughnessy J, Kim SB, Isakoff SJ, Barrios C, Saji S, Bondarenko I, Nowecki Z, Lian Q, Reilly SJ, Hinton H, Wongchenko MJ, Kovic B, Mani A, Oliveira M. Ipatasertib plus paclitaxel for PIK3CA/AKT1/PTEN-altered hormone receptor-positive HER2-negative advanced breast cancer: primary results from cohort B of the IPATunity130 randomized phase 3 trial. Breast Cancer Res Treat. 2022 Feb;191(3):565-576. doi: 10.1007/s10549-021-06450-x. Epub 2021 Dec 3.

Drugs

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

Indications