NCT02162719

A Study Assessing the Safety and Efficacy of Adding Ipatasertib to Paclitaxel Treatment in Participants With Breast Cancer That Has Spread Beyond the Initial Site, and the Cancer Does Not Have Certain Hormonal Receptors

A Randomized, Phase II, Multi-Center, Placebo-Controlled Study of Ipatasertib (GDC-0068), an Inhibitor of Akt, in Combination With Paclitaxel as Front-Line Treatment for Patients With Metastatic Triple-Negative Breast Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 124 (actual)
• Sponsor: Genentech, Inc. · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This multicenter, randomized, double-blind study will estimate the efficacy, safety and tolerability of ipatasertib combined with paclitaxel compared with placebo combined with paclitaxel in participants with inoperable locally advanced or metastatic triple-negative breast cancer (mTNBC), as measured by progression-free survival (PFS) in all participants and in participants with phosphatase and tensin homolog (PTEN)-low tumors.

Conditions

• Breast Neoplasms

Interventions

Type	Name	Description
DRUG	Ipatasertib	Participants received ipatasertib orally 400 milligrams (mg) daily on Days 1-21 of each 28-day cycle.
DRUG	Paclitaxel	Participants received paclitaxel 80 milligrams per square meter (mg/m\^2) intravenously (IV) on Days 1, 8, and 15 of each cycle.
DRUG	Placebo	Participants received oral placebo matched to ipatasertib, daily on Days 1-21 of each 28-day cycle.

Timeline

• Start date: 2014-08-19
• Primary completion: 2016-06-07
• Completion: 2019-08-31
• First posted: 2014-06-13
• Last updated: 2021-03-10
• Results posted: 2021-01-11

Locations

44 sites across 8 countries: United States, Belgium, France, Italy, Singapore, South Korea, Spain, Taiwan