At a glance
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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
In Brief
A Phase 2 clinical trial evaluating Ipatasertib, Paclitaxel, and 1 other intervention for Breast Neoplasms. Completed, enrolled 124 participants across 44 sites in 8 countries.
Detailed 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.
Study Details
Timeline
Interventions
Participants received ipatasertib orally 400 milligrams (mg) daily on Days 1-21 of each 28-day cycle.
Participants received paclitaxel 80 milligrams per square meter (mg/m\^2) intravenously (IV) on Days 1, 8, and 15 of each cycle.
Participants received oral placebo matched to ipatasertib, daily on Days 1-21 of each 28-day cycle.