for females ages 18 years and up (full criteria)
at Los Angeles, California and other locations
study started



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.

Official Title

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


Breast Neoplasms Paclitaxel Ipatasertib Ipatasertib + Paclitaxel


You can join if…

Open to females ages 18 years and up

  • Histologically documented triple-negative adenocarcinoma of the breast that is inoperable locally advanced or metastatic and is not amenable to resection with curative intent
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Availability of a representative formalin-fixed, paraffin-embedded (FFPE) tumor specimen, required prior to randomization
  • Measurable disease, according to the RECIST v1.1
  • Adequate hematologic and organ function within 14 days before the first study treatment
  • For female participants of childbearing potential, agreement (by both participant and partner) to use an effective form of contraception for the duration of the study and for 6 months after last dose of study treatment

You CAN'T join if...

  • Any previous therapy, including chemotherapy or hormonal or targeted therapy, for inoperable locally advanced or metastatic triple-negative adenocarcinoma of the breast. Participants may have received prior neoadjuvant or adjuvant chemotherapy and/or radiation treatment for locally advanced triple negative adenocarcinoma, provided all treatments were completed greater than or equal to (>/=) 6 months prior to Cycle 1 Day 1. Locally recurrent disease must not be amenable to resection with curative intent
  • Any radiation treatment to metastatic site within 28 days of Cycle 1, Day 1
  • Known Human Epidermal Growth Factor Receptor 2 (HER2) positive, erythrocyte receptor (ER) positive, or progesterone receptor (PR) positive breast cancer
  • Previous therapy with Akt, PI3K, and/or mTOR inhibitors
  • Major surgical procedure, open biopsy, or significant traumatic injury within 30 days prior to Cycle 1, Day 1 or anticipation of need for a major surgical procedure during the course of the study
  • Known presence of the brain or spinal cord metastasis, as determined by computed tomography (CT) or magnetic resonance imaging (MRI) evaluation during screening or prior radiographic assessments


  • Cedars Sinai Medical Center
    Los Angeles California 90048 United States
  • Cancer Care Assoc Med Group
    Los Angeles California 90095-1772 United States
  • UCLA Medical Center
    Los Angeles California 90095 United States


accepting new patients
Start Date
Completion Date
Genentech, Inc.
Sign up for this study
Phase 2
Study Type
Last Updated