This study is currently not recruiting participants.

GO29227; 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

Study of Investigational Medication with Paclitaxel for Advanced Triple-Negative Breast Cancer

Not Recruiting
18 years - 100 years
Female
Phase N/A

Brief description of study.

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

Detailed description of study

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

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Breast Cancer
  • Age: 18 years - 100 years
  • Gender: Female

This study investigates the effects of an investigational medication combined with paclitaxel for patients with advanced triple-negative breast cancer that cannot be operated on. Triple-negative breast cancer is a type of cancer that does not have the three common receptors known to fuel most breast cancer growth. The study aims to see how well patients do without their cancer getting worse, especially focusing on those with low levels of a protein called PTEN.

Participants will receive either the investigational medication with paclitaxel or a placebo with paclitaxel. A placebo is an inactive substance that looks like the investigational medication but does not contain any medicine. The study will assess how safe and tolerable the investigational medication is when used with paclitaxel.

  • Who can participate: Adults with inoperable locally advanced or metastatic triple-negative breast cancer can participate. The study includes individuals with low levels of the PTEN protein.
  • Study details: Participants will be randomly assigned to receive either the investigational medication with paclitaxel or a placebo with paclitaxel.
Updated on 19 Feb 2024. Study ID: 1405176398

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