A Phase III Study of Ipatasertib plus Paclitaxel to Treat Locally Advanced or Metastatic Breast Cancer

Full Title

CO40016: A Double-Blind, Placebo-Controlled, Randomized Phase III Study of Ipatasertib in Combination with Paclitaxel as a Treatment for Patients with PIK3CA/AKT1/PTEN-Altered, Locally Advanced or Metastatic, Triple-Negative Breast Cancer or Hormone Receptor-Positive, HER2-Negative Breast Cancer

Purpose

Paclitaxel is a standard treatment for breast cancer. In this study, researchers are comparing the effectiveness of paclitaxel plus the investigational drug ipatasertib with paclitaxel alone in patients with locally advanced or metastatic breast cancer that contains certain genetic mutations.

Ipatasertib is designed to block the activated form of Akt, a protein that is known to promote the growth of cancer cells. It has been shown to prevent or slow the growth of many different types of cancer cells, including breast cancer cells. Initial research studies suggest that the combination of ipatasertib and paclitaxel may improve the response to treatment.

Patients will be randomly assigned to receive treatment with paclitaxel plus ipatasertib or paclitaxel plus a placebo (inactive drug). Ipatasertib is taken orally (by mouth), and paclitaxel is given intravenously (by vein).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have locally advanced (inoperable) or metastatic triple-negative breast cancer or hormone receptor-positive HER2-negative breast cancer.
  • Patients’ tumors must contain a mutation in one of three genes (PIK3CA, AKT1, or PTEN) which are part of the same molecular pathway as Akt.
  • Patients may not have previously received chemotherapy for advanced breast cancer.
  • Patients with inoperable breast cancer may have previously received chemotherapy as long as it was completed more than a year before entering the study.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Lillian Smyth at 646-888-4894.

Protocol

17-637

Phase

III

Investigator

Co-Investigators

Diseases