A Phase III Study of Paclitaxel with Capivasertib or Placebo as Initial Treatment for Inoperable or Metastatic Triple-Negative Breast Cancer

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Full Title

A Phase III Double-blind Randomised Study Assessing the Efficacy and Safety of Capivasertib + Paclitaxel Versus Placebo + Paclitaxel as First-line Treatment for Patients with Histologically Confirmed, Locally Advanced (Inoperable) or Metastatic Triple-Negative Breast Cancer (TNBC) (WIRB)

Purpose

In this study, researchers want to find out if the investigational drug capivasertib given with paclitaxel is more effective than paclitaxel alone as initial treatment for inoperable or metastatic triple-negative breast cancer, a form of the disease in which the tumor lacks receptors for estrogen, progesterone, and HER2. Capivasertib is designed to inhibit breast cancer growth by blocking AKT, a family of enzymes cancer cells use to grow.

Patients in this study will be randomly assigned to receive paclitaxel with either capivasertib or a placebo (inactive drug). Capivasertib 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 inoperable or metastatic triple-negative breast cancer.
  • Patients may not have received chemotherapy for inoperable or metastatic breast cancer.
  • At least 4 weeks must pass between any prior radiation therapy or major surgery and 12 months since completion of any previous chemotherapy and entry into the study.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self-care, and 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 call 646-888-5434.

Protocol

19-453

Phase

III

Investigator

Co-Investigators