A Phase III Study of Taselisib plus Fulvestrant versus Placebo plus Fulvestrant in Women with Recurrent or Metastatic HR-Positive HER2-Negative Breast Cancer

Full Title

A Phase III, Double-Blind, Placebo-Controlled, Randomized Study of Taselisib Plus Fulvestrant Versus Placebo Plus Fulvestrant in Postmenopausal Women with Estrogen Receptor-Positive and HER2-Negative Locally Advanced or Metastatic Breast Cancer Who Have Disease Recurrence or Progression During or After Aromatase Inhibitor Therapy

Purpose

Fulvestrant is used to treat estrogen receptor-positive breast cancer that has persisted or come back despite anti-estrogen therapy. In this study, researchers want to see if adding the investigational drug taselisib to fulvestrant therapy is more effective than fulvestrant alone in postmenopausal women with hormone receptor (HR)-positive, HER2-negative breast cancer that has come back or spread despite aromatase inhibitor therapy.

Taselisib works by blocking an enzyme involved in cancer growth called PI3 kinase. Patients in this study will be randomly assigned to receive fulvestrant (which is given by injection in the clinic) with taselisib (a pill taken by mouth) or fulvestrant with a placebo (inactive pill).

Eligibility

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

  • Patients must have HR-positive HER2-negative breast cancer that has come back or spread despite aromatase inhibitor therapy.
  • Patients may not have had more than one prior regimen of chemotherapy for metastatic breast cancer, and no prior fulvestrant or PI3 kinase, mTOR, or AKT inhibitors.
  • At least 2 weeks must pass between completion of prior anticancer treatments and entry into 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 women age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Pamela Drullinsky at 516-256-3651.

Protocol

15-111

Phase

III

Investigator

Co-Investigators

Diseases