A Phase III Study of BKM120 with Fulvestrant in Postmenopausal Women with Locally Advanced or Metastatic Hormone Receptor-Positive HER2-Negative Breast Cancer

Protocol
12-290
Full Title
A Phase III Randomized, Double Blind Placebo Controlled Study of BKM120 with Fulvestrant, in Postmenopausal Women with Hormone Receptor-positive HER2-negative Locally Advanced or Metastatic Breast Cancer Which Progressed on or After Aromatase Inhibitor Treatment
Phase
III
Purpose

The purpose of this study is to see if combining the investigational drug BKM120 with fulvestrant is more effective than fulvestrant alone in postmenopausal women with hormone receptor-positive HER2-negative locally advanced or metastatic breast cancer that has continued to grow despite aromatase inhibitor therapy.

BKM120 is an investigational drug that blocks a molecule called PI3 kinase, which appears to function abnormally in many cancers. It is taken orally (by mouth). Fulvestrant is a standard drug used to treat postmenopausal women with hormone receptor-positive breast cancer that has continued growing despite hormonal therapy. It is given via injection.

Women in this study will be randomly assigned to receive fulvestrant with BKM120 or fulvestrant with a placebo.

Eligibility

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

  • Patients must be postmenopausal women with hormone receptor-positive HER2-negative inoperable locally advanced or metastatic breast cancer that has continued to grow despite aromatase inhibitor therapy (such as letrozole or anastrozole).
  • Patients may not have had more than one prior regimen of chemotherapy for advanced disease.
  • Patients must have recovered from the serious side effects of prior therapies.
  • Patients must be able to be ambulatory for more than half of their normal waking hours.
  • This study is open to patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Maura Dickler at 646-888-5456.

Disease(s)
Breast Cancer
Related Diseases