A Phase III Study of BKM120 With Fulvestrant in Patients With HR+,HER2-, AI Treated, Locally Advanced or Metastatic Breast Cancer Who Progressed on or After mTORi

Study ID

Cancer Related

Healthy Volunteers

Study Sites

  • Clements University Hospital
  • UT Southwestern Ambulatory Services
  • Zale Lipshy University Hospital
  • Parkland Health & Hospital System

Sarah Weyandt

Principal Investigator
Barbara Haley, M.D.

Official Title

A Phase III Randomized, Double Blind, Placebo Controlled Study of BKM120 With Fulvestrant, in Postmenopausal Women With Hormone Receptor-positive HER2-negative AI Treated, Locally Advanced or Metastatic Breast Cancer Who Progressed on or After mTOR Inhibitor Based Treatment

Brief Overview

This study will evaluate whether the addition of daily BKM120 to fulvestrant is effective
and safe in treating patients with HR+, HER2-, AI treated locally advanced or metastatic
breast cancer who progressed on or after mTor inhibitor based treatment.

Participant Eligibility

Inclusion Criteria:

- Postmenopausal women

- Breast cancer that is locally advanced or metastatic

- HER2 negative disease, and a known positive hormone receptor status (common breast
cancer classification tests)

- A tumor sample must be shipped to a central lab for identification of biomarkers
(PI3K activation status) before randomization

- Prior treatment with AIs

- Evidence of progression to the combination of mTORi and endocrine therapy given as
the last therapy prior to study entry

- Adequate bone marrow and organ function

Exclusion Criteria:

- More than 1 prior chemotherapy given for locally advanced or metastatic disease

- Previous treatment with PI3K inhibitors, AKT inhibitors or fulvestrant

- Symptomatic CNS metastases

- Concurrent malignancy or malignancy within 3 years prior to start of study treatment

- Certain drugs or radiation within 2-4 weeks of enrollment

- Increasing or chronic treatment (> 5 days) with corticosteroids or another
immunosuppressive agent

- Active heart (cardiac) disease or a history of cardiac dysfunction as defined in the

- Hyper sensitivity to fulvestrant treatment excipients

- Certain scores on an anxiety and depression mood questionnaire given at screening

- Acute viral hepatitis or history of chronic or acute HBV, HCV, HAV, HDV, HEV

- Other protocol defined criteria may apply