Phase III Study of BKM120/Placebo With Fulvestrant in Postmenopausal Patients With Hormone Receptor Positive HER2-negative Locally Advanced or Metastatic Breast Cancer Refractory to Aromatase Inhibitor

Status: Recruiting
Phase: Phase 3
Diagnosis: Breast: Metastatic
NCT ID: NCT01610284 (View complete trial on
DFCI Protocol ID: 12-393


The purpose of this study is to determine wether the addition of daily BKM120 to fulvestrant is effective and safe in treating patients with hormone receptor-positive, HER2-negative locally advanced or metastatic breast cancer refractory to aromatase inhibitor.


Conducting Institutions:
Massachusetts General Hospital

Overall PI:
Aditya Bardia MD, MPH, Massachusetts General Hospital

Site-responsible Investigators:

Massachusetts General Hospital: Cancer Trials Call Center, 877-789-6100

Eligibility Criteria

Inclusion Criteria: - Locally advanced or metastatic breast cancer - HER2-negative and hormone receptor-positive status (common breast cancer classification tests) - Postmenopausal woman - A tumor sample must be shipped to a Novartis designated laboratory for identification of biomarkers (PI3K activation status) - Progression or recurrence of breast cancer while on or after aromatase inhibitor treatment - Measurable disease or non measurable disease bone lesions in the absence of measurable disease as per RECIST 1.1 - Adequate bone marrow and organ function defined by laboratory values Exclusion Criteria: - Previous treatment with PI3K inhibitors, AKT inhibitors, mTOR inhibitor or fulvestrant - More than one prior chemotherapy line for metastatic disease - Symptomatic brain metastases - Increasing or chronic treatment (> 5 days) with corticosteroids or another immunosuppressive agent - Active heart (cardiac) disease as defined in the protocol - Certain scores on an anxiety and depression mood questionnaires - Other protocol-defined inclusion/exclusion criteria may apply
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