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Study of LEE011 With Fulvestrant and BYL719 or BKM120 in Advanced Breast Cancer

Status: Recruiting
Phase: Phase 1/Phase 2
Diagnosis: Breast: Metastatic
NCT ID: NCT02088684 (View complete trial on
DFCI Protocol ID: 14-098


The purpose of this trial is to explore the clinical utility of the three investigational agents in HR+, HER2- breast cancer. LEE011 (CDK4/6 inhibitor), BKM120 (PI3K-pan class I-inhibitor) and BYL719 (PI3K-alpha specific class I inhibitor) in combination with fulvestrant. This is a multi-center, open-label Phase Ib/II study. The Phase Ib portion of the study is a dose escalation to estimate the MTD and/or RP2D for three regimens: LEE011 with fulvestrant; LEE011 and BKM120 with fulvestrant; LEE011and BYL719 with fulvestrant. The Phase II portion of the study will be a randomized study to assess the anti-tumor activity as well as safety and tolerability of LEE011 with fulvestrant to LEE011 and BKM120 with fulvestrant, and LEE011 and BYL719 with fulvestrant in patients with ER+/HER2- locally advanced or metastatic breast cancer. Approximately 216 adult women with ER+/HER2- locally advanced or metastatic breast cancer will be enrolled.


Conducting Institutions:
Dana-Farber Cancer Institute, Brigham and Women's Hospital

Overall PI:
Sara Tolaney, MD, Dana-Farber Cancer Institute

Site-responsible Investigators:

Dana-Farber Cancer Institute: Breast Cancer Nursing Team, 617-632-3478

Eligibility Criteria

Inclusion Criteria: - Postmenopausal, Hormone receptor positive (HR+), HER2 negative breast cancer - Unlimited number of lines of endocrine therapy and up to two lines of cytotoxic chemotherapy in the metastatic setting (Phase Ib) - Unlimited number of lines of endocrine therapy and one line of cytotoxic chemotherapy in the metastatic setting (Phase II) Exclusion Criteria: - HER2-overexpression in the patient's tumor tissue - Inadequate bone marrow function or evidence of end-organ damage - Severe or uncontrolled medical issues - Diabetes mellitus Other protocol-defined inclusion/exclusion criteria may apply
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