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Status: RecruitingPhase: Phase 1/Phase 2Diagnosis: Breast: MetastaticNCT ID: NCT02088684
(View complete trial on ClinicalTrials.gov)
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
Contacts: Dana-Farber Cancer Institute:
Breast Cancer Nursing Team, 617-632-3478