Study of LEE011 With Fulvestrant and BYL719 or BKM120 in Advanced Breast Cancer
Status:
Completed
Trial end date:
2018-04-17
Target enrollment:
Participant gender:
Summary
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 was planned to 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
were planned to be enrolled.