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

• Status: Completed
• Trial end date: 2018-04-17
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Estradiol; Fulvestrant

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