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

Completed · Phase 1

Conditions studied: Breast Cancer

In brief

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.

Key facts

Study ID

NCT02088684

Run by

Novartis Pharmaceuticals

People needed

70

Starts

2014-05-19

Expected to finish

2018-04-17

Last updated by the study team

2020-12-17

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• University of Alabama at Birmingham/ Kirklin Clinic Dept Onc — Birmingham, Alabama, United States
• Dana Farber Cancer Institute Onc. Dept. — Boston, Massachusetts, United States
• Sarah Cannon Research Institute Onc Dept — Nashville, Tennessee, United States
• Novartis Investigative Site — Lyon, France
• Novartis Investigative Site — Milan, MI, Italy
• Novartis Investigative Site — Modena, MO, Italy
• Novartis Investigative Site — Singapore, Singapore
• Novartis Investigative Site — Seoul, Korea, South Korea
• Novartis Investigative Site — Madrid, Spain
• Novartis Investigative Site — Taipei, Taiwan ROC, Taiwan
• Novartis Investigative Site — Leicester, United Kingdom

Full record on ClinicalTrials.gov

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