Dose Escalation Study of LEE011 in Combination With Buparlisib and Letrozole in HR+, HER2-negative Post-menopausal Women With Advanced Breast Cancer.
NCT02154776 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 13
Last updated 2020-12-19
Summary
This is a multi-center, open-label, non-randomized, phase I study
Conditions
- Advanced or Metastatic Breast Cancer
Interventions
- DRUG
-
LEE011
3 weeks on and 1 week off
- DRUG
-
Buparlisib
daily
- DRUG
-
2.5 mg daily;
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Novartis Pharmaceuticals · Novartis Pharmaceuticals
Study Design
- Allocation
- NA
- Purpose
- OTHER
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2014-06-27
- Primary Completion
- 2016-10-26
- Completion
- 2016-10-26
- FDA Drug
- Yes
Countries
- United States
- Spain
Study Locations
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