A Pharmacodynamics Pre-surgical Study of LEE011 in Early Breast Cancer Patients (MONALEESA-1)
Part of paid clinical trials in Fayetteville, Arkansas.
- Sponsor
- Novartis Pharmaceuticals
- Study ID
- NCT01919229
- Phase
- PHASE2
- Status
- Terminated
Conditions
Eligibility Criteria
- Sex
- FEMALE
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- LEE011 (ribociclib) — DRUGRibociclib was supplied in 200 mg hard gelatin capsules for oral use.
- letrozole — DRUGLetrozole was supplied in 2.5mg tablets for oral use.
Study Details
This is a multi-center, open-label Phase II randomized pre-surgical pharmacodynamics study.
Key Dates
- Start date
- Oct 31, 2013
- Status verified
- Nov 2015
- Primary completion
- Sep 30, 2014
- Completion
- Sep 30, 2014
Study Design
- Enrollment
- 14 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
Arms
- Active Comparator: LetrozoleLetrozole 2.5 mg alone once daily
- Experimental: LEE011 400 mg + letrozoleLetrozole 2.5 mg once daily and ribociclib 400 mg (2 capsules of 200 mg each) once daily.
- Experimental: LEE011 600mg + letrozoleLetrozole 2.5 mg once daily and ribociclib 600 mg (3 capsules of 200 mg each) once daily.
Primary Outcome Measure
Cell Cycle Response Rate Per Cell Proliferation Marker Ki67 [ Time Frame: Day 1, Day15 ]
Locations (4)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Highlands Oncology Group SC | Fayetteville | Arkansas | 72703 | - |
| University of California at Los Angeles UCLA SC | Los Angeles | California | 90095 | - |
| Massachusetts General Hospital SC-9 | Boston | Massachusetts | 02114 | - |
| University of Texas/MD Anderson Cancer Center Dept of MD Anderson (8) | Houston | Texas | 77030-4009 | - |
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