Study of Efficacy and Safety of LEE011 in Postmenopausal Women With Advanced Breast Cancer
Completed · Phase 3 · Has a placebo group
Conditions studied: Advanced, Metastatic Breast Cancer
In brief
The primary purpose of this study was to assess the efficacy of ribociclib, as measured by progression free survival (PFS), in postmenopausal women with hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer who received no prior treatment for advanced disease.
Key facts
- Study ID
- NCT01958021
- Run by
- Novartis Pharmaceuticals
- People needed
- 668
- Starts
- 2013-12-17
- Expected to finish
- 2023-03-16
- Last updated by the study team
- 2025-03-07
Who can join
Age: 18 and older, up to 100. Sex: female. Healthy volunteers: not accepted.
Where it is running
- Arizona Oncology Associates PC HAL — Sedona, Arizona, United States
- Highlands Oncology Group — Fayetteville, Arkansas, United States
- NEA Baptist Cancer Center — Jonesboro, Arkansas, United States
- Alta Bates Cancer Center — Berkeley, California, United States
- City of Hope National Medical Center — Duarte, California, United States
- Glendale Adventist Medical Center — Glendale, California, United States
- The Angeles Clinic and Research Institute — Los Angeles, California, United States
- Cedars Sinai Medical Center SC-5 — Los Angeles, California, United States
- Comprehensive Cancer Center — Sacramento, California, United States
- Univ of Colorado School of Medicine — Aurora, Colorado, United States
- Rocky Mountain Cancer Centers — Longmont, Colorado, United States
- University Cancer Institute — Boynton Beach, Florida, United States
- Florida Cancer Research Institute — Davie, Florida, United States
- Florida Cancer Specialists — Fort Myers, Florida, United States
- Memorial Hospital — Hollywood, Florida, United States
- University Of Miami — Miami, Florida, United States
- Florida Retina Institute — Orlando, Florida, United States
- Sacred Heart Medical Oncology — Pensacola, Florida, United States
- Florida Cancer Specialists-North — St. Petersburg, Florida, United States
- Georgia Cancer Specialists — Decatur, Georgia, United States
- Lewis Hall Singletary Onc Ctr at John D. Archbold Mem Hosp. — Thomasville, Georgia, United States
- Moanalua Medical Center Attn Oncology Dept — Honolulu, Hawaii, United States
- University of Illinois Cancer Center at Chicago — Chicago, Illinois, United States
- University of Chicago — Chicago, Illinois, United States
- Ironwood Cancer and Research Centers — Chandler, Arizona, United States
Full record on ClinicalTrials.gov
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