Study of Efficacy and Safety in Premenopausal Women With Hormone Receptor Positive, HER2-negative Advanced Breast Cancer
Completed · Phase 3 · Has a placebo group
Conditions studied: Advanced Metastatic Breast Cancer
In brief
The purpose of this study was to determine whether treatment with tamoxifen or a non-steroidal aromatase inhibitors (NSAI) + goserelin + LEE011 prolonged progression-free survival (PFS) compared to treatment with tamoxifen or a NSAI + goserelin + placebo in premenopausal women with hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer.
Key facts
- Study ID
- NCT02278120
- Run by
- Novartis Pharmaceuticals
- People needed
- 672
- Starts
- 2014-11-20
- Expected to finish
- 2023-04-20
- Last updated by the study team
- 2024-03-12
Who can join
Age: 18 and older, up to 59. Sex: female. Healthy volunteers: not accepted.
Where it is running
- University Of California Los Angeles Dept of Onc — Los Angeles, California, United States
- Comprehensive Cancer Center at Saint Joseph Hospital SC — Denver, Colorado, United States
- Danbury Hospital SC — Danbury, Connecticut, United States
- Florida Cancer Specialists Onc Dept — Fort Myers, Florida, United States
- Florida Cancer Specialists SC-2 — Fort Myers, Florida, United States
- Memorial Cancer Institute SC — Hollywood, Florida, United States
- University Of Miami Univ Miami 2 — Miami, Florida, United States
- NorthWest Georgia Oncology Centers IRB — Marietta, Georgia, United States
- Moanalua Medical Center. Attn: Oncology Dept SC — Honolulu, Hawaii, United States
- University of Chicago SC-3 — Chicago, Illinois, United States
- Norton Cancer Institute SC — Louisville, Kentucky, United States
- Sidney Kimmel CCC At JH Dept of Onc. — Baltimore, Maryland, United States
- Massachusetts General Hospital Onc Dept — Boston, Massachusetts, United States
- University of Michigan Comprehensive Cancer Center Onc Dept — Ann Arbor, Michigan, United States
- Washington Uni School of Med SC — St Louis, Missouri, United States
- Meridian Health Systems SC — Neptune City, New Jersey, United States
- University of New Mexico Hospital SC-2 — Albuquerque, New Mexico, United States
- Clinical Research Alliance . — Lake Success, New York, United States
- Duke Univ Medical Center Duke (SC) — Durham, North Carolina, United States
- Penn State University Milton S Hershey Medical Center — Hershey, Pennsylvania, United States
- Bon Secours Cancer Center SC — Greenville, South Carolina, United States
- Erlanger Medical Center SC — Chattanooga, Tennessee, United States
- SCRI Oncology Partners Tennessee Oncology (3) — Nashville, Tennessee, United States
- The Center for Cancer and Blood Disorders SC — Fort Worth, Texas, United States
- Comprehensive Blood and Cancer SC-2 — Bakersfield, California, United States
Full record on ClinicalTrials.gov
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