Study of 2 Ribociclib Doses in Combination With Aromatase Inhibitors in Women With HR+, HER2- Advanced Breast Cancer
Completed · Phase 2
Conditions studied: Breast Cancer
In brief
The purpose of the study was to evaluate the safety and efficacy of a reduced ribociclib starting dose of 400 mg in combination with a non-steroidal aromatase inhibitor (NSAI) (letrozole or anastrozole) for the treatment of pre- and postmenopausal women with hormone receptor-positive (HR-positive), HER2-negative advanced breast cancer (aBC) who have received no prior therapy for advanced disease. Premenopausal women were required to receive goserelin in both treatment arms.
Key facts
- Study ID
- NCT03822468
- Run by
- Novartis Pharmaceuticals
- People needed
- 376
- Starts
- 2019-06-11
- Expected to finish
- 2024-08-30
- Last updated by the study team
- 2025-10-16
Who can join
Age: 18 and older, up to 100. Sex: female. Healthy volunteers: not accepted.
Where it is running
- Marin Cancer Care — Greenbrae, California, United States
- Rocky Mountain Cancer Centers — Longmont, Colorado, United States
- Florida Retina Institute — Orlando, Florida, United States
- Weinberg Cancer Institute at FSH — Baltimore, Maryland, United States
- Nebraska Hematology Oncology P C — Lincoln, Nebraska, United States
- Nebraska Cancer Specialists — Omaha, Nebraska, United States
- Comprehensive Cancer Cntr Of Nevada — Henderson, Nevada, United States
- New York Oncology Hematology — Albany, New York, United States
- Mount Sinai School Of Medicine — New York, New York, United States
- Montefiore Medical Center — The Bronx, New York, United States
- Millennium Research Clin Develop — Houston, Texas, United States
- Texas Oncology — McAllen, Texas, United States
- Northwest Medical Specialties — Tacoma, Washington, United States
- Novartis Investigative Site — San Juan, Argentina
- Novartis Investigative Site — Innsbruck, Tyrol, Austria
- Novartis Investigative Site — Linz, Austria
- Novartis Investigative Site — Salzburg, Austria
- Novartis Investigative Site — Vienna, Austria
- Novartis Investigative Site — Edegem, Belgium
- Novartis Investigative Site — Namur, Belgium
- Novartis Investigative Site — Natal, Rio Grande do Norte, Brazil
- Novartis Investigative Site — Florianópolis, Santa Catarina, Brazil
- Novartis Investigative Site — São Paulo, São Paulo, Brazil
- Novartis Investigative Site — São Paulo, São Paulo, Brazil
- Southern Cancer Center PC — Mobile, Alabama, United States
Full record on ClinicalTrials.gov
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