Roll-over Study to Allow Continued Access to Ribociclib
Running, not enrolling · Phase 4
Conditions studied: Metastatic Breast Cancer
In brief
The purpose of this study is to assess the long-term safety of ribociclib (LEE011) in combination with other drugs and provide post-trial access (PTA) to participants who are currently receiving treatment with ribociclib in combination with other drugs and continuing to have clinical benefit in a Novartis-sponsored global study that has reached its primary objective(s).
Key facts
- Study ID
- NCT05161195
- Run by
- Novartis Pharmaceuticals
- People needed
- 134
- Starts
- 2022-07-07
- Expected to finish
- 2030-08-14
- Last updated by the study team
- 2026-06-23
Who can join
Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Highlands Oncology Group — Fayetteville, Arkansas, United States
- Beverly Hills Cancer Center — Beverly Hills, California, United States
- Poudre Valley Hospital — Fort Collins, Colorado, United States
- Mid Florida Hematology And Onc Ctr — Orange, Florida, United States
- Summit Cancer Care — Savannah, Georgia, United States
- John D Archbold Memorial Hospital — Thomasville, Georgia, United States
- Duly Health and Care — Plainfield, Illinois, United States
- Indian Univ Health Goshen Center forCancer — Goshen, Indiana, United States
- Northern Light Mercy Hospital — Portland, Maine, United States
- Englewood Health — Englewood, New Jersey, United States
- The Valley Hospital-Luckow Pavillion — Paramus, New Jersey, United States
- Eastchester Center for Cancer Care — The Bronx, New York, United States
- University Hospitals of Cleveland Seidman Cancer Center — Cleveland, Ohio, United States
- Oklahoma Cancer Specialists and Research Institute — Tulsa, Oklahoma, United States
- Millennium Research Clin Develop — Houston, Texas, United States
- Novartis Investigative Site — San Juan, Argentina
- Novartis Investigative Site — Natal, Rio Grande do Norte, Brazil
- Novartis Investigative Site — Ijuí, Rio Grande do Sul, Brazil
- Novartis Investigative Site — Florianópolis, Santa Catarina, Brazil
- Novartis Investigative Site — São Paulo, São Paulo, Brazil
- Novartis Investigative Site — São Paulo, São Paulo, Brazil
- Novartis Investigative Site — Sao Jose Rio Preto, Brazil
- Novartis Investigative Site — São Paulo, Brazil
- Novartis Investigative Site — Chongqing, Chongqing Municipality, China
- Ironwood Cancer and Research Centers — Chandler, Arizona, United States
Full record on ClinicalTrials.gov
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