A Phase IV Study to Collect Data on the Efficacy and Safety of RIBociclib in Older Women With Breastcancer
NCT03956654 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 78
Last updated 2024-08-09
Summary
The RibOB study is a prospective, open lable, single arm trial which will evaluate the clinical efficacy, overall safety and tolerability of ribociclib in combination with letrozole in older women (≥70 years) with HR+/HER2- aBC and no prior hormonal treatment for advanced disease (as per approved indication).
Conditions
Interventions
- DRUG
-
combination of ribociclib and letrozole
Sponsors & Collaborators
-
Universitaire Ziekenhuizen KU Leuven
lead OTHER
Principal Investigators
-
Hans Wildiers, prof. dr. · UZ Gasthuisberg
Eligibility
- Min Age
- 70 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-12-11
- Primary Completion
- 2022-05-31
- Completion
- 2024-06-30
- FDA Drug
- Yes
Countries
- Belgium
Study Locations
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