A Phase IV Study to Collect Data on the Efficacy and Safety of RIBociclib in Older Women With Breastcancer

Sponsor
Universitaire Ziekenhuizen KU Leuven
Study ID
NCT03956654
Status
Completed

Conditions

Eligibility Criteria

Sex
FEMALE
Age
70 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ribociclib — DRUG
    combination of ribociclib and letrozole

Study Details

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).

Key Dates

Start date
Dec 11, 2018
Status verified
Aug 2024
Primary completion
May 31, 2022
Completion
Jun 30, 2024

Study Design

Enrollment
78 participants (actual)

Primary Outcome Measure

Progression-free survival (PFS) [ Time Frame: 2018-2022 ]

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