NCT03956654

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

A Phase IV Study to Collect Data on the Efficacy and Safety of RIBociclib With Letrozole in Older Women (≥70 Years) With HR+ and HER2- Advanced Breast Cancer (aBC) With no Prior Systemic Therapy for Advanced Disease.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 78 (actual)
• Sponsor: Universitaire Ziekenhuizen KU Leuven · Academic / Other
• Sex: Female
• Age: 70 Years
• Healthy volunteers: Not accepted

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).

Detailed description

The RibOB study is an observational prospective, open lable single arm phase IV 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- advanced breast cancer and no prior hormonal treatment for advanced disease as per the indication approved by the European Medicines Authority (EMA) and as made available by Belgian national authorities in the national health care system. A total of maximum 150 patients will be enrolled for treatment with Letrozole (2.5 mg once daily) + ribociclib 600 mg (day 1 to 21 in a 28 day cycle), which will continue until disease progression, intolerable toxicity or patient/physician decision to withdraw. During the study, patients will be continuously evaluated for disease progression as per national standard of care (approximately every 12 weeks radiologically); for safety; and for quality of life and geriatric assessment components including functional status with QoL assessment and CGA at 3 months (+/- 2 weeks) and at 1 year (+/-2 weeks).

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Ribociclib	combination of ribociclib and letrozole

Timeline

• Start date: 2018-12-11
• Primary completion: 2022-05-31
• Completion: 2024-06-30
• First posted: 2019-05-21
• Last updated: 2024-08-09

Locations

1 site across 1 country: Belgium

Regulatory

• FDA-regulated drug study