REBECCA Real-world Early BrEast CanCer mAnagement

Recruiting

• Conditions: Breast Cancer

• Registration Number: NCT06856343
• Lead Sponsor: AstraZeneca

Brief Summary

This is a French observational, national, multicenter prospective cohort study of patients with HER2-negative eBC treated with olaparib at their physician's discretion.

Detailed Description

The purpose to this observational study is to evaluate the rate of completion of adjuvant Olaparib treatment for HER2-negative early breast cancer patients in France.

Study Timeline

• Study First Submitted: 2024-12-12
• Study Start: 2024-12-30
• Study First Submitted QC: 2025-02-26
• Study First Posted: 2025-03-04
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-05
• Last Update Posted: 2025-05-06
• Primary Completion: 2028-01-31
• Study Completion: 2028-01-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 126

Inclusion Criteria

• Male or female aged ≥ 18 years
• Patient diagnosed with HER2-negative eBC
• Patient about to be initiated with adjuvant Olaparib at their physician's discretion
• Patient has been informed and does not object to participation in the study.

Exclusion Criteria

• Patient not consenting to participate.
• Patients included in the Early Access Program

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of patients who receive Olaparib for the full treatment duration	18 months after inclusion	The primary outcome is the evaluation of the proportion of patients who receive Olaparib for the full treatment duration, described as 12 months of treatment.

Secondary Outcome Measures

Name	Time	Method
BRCA characteristics: Mutation type	18 months after inclusion	Regarding BRCA characteristics: Mutation type: Tumoral (if only tumoral testing performed), somatic, germline.
Type of variants	18 months after inclusion	Type of variants: BRCA1 and/or BRCA2, PALB2 mutation, presence of other HRR gene mutations, presence of other mutations
Medical history	18 months after inclusion	Family and personal history of cancer/type
Time to Olaparib treatment discontinuation	18 months after inclusion	Time to Olaparib Treatment Discontinuation (TTD) or death

Trial Locations

Locations (1)

Research Site; 🇫🇷 Valence Cedex 9, France