Recruiting NCT06856343

REBECCA Real-world Early BrEast CanCer mAnagement

— Observational Breast Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to: Registry conditions: Breast Cancer. Basic parameters: from 18 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: France
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

REBECCA Real-world Early BrEast CanCer mAnagement REBECCA. a French National Multicentric Real-world Study of Early Breast Cancer Patients

Overview

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.

Primary outcome measures

Proportion of patients who receive Olaparib for the full treatment duration [Time frame: 18 months after inclusion]

Secondary outcome measures (4)

BRCA characteristics: Mutation type [Time frame: 18 months after inclusion]
Type of variants [Time frame: 18 months after inclusion]
Medical history [Time frame: 18 months after inclusion]
Time to Olaparib treatment discontinuation [Time frame: 18 months after inclusion]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model: Cohort

Study locations

France · 58 centers

Research Site — Clermont-Ferrand
Research Site — Gleizé
Research Site — Grenoble
Research Site — Lyon
Research Site — Metz-Tessy
Research Site — Saint-Etienne
Research Site — Saint-Priest-en-Jarez
Research Site — Thonon-les-Bains
… and 50 more centers

Identifiers

NCT: NCT06856343 · D0817R00068

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗