Clinical trial NCT06856343: REBECCA Real-world Early BrEast CanCer mAnagement
Official title: REBECCA Real-world Early BrEast CanCer mAnagement REBECCA. a French National Multicentric Real-world Study of Early Breast Cancer Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Cancer
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2025-03-04
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will be recruited from about 60 participating sites to reach the target of 126 subjects, with a maximum of 60% of subtype TN overall.

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.

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

Primary outcomes:
measure: Proportion of patients who receive Olaparib for the full treatment duration
timeFrame: 18 months after inclusion
Secondary outcomes:
measure: BRCA characteristics: Mutation type
timeFrame: 18 months after inclusion
measure: Type of variants
timeFrame: 18 months after inclusion
measure: Medical history
timeFrame: 18 months after inclusion
measure: Time to Olaparib treatment discontinuation
timeFrame: 18 months after inclusion
Other outcomes:
Locations:
city: Agen Cedex 9
country: France
facility: Research Site
city: Argenteuil Cedex
country: France
facility: Research Site
city: Avignon Cedex 9
country: France
facility: Research Site
city: Beauvais Cedex
country: France
facility: Research Site
city: Beuvry
country: France
facility: Research Site
city: Bezannes
country: France
facility: Research Site
city: Caen
country: France
facility: Research Site
city: Chambray Les Tours
country: France
facility: Research Site
city: Champigny Sur Marne Cedex
country: France
facility: Research Site
city: Clermont Ferrand Cedex 2
country: France
facility: Research Site
city: Compiegne Cedex
country: France
facility: Research Site
city: Creil Cedex 1
country: France
facility: Research Site
city: Dechy
country: France
facility: Research Site
city: FORT DE France Cedex
country: France
facility: Research Site
city: Frejus Cedex
country: France
facility: Research Site
city: Gleize
country: France
facility: Research Site
city: Grenoble
country: France
facility: Research Site
city: Le Blanc Mesnil
country: France
facility: Research Site
city: Lille Cedex
country: France
facility: Research Site
city: Limoges Cedex 1
country: France
facility: Research Site
city: Lyon Cedex 04
country: France
facility: Research Site
city: Marseille Cedex 05
country: France
facility: Research Site
city: Metz Tessy
country: France
facility: Research Site
city: Montpellier Cedex 5
country: France
facility: Research Site
city: Montpellier
country: France
facility: Research Site
city: Nancy
country: France
facility: Research Site
city: Nice Cedex 2
country: France
facility: Research Site
city: Osny
country: France
facility: Research Site
city: Paris Cedex 14
country: France
facility: Research Site
city: Perigueux
country: France
facility: Research Site
city: Plerin Cedex
country: France
facility: Research Site
city: Poitiers Cedex
country: France
facility: Research Site
city: Rouen Cedex
country: France
facility: Research Site
city: Salouel
country: France
facility: Research Site
city: St Brieuc Cedex 1
country: France
facility: Research Site
city: St Doulchard
country: France
facility: Research Site
city: St Etienne Cedex 2
country: France
facility: Research Site
city: St Gregoire Cedex
country: France
facility: Research Site
city: St Martin Boulogne
country: France
facility: Research Site
city: St Pierre Cedex
country: France
facility: Research Site
city: St Priest En Jarez Cedex
country: France
facility: Research Site
city: Thonon les bains
country: France
facility: Research Site
city: Valence Cedex 9
country: France
facility: Research Site
city: Valence
country: France
facility: Research Site
Study officials:
References: