REBECCA Real-world Early BrEast CanCer mAnagement (REBECCA)

May 22, 2026 updated by: AstraZeneca

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

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

Study Overview

Status

Recruiting

Conditions

Breast Cancer

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 Type

Observational

Enrollment (Estimated)

126

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: AstraZeneca Clinical Study Information Center
Phone Number: 1-877-240-9479
Email: information.center@astrazeneca.com

Study Locations

France
- Auvergne-Rh ne-Alpes
  - Clermont-Ferrand, Auvergne-Rh ne-Alpes, France, 63050
    - Recruiting
    - Research Site
  - Gleizé, Auvergne-Rh ne-Alpes, France, 69400
    - Recruiting
    - Research Site
  - Grenoble, Auvergne-Rh ne-Alpes, France, 38000
    - Not yet recruiting
    - Research Site
  - Lyon, Auvergne-Rh ne-Alpes, France, 69317
    - Recruiting
    - Research Site
  - Metz-Tessy, Auvergne-Rh ne-Alpes, France, 74370
    - Recruiting
    - Research Site
  - Saint-Etienne, Auvergne-Rh ne-Alpes, France, 42030
    - Not yet recruiting
    - Research Site
  - Saint-Priest-en-Jarez, Auvergne-Rh ne-Alpes, France, 42271
    - Not yet recruiting
    - Research Site
  - Thonon-les-Bains, Auvergne-Rh ne-Alpes, France, 74200
    - Recruiting
    - Research Site
  - Valence, Auvergne-Rh ne-Alpes, France, 26000
    - Recruiting
    - Research Site
  - Valence, Auvergne-Rh ne-Alpes, France, 26953
    - Not yet recruiting
    - Research Site
- Bourgogne-Franche-Comt
  - Dijon, Bourgogne-Franche-Comt, France, 21079
    - Not yet recruiting
    - Research Site
- Brittany Region
  - Plérin, Brittany Region, France, 22190
    - Recruiting
    - Research Site
  - Rennes, Brittany Region, France, 35042
    - Not yet recruiting
    - Research Site
  - Saint-Brieuc, Brittany Region, France, 22027
    - Not yet recruiting
    - Research Site
  - Saint-Grégoire, Brittany Region, France, 35768
    - Recruiting
    - Research Site
- Centre-Val de Loire
  - Chambray-lès-Tours, Centre-Val de Loire, France, 37170
    - Recruiting
    - Research Site
  - Saint-Doulchard, Centre-Val de Loire, France, 18230
    - Recruiting
    - Research Site
- Grand Est
  - Bezannes, Grand Est, France, 51430
    - Recruiting
    - Research Site
  - Haguenau, Grand Est, France, 67504
    - Not yet recruiting
    - Research Site
  - Nancy, Grand Est, France, 54100
    - Recruiting
    - Research Site
- Hauts-de-France
  - Beauvais, Hauts-de-France, France, 60021
    - Recruiting
    - Research Site
  - Beuvry, Hauts-de-France, France, 62660
    - Recruiting
    - Research Site
  - Compiègne, Hauts-de-France, France, 60204
    - Not yet recruiting
    - Research Site
  - Creil, Hauts-de-France, France, 60109
    - Not yet recruiting
    - Research Site
  - Dechy, Hauts-de-France, France, 59187
    - Recruiting
    - Research Site
  - Lille, Hauts-de-France, France, 59020
    - Not yet recruiting
    - Research Site
  - Lille, Hauts-de-France, France, 59037
    - Not yet recruiting
    - Research Site
  - Saint-Martin-Boulogne, Hauts-de-France, France, 62280
    - Not yet recruiting
    - Research Site
  - Salouël, Hauts-de-France, France, 80054
    - Recruiting
    - Research Site
- La R Union
  - Saint-Pierre-des-Corps, La R Union, France, 97448
    - Not yet recruiting
    - Research Site
- Martinique
  - FORT de France Cedex, Martinique, France, 97261
    - Not yet recruiting
    - Research Site
- New Aquitaine
  - Agen, New Aquitaine, France, 47923
    - Not yet recruiting
    - Research Site
  - Libourne, New Aquitaine, France, 33505
    - Not yet recruiting
    - Research Site
  - Limoges, New Aquitaine, France, 87042
    - Not yet recruiting
    - Research Site
  - Poitiers, New Aquitaine, France, 86021
    - Recruiting
    - Research Site
  - Périgueux, New Aquitaine, France, 24000
    - Recruiting
    - Research Site
- Normandy
  - Caen, Normandy, France, 14000
    - Recruiting
    - Research Site
  - Rouen, Normandy, France, 76175
    - Recruiting
    - Research Site
- Occitanie
  - Béziers, Occitanie, France, 34500
    - Not yet recruiting
    - Research Site
  - Montpellier, Occitanie, France, 34070
    - Recruiting
    - Research Site
  - Montpellier, Occitanie, France, 34298
    - Recruiting
    - Research Site
  - Nîmes, Occitanie, France, 30900
    - Recruiting
    - Research Site
  - Perpignan, Occitanie, France, 66046
    - Recruiting
    - Research Site
  - Toulouse, Occitanie, France, 31300
    - Recruiting
    - Research Site
- Pays de la Loire Region
  - Nantes, Pays de la Loire Region, France, 44202
    - Not yet recruiting
    - Research Site
- Provence-Alpes-C Te d'Azur
  - Avignon, Provence-Alpes-C Te d'Azur, France, 84918
    - Not yet recruiting
    - Research Site
  - Fréjus, Provence-Alpes-C Te d'Azur, France, 83608
    - Not yet recruiting
    - Research Site
  - Marseille, Provence-Alpes-C Te d'Azur, France, 13385
    - Not yet recruiting
    - Research Site
  - Nice, Provence-Alpes-C Te d'Azur, France, 06105
    - Not yet recruiting
    - Research Site
- Île-de-France Region
  - Argenteuil, Île-de-France Region, France, 95107
    - Not yet recruiting
    - Research Site
  - Champigny-sur-Marne, Île-de-France Region, France, 94507
    - Recruiting
    - Research Site
  - Le Blanc-Mesnil, Île-de-France Region, France, 93150
    - Not yet recruiting
    - Research Site
  - Osny, Île-de-France Region, France, 95520
    - Recruiting
    - Research Site
  - Paris, Île-de-France Region, France, 75651
    - Recruiting
    - Research Site
  - Paris, Île-de-France Region, France, 75674
    - Recruiting
    - Research Site
  - Paris, Île-de-France Region, France, 75908
    - Not yet recruiting
    - Research Site
  - Paris, Île-de-France Region, France, 75970
    - Not yet recruiting
    - Research Site
  - Sarcelles, Île-de-France Region, France, 95200
    - Recruiting
    - Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients who receive Olaparib for the full treatment duration Time Frame: 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.	18 months after inclusion

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 30, 2024

Primary Completion (Estimated)

January 31, 2028

Study Completion (Estimated)

January 31, 2028

Study Registration Dates

First Submitted

December 12, 2024

First Submitted That Met QC Criteria

February 26, 2025

First Posted (Actual)

March 4, 2025

Study Record Updates

Last Update Posted (Actual)

May 26, 2026

Last Update Submitted That Met QC Criteria

May 22, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

D0817R00068

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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REBECCA Real-world Early BrEast CanCer mAnagement (REBECCA)