NCT06856343

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
126

participants targeted

Target at P50-P75 for all trials

Timeline
22mo left

Started Dec 2024

Typical duration for all trials

Geographic Reach
1 country

58 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress44%
Dec 2024Jan 2028

First Submitted

Initial submission to the registry

December 12, 2024

Completed
18 days until next milestone

Study Start

First participant enrolled

December 30, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 4, 2025

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2028

Last Updated

March 25, 2026

Status Verified

March 1, 2026

Enrollment Period

3.1 years

First QC Date

December 12, 2024

Last Update Submit

March 24, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Proportion of patients who receive Olaparib for the full treatment duration

    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 Outcomes (4)

  • BRCA characteristics: Mutation type

    18 months after inclusion

  • Type of variants

    18 months after inclusion

  • Medical history

    18 months after inclusion

  • Time to Olaparib treatment discontinuation

    18 months after inclusion

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (58)

Research Site

Clermont-Ferrand, Auvergne-Rh ne-Alpes, 63050, France

RECRUITING

Research Site

Gleizé, Auvergne-Rh ne-Alpes, 69400, France

RECRUITING

Research Site

Grenoble, Auvergne-Rh ne-Alpes, 38000, France

NOT YET RECRUITING

Research Site

Lyon, Auvergne-Rh ne-Alpes, 69317, France

RECRUITING

Research Site

Metz-Tessy, Auvergne-Rh ne-Alpes, 74370, France

RECRUITING

Research Site

Saint-Etienne, Auvergne-Rh ne-Alpes, 42030, France

NOT YET RECRUITING

Research Site

Saint-Priest-en-Jarez, Auvergne-Rh ne-Alpes, 42271, France

NOT YET RECRUITING

Research Site

Thonon-les-Bains, Auvergne-Rh ne-Alpes, 74200, France

RECRUITING

Research Site

Valence, Auvergne-Rh ne-Alpes, 26000, France

RECRUITING

Research Site

Valence, Auvergne-Rh ne-Alpes, 26953, France

NOT YET RECRUITING

Research Site

Dijon, Bourgogne-Franche-Comt, 21079, France

NOT YET RECRUITING

Research Site

Plérin, Brittany Region, 22190, France

RECRUITING

Research Site

Rennes, Brittany Region, 35042, France

NOT YET RECRUITING

Research Site

Saint-Brieuc, Brittany Region, 22027, France

NOT YET RECRUITING

Research Site

Saint-Grégoire, Brittany Region, 35768, France

RECRUITING

Research Site

Chambray-lès-Tours, Centre-Val de Loire, 37170, France

RECRUITING

Research Site

Saint-Doulchard, Centre-Val de Loire, 18230, France

RECRUITING

Research Site

Bezannes, Grand Est, 51430, France

RECRUITING

Research Site

Haguenau, Grand Est, 67504, France

NOT YET RECRUITING

Research Site

Nancy, Grand Est, 54100, France

RECRUITING

Research Site

Beauvais, Hauts-de-France, 60021, France

RECRUITING

Research Site

Beuvry, Hauts-de-France, 62660, France

RECRUITING

Research Site

Compiègne, Hauts-de-France, 60204, France

NOT YET RECRUITING

Research Site

Creil, Hauts-de-France, 60109, France

NOT YET RECRUITING

Research Site

Dechy, Hauts-de-France, 59187, France

RECRUITING

Research Site

Lille, Hauts-de-France, 59020, France

NOT YET RECRUITING

Research Site

Lille, Hauts-de-France, 59037, France

NOT YET RECRUITING

Research Site

Saint-Martin-Boulogne, Hauts-de-France, 62280, France

NOT YET RECRUITING

Research Site

Salouël, Hauts-de-France, 80054, France

RECRUITING

Research Site

Saint-Pierre-des-Corps, La R Union, 97448, France

NOT YET RECRUITING

Research Site

FORT de France Cedex, Martinique, 97261, France

NOT YET RECRUITING

Research Site

Caen, Normandy, 14000, France

RECRUITING

Research Site

Rouen, Normandy, 76175, France

RECRUITING

Research Site

Agen, Nouvelle-Aquitaine, 47923, France

NOT YET RECRUITING

Research Site

Libourne, Nouvelle-Aquitaine, 33505, France

NOT YET RECRUITING

Research Site

Limoges, Nouvelle-Aquitaine, 87042, France

NOT YET RECRUITING

Research Site

Périgueux, Nouvelle-Aquitaine, 24000, France

RECRUITING

Research Site

Poitiers, Nouvelle-Aquitaine, 86021, France

RECRUITING

Research Site

Béziers, Occitanie, 34500, France

NOT YET RECRUITING

Research Site

Montpellier, Occitanie, 34070, France

RECRUITING

Research Site

Montpellier, Occitanie, 34298, France

RECRUITING

Research Site

Nîmes, Occitanie, 30900, France

RECRUITING

Research Site

Perpignan, Occitanie, 66046, France

RECRUITING

Research Site

Toulouse, Occitanie, 31300, France

RECRUITING

Research Site

Nantes, Pays de la Loire Region, 44202, France

NOT YET RECRUITING

Research Site

Avignon, Provence-Alpes-C Te d'Azur, 84918, France

NOT YET RECRUITING

Research Site

Fréjus, Provence-Alpes-C Te d'Azur, 83608, France

NOT YET RECRUITING

Research Site

Marseille, Provence-Alpes-C Te d'Azur, 13385, France

NOT YET RECRUITING

Research Site

Nice, Provence-Alpes-C Te d'Azur, 06105, France

NOT YET RECRUITING

Research Site

Argenteuil, Île-de-France Region, 95107, France

NOT YET RECRUITING

Research Site

Champigny-sur-Marne, Île-de-France Region, 94507, France

RECRUITING

Research Site

Le Blanc-Mesnil, Île-de-France Region, 93150, France

NOT YET RECRUITING

Research Site

Osny, Île-de-France Region, 95520, France

RECRUITING

Research Site

Paris, Île-de-France Region, 75651, France

RECRUITING

Research Site

Paris, Île-de-France Region, 75674, France

RECRUITING

Research Site

Paris, Île-de-France Region, 75908, France

NOT YET RECRUITING

Research Site

Paris, Île-de-France Region, 75970, France

NOT YET RECRUITING

Research Site

Sarcelles, Île-de-France Region, 95200, France

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Central Study Contacts

AstraZeneca Clinical Study Information Center

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 12, 2024

First Posted

March 4, 2025

Study Start

December 30, 2024

Primary Completion (Estimated)

January 31, 2028

Study Completion (Estimated)

January 31, 2028

Last Updated

March 25, 2026

Record last verified: 2026-03

Locations