Breast CancerREBECCANCT06856343
REBECCA Real-world Early BrEast CanCer mAnagement
An observational study of Breast Cancer, run by AstraZeneca at 58 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- How many people
- 126 participants
- Where
- 58 sitesFrance
- Study dates
- 30 Dec 2024to 31 Jan 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Patient not consenting to participate.
- Patients included in the Early Access Program
Trial locations and contacts
58 sites in 1 country. Contact the study team or a site near you to ask about taking part.
AstraZeneca Clinical Study Information Center contact
58 sites in 1 country
France58 sites, 58 recruiting
- Not yet recruiting
Research Site
Agen, New Aquitaine, 47923
- Not yet recruiting
Research Site
Argenteuil, Île-de-France Region, 95107
- Not yet recruiting
Research Site
Avignon, Provence-Alpes-C Te d'Azur, 84918
- Recruiting
Research Site
Beauvais, Hauts-de-France, 60021
- Recruiting
Research Site
Beuvry, Hauts-de-France, 62660
- Recruiting
Research Site
Bezannes, Grand Est, 51430
- Not yet recruiting
Research Site
Béziers, Occitanie, 34500
- Recruiting
Research Site
Caen, Normandy, 14000
- Recruiting
Research Site
Chambray-lès-Tours, Centre-Val de Loire, 37170
- Recruiting
Research Site
Champigny-sur-Marne, Île-de-France Region, 94507
- Recruiting
Research Site
Clermont-Ferrand, Auvergne-Rh ne-Alpes, 63050
- Not yet recruiting
Research Site
Compiègne, Hauts-de-France, 60204
- Not yet recruiting
Research Site
Creil, Hauts-de-France, 60109
- Recruiting
Research Site
Dechy, Hauts-de-France, 59187
- Not yet recruiting
Research Site
Dijon, Bourgogne-Franche-Comt, 21079
- Not yet recruiting
Research Site
FORT de France Cedex, Martinique, 97261
- Not yet recruiting
Research Site
Fréjus, Provence-Alpes-C Te d'Azur, 83608
- Recruiting
Research Site
Gleizé, Auvergne-Rh ne-Alpes, 69400
- Not yet recruiting
Research Site
Grenoble, Auvergne-Rh ne-Alpes, 38000
- Not yet recruiting
Research Site
Haguenau, Grand Est, 67504
- Not yet recruiting
Research Site
Le Blanc-Mesnil, Île-de-France Region, 93150
- Not yet recruiting
Research Site
Libourne, New Aquitaine, 33505
- Not yet recruiting
Research Site
Lille, Hauts-de-France, 59020
- Not yet recruiting
Research Site
Lille, Hauts-de-France, 59037
- Not yet recruiting
Research Site
Limoges, New Aquitaine, 87042
- Recruiting
Research Site
Lyon, Auvergne-Rh ne-Alpes, 69317
- Not yet recruiting
Research Site
Marseille, Provence-Alpes-C Te d'Azur, 13385
- Recruiting
Research Site
Metz-Tessy, Auvergne-Rh ne-Alpes, 74370
- Recruiting
Research Site
Montpellier, Occitanie, 34070
- Recruiting
Research Site
Montpellier, Occitanie, 34298
- Recruiting
Research Site
Nancy, Grand Est, 54100
- Not yet recruiting
Research Site
Nantes, Pays de la Loire Region, 44202
- Not yet recruiting
Research Site
Nice, Provence-Alpes-C Te d'Azur, 06105
- Recruiting
Research Site
Nîmes, Occitanie, 30900
- Recruiting
Research Site
Osny, Île-de-France Region, 95520
- Recruiting
Research Site
Paris, Île-de-France Region, 75651
- Recruiting
Research Site
Paris, Île-de-France Region, 75674
- Not yet recruiting
Research Site
Paris, Île-de-France Region, 75908
- Not yet recruiting
Research Site
Paris, Île-de-France Region, 75970
- Recruiting
Research Site
Périgueux, New Aquitaine, 24000
- Recruiting
Research Site
Perpignan, Occitanie, 66046
- Recruiting
Research Site
Plérin, Brittany Region, 22190
- Recruiting
Research Site
Poitiers, New Aquitaine, 86021
- Not yet recruiting
Research Site
Rennes, Brittany Region, 35042
- Recruiting
Research Site
Rouen, Normandy, 76175
- Not yet recruiting
Research Site
Saint-Brieuc, Brittany Region, 22027
- Recruiting
Research Site
Saint-Doulchard, Centre-Val de Loire, 18230
- Not yet recruiting
Research Site
Saint-Etienne, Auvergne-Rh ne-Alpes, 42030
- Recruiting
Research Site
Saint-Grégoire, Brittany Region, 35768
- Not yet recruiting
Research Site
Saint-Martin-Boulogne, Hauts-de-France, 62280
- Not yet recruiting
Research Site
Saint-Pierre-des-Corps, La R Union, 97448
- Not yet recruiting
Research Site
Saint-Priest-en-Jarez, Auvergne-Rh ne-Alpes, 42271
- Recruiting
Research Site
Salouël, Hauts-de-France, 80054
- Recruiting
Research Site
Sarcelles, Île-de-France Region, 95200
- Recruiting
Research Site
Thonon-les-Bains, Auvergne-Rh ne-Alpes, 74200
- Recruiting
Research Site
Toulouse, Occitanie, 31300
- Recruiting
Research Site
Valence, Auvergne-Rh ne-Alpes, 26000
- Not yet recruiting
Research Site
Valence, Auvergne-Rh ne-Alpes, 26953
About this study
Official title: 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.
Read the 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.
- Conditions
- Breast Cancer
- Medical subject headings
- Breast Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 18 months after inclusion
Secondary outcomes (4)
BRCA characteristics: Mutation type
Regarding BRCA characteristics: Mutation type: Tumoral (if only tumoral testing performed), somatic, germline.
Measured: 18 months after inclusion
Type of variants
Type of variants: BRCA1 and/or BRCA2, PALB2 mutation, presence of other HRR gene mutations, presence of other mutations
Measured: 18 months after inclusion
Medical history
Family and personal history of cancer/type
Measured: 18 months after inclusion
Time to Olaparib treatment discontinuation
Time to Olaparib Treatment Discontinuation (TTD) or death
Measured: 18 months after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2025
- Study start30 Dec 2024
- Primary completion31 Jan 2028 (estimated)
- Study completion31 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06856343
- Sponsor's protocol ID
- D0817R00068
- Acronym
- REBECCA
- Status last verified
- Aug 2026
- First submitted
- 12 Dec 2024
- Last updated
- 25 Aug 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REBECCA Real-world Early BrEast CanCer mAnagement REBECCA. a French National Multicentric Real-world Study of Early Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT06856343
- Acronym / sponsor ID
- REBECCA / D0817R00068
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 30 Dec 2024 (actual)
- Primary completion
- 31 Jan 2028 (estimated)
- Study completion
- 31 Jan 2028 (estimated)
- First posted
- 4 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- Patient not consenting to participate.
- Patients included in the Early Access Program
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2026.
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
AstraZeneca Clinical Study Information Center contact
58 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by AstraZeneca at 58 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 58 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact AstraZeneca Clinical Study Information Center (1-877-240-9479, information.center@astrazeneca.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients who receive Olaparib for the full treatment duration (time frame: 18 months after inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2026.