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NCT Number: NCT06856343

REBECCA Real-world Early BrEast CanCer mAnagement

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

Recruiting

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Clermont-Ferrand, Auvergne-Rh ne-Alpes, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. BRCA characteristics: Mutation type

    Time frame: 18 months after inclusion

    Regarding BRCA characteristics: Mutation type: Tumoral (if only tumoral testing performed), somatic, germline.

  2. 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

  3. Medical history

    Time frame: 18 months after inclusion

    Family and personal history of cancer/type

  4. Time to Olaparib treatment discontinuation

    Time frame: 18 months after inclusion

    Time to Olaparib Treatment Discontinuation (TTD) or death

Study contacts

Contact information is provided by the study sponsor or research team.

AstraZeneca Clinical Study Information Center

CONTACT

[email protected]

1-877-240-9479

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Acronym: REBECCA

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Mar 4, 2025
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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