REBECCA Real-world Early BrEast CanCer mAnagement
ConditionBreast Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAstraZeneca
About this trial
This is a French observational, national, multicenter prospective cohort study of patients with HER2-negative eBC treated with olaparib at their physician's discretion.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Patient not consenting to participate.
Patients included in the Early Access Program
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
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.
Time frame
18 months after inclusionSecondary outcomes
1
BRCA characteristics: Mutation type
Regarding BRCA characteristics: Mutation type: Tumoral (if only tumoral testing performed), somatic, germline.
Time frame
18 months after inclusion2
Type of variants
Type of variants: BRCA1 and/or BRCA2, PALB2 mutation, presence of other HRR gene mutations, presence of other mutations
Time frame
18 months after inclusion3
Medical history
Family and personal history of cancer/type
Time frame
18 months after inclusion4
Time to Olaparib treatment discontinuation
Time to Olaparib Treatment Discontinuation (TTD) or death
Time frame
18 months after inclusionSponsors and contacts
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Source ClinicalTrials.gov