Breast Cancer
Conditions
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.
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.
Interventions
None listed
Sponsors
Study design
Eligibility
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients who receive Olaparib for the full treatment duration | 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
| Measure | Time frame | Description |
|---|---|---|
| BRCA characteristics: Mutation type | 18 months after inclusion | Regarding BRCA characteristics: Mutation type: Tumoral (if only tumoral testing performed), somatic, germline. |
| Type of variants | 18 months after inclusion | Type of variants: BRCA1 and/or BRCA2, PALB2 mutation, presence of other HRR gene mutations, presence of other mutations |
| Medical history | 18 months after inclusion | Family and personal history of cancer/type |
| Time to Olaparib treatment discontinuation | 18 months after inclusion | Time to Olaparib Treatment Discontinuation (TTD) or death |
Countries
France