Status:
UNKNOWN
Cohort Study of Patients With HER2-negative MBC and BRCA 1/2 Pathogenic Mutation
Lead Sponsor:
Samsung Medical Center
Conditions:
Breast Cancer Metastatic
Eligibility:
All Genders
20+ years
Brief Summary
The purpose of this study is to investigate the prevalence germline pathogenic BRCA1/2 mutation in a large group of potential candidate of PARP inhibitors, among the unselected patients with HER2-nega...
Detailed Description
This is a multicenter, prospective, non-interventional study on the prevalence of germline pathogenic BRCA1/2 mutation (Blood) and somatic pathogenic BRCA1/2 mutation (Tissue, optional) in patients wi...
Eligibility Criteria
Inclusion
- Age ≥ 20 years old
- Histologically confirmed, unresectable locally advanced or metastatic breast invasive carcinoma
- Human Epidermal Growth Factor Receptor 2 (HER2) negative breast cancer
- Germline mutational status of BRCA1 and/or BRCA2 can be known or unknown
- Signed written informed consent
- The patient is regarded as good candidate for active palliative management at time of enrollment. The patient with terminal cancer which is not appropriate for further endocrine treatment or chemotherapy cannot be enrolled to this study.
Exclusion
- HER2 positive breast cancer
- Amenable to curative surgery
Key Trial Info
Start Date :
October 17 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2021
Estimated Enrollment :
583 Patients enrolled
Trial Details
Trial ID
NCT04368442
Start Date
October 17 2019
End Date
December 31 2021
Last Update
April 29 2020
Active Locations (1)
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1
Samsung Medical Center
Seoul, South Korea, 135-710