Ignite Creation Date:
2024-05-06 @ 2:36 PM
Last Modification Date:
2024-10-26 @ 1:34 PM
Study NCT ID:
NCT04368442
Status:
UNKNOWN
Last Update Posted:
2020-04-29
First Post:
2020-04-23
Brief Title:
Cohort Study of Patients With HER2-negative MBC and BRCA 12 Pathogenic Mutation
Sponsor:
Samsung Medical Center
Organization:
Samsung Medical Center
Study Overview
Official Title:
Epidemiologic Evaluation and Clinical Outcomes for HER2-negative Metastatic Breast Cancer MBC Patients With Germline BRCA1 and 2 Pathogenic Mutation in Korea
Status:
UNKNOWN
Status Verified Date:
2020-04
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BRCAm
Brief Summary:
The purpose of this study is to investigate the prevalence germline pathogenic BRCA12 mutation in a large group of potential candidate of PARP inhibitors among the unselected patients with HER2-negative unresectable locally advanced or metastatic breast cancer
Detailed Description:
This is a multicenter prospective non-interventional study on the prevalence of germline pathogenic BRCA12 mutation Blood and somatic pathogenic BRCA12 mutation Tissue optional in patients with HER2-negative unresectable locally advanced or metastatic breast cancer
1 For the assessment of germline mutational status of BRCA1 and BRCA2 1Collect peripheral blood from each subject 2 Extract DNA from the collected blood 3From the extracted DNA germline BRCA12 mutational status will be assessed by next generation sequencingNGS using NGeneBioBRCAaccuTest
2 For the assessment of somatic mutational status of BRCA1 and BRCA2 1Collect FFPE from about 100 subjects 2 Extract DNA from the FFPE 3From the extracted DNA somatic BRCA12 mutational status will be assessed by next generation sequencingNGS using NGeneBioBRCAaccuTest
3 Collect variables on the patients and compare clinical outcomes Overall survival Invasive Disease-free survival Distant Disease-free survival Progression free survival that can be affected by clinicopathologic characteristics and type of treatment
1 For the assessment of germline mutational status of BRCA1 and BRCA2 1Collect peripheral blood from each subject 2 Extract DNA from the collected blood 3From the extracted DNA germline BRCA12 mutational status will be assessed by next generation sequencingNGS using NGeneBioBRCAaccuTest
2 For the assessment of somatic mutational status of BRCA1 and BRCA2 1Collect FFPE from about 100 subjects 2 Extract DNA from the FFPE 3From the extracted DNA somatic BRCA12 mutational status will be assessed by next generation sequencingNGS using NGeneBioBRCAaccuTest
3 Collect variables on the patients and compare clinical outcomes Overall survival Invasive Disease-free survival Distant Disease-free survival Progression free survival that can be affected by clinicopathologic characteristics and type of treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None