Cohort Study of Patients With HER2-negative MBC and BRCA 1/2 Pathogenic Mutation

• Conditions: Breast Cancer Metastatic

• Registration Number: NCT04368442
• Lead Sponsor: Samsung Medical Center

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-negative unresectable locally advanced or metastatic breast cancer.

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 with HER2-negative unresectable locally advanced or metastatic breast cancer.

1. For the assessment of germline mutational status of BRCA1 and BRCA2, (1)Collect peripheral blood from each subject. (2) Extract DNA from the collected blood. (3)From the extracted DNA, germline BRCA1/2 mutational status will be assessed by next generation sequencing(NGS) using NGeneBioBRCAaccuTest®

2. For the assessment of somatic mutational status of BRCA1 and BRCA2, (1)Collect FFPE from about 100 subjects. (2) Extract DNA from the FFPE. (3)From the extracted DNA, somatic BRCA1/2 mutational status will be assessed by next generation sequencing(NGS) 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 Timeline

• Study Start: 2019-10-17
• Status Verified: 2020-04
• Study First Submitted: 2020-04-23
• Study First Submitted QC: 2020-04-28
• Last Update Submitted: 2020-04-28
• Study First Posted: 2020-04-29
• Last Update Posted: 2020-04-29
• Primary Completion: 2020-12-31
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 583

Inclusion Criteria

• 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 Criteria

• HER2 positive breast cancer
• Amenable to curative surgery

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Progression free survival	Length of time from the first date of each line of palliative endocrine treatment or chemotherapy until the date of the first documented progression of breast cancer or death of any cause,, assessed up to 60 months	Progression free survival of each of palliative systemic treatment

Secondary Outcome Measures

Name	Time	Method
Overall survival 2	Length of time from the first date of the first line of chemotherapy, assessed up to 60 months	Overall survival from diagnosis of unresectable locally advanced/MBC
Overall survival 1	Length of time from the date of first neoadjuvant chemotherapy or curative surgery until death for any cause,, assessed up to 60 months	Overall survival from initial diagnosis
Disease-free survival	Length of time from the date of first neoadjuvant chemotherapy or curative surgery until the date of the first recurrence of breast cancer, diagnosis of second invasive cancer, or death for any cause whichever comes first, assessed up to 60 months	Invasive Disease-free survival

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of