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

Epidemiologic Evaluation and Clinical Outcomes for HER2-negative Metastatic Breast Cancer (MBC) Patients With Germline BRCA1 and 2 Pathogenic Mutation in Korea

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.

Study Overview

• Status: Unknown
• Conditions: Breast Cancer Metastatic

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 Type: Observational
• Enrollment (Anticipated): 583

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 135-710
    • Recruiting
    • Samsung Medical Center
    • Contact: Yeon-Hee Park, MD, Ph.D; Phone Number: 82-2-3410-1780; Email: yeonh.park@samsung.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Korean patients with HER2-negative unresectable locally advanced or metastatic breast cancer

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression free survival	Progression free survival of each of palliative systemic treatment	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival 1	Overall survival from initial diagnosis	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 2	Overall survival from diagnosis of unresectable locally advanced/MBC	Length of time from the first date of the first line of chemotherapy, assessed up to 60 months
Disease-free survival	Invasive 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

Collaborators and Investigators

• Sponsor: Samsung Medical Center
• Investigators: Principal Investigator: YEON HEE PARK, Samsung Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): October 17, 2019
• Primary Completion (Anticipated): December 31, 2020
• Study Completion (Anticipated): December 31, 2021

Study Registration Dates

• First Submitted: April 23, 2020
• First Submitted That Met QC Criteria: April 28, 2020
• First Posted (Actual): April 29, 2020

Study Record Updates

• Last Update Posted (Actual): April 29, 2020
• Last Update Submitted That Met QC Criteria: April 28, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: BRCA
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 2019-06-027

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No