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

NCT04368442 | Unknown DMC

• 1 other identifier: 2019-06-027
• Study Type: observational
• Target: 583
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer Metastatic

Keywords

BRCA

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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 2

  Length of time from the first date of the first line of chemotherapy, assessed up to 60 months

• 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

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• HER2 positive breast cancer
• Amenable to curative surgery

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, 135-710, South Korea

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

1. DNA form the peripheral blood 2. (optional) Extracted DNA from the FFPE

Study Officials

• YEON HEE PARK

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

YEON HEE MD PARK

CONTACT

82-2-3410-1780; yhparkhmo@skku.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., Ph.D., Division of hematology and oncology

Study Record Dates

• First Submitted: April 23, 2020
• First Posted: April 29, 2020
• Study Start: October 17, 2019
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2021
• Last Updated: April 29, 2020

Record last verified: 2020-04

Locations

KR (1)