Cohort Study of Patients With HER2-negative MBC and BRCA... | NCT04368442

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

NCT04368442

Sponsor

Samsung Medical Center

Status

Unknown status

Last Update Posted

Apr 29, 2020Actual

Enrollment

583Estimated

Phase

Not provided

Conditions

Breast Cancer Metastatic

Interventions

Not provided

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 17, 2019Actual

Primary Completion Date

Dec 31, 2020Estimated

Completion Date

Dec 31, 2021Estimated

First Submitted Date

Apr 23, 2020

First Submission Date that Met QC Criteria

Apr 28, 2020

First Posted Date

Apr 29, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 28, 2020

Last Update Posted Date

Apr 29, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Yeon Hee Park, M.D., Ph.D., Division of hematology and oncology, Samsung Medical CenterPrincipal Investigator

Lead Sponsor

Samsung Medical CenterOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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®
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®
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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

3 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

583Estimated

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
YEON HEE MD PARK	Contact	82-2-3410-1780		yhparkhmo@skku.edu

Overall Officials

Name	Affiliation	Role
YEON HEE PARK	Samsung Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Samsung Medical Center	Recruiting	Seoul		135-710	South Korea