Molecular Profiling in Young (<50 Years of Age) Patients... | NCT04098640

Studies
Molecular Profiling in Young (<50 Years of Age) Patients With Metastatic Breast Cancer

NCT04098640

Sponsor

Seoul National University Hospital

Status

Enrolling by invitation

Last Update Posted

Apr 17, 2025Actual

Enrollment

200Estimated

Phase

Not Applicable

Conditions

Breast Cancer

Interventions

FoundationOne CDx

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

Dec 2024

Overall Recruitment Status or Expanded Access Status

Enrolling by invitation

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 23, 2019Actual

Primary Completion Date

Dec 31, 2025Estimated

Completion Date

Dec 31, 2025Estimated

First Submitted Date

Sep 19, 2019

First Submission Date that Met QC Criteria

Sep 19, 2019

First Posted Date

Sep 23, 2019Actual

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 14, 2025

Last Update Posted Date

Apr 17, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Seock-Ah Im, Professor, Seoul National University HospitalPrincipal Investigator

Lead Sponsor

Seoul National University HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

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

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Breast cancer is the most common cancer in women worldwide, especially in developed countries. In developing countries, including South Korea, the incidence and mortality rate of breast cancer is rapidly increasing. One of the most important characteristics of breast cancer in South Korea, as well as in other Asian countries, is the younger onset of disease compared to Western.

Medical treatment of breast cancer is evolving rapidly, incorporating immune checkpoint blockades and molecularly targeted agents. However, data and knowledge are still limited in terms of molecular characteristics of Asian breast cancer, compared to that of Western countries, and this remains a major hurdle for drug development in Asian breast cancer patients.

The primary objective of this study is to elucidate the genetic characteristic of young (<50 years of age) Korean patients with metastatic breast cancer using FoundationOne CDx.

Detailed Description

Secondary Objective(s):

To evaluate the prognostic and predictive role of tumor mutation burden.
To reveal the correlation between genetic characteristics and immunohistochemical expression of selected proteins (including DNA damage repair (DDR) molecules and various immune modulating molecules including PD-L1, PD-1, IDO, and OX40).
Compare molecular characteristics of breast cancer according to age groups (<35 years vs. 35-50 years).
To offer genomic profiling guided therapy to patients as early as possible (preferably, 1st- or 2nd-line of treatment). In addition, to explore how genomic profiling guided therapy could improve patient outcome as an ad-hoc if sufficient number of patients can be followed up (compared to historic data).

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
FMI	Other	FoundationOne CDx will be performed using archival tumor tissue	Genetic: FoundationOne CDx

Interventions

Name	Type	Description	Arm Group Labels	Other Names
FoundationOne CDx	Genetic	FoundationOne CDx will be performed using archival tumor tissue	FMI

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Genetic characteristic of young (<50 years of age) Korean patients with metastatic breast cancer.	Genetic characteristics will be evaluated using FoundationOne CDx.	After the end of patient enrollment

Secondary Outcomes

Measure	Description	Time Frame
Evaluate the prognostic and predictive role of tumor mutation burden	Tumor mutation burden will be analysed using FoundationOne CDx.	After the end of patient enrollment
Reveal the correlation between genetic characteristics and immunohistochemical expression of selected proteins.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients between 19 - 50 years of age on the day of signing informed consent.
Able to provide written informed consent for voluntary participation in the trial.
With metastatic breast cancer
Willing to provide biopsies from the primary tumor or lymph nodes at screening to the central laboratory. (with at least 10 unstained slides and 1 H&E slide)

Exclusion Criteria:

Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Seock-Ah Im, MD PhD	Seoul National University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National University Hospital		Seoul	Seoul	110-744	South Korea

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001943	Breast Neoplasms

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases

Browse Leaves

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Browse Branches

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