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

NCT ID: NCT04098640

Last Updated: 2025-04-17

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-23
• Study Completion Date: 2025-12-31

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):

1. To evaluate the prognostic and predictive role of tumor mutation burden.

2. 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).

3. Compare molecular characteristics of breast cancer according to age groups (<35 years vs. 35-50 years).

4. 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).

Conditions

Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

FMI

FoundationOne CDx will be performed using archival tumor tissue

Group Type: OTHER

FoundationOne CDx

Intervention Type: GENETIC

FoundationOne CDx will be performed using archival tumor tissue

Interventions

FoundationOne CDx

FoundationOne CDx will be performed using archival tumor tissue

Intervention Type: GENETIC

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.

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Seock-Ah Im

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Seock-Ah Im, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

Seoul National University Hospital

Seoul, Seoul, South Korea

Countries

South Korea

Other Identifiers

SNUH_FMI

Identifier Type: -

Identifier Source: org_study_id