Ireland
--:--IST
Enrolling by invitation Not applicable

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

NCT04098640 · tracked via the Priya Life Science South Korea tracker
Phase
Not applicable
Started
2019-09-23
Last updated
2025-04-17

Condition(s) studied

Breast Cancer

Investigational drug(s) / intervention(s)

FoundationOne CDx

FoundationOne CDx: FoundationOne CDx will be performed using archival tumor tissue

Study 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.

Eligibility

Sex
FEMALE
Min age
19 Years
Max age
50 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

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

Trial sites (1)

FacilityCityRegionStatus
Seoul National University Hospital Seoul Seoul
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04098640 on ClinicalTrials.gov ↗ ← All trials in South Korea