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

NCT04098640 | Enrolling By Invitation

• 1 other identifier: SNUH_FMI
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

Young patient; Asian

Outcome Measures

Primary Outcomes (1)

• 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 (4)

• Evaluate the prognostic and predictive role of tumor mutation burden

  After the end of patient enrollment

• Reveal the correlation between genetic characteristics and immunohistochemical expression of selected proteins.

  After the end of patient enrollment

• Compare molecular characteristics of breast cancer according to age groups.

  After the end of patient enrollment

• To offer genomic profiling guided therapy to patients 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).

  After the end of patient enrollment

Study Arms (1)

FMI

OTHER

FoundationOne CDx will be performed using archival tumor tissue

Genetic: FoundationOne CDx

Interventions

FoundationOne CDx GENETIC

FoundationOne CDx will be performed using archival tumor tissue

FMI

Eligibility Criteria

• Age: 19 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, Seoul, 110-744, South Korea

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Seock-Ah Im, MD PhD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 19, 2019
• First Posted: September 23, 2019
• Study Start: September 23, 2019
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: April 17, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)