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

Molecular Profiling Using FoundationOne CDx in Young (<50 Years of Age) Patients With Metastatic Breast Cancer (ML41263)

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Breast Cancer
• Intervention / Treatment: Genetic: 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).

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 110-744
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 50 years (Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: FMI; FoundationOne CDx will be performed using archival tumor tissue	Genetic: FoundationOne CDx; FoundationOne CDx will be performed using archival tumor tissue

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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 Outcome Measures

Outcome Measure	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.	FoundationOne CDx results and immunohistochemical expression will be analysed.	After the end of patient enrollment
Compare molecular characteristics of breast cancer according to age groups.	Genetic characteristics will be analysed 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).	The result of FoundationOne CDx will be used in patient treatment	After the end of patient enrollment

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Investigators: Principal Investigator: Seock-Ah Im, MD PhD, Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 23, 2019
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: September 19, 2019
• First Submitted That Met QC Criteria: September 19, 2019
• First Posted (Actual): September 23, 2019

Study Record Updates

• Last Update Posted (Actual): April 17, 2025
• Last Update Submitted That Met QC Criteria: April 14, 2025
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Asian; Young patient
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: SNUH_FMI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No