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

Seoul National University

Status: Invitation-only

Conditions: Breast Cancer

Treatments: Genetic: FoundationOne CDx

Study type: Interventional

Funder types: Other

Identifiers

NCT04098640

SNUH_FMI

Details and patient eligibility

About

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.

Full 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).

Enrollment: 200 estimated patients

Sex: Female

Ages: 19 to 50 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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200 participants in 1 patient group

FMI

Other group

Description:

FoundationOne CDx will be performed using archival tumor tissue

Treatment:

Genetic: FoundationOne CDx