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Enrolling by Invitation

NCT Number: NCT04098640

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

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.

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Key information

Conditions

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

Age range

19 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital

Seoul, 110-744, South Korea

About this study

Secondary Objective(s):

  • To evaluate the prognostic and predictive role of tumor mutation burden.
  • 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).
  • Compare molecular characteristics of breast cancer according to age groups (<35 years vs. 35-50 years).
  • 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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

FoundationOne CDx

Genetic

FoundationOne CDx will be performed using archival tumor tissue

Primary outcomes

  1. Genetic characteristic of young (<50 years of age) Korean patients with metastatic breast cancer.

    Time frame: After the end of patient enrollment

    Genetic characteristics will be evaluated using FoundationOne CDx.

Secondary outcomes

  1. Evaluate the prognostic and predictive role of tumor mutation burden

    Time frame: After the end of patient enrollment

    Tumor mutation burden will be analysed using FoundationOne CDx.

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

    Time frame: After the end of patient enrollment

    FoundationOne CDx results and immunohistochemical expression will be analysed.

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

    Time frame: After the end of patient enrollment

    Genetic characteristics will be analysed according to age groups.

  4. 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).

    Time frame: After the end of patient enrollment

    The result of FoundationOne CDx will be used in patient treatment

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2025
Study completion
2025
First posted
Sep 23, 2019
Registry last updated
Apr 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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