An interventional study of FoundationOne CDx in Breast Cancer, sponsored by Seoul National University Hospital. Enrolling by invitation at 1 site in Korea, Republic of. Open to female participants aged 19 Years to 50 Years. Per ClinicalTrials.gov, last updated 2025-04-17.
Sponsored by Seoul National University Hospital · Not applicable, Interventional, and Diagnostic
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.
Secondary Objective(s):
12,543 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's planned enrollment of 200 is above the median of 72 across 9,302 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Seoul National University Hospital is the lead sponsor of 1,860 studies on the registry; 275 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
FoundationOne CDx will be performed using archival tumor tissue
Genetic: FoundationOne CDx
FoundationOne CDx will be performed using archival tumor tissue
Genetic characteristic of young (<50 years of age) Korean patients with metastatic breast cancer.
Genetic characteristics will be evaluated using FoundationOne CDx.
Time frame: After the end of patient enrollment
Evaluate the prognostic and predictive role of tumor mutation burden
Tumor mutation burden will be analysed using FoundationOne CDx.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: After the end of patient enrollment
Plan to share: No
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Seoul National University Hospital