Clinical trial · Interventional
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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| FoundationOne CDx | Genetic | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- FMI
- description
- FoundationOne CDx will be performed using archival tumor tissue
- interventionNames
- Genetic: FoundationOne CDx
Primary outcomes (1)
- measure
- Genetic characteristic of young (<50 years of age) Korean patients with metastatic breast cancer.
- timeFrame
- After the end of patient enrollment
- description
- Genetic characteristics will be evaluated using FoundationOne CDx.
Secondary outcomes (4)
- measure
- Evaluate the prognostic and predictive role of tumor mutation burden
- timeFrame
- After the end of patient enrollment
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 19 Years
- Maximum age
- 50 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available