Breast Cancer
Conditions
Keywords
Young patient, Asian
Brief summary
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.
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).
Interventions
GENETICFoundationOne CDx
FoundationOne CDx will be performed using archival tumor tissue
Sponsors
Seoul National University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
19 Years to 50 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Genetic characteristic of young (<50 years of age) Korean patients with metastatic breast cancer. | After the end of patient enrollment | Genetic characteristics will be evaluated using FoundationOne CDx. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the prognostic and predictive role of tumor mutation burden | After the end of patient enrollment | Tumor mutation burden will be analysed using FoundationOne CDx. |
| Reveal the correlation between genetic characteristics and immunohistochemical expression of selected proteins. | After the end of patient enrollment | FoundationOne CDx results and immunohistochemical expression will be analysed. |
| Compare molecular characteristics of breast cancer according to age groups. | After the end of patient enrollment | Genetic characteristics will be analysed according to age groups. |
| 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). | After the end of patient enrollment | The result of FoundationOne CDx will be used in patient treatment |
Countries
South Korea
Outcome results
None listed