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The purpose of this study is to investigate effects of systemic treatments on genomic profiles in patients with breast cancer and to compare genomic profiling between premenopausal and postmenopausal women by systemic treatments in breast cancer.
Prospective single arm trial using three patients' cohorts. One-hundred patients for each cohort and a total of 300 patients (600 biopsy samples) will be entered to this trial.
The hypothesis is that genomic alterations measured by CancerSCAN and cfDNA, Whole exome sequencing (WES), Whole transcriptome sequencing (WTS), FACS(Fluorescence-Activated Cell Sorting), cytokine and immunologic signature analysis would be different between pre- and post-menopausal women and would be predictive biomarkers for each cohort according to pre- and post-menopausal status. Three groups of patients will be recruited:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Biomarker group |
|
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| Measure | Description | Time Frame |
|---|---|---|
| Genomic profiling will be assessed by tissue sampling and blood. | Tissue and blood will be tested for CancerSCAN, cfDNA, WES, WTS, FACS, cytokine and immunologic signature analysis platform.NAC to study the multiscale relationships among DCE-MRI features, NGS data, and pathologic response to NAC and to evaluate the role of radiogenomics in predicting pathologic response of the patients. | 2year |
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Inclusion Criteria:
Patients older than 20 years
Patients with histologically confirmed breast cancer at three disease status
Patients with PS ECOG 0 - 2
Patients are willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations.
Written informed consent form
Patients must have acceptable bone marrow, liver and renal function measured within 28 days prior to study as defined below:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yeon Hee Park, MD, PH.D | Contact | 82-2-3410-3459 | yeonh.park@samsung.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsung Medical Center | Recruiting | Seoul | 135-710 | South Korea |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| D017437 |
| Skin and Connective Tissue Diseases |