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It analyzes the Tumor microenvironment(TME) changes in non pathologic complete response(pCR) subjects among subjects who were administered neoadjuvant pembrolizumab and those who were not administered neoadjuvant pembrolizumab for triple negative breast cancer.
(Neoadjuvant Weekly paclitaxel, Carboplatin +- Pembrolizumab followed by Doxorubicin, Cyclophosphamide +- Pembrolizumab regimen)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects administered Neoadjuvant Pembrolizumab | Neoadjuvant Weekly paclitaxel, Carboplatin followed by Doxorubicin, Cyclophosphamide add Pembrolizumab |
| |
| Subjects not administered Neoadjuvant Pembrolizumab | Neoadjuvant Weekly paclitaxel, Carboplatin followed by Doxorubicin, Cyclophosphamide |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Visium, Whole Genome Sequencing(WGS)/Whole Transcriptome Sequencing(WTS) | Genetic | Visium : Spatial transcriptomics WGS/WTS : detection of somatic mutation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Genomic profiling will be assessed by tissue and blood samples(analyze the TME changes) | Tissue and blood will be tested for Spatial transcriptomics, WGS(Wilcoxon rank sum test or Chi-square test, cell-cell interaction) | 3year |
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Inclusion Criteria:
Exclusion Criteria:
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Locally advanced triple negative breast cancer subjects who were administered neoadjuvant chemotherapy with Weekly paclitaxel, Carboplatin followed by Doxorubicin, Cyclophosphamide add Pembrolizumab or not
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yeon Hee Park, MD, Ph.D | Contact | 82-2-3410-1780 | yeonh.park@samsung.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsung Medical Center | Recruiting | Seoul | 06351 | South Korea |
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Blood : Germline DNA Tissue : DNA/RNA
| ID | Term |
|---|---|
| D064726 | Triple Negative Breast Neoplasms |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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