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The purpose of the study is to address the following hypotheses: the PD-1 inhibitor Sintilimab 200mg for intravenous (IV) administration will be given together with three-week epirubincin, cyclophosphamide (EC) × 4 treatments from the second cycle followed by weekly nab-paclitaxel x12 treatments or three-week nab-paclitaxel x4 treatments. This regimen will induce higher pathologic complete response (pCR) rate in triple negative breast cancer than historical pCR rates (30-40%) observed with chemotherapy alone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sintilimab | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sintilimab | Drug | The PD-1 inhibitor Sintilimab 200mg for intravenous (IV) administration will be given together with three-week epirubincin, cyclophosphamide (EC) × 4 treatments from the second cycle followed by weekly nab-paclitaxel x12 treatments or three-week nab-paclitaxel x4 treatments. |
| Measure | Description | Time Frame |
|---|---|---|
| Pathologic Complete Response (pCR) | Pathologic response will be assessed in the surgically resected cancer and lymph nodes after completion of all chemotherapy by the local pathologist as part of routine care. Pathologic complete response is defined as no invasive cancer in the resected breast tissue and lymph nodes (ypT0/Tis, ypN0). | 21 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nan Shao | Contact | 02087755766 | 8198 | shaon@mail.sysu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Sun Yat-sen University | Guangzhou | China |
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| ID | Term |
|---|---|
| D064726 | Triple Negative Breast Neoplasms |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
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| ID | Term |
|---|---|
| C000632826 | sintilimab |
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|
| D012871 |
| Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |