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This study aims to evaluate the efficacy and safety of a PD-1 inhibitor combined with different chemotherapy regimens (PCb-EC and PCb), in order to develop a superior and well-tolerated neoadjuvant therapeutic strategy for patients with triple-negative breast cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PCb-EC+PD1 | Active Comparator |
| |
| PCb+PD1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Toripalimab | Drug | Toripalimab 240mg every cycle |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Pathologic complete response (pCR) rates | Up to 180 days |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate(ORR) | up to 180 days | |
| Event-free survival (EFS) | up to 5 years | |
| Invasive Disease-Free Survival (IDFS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhenzhen Liu | Contact | +8613603862755 | zlyyliuzhenzhen0800@zzu.edu.cn |
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IPD that underlie the results of the study will be made avaliable after de-indentification.
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Within 18 months after the publication of the results.
Researchers can gain access to the data from the corresponding author upon written request with detailed study plan.
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| PCb-EC |
| Drug |
Albumin Paclitaxel + Carboplatin*4 Followed by Epirubicin + Cyclophosphamide*4 |
|
| PCb | Drug | Albumin Paclitaxel + Carboplatin *6 |
|
| up to 5 years |
| Overall Survival (OS) | up to 5 years |
| Adverse events | up to 18 months |
| EORTC QLQ-C30 questionnaire | All of the scales and single-item measures range in score from 0 to 100. A high scale scorerepresents a higher response level | up to 18 months |
| EORTC QLQ-BR23 questionnaire | All of the scales and single-item measures range in score from 0 to 100. A high score for the functional scales represents a high/healthy level of functioning, | up to 18 months |
| 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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| ID | Term |
|---|---|
| C000656314 | toripalimab |
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