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This study was an open-label, multicenter, randomized study. It is planned to include 136 patients with stage II-III triple negative breast cancer. Eligible subjects will be randomized to receive either the experimental arm: adebrelimab plus stereotactic radiotherapy followed by adebrelimab plus chemotherapy (nab-paclitaxel + carboplatin) or the control arm: adebrelimab plus nab-paclitaxel + carboplatin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| adebrelimab plus stereotactic radiotherapy and chemotherapy | Experimental |
| |
| adebrelimab plus nab-paclitaxel + carboplatin | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| adebrelimab plus stereotactic radiotherapy followed by adebrelimab plus chemotherapy (nab-paclitaxel + carboplatin) | Drug | Adebrelimab plus radiotherapy phase: radiotherapy was started on the day of the second cycle of adebrelimab administration every other day for 3 fractions; Adebrelimab plus chemotherapy phase: starting within 3-5 weeks after completion of radiotherapy, every 3 weeks for 6 cycles. |
| Measure | Description | Time Frame |
|---|---|---|
| tpCR | total pathologic complete response | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Caigang Liu, Dr. | Contact | 18940254967 | liucg@sj-hospital.org | |
| Nan Niu, Dr. | Contact | 18940256668 | niunannancy@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shengjing Hospital of China Medical University | Recruiting | Shenyang | Liaoning | 110022 | China |
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|
| adebrelimab plus chemotherapy (nab-paclitaxel + carboplatin) | Drug | adebrelimab plus chemotherapy (nab-paclitaxel + carboplatin) |
|
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| C520255 | 130-nm albumin-bound paclitaxel |
| D016190 | Carboplatin |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
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