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| Name | Class |
|---|---|
| Jiangsu HengRui Medicine Co., Ltd. | INDUSTRY |
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This is an open-label, phase II study evaluating the efficacy and safety of SHR-A1811 alone or in combination with Adebrelimab in Stage II-III HR Positive/HER2 Low Breast Cancer. Subjects will receive the neoadjuvant therapy of SHR-A1811 alone or in combination with Adebrelimab for six cycles, and then undergo surgery within 4 weeks after neoadjuvant therapy. Efficacy will be assessed every 2 cycles.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 (PD-L1 Positive) SHR-A1811 Injection + Adebrelimab Injection | Experimental | SHR-A1811 Injection + Adebrelimab Injection Drug: SHR-A1811 Injection Drug: Adebrelimab Injection |
|
| Arm 2 (PD-L1 Negative) SHR-A1811 Injection + Adebrelimab Injection | Experimental | SHR-A1811 Injection + Adebrelimab Injection Drug: SHR-A1811 Injection Drug: Adebrelimab Injection |
|
| Arm 3 SHR-A1811 Injection | Experimental | SHR-A1811 Injection Drug: SHR-A1811 Injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-A1811 Injection + Adebrelimab Injection | Drug | Drug: SHR-A1811 Injection Drug: Adebrelimab Injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total pathological complete response (tpCR: ypT0-is/ypN0) | At the time of surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Breast pathological complete response (bpCR:ypT0-is) | At the time of surgery | |
| Residual cancer burden (RCB) | At the time of surgery | |
| Best overall response rate (BORR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nan Niu, MD | Contact | 86-18940256668 | niunannancy@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Caigang Liu, MD | Shengjing Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shengjing Hospital affiliated to China Medical University | Recruiting | Shenyang | Liaoning | 110004 | China |
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| SHR-A1811 Injection + Adebrelimab Injection | Drug | Drug: SHR-A1811 Injection Drug: Adebrelimab Injection |
|
| SHR-A1811 Injection | Drug | Drug: SHR-A1811 Injection |
|
| During 18 weeks of the neoadjuvant treatment |
| Overall survival (OS) | 5 years |
| Disease-free survival (DFS) | 5 years |
| Event-free survival (EFS) | 5 years |
| Health-related quality of life (HRQOL) (EORTC QLQ-C30) | The European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ) Core 30 (EORTC QLQ-C30) | During 18 weeks of the neoadjuvant treatment |
| Health-related quality of life (HRQOL) | The European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire Breast Cancer (EORTC QLQ- BR23) will be used to measure the HRQOL | During 18 weeks of the neoadjuvant treatment |