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| Name | Class |
|---|---|
| Jiangsu Hengrui Pharmaceutical Co., Ltd. | INDUSTRY |
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This study is an open-label, single-arm, multicenter clinical study. 94 patients with germline BRCA-mutated HER2-negative early breast cancer are planned to be enrolled and treated with fluzoparib combined with camrelizumab to observe and evaluate the efficacy and safety of neoadjuvant fluzoparib combined with camrelizumab in the treatment of germline BRCA-mutated HER2-negative early breast cancer。
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Camrelizumab+Fluzoparib | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Camrelizumab+Fluzoparib | Drug | Fluzoparib:150mg was given orally twice daily Camrelizumab:200 mg IV drip on Day 1 of each cycle |
|
| Measure | Description | Time Frame |
|---|---|---|
| tpCR(ypT0/is ypN0) | total pathological complete response | 6 months |
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Inclusion Criteria:
HER2 negative: IHC 0/1 + or IHC2 + but ISH negative; Tumor stage: II-III; Primary tumor size: ≥ 1 cm Nodal Status: N0-3
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shu Wang, Dr. | Breast Center, Peking University People's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Breast Cancer, Peking University People's Hospital | Beijing | Beijing Municipality | 100044 | China |
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