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| Name | Class |
|---|---|
| Jiangsu HengRui Medicine Co., Ltd. | INDUSTRY |
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Although many PARP inhibitors did not improve pCR in neoadjuvant studies, it is not an unchallenged conclusion that TNBC does not benefit from use of PARP inhibitors in neoadjuvant therapy.This study is an open-label, two-cohort, multicenter trial. 60 patients with germline BRCA-mutated three-negative early breast cancer are planned to be enrolled and treated with fluzoparib combined with chemotherapy according to tumor response after EC (epirubicin and cyclophosphamide) for 2 cycles.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort1: Epirubicin+Cyclophosphamide | Experimental | 2 cycles of EC (Epirubicin+Cyclophosphamide) induced chemotherapy, if tumor response is CR or PR: Epirubicin+Cyclophosphamide for 2 cycles Fluzoparib+Paclitaxel for 2 cycles |
|
| Cohort2: Fluzoparib+Paclitaxel | Experimental | 2 cycles of EC (Epirubicin+Cyclophosphamide) induced chemotherapy, if tumor response is SD: Fluzoparib+Paclitaxel for 4 cycles |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluzoparib+Paclitaxel | Drug | Fluzoparib+Paclitaxel for 4 cycles if tumor response is SD after 2 cycles of EC induced chemotherapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| tpCR(ypT0/is ypN0) | pCR is defined as the absence of invasive residual disease in the breast and in the axillary lymph nodes (ypT0/is ypN0). | 6 months from the patients enrolled |
| Measure | Description | Time Frame |
|---|---|---|
| Event-free Survival (EFS) as assessed by Investigator | EFS is defined as the time from enrollment to disease progression or death due to any cause | Up to approximately 3 years |
| AEs and SAEs | adverse events and serious adverse events |
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Inclusion Criteria:
Women ≥ 18 and ≤ 70 years of age with treatment-naïve breast cancer
Histopathologically confirmed early or locally advanced three-negative invasive breast cancer as defined by the ASCO/CAP guidelines while meeting the following conditions:
HER2 negative: IHC 0/1 + or IHC2 + but ISH negative; ER and/or PR negative (not eligible for endocrine therapy): IHC nuclear staining ≤ 1%
Tumor stage: II-III: Primary tumor size: ≥ 2cm
ECOG score 0 ~ 1;
Centrally confirmed BRCA1 or BRCA2 germline mutation;
Eligible level of organ function
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaoan Liu, Professor | Contact | 025-68308162 | liuxiaoan@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Xiaoan Liu, Professor | Jiangsu Province Hospital/ The First Affiliated Hospital of Nanjing Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| JiangSu Province Hospital/ The First Affiliated Hospital of Nanjing Medical University | Recruiting | Nanjing | Jiangsu | 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 |
|---|---|
| C098534 | EC regimen |
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| Epirubicin+Cyclophosphamide | Drug | Epirubicin+Cyclophosphamide |
|
| From enrollment to the surgery (approximately 6 months) |
| D012871 |
| Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |