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This open label, multi-centre phase II study will assess the efficacy and safety of single agent SC10914 in metastatic breast cancer patients with gBRCA 1/2 mutations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SC10914 group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SC10914 | Drug | SC10914 400mg tid |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | Using Independent Central Review Data Assessed by Modified Response Evaluation Criteria In Solid Tumours (RECIST v1.1) | Assessed up to a maximum of 30 months |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival (PFS) | Using Independent Central Review According to Modified Response Evaluation Criteria In Solid Tumours (RECIST v1.1) | Assessed up to a maximum of 30 months |
| Overall Survival (OS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| zhang qingsheng, MD,PhD | Contact | 13913886090 | zhangqinsheng@sh-qingfeng.net | |
| wu han, MD | Contact | 13770507990 |
| Name | Affiliation | Role |
|---|---|---|
| hu xichun, MD | Fudan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan University Shanghai Cancer Center | Recruiting | Shanghai | Shanghai Municipality | 200000 | China |
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from eligible until death due to any cause
| Assessed up to a maximum of 30 months |