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This Phase Ⅱ study was designed to assess the efficacy and safety of the combination of tucidinostat, angiogenesis inhibitors and fulvestrant for advanced HR-positive, HER2-negative breast cancer patients after the failure of CDK4/6 inhibitor.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chidamide,Fulvestrant ,angiogenesis inhibitors | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chidamide,Fulvestrant,angiogenesis inhibitors | Drug | chidamide,30mg,po. biw fulvestrant ,500mg, im., d1(c1d15), q4w angiogenesis inhibitors , according to the doctor's advice |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate(ORR) | Objective Response Rate(ORR)by RECIST 1.1,the total proportion of patients with complete response(CR), partial response(PR) | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival(PFS) | Time from treatment until disease progression or death | 2 years |
| Disease Control Rate (DCR) | he total proportion of patients with complete response(CR), partial response(PR)and stable disease(SD) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| jundong wu | Contact | 13829663428 | wujun-dong@163.com | |
| haoming wu | Contact | 15811833918 | ahand@126.com |
| Name | Affiliation | Role |
|---|---|---|
| caiwen du | Cancer Hospital Chinese Academy of Medical Science, Shenzhen Center | Principal Investigator |
| jundong wu | Affiliated Tumor Hospital of Shantou University Medical College | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Affiliated Tumor Hospital of Shantou University Medical College | Shantou | China |
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| 2 years |
| Clinical Benefit Rate (CBR) | The total proportion of patients with Partial Response (PR), Complete Response (CR) or Stable Disease (SD) ≥6 months | 2 years |
| Overall survival (OS) | Time from treatment until death from any cause | 2 years |