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The trial used a multicenter, open, single-arm design in which patients were treated with Chidamide combined with Fulvestrant.The primary objective is to evaluate the preliminary efficacy and safety of Chidamide in combination with Fulvestrant.Patients included in the trial were advanced breast cancer progressing on first-line aromatase inhibitor + Cyclin-dependent kinases(CDK)4/6i rescue therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| chidamide + fulvestrant | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chidamide+ Fulvestrant | Drug | Drug: Chidamide chidamide 30mg orally,Biw Drug: Fulvestrant Fulvestrant 500mg i.m. injections every 28 days (Cycle n Day 1) with 1 additional dose on Day 15 of Cycle 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) | PFS is defined as the time from the date of randomization to the date of the first documented progression or death due to any cause. | Up to approximately 16 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (ORR) | Overall response rate (ORR) is defined as the proportion of patients with the best overall response of complete response (CR) or partial response (PR) according to RECIST 1.1. | Up to approximately 16 months |
| Overall Survival (OS) |
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Inclusion Criteria:
Exclusion Criteria:
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Time from date of randomization to the date of death from any cause. |
| Up to approximately 38 months |
| Clinical Benefit Rate (CBR) | Clinical benefit rate (CBR), defined as the proportion of patients with a best overall response of complete response (CR) or partial response (PR) or stable disease (SD) lasting 24 weeks or longer as defined in RECIST 1.1. | Up to approximately 16 months |
| Duration of Response (DOR) | Time from the first documented response (CR or PR) to the first documented progression or death due to underlying cancer as defined in RECIST 1.1. | Up to approximately 16 months |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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