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To evaluate the efficacy of tucidinostat-based therapy in hormone receptor-positive metastatic breast cancer patients previously treated with CDK4/6 inhibitor therapy in the real world.
Cyclin-dependent kinase (CDK) 4/6 inhibitors have changed the treatment pattern of patients with hormone receptor-positive HER2-negative advanced breast cancer significantly prolongling patients'PFS and OS,but there is no optimal therapy after its progression.Tucidinostat (formerly known as chidamide) is an oral subtype-selective histone deacetylase inhibitor, ACE trial demonstrated that tucidinostat plus exemestane improved PFS compared with placebo plus exemestane in HR+,MBC patients that progressed after previous endocrine therapy,only 7 patients enrolled in the trial had previously received CDK4/6 inhibitors.The aim of this trial is to evaluate the efficacy of tucidinostat-based therapy in hormone receptor-positive metastatic breast cancer patients previously treated with CDK4/6 inhibitor therapy in the real world.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tucidinostat-based therapy | 30 mg tucidinostat was given orally(as six 5 mg tablets per day) twice a week (either, Monday and Thursday, Tuesday and Friday, or Wednesday and Saturday) for 4 consecutive weeks in a 4-week cycle.The endocrine drugs combined with tucidinostat were given based on previous treatment.Patients received tucidinostat-based treatment until disease progression or intolerable adverse events. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tucidinostat | Drug | Tucidinostat in combination with endocrine drugs |
|
| Measure | Description | Time Frame |
|---|---|---|
| PFS | Progression free survival | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | Number of participants with treatment-related adverse events as assessed by Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0) | 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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Patients diagnosed with breast cancer (according to International Classification of Diseases-10, ICD-10) with confirmed metastasis, regardless of being de novo diagnosed or progressed from a non-metastatic stage.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jinmei Zhou | Contact | +86-010-66947427 | jinzhu2714@sina.com |
| Name | Affiliation | Role |
|---|---|---|
| Tao wang | Beijing 302 Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Fifth Medical Center of PLA General Hospital | Recruiting | Beijing | Beijing Municipality | 100071 | China |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| C547816 | N-(2-amino-5-fluorobenzyl)-4-(N-(pyridine-3-acrylyl)aminomethyl)benzamide |
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| D017437 |
| Skin and Connective Tissue Diseases |