Outcome of Tucidinostat-Based Therapy in HR+ Metastatic Breast Cancer Patients Previously Treated With CDK4/6 Inhibitor

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-07-10

Study Completion Date

2022-08-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Breast Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

Tucidinostat

Intervention Type DRUG

Tucidinostat in combination with endocrine drugs

Interventions

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Tucidinostat

Tucidinostat in combination with endocrine drugs

Intervention Type DRUG

Other Intervention Names

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Chidamide

Eligibility Criteria

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Inclusion Criteria

* 1.woman, age \> 18 years old 2.Diagnosed with HR+/HER2- Metastatic Breast Cancer 3.Patients received tucidinostat-based therapy after progression on CDK4/6 inhibitor 4.Complete medical history was available