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

Sponsor
Beijing 302 Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05276713
Collaborator
(none)
50
Enrollment
1
Location
36.7
Anticipated Duration (Months)
1.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

Detailed Description

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
50 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
A Single-center Study of the Outcome of Tucidinostat-Based Therapy in Hormone Receptor-Positive Metastatic Breast Cancer Patients Previously Treated With CDK4/6 Inhibitor Therapy
Actual Study Start Date :
Jul 10, 2019
Anticipated Primary Completion Date :
Jun 1, 2022
Anticipated Study Completion Date :
Aug 1, 2022

Arms and Interventions

Arm Intervention/Treatment
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.

Drug: Tucidinostat
Tucidinostat in combination with endocrine drugs
Other Names:
  • Chidamide

    		•

    Outcome Measures

    Primary Outcome Measures

    1. PFS [6 weeks]

      Progression free survival

    Secondary Outcome Measures

    1. Adverse events [6 weeks]

      Number of participants with treatment-related adverse events as assessed by Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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
    Exclusion Criteria:
    • 1.Medical history was incomplete

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The Fifth Medical Center of PLA General Hospital Beijing Beijing China 100071

    Sponsors and Collaborators

    • Beijing 302 Hospital

    Investigators

    • Study Director: Tao wang, Beijing 302 Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Beijing 302 Hospital
    ClinicalTrials.gov Identifier:
    NCT05276713
    Other Study ID Numbers:
    • Breast-Chi-2022
    First Posted:
    Mar 11, 2022
    Last Update Posted:
    Mar 11, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Breast Neoplasms

    Study Results

    No Results Posted as of Mar 11, 2022