Clinical Study of Fulvestrant Combined With Chidamide in the Treatment of Hormone Receptor-positive Advanced Breast Cancer Resistant to CDK4/6 Inhibitors

Sponsor
Liaoning Tumor Hospital & Institute (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05191914
Collaborator
(none)
20
1
10.7

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Chidamide+ Fulvestrant
Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Clinical Study of Fulvestrant Combined With Chidamide in the Treatment of Hormone Receptor-positive Advanced Breast Cancer Resistant to Cyclin-dependent Kinases(CDK)4/6 Inhibitors
Anticipated Study Start Date :
Feb 7, 2022
Anticipated Primary Completion Date :
Jul 30, 2022
Anticipated Study Completion Date :
Dec 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: chidamide + fulvestrant

Drug: Chidamide+ Fulvestrant
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

Outcome Measures

Primary Outcome Measures

  1. Progression Free Survival (PFS) [Up to approximately 16 months]

    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.

Secondary Outcome Measures

  1. Overall Response Rate (ORR) [Up to approximately 16 months]

    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.

  2. Overall Survival (OS) [Up to approximately 38 months]

    Time from date of randomization to the date of death from any cause.

  3. Clinical Benefit Rate (CBR) [Up to approximately 16 months]

    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.

  4. Duration of Response (DOR) [Up to approximately 16 months]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • age ≥ 18 years, postmenopausal * female patients;

  • histologically or cytologically confirmed hormone receptor positive (ER positive, PR positive or negative), human epidermal growth factor receptor 2 negative # breast cancer patients;

  • the disease before enrollment is overall unresectable locally advanced or metastatic breast cancer, and at least one measurable lesion or no measurable lesion and bone metastasis alone patients;

  • for locally advanced or metastatic breast cancer, previous progression by first-line aromatase inhibitors combined with Cyclin-dependent kinases(CDK)4/6 inhibitors;

  • the total number of regimens regardless of rescue therapy or adjuvant therapy before enrollment is ≤ 3, of which the number of rescue chemotherapy regimens is ≤ 1;

  • Eastern Collaborative Oncology Group(ECOG) score 0-1;

  • absolute neutrophil count ≥ 1.5 × 109/L, platelets ≥ 100 × 109/L, hemoglobin ≥ 90 g/L;

  • expected survival time ≥ 3 months;

  • Voluntarily participate in this clinical trial and sign the written informed consent form

Exclusion Criteria:
  • no measurable lesions (except simple bone metastasis), such as pleural or pericardial exudate, ascites, etc.;

  • underwent major surgical procedures or significant trauma before enrollment, or patients are expected to undergo major surgical treatment;

  • Patients who have previously been treated with fulvestrant or histone deacetylase inhibitors (including romidepsin, vorinostat), but have received only one cycle (≤ 2 times, d1, d15, respectively) of fulvestrant within 28 days (before enrollment) are allowed;

  • known to have a history of allergy to the drug components of this protocol;

  • the presence of brain (membrane) metastasis during the screening period;

  • a history of immunodeficiency, including HIV test positive, or suffering from other acquired, congenital immunodeficiency diseases, or a history of organ transplantation;

  • uncontrolled important cardiovascular disease;

  • abnormal liver function [total bilirubin > 1.5 times the upper limit of normal; alanine aminotrans(ALT)/aspartate aminotransferase(AST) > 2.5 times the upper limit of normal in patients without liver metastasis, alanine aminotrans(ALT)/aspartate aminotransferase(AST) > 5 times the upper limit of normal in patients with liver metastasis], abnormal renal function (serum creatinine > 1.5 times the upper limit of normal);

  • pregnant, lactating female patients or women of childbearing potential baseline pregnancy test positive; or during the study and the last dose of at least 8 to take effective contraceptive measures in subjects of childbearing age;

  • According to the investigator's judgment, there are concomitant diseases that seriously endanger the patient's safety or affect the patient's completion of the study (such as: severe hypertension, diabetes, thyroid disease, active infection, etc.);

  • History of definite neurological or psychiatric disorders, including epilepsy or dementia;

  • Unsuitable for participation in the study as judged by the investigator.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Liaoning Tumor Hospital & Institute

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Tao Sun, Director, Liaoning Tumor Hospital & Institute
ClinicalTrials.gov Identifier:
NCT05191914
Other Study ID Numbers:
  • CSIIT-C10
First Posted:
Jan 14, 2022
Last Update Posted:
Jan 14, 2022
Last Verified:
Jan 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 14, 2022