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Chidamide in Combination With Vincristine Metronomic Chemotherapy for Advanced Triple-negative Breast Cancer

Sponsor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences (Other)
Overall Status
Recruiting
CT.gov ID
NCT05747313
Collaborator
(none)
40
Enrollment
1
Location
1
Arm
14
Anticipated Duration (Months)
2.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The mechanism of action of cidabenamide and the advantages of vincristine metronomic chemotherapy make it possible to combine the two drugs. Therefore, it is necessary to conduct a prospective study to investigate the value of chidamide in combination with vincristine metronomic treatment for triple-negative breast cancer.

Condition or Disease Intervention/Treatment Phase
Phase 1/Phase 2

Detailed Description

The mechanism of action of cidabenamide and the advantages of vincristine metronomic chemotherapy make it possible to combine the two drugs. Therefore, it is necessary to conduct a prospective study to investigate the value of chidamide in combination with vincristine metronomic treatment for triple-negative breast cancer.The current study was designed to explore the efficacy of oral two-metronomic agents (chidamide in combination with vincristine) in advanced triple-negative patient in China.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
The experiment was a single-arm study design. The study is divided into two phases. Phase I : single-arm, open, dose-climbing Phase Ib clinical study to determine the safety and tolerability of the combination regimen and to define the dose-limiting toxicity (DLT), maximum tolerated dose (MTD) or recommended dose for Phase II studies of this combination regimen. Phase II : Single-arm, open, single-center Phase II clinical study to assess the efficacy and safety of the recommended dose administered in Phase II.The experiment was a single-arm study design. The study is divided into two phases. Phase I : single-arm, open, dose-climbing Phase Ib clinical study to determine the safety and tolerability of the combination regimen and to define the dose-limiting toxicity (DLT), maximum tolerated dose (MTD) or recommended dose for Phase II studies of this combination regimen. Phase II : Single-arm, open, single-center Phase II clinical study to assess the efficacy and safety of the recommended dose administered in Phase II.
Masking:
None (Open Label)
Masking Description:
Open Label
Primary Purpose:
Treatment
Official Title:
A Prospective, Single-arm, Open-lable, Single-center Phase Ib/II Clinical Study of Chidamide in Combination With Vincristine Metronomic Chemotherapy for Advanced Triple-negative Breast Cancer
Actual Study Start Date :
Nov 1, 2022
Anticipated Primary Completion Date :
Jun 1, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Study group

Phase Ib: The dose of vincristine administered in this phase is 40 mg on days 1,3,5 of each cycle. The timepoint for chidamide dosing in this phase is twice weekly, i.e., dosing on days 1,4,8,11,15,18 of each cycle. Take 30 minutes after a meal. Phase II: This phase is based on the MTD/RP2D determined in phase I. The phase II expansion group study was conducted. Vincristine is administered at a dose of 40 mg on days 1,3,5 of each cycle. Chidamide was administered at a dose of MTD/RP2D twice a week on days 1,4,8,11,15 and 18 of each cycle. It is to be taken 30 minutes after a meal.

Drug: Chidamide
Phase Ib: The dose of vincristine administered in this phase is 40 mg on days 1,3,5 of each cycle. The timepoint for chidamide dosing in this phase is twice weekly, i.e., dosing on days 1,4,8,11,15,18 of each cycle. Take 30 minutes after a meal. Phase II: This phase is based on the MTD/RP2D determined in phase I. The phase II expansion group study was conducted. Vincristine is administered at a dose of 40 mg on days 1,3,5 of each cycle. Chidamide was administered at a dose of MTD/RP2D twice a week on days 1,4,8,11,15 and 18 of each cycle. It is to be taken 30 minutes after a meal.
Other Names:
  • Epidaza

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Progression-free Survival [At 1 year]

      1-year progression-free survival (PFS1). Evidence of local recurrence, distant metastasis, or death from any cause within 1 year counted as events in the time-to-event Kaplan-Meier analysis of progression-free survival. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions

    Secondary Outcome Measures

    1. Number of Patients With Clinical Responses (Phase I) [Up to 1 year]

      The number of patients with clinical responses (CR, VGPR, PR, or minimal response [MR]) will be summarized by stage.

    2. Overall Toxicity Rate [Up to 1 year]

      The overall toxicity rates (percentages) for grade 3 or higher adverse events considered at least possibly related to treatment are reported below by stage for Phase I patients.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • female;

    • aged ≥ 18 years and ≤75 years;

    • histologically proved metastatic triple-negative breast cancer;

    • at least one measurable or evaluable lesion based on RECIST 1.1 criteria;

    • estimated life expectancy ≥ 3 months; (6) normal heart, liver, and kidney function;

    • Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1; -

    • informed consent signed by the participants.

    Exclusion Criteria:

    • received neoadjuvant or adjuvant therapy containing vinorelbine or capecitabine within one year prior to treatment initiation;

    • participated in other new drug clinical trials within 4 weeks before enrollment;

    • inflammatory breast cancer;

    • symptomatic visceral disease;

    • second primary malignancy;

    • mental disorder.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital Beijing Beijing China 00

    Sponsors and Collaborators

    • Cancer Institute and Hospital, Chinese Academy of Medical Sciences

    Investigators

    • Study Director: Binghe Xu, National Cancer Center/National Clinical Research Center for Cancer

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Cancer Institute and Hospital, Chinese Academy of Medical Sciences
    ClinicalTrials.gov Identifier:
    NCT05747313
    Other Study ID Numbers:
    • CSIIT-C39
    First Posted:
    Feb 28, 2023
    Last Update Posted:
    Feb 28, 2023
    Last Verified:
    Feb 1, 2023
    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
    Keywords provided by Cancer Institute and Hospital, Chinese Academy of Medical Sciences
    Breast Cancer
    metronomic treatment
    Additional relevant MeSH terms:
    Breast Neoplasms
    Triple Negative Breast Neoplasms

    Study Results

    No Results Posted as of Feb 28, 2023