Back to resultsChidamide in Combination With Vincristine Metronomic Chemotherapy for Advanced Triple-negative Breast Cancer
Primary Purpose
Breast Cancer, Chemotherapy Effect
Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Chidamide
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring Breast Cancer, metronomic treatment
Eligibility Criteria
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.
Sites / Locations
- National Cancer Center/National Clinical Research Center for Cancer/Cancer HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Study group
Arm Description
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.
Outcomes
Primary Outcome Measures
Progression-free Survival
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
Number of Patients With Clinical Responses (Phase I)
The number of patients with clinical responses (CR, VGPR, PR, or minimal response [MR]) will be summarized by stage.
Overall Toxicity Rate
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.
Full Information
NCT ID
NCT05747313
First Posted
February 17, 2023
Last Updated
February 17, 2023
Sponsor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT05747313
Brief Title
Chidamide in Combination With Vincristine Metronomic Chemotherapy for Advanced Triple-negative Breast Cancer
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2022 (Actual)
Primary Completion Date
June 1, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Chemotherapy Effect
Keywords
Breast Cancer, metronomic treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
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.
Masking
None (Open Label)
Masking Description
Open Label
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Study group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Chidamide
Other Intervention Name(s)
Epidaza
Intervention Description
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.
Primary Outcome Measure Information:
Title
Progression-free Survival
Description
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
Time Frame
At 1 year
Secondary Outcome Measure Information:
Title
Number of Patients With Clinical Responses (Phase I)
Description
The number of patients with clinical responses (CR, VGPR, PR, or minimal response [MR]) will be summarized by stage.
Time Frame
Up to 1 year
Title
Overall Toxicity Rate
Description
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.
Time Frame
Up to 1 year
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Qiao Li
Phone
15910573527
Ext
87788819
Email
liqiaopumc@qq.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yue Chai
Phone
13350804092
Email
cy972628990@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Binghe Xu
Organizational Affiliation
National Cancer Center/National Clinical Research Center for Cancer
Official's Role
Study Director
Facility Information:
Facility Name
National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
00
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qiao Li, Dr.
Phone
+8615910573527
Email
liqiaopumc@qq.com
First Name & Middle Initial & Last Name & Degree
Yue Chai, Dr.
Phone
13350804092
Email
cy972628990@163.com
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
The individual data will not be made available in order to protect the participant's identity.
Learn more about this trial
Chidamide in Combination With Vincristine Metronomic Chemotherapy for Advanced Triple-negative Breast Cancer
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