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Trial Title:
Chidamide in Combination With Vincristine Metronomic Chemotherapy for Advanced Triple-negative Breast Cancer
NCT ID:
NCT05747313
Condition:
Breast Cancer
Chemotherapy Effect
Conditions: Official terms:
Breast Neoplasms
Triple Negative Breast Neoplasms
Conditions: Keywords:
Breast Cancer
metronomic treatment
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
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.
Primary purpose:
Treatment
Masking:
None (Open Label)
Masking description:
Open Label
Intervention:
Intervention type:
Drug
Intervention name:
Chidamide
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.
Arm group label:
Study group
Other name:
Epidaza
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.
Criteria for 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.
Gender:
Female
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital
Address:
City:
Beijing
Zip:
00
Country:
China
Status:
Recruiting
Contact:
Last name:
Qiao Li, Dr.
Phone:
+8615910573527
Email:
liqiaopumc@qq.com
Contact backup:
Last name:
Yue Chai, Dr.
Phone:
13350804092
Email:
cy972628990@163.com
Start date:
November 1, 2022
Completion date:
December 31, 2023
Lead sponsor:
Agency:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Agency class:
Other
Source:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05747313
