Chidamide in Combination With Vincristine Metronomic Chemotherapy for Advanced Triple-negative Breast Cancer
NCT ID: NCT05747313
Last Updated: 2023-02-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
40 participants
INTERVENTIONAL
2022-11-01
2023-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
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.
TREATMENT
NONE
Study Groups
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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.
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.
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* participated in other new drug clinical trials within 4 weeks before enrollment;
* inflammatory breast cancer;
* symptomatic visceral disease;
* second primary malignancy;
* mental disorder.
18 Years
75 Years
FEMALE
No
Sponsors
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Cancer Institute and Hospital, Chinese Academy of Medical Sciences
OTHER
Responsible Party
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Principal Investigators
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Binghe Xu
Role: STUDY_DIRECTOR
National Cancer Center/National Clinical Research Center for Cancer
Locations
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National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Qiao Li, Dr.
Role: primary
Yue Chai, Dr.
Role: backup
Other Identifiers
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CSIIT-C39
Identifier Type: -
Identifier Source: org_study_id