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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Breast Cancer, Chemotherapy Effect

Intervention / Treatment
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* Drug: Chidamide


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study group<br>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<br>* 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.<br>* Other names: Epidaza;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | At 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Up to 1 year | 
| 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. | Up to 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast Cancer, metronomic treatment