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
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Progression-free Survival
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Open Label
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Chidamide (Drug)
结局指标
主要结局
Progression-free Survival
时间窗: 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
次要结局
- Number of Patients With Clinical Responses (Phase I)(Up to 1 year)
- Overall Toxicity Rate(Up to 1 year)