NCT05633914招募中2 期
A Phase II Study of Tucidinostat and Nab-paclitaxel in Advanced HR+/HER2- Breast Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Objective Response Rate（ORR）
研究概览
简要总结
This study is looking to see whether the combination of Tucidinostat and nab-paclitaxel is safe and effective in participants with advanced HR+/HER2- breast cancer.
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
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
- •Age≥18 years, ≤75, female;
- •Histologically confirmed HR positive and HER2 negative postmenopausal metastatic breast cancer patients [HER2 negative is defined as immunohistochemistry(IHC) 0 or IHC 1+, and if the score of IHC is 2+, fluorescence in situ hybridization technology (FISH) test must be negative, HR positve is defined as ER or PR ≥1%];
- •Primary endocrine resistance or at least experienced one line of endocrine therapy for recurrent or metastatic disease;
- •No more than 1 prior line of chemothrapy for recurrent or metastatic disease;
- •Patients who have been exposed to taxanes in neoadjuvant or adjuvant setting will be allowed to enroll, if they have obtained benifits from neoadjuvant treatment or have progressed ≥ 12 months from completion of adjuvant treatment;
- •ECOG performance status ≤ 1;
- •At least one measurable disease based on RECIST v1.1
- •Adequate organ function;
- •Life expectancy is more than 3 months;
- •Willing and able to provide written informed consent.
排除标准
- •Prior exposed to histone deacetylase inhibitors, or received taxanes for metastatic disease;
- •Known hypersensitivity to any formulation component of the study drug;
- •Received chemotherapy, targeted therapy, Chinese herbal medicine with anti-tumor indications, or immunomodulatory drugs (including thymosin, interferon, interleukin, etc.) within 4 weeks before enrollment, or still within 5 half-lives of such drugs;
- •Toxicities that did not recover to National Cancer Institute Common Adverse Event Terminology Version 5.0 (NCICTCAEv5.0) grade 0 or 1 toxicity from prior antineoplastic therapy prior to the first dose of study treatment(alopecia, grade 2 fatigue, grade 2 anemia, non-clinically critical and asymptomatic laboratory abnormalities can be enrolled);
- •Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
- •Pregnant or lactating female.
- •Any other conditions deemed inappropriate by the investigator to participate in this study.
研究组 & 干预措施
Tucidinostat and nab-paclitaxel
Experimental
干预措施: Tucidinostat (Drug)
Tucidinostat and nab-paclitaxel
Experimental
干预措施: nab-paclitaxel (Drug)
结局指标
主要结局
Objective Response Rate（ORR）
时间窗: 2 years
ORR by RECIST 1.1,the total proportion of patients with complete response（CR）, partial response（PR）
次要结局
- Progression-free survival(PFS)(2 years)
- Disease Control Rate （DCR）(2 years)
研究者
研究点 (1)
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