NCT06750848尚未招募2 期
Chidamide Combined With Angiogenesis Inhibitors and Fulvestrant for Advanced HR-positive, HER2-negative Breast Cancer After Prior CDK4/6 Inhibitor Progression : a Single Arm, Phase Ⅱ Study
Jundong Wu1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2024年12月20日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Objective Response Rate（ORR）
研究概览
简要总结
This Phase Ⅱ study was designed to assess the efficacy and safety of the combination of tucidinostat, angiogenesis inhibitors and fulvestrant for advanced HR-positive, HER2-negative breast cancer patients after the failure of CDK4/6 inhibitor.
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
- All
- 接受健康志愿者
- 否
入选标准
- •1.Age≥18 years, ≤75, female; 2.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 ≥10%]; 3.Prior CDK4/6 inhibitor progression or intolerance to CDK4/6i before enrollment; 4.Premenopausal patients need OFS; 5.Recurrence and metastasis progressed more than 6 months after receiving endocrine therapy or more than 2 years after receiving adjuvant endocrine therapy; 6.ECOG performance status ≤ 1; 7.At least one measurable disease based on RECIST v1.1 8.Adequate organ function; 9.Life expectancy is more than 3 months; 10.Willing and able to provide written informed consent
排除标准
- •1.Prior exposed to histone deacetylase inhibitors; 2.Received TKI before enrollment; 3.Exist visceral crisis; 4.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; 5.Poorly controlled diabetes (FBG>10mmol/L); 6.Poorly controlled hypertension (SBP>150 mmHg, DBP>90 mmHg); 7.Urinalysis shows urine protein ≥ 2+ or 24-hour protein quantity test shows urinary protein ≥1 g; 8.PT>16s, APTT> 43s, TT>21s, FIB<2g/L; 9.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); 10.Pregnant or lactating female. 11.Any other conditions deemed inappropriate by the investigator to participate in this study.
研究组 & 干预措施
Chidamide，Fulvestrant ，angiogenesis inhibitors
Experimental
干预措施: Chidamide，Fulvestrant，angiogenesis inhibitors (Drug)
结局指标
主要结局
Objective Response Rate（ORR）
时间窗: 2 years
Objective Response Rate（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)
- Clinical Benefit Rate (CBR)(2 years)
- Overall survival (OS)(2 years)
研究者
Jundong Wu
Affiliated Cancer Hospital of Shantou University Medical College
Affiliated Cancer Hospital of Shantou University Medical College
研究点 (1)
Loading locations...
相似试验
Unknown
2 期
Chidamide Combined With VDDT Regimen in the Relapse and Refractory Diffuse Large B Cell LymphomaDiffuse Large B-cell LymphomaNCT02733380Henan Cancer Hospital20
尚未招募
2 期
Chidamide Combined With Sintilimab and Bevacizumab for the First-line Treatment of Advanced Liver CancerLiver CancerNCT06408623Cancer Institute and Hospital, Chinese Academy of Medical Sciences48
已完成
2 期
Chidamide Combined With Zimberelimab in the Treatment of Metastatic Triple-negative Breast Cancer PatientsTriple Negative Breast CancerNCT05632848Sun Yat-sen University47
Unknown
2 期
Chidamide With PET Regimen for Angioimmunoblastic T Cell Lymphoma (PET: Prednisone, Etoposide and Thalidomide)Angioimmunoblastic T-cell LymphomaNCT03273452Qingdao University30
尚未招募
2 期
A Prospective, Randomized, Open, Phase II Clinical Study of Chidamide in Combination with Camrelizumab and Apatinib for Advanced Esophageal CancerAdvanced Esophageal CarcinomaNCT06745193Peking University63