Trial of Tucidinostat in Combination With Fulvestrant in Patients With Hormone-receptor Positive Advanced Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 73
- 主要终点
- Progression Free Survival (PFS)
研究概览
简要总结
The purpose of the study is evaluate the efficacy and safety of tucidinostat in combination with fulvestrant in patients with hormone-receptor positive advanced breast cancer.
详细描述
Hormone-receptor positive breast cancer is the most common subtype in breast cancer. Tucidinostat is an oral subtype-selective histone deacetylase inhibitor, which showed preliminary signs of encouraging anti-tumour activity in patients with advanced hormone-receptor positive breast cancer in the previous studies. The aim of this study is to evaluate the efficacy and safety of Tucidinostat in combination with fulvestrant in patients with recurrent or metastatic hormone-receptor positive 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
- •Female patients aged 18-75 years (including cutoff value);
- •The disease condition is inoperable, recurrent breast cancer, or metastatic breast cancer;
- •Histological or cytological confirmation of hormone receptor-positive [estrogen receptor (ER) positive and progesterone receptors (PgR) positive or negative] breast cancer;
- •At least one measurable lesion according to RECIST 1.1;
- •Prior treatment: have not received systemic chemotherapy for recurrent or metastatic breast cancer;
- •Eastern Cooperative Oncology Group Performance Status of 0-1;
- •Adequate function of major organs meets the following requirements):
- •Absolute Neutrophils count≥ 1.5×10^9/L; Platelets count≥ 90×10^9/L; Hemoglobin ≥ 90g/L; Total bilirubin≤ 1.5 × the upper limit of normal (ULN); ALT and AST ≤ 2.5 × ULN; BUN and Cr ≤ 1.5 × ULN; Left ventricular ejection fraction (LVEF) ≥ 50%; QTcF(Fridericia correction) ≤ 470 ms; International normalized ratio(INR)≤1.5 × ULN; activated partial thromboplastin time(APTT) ≤ 1.5 × ULN;
- •Life expectancy ≥ 3 months;
- •Have signed informed consent.
排除标准
- •Patients have untreated central nervous system (CNS) metastases;
- •Patients with no measurable lesion according to RECIST 1.1;
- •Patients with bilateral breast cancer;
- •Patients with human epidermal growth factor receptor-2 (Her-2) positive;
- •Recurrent or metastatic disease occurs within 2 years during adjuvant endocrine therapy;
- •Patients previously received systemic chemotherapy for recurrent or metastatic breast cancer;
- •Patients previously received any HDAC inhibitor or fulvestrant treatment;
- •There are ascites, pleural effusion, pericardial effusion with clinical symptoms at baseline, those who need drainage, or those who have undergone drainage of serous effusion within 4 weeks before the first dose;
- •Inability to swallow, intestinal obstruction or other factors affecting the administration and absorption of the drug;
- •Patients with other invasive malignancies within 5 years or at the same time, with the exception of curatively-treated basal cell or squamous cell carcinoma of the skin or cervical carcinoma in situ;
- •Patients with a history of allergies to the drug components of this regimen;
- •Patients with active HBV and HCV infection; stable hepatitis B after drug treatment (HBV virus copy number is higher than the upper limit of reference value) and cured hepatitis C patients (HCV virus copy number exceeds the lower limit of detection method) can be included;
- •Patients with a history of immunodeficiency, including HIV positive, or other acquired or congenital immunodeficiency disease, history of organ transplantation;
- •Patients have uncontrolled or significant cardiovascular disease, including: Myocardial infarction (< the last 12 months); Uncontrolled angina (< the last 6 months); Congestive heart failure (< the last 6 months), or Left Ventricular Ejection Fraction (LVEF) < 50% prior to study entry;
- •Any mental or cognitive disorder, that would interfere the ability to understand the informed consent document or the operation and compliance of study;
- •Any other condition which is inappropriate for the study in the opinion of the investigators.
研究组 & 干预措施
Tucidinostat + Fulvestrant
Patients receive 30 mg Chidamide twice per week. Fulvestrant 500mg (2 syringes of Fulvestrant 250mg), Fulvestrant 500 mg i.m. every 28 (+/- 3) days plus an additional 500 mg on day 14 (+/-3) of first month only.
Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
干预措施: Tucidinostat (Drug)
Tucidinostat + Fulvestrant
Patients receive 30 mg Chidamide twice per week. Fulvestrant 500mg (2 syringes of Fulvestrant 250mg), Fulvestrant 500 mg i.m. every 28 (+/- 3) days plus an additional 500 mg on day 14 (+/-3) of first month only.
Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
干预措施: Fulvestrant (Drug)
结局指标
主要结局
Progression Free Survival (PFS)
时间窗: From date of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years.
PFS was defined as the time from treatment until objective disease progression according to Response Evaluation Criteria in Solid Tumours version 1.1 (RECIST 1.1), or death by any cause, whichever is first met.
次要结局
- Duration of response (DOR)(From the day of treatment to the date of first documented progression, assessed up to 3 years.)
- overall survival (OS)(Time from treatment to death from any cause, assessed up to 3 years.)
- 4.Clinical Benefit Rate (CBR)(From the day of treatment to the date of first documented progression, assessed up to 3 years.)
- Adverse event(AE)(From the day of treatment to the date of first documented progression, assessed up to 3 years.)
- Objectivel response rate (ORR)(Response is assessed once every 8 weeks, from the day of treatment to the date of first documented progression, assessed up to 3 years.)
研究者
Anqin Zhang
Chief Physician
Guangdong Women and Children Hospital