NCT04582955Unknown不适用
Chidamide Combined With Neoadjuvant Chemotherapy in Early Triple-negative Breast Cancer
Tianjin Medical University Cancer Institute and Hospital1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2020年10月30日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Efficacy Outcome: pathologic complete response（pCR） rate（ypT0/is ypN0）
研究概览
简要总结
Objective to evaluate the efficacy and safety of neoadjuvant therapy with Chidamide combined with chemotherapy for stage II - III triple-negative breast cancer，and to compare the efficacy and safety of chemotherapy with Chidamide and chemotherapy alone in the neoadjuvant treatment of stage II - III triple-negative 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 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 and ≤ 70, postmenopausal / premenopausal women;
- •Patients with unilateral or bilateral primary invasive triple-negative (ER expression < 1%, PR < 1%, and HER2 negative *) confirmed by histology or cytology;
- •non-metastatic invasive TNBC（stage II-III）with at least one axillary lymph node involvement (T1cN1-2M0 or T2-3N1-2M0);
- •previously untreated for breast cancer;
- •There was at least one measurable primary lesion (according to RECIST v1.1);
- •ECoG score 0-1;
- •Adequate organ and marrow function as defined below:
- •absolute value of neutrophils ≥ 1.5 × 109 / L, platelets ≥ 100 × 109 / L, hemoglobin≥ 90 g / L;
- •Volunteer to participate in this clinical trial and sign written informed consent
排除标准
- •No measurable lesions, such as pleural or pericardial effusion, ascites, etc;
- •Major surgical procedures or significant trauma were performed within 4 weeks before enrollment, or patients were expected to receive major surgical treatment (not related to breast cancer);
- •Previously treated with chemotherapy or HDAC inhibitors (including romidepsin, vorinostat, belinostat, and panobinostat，etc);
- •Have allergic history to the components of this regimen;
- •Treated with radiotherapy within 4 weeks before admission;
- •Have a history of immunodeficiency, including HIV positive, or other acquired or congenital immunodeficiency diseases, or have a history of organ transplantation;
- •Uncontrolled cardiovascular diseases, history of clinically significant QT interval prolongation, or QTc interval > 450 ms at screening;
- •Abnormal liver function [total bilirubin > 1.5 times of the upper limit of normal value; ALT / AST > 2.5 times of upper limit of normal value for patients without liver metastasis ; ALT / AST > 5 times of upper limit of normal value for patients with liver metastasis ], abnormal renal function (serum creatinine > 1.5 times of upper limit of normal value);
- •Pregnant, lactating or fertile women with a positive baseline pregnancy test; or subjects of childbearing age who are not willing to take effective contraceptive measures during the study period and at least 8 weeks after the last administration;
- •According to the judgment of the investigator, there are some concomitant diseases (such as severe hypertension, diabetes, thyroid disease, active infection, etc.) that seriously endanger the safety of patients or affect patients to complete the study;
- •A clear history of epilepsy or dementia, including neurological disorders;
- •The investigator determined not suitable to participate in this study.
研究组 & 干预措施
Arm A
Experimental
Chidamide, orally,20mg at day 0,4,7,11,21,every 3 weeks; in combination with Docetaxel 75mg/m2,intravenous infusion，at day1 every 3 weeks，and Epirubicin 75mg/m2, intravenous infusion，at day1 every 3 weeks
干预措施: Chidamide in combination with chemotherapy (Drug)
结局指标
主要结局
Efficacy Outcome: pathologic complete response（pCR） rate（ypT0/is ypN0）
时间窗: 1years
pCR defined as no invasive tumour residuals in breast and no invasive and no non-invasive tumour residuals in axillary lymph nodes (ypT0/is ypN0) after neoadjuvant therapy
次要结局
- Objective Response Rate (ORR) by RECIST v1.1(12 months)
- Event-free survival(60 months)
- Breast conserving surgery rate(12 months)
- Incidence of Adverse Events (AEs)(12 months)
- pCR by other definitions(12 months)
- Overall survival(72 months)
研究者
研究点 (1)
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