A Prospective, Single Center, Randomized, Open-labled Stage III Clinical Trial Comparing the Efficacy and Safety of Anthracyclin Followed by Weekly Paclitaxel Versus Dose-dense Anthracyclin Followed by Weekly Paclitaxel Versus Dose-dense Anthracyclin Followed by Weekly Paclitaxel Combined With Carboplatin for High-risk, Triple-negative Early Breast Cancer
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 808
- 试验地点
- 1
- 主要终点
- Disease free survival
研究概览
简要总结
This is a prospective, single center, randomized, open-labled stage III clinical trial comparing the efficacy and safety of anthracyclin followed by weekly paclitaxel versus dose-dense anthracyclin followed by weekly paclitaxel versus dose-dense anthracyclin followed by weekly paclitaxel combined with carboplatin for high-risk, triple-negative early breast cancer.
详细描述
This is a prospective, single center, randomized, open-labled stage III clinical trial comparing the efficacy and safety of anthracyclin followed by weekly paclitaxel versus dose-dense anthracyclin followed by weekly paclitaxel versus dose-dense anthracyclin followed by weekly paclitaxel combined with carboplatin for high-risk, triple-negative early breast cancer.High risk is defined as positive lymph nodes or negative lymph nodes but ki-67 is not less than 50%. We aim to explore whether the addition of carboplatin can improve the disease-free survival of early high-risk triple-negative breast cancer. At the same time, the experimental group's anthracyclines must be given in a dose-dense manner, while anthracyclines in the control group are dose-dense or not.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
- •Histologically documented TNBC after early breast cancer surgery (absence of HER2, ER, and PR expression)
- •Has adequate organ function meeting the following criteria: (1) adequate bone marrow function: hemoglobin ≥ 90 g/L (no blood transfusion within 14 days); absolute neutrophil count ≥ 1.5 x 109 /L; platelet count ≥ 75 * 109 /L; (2)adequate liver and kidney function: Alanine Aminotransferase (ALT) ≤ 3×upper limit of normal (ULN), Aspartate Aminotransferase (AST) ≤ 3×ULN, Total Bilirubin (TBIL)≤ 1.5×ULN, serum creatinine ≤ 1×ULN#and with endogenous creatinine clearance rate of >50 ml/min (Cockcroft-Gault formula).
- •Women aged 18-70 years old;
- •Lymph nodes positive or lymph nodes negative but with ki67 no less than 50%
- •Have the cognitive ability to understand the protocol and be willing to participate and to be followed up
- •For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures as outlined for each specific treatment arm
排除标准
- •Has received neoadjuvant therapy (include chemotherapy, targeted therapy, radiotherapy or endocrine therapy;
- •Has bilateral breast cancer;
- •Has previous history of additional malignancy, with the exception of adequately treated basal cell carcinoma and cervical carcinoma in situ.
- •Has metastatic breast cancer
- •Is pregnant, is breast feeding women, or women of childbearing age who cannot practice effective contraceptives;
- •Patients participating in other clinical trials at the same time;
- •Has severe organ dysfunction (cardiopulmonary liver and kidney) insufficiency, left ventricular ejection fraction (LVEF) < 50% (cardiac ultrasound); severe cardio cerebral vascular disease within the 6 months previous of randomization (such as unstable angina, chronic heart failure, uncontrolled hypertension with blood pressure>150/90mmgh, myocardial infarction, or cerebral blood vessel); diabetic patients with poor blood glucose control; patients with severe hypertension;
- •Has known allergy to taxane
- •Has severe or uncontrolled infection;
- •Has a history of psychotropic substance abuse and were unable to abandon drug habits, or those with history of mental disorders;
- •the researchers judged patients to be unsuitable for the study.
研究组 & 干预措施
carboplatin group
epirubincin 90mg/m2 d1 and CTX 600mg/m2 d1, every 2 weeks followed by paclitaxel 80mg/m2 and carboplatin AUC=2 d1,d8,d15, every 4 weeks.
干预措施: ddCTX (Drug)
conventional group
epirubincin 90mg/m2 d1 and CTX 600mg/m2 d1, every 2 or 3 weeks followed by paclitaxel 80mg/m2 d1,d8,d15, every 3 weeks.
干预措施: Epirubicin (Drug)
conventional group
epirubincin 90mg/m2 d1 and CTX 600mg/m2 d1, every 2 or 3 weeks followed by paclitaxel 80mg/m2 d1,d8,d15, every 3 weeks.
干预措施: CTX (Drug)
conventional group
epirubincin 90mg/m2 d1 and CTX 600mg/m2 d1, every 2 or 3 weeks followed by paclitaxel 80mg/m2 d1,d8,d15, every 3 weeks.
干预措施: Paclitaxel (Drug)
carboplatin group
epirubincin 90mg/m2 d1 and CTX 600mg/m2 d1, every 2 weeks followed by paclitaxel 80mg/m2 and carboplatin AUC=2 d1,d8,d15, every 4 weeks.
干预措施: ddEpirubicin (Drug)
carboplatin group
epirubincin 90mg/m2 d1 and CTX 600mg/m2 d1, every 2 weeks followed by paclitaxel 80mg/m2 and carboplatin AUC=2 d1,d8,d15, every 4 weeks.
干预措施: Paclitaxel(with carbo) (Drug)
carboplatin group
epirubincin 90mg/m2 d1 and CTX 600mg/m2 d1, every 2 weeks followed by paclitaxel 80mg/m2 and carboplatin AUC=2 d1,d8,d15, every 4 weeks.
干预措施: Carboplatin (Drug)
结局指标
主要结局
Disease free survival
时间窗: 3 year
次要结局
- overall survival(5 year)
- recurrence free survival(5 year)
- distant disease free survival(5 year)
- Disease free survival(5 year)