Adjuvant 6 Cycles of Docetaxel and Cyclophosphamide or 3 Cycles of Cyclophosphamide/Epirubicin/Fluorouracil Followed by 3 Cycles of Docetaxel Versus 4 Cycles of Epirubicin and Cyclophosphamide Followed by Weekly Paclitaxel in HER2-negative Operable Breast Cancer
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,570
- 试验地点
- 1
- 主要终点
- Disease-Free Survival
研究概览
简要总结
We aimed to evaluate the noninferiority of short-term anthracycline-free chemotherapy (TC, six cycles of docetaxel and cyclophosphamide) or short-term anthracycline-based chemotherapy (CEF-T, three cycles of cyclophosphamide/epirubicin/fluorouracil followed by three cycles of docetaxel) to a standard anthracycline/taxane-containing chemotherapy (EC-P, epirubicin, and cyclophosphamide for four cycles followed by paclitaxel for twelve weeks) in HER2-negative operable breast cancer.
详细描述
It was initiated as an adjuvant chemotherapy trial to test noninferiority of an anthracycline-free short-term regimen (T75C600 x 6 [TC] once every 3 weeks) or a short-term regimen (C500E100F500 x 3 once every 3 weeks followed by T100 x 3 every 3 weeks [CEF-T]) compared with a standard long-term anthracycline-containing regimen (E90C600 x 4 once every 3 weeks followed by P80 x 12 once every week [EC-P]) in HER2-negative breast cancer. Patients were randomly assigned (1:1:1) to each arm after completing the surgical excision of the primary tumor.
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 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients, age at diagnosis 18 - 75 years
- •Histological confirmed unilateral primary invasive carcinoma of the breast
- •Adequate surgical treatment with complete resection of the tumor (R0) and resection of > or = 10 axillary nodes or SLN in clinically N0 patients
- •Node positive disease or node-negative disease with at least one other risk factor (tumor size > or = 2 cm, grade > or = II)
- •HER2-negative disease
- •No evidence for distant metastasis (M0) after conventional staging
- •Performance Status ECOG < or = 1
- •The patient must be accessible for treatment and follow-up
- •LVEF> 50%
- •Negative pregnancy test (urine or serum) within 7 days prior to randomization in premenopausal patients
- •Leucocytes > or = 4 x 10^9/L
- •platelets > or = 100 x 10^9/L
- •haemoglobin > or = 9 g/dL
- •total bilirubin < or = 1.5 UNL
- •ASAT (SGOT) and ALAT (SGPT) < or = 2.5 UNL
- •creatinine < 175 mmol/L (2 mg/dL)
排除标准
- •Has received neoadjuvant therapy (include chemotherapy, targeted therapy, radiotherapy or endocrine therapy）;
- •Has bilateral breast cancer;
- •Has the previous history of additional malignancy, with the exception of adequately treated basal cell carcinoma and cervical carcinoma in situ.
- •Has metastatic (Stage 4) breast cancer;
- •Has any >T4 lesion (UICC1987) (with skin involvement, mass adhesion and fixation, and inflammatory breast cancer);
- •Is pregnant, is breastfeeding 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 and excipients;
- •Has severe or uncontrolled infection.
研究组 & 干预措施
TC*6
6 cycles of (Docetaxel 75mg/m2 ivgtt d1+ Cyclophosphamide 600 mg/m2 iv d1, 21 days per cycle) .
干预措施: Docetaxel Cyclophosphamide (Drug)
CEF*3-T*3
3 cycles of CEF (Epirubicin 100 mg/m2 ivgtt d1+Cyclophosphamide 500 mg/m2 iv d1+ 5-fluorouracil 500 mg/m2 iv d1, 21 days per cycle) followed by 3 cycles of Docetaxel (Docetaxel 100mg/m2, ivgtt d1, 21 days per cycle)
干预措施: Cyclophosphamide Fluorouracil Epirubicin Docetaxel (Drug)
EC*4-wP*12
4 cycles of EC (Epirubicin 90 mg/m2 ivgtt d1+Cyclophosphamide 600 mg/m2 iv d1, 21 days per cycle) followed by 4 cycles of Paclitaxel (Paclitaxel 80mg/m2, ivgtt d1,8,15, 21days per cycle)
干预措施: Epirubicin Cyclophosphamide Paclitaxel (Drug)
结局指标
主要结局
Disease-Free Survival
时间窗: 5 years
Defined as the time from randomization to occurrence of a new event including local recurrence, regional relapse, distant metastasis, contralateral primary breast cancer, second non-breast invasive cancer (excluding non-melanoma skin cancers), or death from any cause.
次要结局
- Overall Survival(5 years)
- Adverse Events(through chemotherapy completion, an average of 6 months)
- Distant Disease-Free Survival(5 years)