Phase III Study to Compare 6 Courses of FEC (Fluorouracil, Epirubicin and Cyclophosphamide) vs. 4 Courses of FEC Followed by 8 Weekly Paclitaxel Administrations, as Adjuvant Treatment for Node Positive Operable BC Patients

Spanish Breast Cancer Research Group64 个研究点分布在 1 个国家目标入组 1,289 人开始时间: 1999年11月最近更新: 2023年3月6日

适应症

干预措施

试验速览

阶段: 3 期
状态: 已完成
发起方: Spanish Breast Cancer Research Group
入组人数: 1,289
试验地点: 64
主要终点: disease-free survival

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The efficacy of adjuvant chemotherapy is limited in patients with a high risk of recurrence.

Also, for axillary positive node patients, optimum chemotherapy regimens are still under discussion. Some previous studies suggest that, in the subset of node-positive patients, treatments based on sequential administration of anthracyclines and taxanes are more efficient. Paclitaxel dose-dense (weekly) administration renders an improved therapeutic index (activity/toxicity).

The study is designed to compare 6 courses of FEC scheme (600/90/600), a combination of proven efficacy in node positive breast cancer patients, versus 4 FEC courses followed by 8 weekly paclitaxel administrations (100mg/m2).

The study hypothesis is that 5-year disease-free survival in the control arm will be 60%. The investigators expect to increase this by 8% with the experimental treatment. With an alpha error of 0.05, 80% power, and a post-randomization estimated drop-out rate of 10%, 1250 patients are needed, 625 per arm.

详细描述

The primary endpoint of study-5-year disease-free survival (DFS) will be assessed by Kaplan Meier analysis. Secondary endpoints included overall survival and analysis of the prognostic and predictive value of clinical and molecular markers. Associations and interactions will be assessed with a multivariable Cox proportional hazards model for DFS for the following covariates: age, menopausal status, tumor size, lymph node status, type of chemotherapy, tumor size, positive lymph nodes, HER2 status, and hormone receptor status. All statistical tests will be two-sided.

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

•Written informed consent.
•Histological diagnosis of breast cancer.
•Node positive operable breast cancer (stages II-III).
•Breast cancer surgery, consisting of radical mastectomy or conservative surgery, plus lymphadenectomy with at least 6 extirpated nodes. Surgery must have happened in the 8 weeks prior to randomisation.
•Age >=18 and <= 70 years old.
•Negative pregnancy test. Adequate contraceptive method during the study participation.
•Performance status of 90-100 (Karnofsky index) or ECOG <=
•Haemoglobin >= 10 g/dl; neutrophils > 1,500/cc; platelets > 100,000/cc.
•Adequate hepatic function with bilirubin, SGOT and SGPT < 1.5 x upper normal limit (UNL).
•Adequate cardiac function documented by left ventricular ejection fraction (LVEF).
•Adequate renal function with creatinine < 1.5 mg/dl.

排除标准

•Previous chemotherapy, hormone therapy and/or radiotherapy for breast cancer.
•Bilateral breast cancer. Lobular in situ carcinoma.
•Previous or current malignancies, except for basal skin carcinoma, cervical in situ carcinoma or superficial bladder carcinoma, adequately treated.
•History of arrhythmias and/or congestive heart failure or cardiac blocking grade 2-3; history of myocardial infarction in 6 months before recruitment.
•Inability for treatment and study compliance.
•Pregnant or lactating women.
•Active infection.
•History of hypersensitivity to cremophor or cyclosporine.
•Pre-existing grade 2 motor or sensorial neurotoxicity (National Cancer Institute Common Toxicity Criteria [NCI CTC]).
•Hormonal receptor status not determined.
•Any other criteria which, in investigator's opinion, may jeopardize patient's security or compliance.
•Administration of other investigational product in the 30 days prior to randomisation; current participation in another clinical trial.