Fluorouracil, Epirubicin and Cyclophosphamide Versus Concurrent Epirubicin and Paclitaxel in Node Positive Early Breast Cancer Patients: a Randomized, Phase III Trial of Gruppo Oncologico Nord-Ovest - Mammella Intergruppo Group
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,055
- 试验地点
- 8
- 主要终点
- overall survival
研究概览
简要总结
In this multicenter, randomized phase III trial, node positive early breast cancer patients are randomly assigned to receive either 6 cycles of FEC (5-fluorouracil 600 mg/m2, epirubicin 60 mg/m2 and cyclophosphamide 600 mg/m2, on day 1, every three weeks) or 4 cycles of EP (epirubicin 90 mg/m2 and paclitaxel 175 mg/m2, on day 1, every three weeks). The primary study endpoint is overall survival (OS). Secondary endpoints include toxicity and event free survival (EFS).
详细描述
At the time the Gruppo Oncologico Nord-Ovest- Mammella Intergruppo trial 5 (GONO-MIG5) was designed in 1996, paclitaxel was known to have efficacy in patients with advanced breast cancer, but its role was still to be established in the adjuvant setting. Therefore the GONO-MIG5 trial was designed to compare a standard anthracycline-containing chemotherapy regimen, i.e. 5fluorouracil, epirubicin, ciclophosphamide (FEC), given for 6 cycles to a new regimen containing both epirubicin and paclitaxel (EP), given concurrently, for 4 cycles. This latter regimen was chosen on the basis of the results obtained in metastatic breast cancer patients, where the combination of doxorubicin and paclitaxel was associated with more than 90% of objective response . Only four cycles of the new regimen were planned since the expected toxicity, particularly the cardiotoxicity, was high, and a short treatment duration was hoped to be the best strategy to obtain a favourable balance between the toxicity and the expected high efficacy.
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
- •Women with histologically confirmed breast cancer who had undergone radical mastectomy or breast-conserving surgery in addition to full ipsilateral axillary lymph node dissection
- •Lymph node-positive disease with less than 10 involved axillary lymph nodes
- •Surgery performed not more than 5 weeks before randomization
- •ECOG performance status 0
- •Absolute neutrophil count ≥ 2,000/mm³
- •WBC ≥ 3,000/mm³
- •Platelet count ≥ 100,000/mm³
- •Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- •AST and ALT ≤ 1.5 times ULN
- •Postoperative regional radiotherapy limited to the remaining breast admitted for patients who received breast-conserving surgery
- •Written informed consent
排除标准
- •Prior or concurrent ipsilateral or contralateral invasive breast carcinoma within the last 10 years
- •Metastatic disease, including metastasis in the ipsilateral supraclavicular lymph nodes
- •Prior chemotherapy or prior cytotoxic regimens or prior hormonal therapy
- •Pregnant or nursing
- •Other serious medical illness requiring medication, uncontrolled infections
- •Other malignancy except adequately treated, cone-biopsied in situ carcinoma of the cervix or basal cell or squamous cell carcinoma of the skin
- •Recent myocardial infarction, congestive heart failure, or serious arrhythmia
研究组 & 干预措施
EP
Epirubicin 90 mg/m2 and paclitaxel 175 mg/m2, 3-hour infusion on day 1, every 21 days
干预措施: epirubicin (Drug)
FEC
5-Fluorouracil 600 mg/m2, epirubicin 60 mg/m2 and cyclophosphamide 600 mg/m2, intravenously on day 1, every 21 days
干预措施: 5-fluorouracil (Drug)
FEC
5-Fluorouracil 600 mg/m2, epirubicin 60 mg/m2 and cyclophosphamide 600 mg/m2, intravenously on day 1, every 21 days
干预措施: epirubicin (Drug)
FEC
5-Fluorouracil 600 mg/m2, epirubicin 60 mg/m2 and cyclophosphamide 600 mg/m2, intravenously on day 1, every 21 days
干预措施: cyclophosphamide (Drug)
EP
Epirubicin 90 mg/m2 and paclitaxel 175 mg/m2, 3-hour infusion on day 1, every 21 days
干预措施: paclitaxel (Drug)
结局指标
主要结局
overall survival
时间窗: within 11 years since the enrolment of the 1st patient
estimated from the date of randomization to the date of death from any cause
次要结局
- event free survival(within 11 years since the enrolment of the 1st patient)
- toxicity as measured according to the World Health Organization Criteria(within the first 30 days after the end of chemotherapy)
研究者
Lucia Del Mastro,MD
MD
IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy