A Randomized Phase III Study Comparing Cyclophosphamide + Methotrexate + Fluorouracil vs. Goserelin + Tamoxifen in Premenopausal, Hormone Receptor-positive, Lymph Node-positive or -Negative Patients
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,099
- 主要终点
- Disease-free survival
研究概览
简要总结
Primarily, this clinical investigation compared the efficacy of cyclophosphamide + methotrexate + fluorouracil chemotherapy vs. goserelin + tamoxifen treatment in terms of prognosis (disease-free survival, overall survival) in premenopausal patients with potentially curative, operated hormone receptor-positive breast cancer.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Premenopausal patients with histologically verified, lymph node-negative (pT1c-pT3) or lymph node-positive (pT1a-pT3) breast cancer
- •Hormone receptor-positive status
- •More than 6 histologically examined lymph nodes
- •Laboratory parameters
- •hematopoiesis: > 3500/µl leukocytes, > 100,000/µl thrombocytes
- •renal function: creatinin < 1.5mg %
- •hepatic function: GOT </= 2.5 x UNL
- •bilirubin: < 1.5mg %
- •metabolic parameters: Na, Ca, K in normal range, normal level of blood sugar
- •blood coagulation: PZ > 60%
- •Concluded healing process following surgery
- •</= 4 weeks interval since surgery
- •Informed consent
排除标准
- •T4 carcinoma; inflammatory breast cancer, carcinoma in situ
- •Simultaneous or sequential bilateral breast cancer
- •Preoperative tumor-reducing radiotherapy or preoperative tumor-specific medical treatment
- •Male patients
- •Pregnancy or lactation
- •Lacking compliance or understanding of the disease
- •General contraindication against cytostatic treatment
- •Serious concomitant disease preventing implementation of adjuvant therapy or regular follow-up
- •Second carcinoma or status post second carcinoma (except for curatively treated squamous cell carcinoma of the skin or cervical carcinoma in situ)
研究组 & 干预措施
2 (CMF scheme)
6 cycles CMF scheme (cyclophosphamide, methotrexate, fluorouracil)
干预措施: Cyclophosphamide (Drug)
2 (CMF scheme)
6 cycles CMF scheme (cyclophosphamide, methotrexate, fluorouracil)
干预措施: Methotrexate (Drug)
2 (CMF scheme)
6 cycles CMF scheme (cyclophosphamide, methotrexate, fluorouracil)
干预措施: Fluorouracil implant (Drug)
1 (Nol + Zol)
Zoladex (3 years) combined with Nolvadex (5 years)
干预措施: Goserelin (Drug)
1 (Nol + Zol)
Zoladex (3 years) combined with Nolvadex (5 years)
干预措施: Tamoxifen (Drug)
结局指标
主要结局
Disease-free survival
Overall survival
次要结局
- Toxicities