A Randomized Phase III Study Comparing Pre- and Postoperative vs. Conventional Adjuvant Treatment Hormone Receptor-negative Breast Cancer Patients
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 429
- 主要终点
- Overall survival
研究概览
简要总结
Primarily, this clinical investigation compared overall survival and recurrence-free survival in patients with hormone receptor-negative breast cancer treated with pre- and postoperative chemotherapy vs. conventional postoperative treatment.
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 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients with bioptically verified breast cancer
- •Estrogen receptor-negative status
- •Age: < 70 years
- •WHO Performance Status < 2
- •Laboratory parameters
- •hematopoiesis: > 3500/mm3 leukocytes, > 100,000/mm3 thrombocytes
- •renal function: creatinin < 1.5mg%
- •hepatic function: GOT max. 2.5 x UNL
- •bilirubin: < 2.0 mg %
- •metabolic parameters: Na, Ca, K in normal range
- •</= 4 weeks interval since surgery
- •Informed consent
排除标准
- •Patients with locally inoperable cancer, M1
- •Other preoperative tumor-specific radiotherapy, chemotherapy or endocrine treatment
- •Pregnancy or lactation
- •General contraindication against cytostatic treatment
- •T4 cancer; inflammatory disease, simultaneous or sequential bilateral breast cancer
- •Lacking compliance or understanding of disease
- •Serious concomitant disease
- •Second carcinoma or status post second carcinoma (except for treated squamous cell carcinoma of the skin or cervical carcinoma in situ)
研究组 & 干预措施
A (pre- + postoperative chemotherapy)
3 cycles CMF (cyclophophamide + Methotrexat + 5-Fluorouracil) followed by surgery. Subsequently node-positive patients received 3 cycles anthracycline-based chemotherapy regime EC (epirubicin + cyclophosphamide) and node-negative patients another 3 cycles CMF.
干预措施: Cyclophosphamide (Drug)
A (pre- + postoperative chemotherapy)
3 cycles CMF (cyclophophamide + Methotrexat + 5-Fluorouracil) followed by surgery. Subsequently node-positive patients received 3 cycles anthracycline-based chemotherapy regime EC (epirubicin + cyclophosphamide) and node-negative patients another 3 cycles CMF.
干预措施: Methotrexate (Drug)
A (pre- + postoperative chemotherapy)
3 cycles CMF (cyclophophamide + Methotrexat + 5-Fluorouracil) followed by surgery. Subsequently node-positive patients received 3 cycles anthracycline-based chemotherapy regime EC (epirubicin + cyclophosphamide) and node-negative patients another 3 cycles CMF.
干预措施: Fluorouracil (Drug)
A (pre- + postoperative chemotherapy)
3 cycles CMF (cyclophophamide + Methotrexat + 5-Fluorouracil) followed by surgery. Subsequently node-positive patients received 3 cycles anthracycline-based chemotherapy regime EC (epirubicin + cyclophosphamide) and node-negative patients another 3 cycles CMF.
干预措施: Epirubicin (Drug)
A (pre- + postoperative chemotherapy)
3 cycles CMF (cyclophophamide + Methotrexat + 5-Fluorouracil) followed by surgery. Subsequently node-positive patients received 3 cycles anthracycline-based chemotherapy regime EC (epirubicin + cyclophosphamide) and node-negative patients another 3 cycles CMF.
干预措施: Surgery (Other)
B (conventional postoperative chemotherapy)
Surgery followed by 3 cycles CMF (cyclophophamide + Methotrexat + 5-Fluorouracil). Subsequently node-positive patients received 3 cycles anthracycline-based chemotherapy regime EC (epirubicin + cyclophosphamide) and node-negative patients another 3 cycles CMF.
干预措施: Cyclophosphamide (Drug)
B (conventional postoperative chemotherapy)
Surgery followed by 3 cycles CMF (cyclophophamide + Methotrexat + 5-Fluorouracil). Subsequently node-positive patients received 3 cycles anthracycline-based chemotherapy regime EC (epirubicin + cyclophosphamide) and node-negative patients another 3 cycles CMF.
干预措施: Methotrexate (Drug)
B (conventional postoperative chemotherapy)
Surgery followed by 3 cycles CMF (cyclophophamide + Methotrexat + 5-Fluorouracil). Subsequently node-positive patients received 3 cycles anthracycline-based chemotherapy regime EC (epirubicin + cyclophosphamide) and node-negative patients another 3 cycles CMF.
干预措施: Fluorouracil (Drug)
B (conventional postoperative chemotherapy)
Surgery followed by 3 cycles CMF (cyclophophamide + Methotrexat + 5-Fluorouracil). Subsequently node-positive patients received 3 cycles anthracycline-based chemotherapy regime EC (epirubicin + cyclophosphamide) and node-negative patients another 3 cycles CMF.
干预措施: Epirubicin (Drug)
B (conventional postoperative chemotherapy)
Surgery followed by 3 cycles CMF (cyclophophamide + Methotrexat + 5-Fluorouracil). Subsequently node-positive patients received 3 cycles anthracycline-based chemotherapy regime EC (epirubicin + cyclophosphamide) and node-negative patients another 3 cycles CMF.
干预措施: Surgery (Other)
结局指标
主要结局
Overall survival
Recurrence-free survival
次要结局
- Rate of breast-conserving procedures