Comparing EC-wP Versus EP-wP as Adjuvant Therapy for Breast Cancer Patients Less Than 40 Years Old
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 521
- 试验地点
- 1
- 主要终点
- disease-free survival
研究概览
简要总结
Manifold data revealed that young breast cancer patients are characterized by aggressive clinical history. The purpose of this study is to evaluate the efficacy and safety of different strategies incorporating paclitaxel to anthracycline-based regimens in young breast cancer patients.
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 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients, age 18~40
- •Unilateral, operable, histologically confirmed adenocarcinoma of the breast
- •Stage I-III
- •Primary surgery with clear margins plus axillary dissection
- •Able to start protocol Rx within 8 weeks of surgery
- •Histological or cytological confirmation of estrogen-receptor positive (ER+) breast cancer: the immunohistochemical cut-off for ER positive status was
- •1% or more staining in nuclei
- •HER-2 negative (IHC 0,1+ or 2+ with a negative in situ hybridization test by chemotherapy
- •pathologically confirmed regional node-positive disease, or node-negative disease with high-risk factors (primary tumor diameter >10 mm when histological grade III, or tumor diameter >20 mm when histological grade II)
- •ECOG performance status 0-1
- •Adequate cardiac, renal, hepatic and hematologic function
排除标准
- •Metastatic disease
- •Bilateral breast cancer (synchronous or metachronous)
- •Prior radiation therapy, hormonal therapy and chemotherapy for breast cancer
- •Previous cancer (except treated basal cell and squamous cell carcinoma of the skin or cancer of the uterine cervix)
- •HER-2 positive (IHC 3+ OR FISH+) and or triple-negative breast cancer
- •Documented history of cardiac disease contradiction anthracyclines
- •Concurrent serious illness
- •Peripheral neuropathy of CTC grade>1
- •History of hypersensitivity to drugs formulated in Cremophor EL polyoxyethylated castor oil), the vehicle used for commercial paclitaxel formulations
- •Pregnancy or lactation
研究组 & 干预措施
EP-wP
epirubicin/paclitaxel followed by weekly paclitaxel
干预措施: Cyclophosphamide (Drug)
EC-wP
epirubicin/cyclophosphamide followed weekly paclitaxel
干预措施: Epirubicin (Drug)
EC-wP
epirubicin/cyclophosphamide followed weekly paclitaxel
干预措施: Cyclophosphamide (Drug)
EC-wP
epirubicin/cyclophosphamide followed weekly paclitaxel
干预措施: Paclitaxel (Drug)
EP-wP
epirubicin/paclitaxel followed by weekly paclitaxel
干预措施: Epirubicin (Drug)
EP-wP
epirubicin/paclitaxel followed by weekly paclitaxel
干预措施: Paclitaxel (Drug)
结局指标
主要结局
disease-free survival
时间窗: every one year
menstrual resumption rate
时间窗: 12 months after chemotherapy
Resumption of menses was defined as at least 2 consecutive menstruations, or at least 1 menstruation with a confirmed premenopausal level of FSH and estradiol after chemotherapy
次要结局
- overall survival(every one year)
研究者
Zhimin Shao
Director of Breast Surgery Department
Fudan University