NCT00424606已完成3 期
A Multicenter Randomized Phase III Study of Adjuvant Treatment With Epirubicin Followed by Docetaxel (E/T) Versus Epirubicin and Docetaxel Combination (ET) in High Risk Lymph Node Negative Breast Cancer Patients
Hellenic Oncology Research Group12 个研究点 分布在 1 个国家目标入组 658 人开始时间: 2001年6月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 658
- 试验地点
- 12
- 主要终点
- Disease-free interval between the two treatment arms
研究概览
简要总结
The combination of taxanes, and especially docetaxel, with an anthracycline seems to be an important part of the chemotherapy regimens used in the adjuvant setting of patients with early-stage node-positive breast cancer patients. Whether sequential or concurrent administration of these drugs is preferable is not yet known, especially in patients with node-negative high risk tumors.
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 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed breast adenocarcinoma.
- •Within 20-45 days after the surgical excision of the primary tumor with tumor-free operation margins; at least 10 axillary lymph nodes have to be removed.
- •Absence of lymph node involvement after eclosion and hormone (E&H) staining and light microscopy evaluation.
- •Premenopausal or postmenopausal women with at least one of the following tumor characteristics is required in order to characterize the tumor as high risk:
- •Estrogen receptor (ER) (-) and progesterone receptor (PR)(-);
- •Ki-67 + > 30%; Grade III; HER2 (3+) (after an amendment on 15.05.2008 women with HER2 (3+) were not included); Perineural infiltration or presence of tumor emboli in blood or lymph vessels.
- •Postmenopausal women with tumors 1-2 cm are eligible if the tumor has at least 2 of the above mentioned high risk criteria.
- •Premenopausal and postmenopausal women with tumors measuring > 2 cm are eligible irrespectively of the expression of the above adverse prognostic tumor criteria.
- •Absence of any clinical or radiological evidence of local or metastatic disease.
- •Age > 18 years.
- •Performance status (WHO) <
- •Adequate bone marrow function (absolute neutrophil count > 1000/mm^3, platelet count > 100000/mm^3, hemoglobin > 9 gr/mm^3).
- •Adequate liver (bilirubin < 1.5 times upper limit of normal and SGOT/SGPT < 2 times upper limit of normal) and renal function (creatinine < 2 mg/dl).
- •Adequate cardiac function (LVEF > 50%).
- •Negative pregnancy test.
- •Informed consent.
排除标准
- •Other invasive malignancy within the past 5 years except nonmelanoma skin cancer.
- •Other concurrent uncontrolled illness that could affect compliance with the study.
- •Psychiatric illness or social situation that would preclude study compliance.
- •Pregnant or nursing women.
- •History of allergic reaction attributed to docetaxel.
- •Other concurrent investigational agents.
研究组 & 干预措施
1
Experimental
干预措施: Docetaxel (Drug)
1
Experimental
干预措施: Epirubicin (Drug)
2
Experimental
干预措施: Epirubicin (Drug)
2
Experimental
干预措施: Docetaxel (Drug)
结局指标
主要结局
Disease-free interval between the two treatment arms
时间窗: Five years
次要结局
- Comparison of overall survival and safety between the two treatment arms(Five years)
研究者
研究点 (12)
Loading locations...
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