NCT01019616Unknown3 期
A Phase Ⅲ Study of Alternative Non-cross-resistant Adjuvant Chemotherapy for Operable Breast Cancer Non-response to Primary Chemotherapy
Tao OUYANG7 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2011年3月4日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 400
- 试验地点
- 7
- 主要终点
- distant disease-free survival (DDFS)
研究概览
简要总结
The purpose of this phase Ⅲ, multi-center, prospective, open-label, randomized,controlled study is to determine whether alternative non-cross-resistant adjuvant chemotherapy can increase distant disease free survival(DDFS) in operable patients non-response to primary chemotherapy.
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 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients, age ≦65 years
- •Biopsy proven lymph node positive, estrogen receptor- positive primary breast cancer
- •Must have completed a 4-cycle neo-adjuvant chemotherapy with a standard regimen(containing anthracycline or paclitaxel)
- •Must have undergone surgery to remove the primary tumor by either a mastectomy or enlarged local excision
- •Postoperative residual positive lymph nodes or G1/G2/G3 of Miller & Payne Grading System
- •Adequate recovery from recent surgery
- •No history of other malignancies
- •No currently uncontrolled diseased or active infection
- •Not pregnant or breast feeding, and on appropriate birth control if of child-bearing potential
- •Adequate cardiovascular function reserve with a myocardial infarction within the past six month
- •Adequate hematologic function with:
- •Absolute neutrophil count (ANC) ≥1500/mm3
- •Platelets ≥100,000/ mm3
- •Hemoglobin ≥10 g/dL
- •Adequate hepatic and renal function with:
- •Serum bilirubin ≤1.5×UNL
- •Alkaline phosphatase and alanine aminotransferase (ALT) ≤2.5 x ULN. (≤5 x ULN is acceptable in the setting of hepatic metastasis)
- •BUN between 1.7 and 8.3 mmol/L
- •Cr between 40 and 110 umol/L
- •Knowledge of the investigational nature of the study and Ability to give informed consent
- •Ability and willingness to comply with study procedures.
排除标准
- •Known or suspected distant metastases
- •Concurrent malignancy or history of other malignancy
- •Uncontrolled diseases(e.g., heart failure, myocardial infarction within 6 months, arrhythmia, unstable diabetes, hypercalcemia) or active infection
- •Geographical, social, or psychological problems that would compromise study compliance
- •Known or suspected hypersensitivity to anthracycline or paclitaxel
研究组 & 干预措施
Chemotherapy
Experimental
干预措施: paclitaxel/anthracycline (Drug)
结局指标
主要结局
distant disease-free survival (DDFS)
时间窗: 3 years after surgery
次要结局
未报告次要终点
研究者
Tao OUYANG
Chairman of Breast Center
Peking University
研究点 (7)
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