NCT03270007招募中4 期
Research of Intensive Treatment in Hormone Receptor<10% and Human Epidermal Growth Factor Receptor-2 Negative Breast Cancer Patients With Positive Lymph Node Residual Disease After Neoadjuvant Chemotherapy
Tao OUYANG1 个研究点 分布在 1 个国家目标入组 304 人开始时间: 2017年11月10日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 304
- 试验地点
- 1
- 主要终点
- distant disease-free survival (DDFS)
研究概览
简要总结
This is a phase IV, single-center, prospective, open-label, randomized,controlled study
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 66 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients, 18≦age ≦66 years
- •Biopsy proven lymph node positive, estrogen receptor<10%、progesterone receptor <10% and human epidermal growth factor receptor-2 negative primary breast cancer
- •Must have completed neo-adjuvant chemotherapy with a standard regimen(containing both anthracycline and paclitaxel)
- •Must have undergone surgery to remove the primary tumor by either a mastectomy or enlarged local excision
- •Postoperative residual positive lymph nodes
- •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
- •without radiotherapy and chemotherapy contraindication
- •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 vinorelbine
研究组 & 干预措施
Chemotherapy
Experimental
干预措施: Vinorelbine (Drug)
结局指标
主要结局
distant disease-free survival (DDFS)
时间窗: 5 years after surgery
次要结局
- relapse-free survival（RFS）、overall survival（OS）(5 years after surgery)
研究者
Tao OUYANG
Chairman of Breast Center
Peking University
研究点 (1)
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