NCT01562288已完成不适用
Adjuvant Chemotherapy Combined With Trastuzumab in the Randomized Phase III Trial N9831 Actively Immunizes Patients Against Tumor Antigens
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,576
- 主要终点
- disease-free survival
研究概览
简要总结
RATIONALE: Studying samples of blood and DNA in the laboratory from patients who received chemotherapy with or without trastuzumab may help doctors learn more about the effects of trastuzumab on cells. It may also help doctors understand how well patients respond to treatment.
PURPOSE: This research trial studies blood and DNA samples from patients with breast cancer treated with chemotherapy with or without trastuzumab.
详细描述
OBJECTIVES:
- To determine the role of trastuzumab in the generation of HER2-specific antibodies in breast cancer patients undergoing adjuvant combination therapy.
- To determine whether the improved disease-free period and overall survival of patients treated in the adjuvant setting with combination of chemotherapy and trastuzumab is dependent on the Fcγ receptor genotype of the patient.
OUTLINE: Previously collected serum and DNA samples are analyzed for HER2-specific antibodies and FcγR genotype by enzyme-linked immunosorbent assay (ELISA) and polymerase chain reaction (PCR).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
disease-free survival
时间窗: up to 1 month
overall survival
时间窗: up to 1 month
次要结局
未报告次要终点
研究者
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