JPRN-C000000263已完成2 期
First-line Trastuzumab monotherapy in patients with HER2-positive metastatic breast cancer(MBC)- a phase 2 study - First-line Trastuzumab monotherapy in patients with HER2-positive metastatic breast cancer(MBC)- a phase 2 study(Her-mono study)
H/D study group on Breast Cancer0 个研究点目标入组 35 人开始时间: 2005年10月15日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 35
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 20years-old 至 75years-old（—）
- 性别
- Female
入选标准
- 未提供
排除标准
- •Documented history of serious hypersensitivity reaction on the medical drugs Severe complication Fever, suspicious of infection Severe pleural fluid and pericardial effusion Symptomatic brain metastasis Active double cancer Interstitial pneumonia or pulmonary fibrosis Neuropathy Grade 2,3 or 4 edema Pregnant or lactating women Doctor' s decision for exclusion
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A study in HER2-positive breast cancer that has spread to other organs or tissues and has not responded to a course of anti-cancer treatment and a study in HER2-positive inoperable gastric cancer or gastric cancer that has spread to other organs or tissues.HER2-positive metastatic breast cancer and HER2-positive locally advanced or metastatic gastric cancer.MedDRA version: 19.0Level: PTClassification code 10066896Term: HER-2 positive gastric cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 19.0Level: PTClassification code 10065430Term: HER-2 positive breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2012-001547-46-DEF. Hoffmann-La Roche Ltd.160