CTRI/2011/07/001915
招募中
2 期
An open label, phase II trial of BIBW 2992 (afatinib) in patients withmetastatic HER2-overexpressing breast cancer failing HER2-targetedtreatment in the neoadjuvant and/or adjuvant treatment setting
Boehringer Ingelheim Pharmaceuticals0 个研究点目标入组 120 人待定
概览
- 阶段
- 2 期
- 干预措施
- 未指定
- 疾病 / 适应症
- 未指定
- 发起方
- Boehringer Ingelheim Pharmaceuticals
- 入组人数
- 120
- 状态
- 招募中
- 最后更新
- 4年前
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •1\. Female patients with more than or equal to 18 years and less than or equal to 65 years with proven diagnosis of HER2\-overexpressing, histologically confirmed breast cancer
- •2\. Stage IV metastatic disease
- •3\. At least one measurable lesion according to RECIST 1\.1\. Skin, bone and brain lesions are considered non\-target lesions
- •4\. Must have failed or progressed on either trastuzumab or lapatanib or trastuzumab and lapatanib treatment in the neoadjuvant and/or adjuvant setting
排除标准
- •1\. Prior treatment with EGFR or HER2\-targeted small molecules or antibodies other than trastuzumab and lapatinib in the neoadjuvant or adjuvant setting
- •2\. Prior treatment with paclitaxel in the past 12 months
- •3\. Must not have received prior vinorelbine treatment
- •4\. Platelet count 100 x 109/L for BIBW 2992 (afatinib) monotherapy
结局指标
主要结局
未指定
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Afatinib in HER2 (Human Epidermal Growth Factor Receptor)-treatment failuresHER2 - overexpressing breast cancerMedDRA version: 19.0 Level: PT Classification code 10057654 Term: Breast cancer female System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 19.0 Level: PT Classification code 10006202 Term: Breast cancer stage IV System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 19.0 Level: PT Classification code 10055113 Term: Breast cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]EUCTR2010-021945-29-GBBoehringer Ingelheim87