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 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 120
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
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
研究者
相似试验
已完成
2 期
An Open Label Phase II Trial of BIBW 2992 in Patients With HER2-negative Metastatic Breast CancerBreast NeoplasmsNCT00425854Boehringer Ingelheim50
终止
2 期
Phase II Trial of BIBW 2992 (Afatinib) in Genetically Pre-screened Cancers With EGFR and/or HER2 Gene Amplification.NeoplasmsNCT00748709Boehringer Ingelheim20
进行中（未招募）
1 期
A randomized, open-label Phase II study of BIBW 2992 versus cetuximab (Erbitux®) in patients with metastatic or recurrent Head and Neck Squamous Cell Carcinoma (HNSCC) after failure of platinum-containing therapy with a cross-over period for progressing patients.EUCTR2008-007097-38-BESCS Boehringer Ingelheim Comm.V146
进行中（未招募）
1 期
A randomized, open-label Phase II study of BIBW 2992 versus cetuximab (Erbitux®) in patients with metastatic or recurrent Head and Neck Squamous Cell Carcinoma (HNSCC) after failure of platinum-containing therapy with a cross-over period for progressing patients.Metastatic or recurrent Head and Neck Squamous Cell CarcinomaEUCTR2008-007097-38-FRBoehringer-Ingelheim France146
进行中（未招募）
1 期
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)EUCTR2010-021945-29-GBBoehringer Ingelheim87