CTRI/2009/091/000942已完成3 期
A Randomized, Open-Label, Two-Arm Study of Neratinib (HKI-272) Plus Paclitaxel Versus Trastuzumab Plus Paclitaxel as First-Line Treatment for ErbB-2-Positive Locally Recurrent or Metastatic Breast Cancer - Not applicable
Wyeth Research Wyeth Pharmaceuticals India Private Limited A Subsidiary of Pfizer Inc0 个研究点目标入组 480 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 480
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.ErbB-2 positive locally recurrent or metastatic breast cancer
- •2.Eastern Cooperative Oncology Group (ECOG) 0-2
- •3.Measurable disease
- •4.Availability of tumor tissue for HER2 status confirmation
- •(there is no upper age limit for inclusion criteria for this trial)
排除标准
- •1.Prior systemic anti-cancer therapy other than endocrine therapy for locally recurrent or metastatic disease
- •2.Prior erbB-2 inhibitor other than trastuzumab or lapatinib in the neoadjuvant or adjuvant setting
- •3.Progression/recurrence within 12 months after completion of adjuvant or neoadjuvant therapy
- •4.history of heart disease
- •5.history of gastrointestinal disease
研究者
相似试验
进行中（未招募）
1 期
Clinical research study comparing anti-tumor acitivty of an investigational drug (neratinib) plus paclitaxel and a combination therapy of trastuzumab (Herceptin) plus paclitaxel in patients with erbB-2 positive locally recurrent or metastatic breast cancerErbB2 Positive Locally Recurrent or Metastatic Breast CancerMedDRA version: 14.1Level: LLTClassification code 10027475Term: Metastatic breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2008-007803-10-HUPuma Biotechnology, Inc480
进行中（未招募）
1 期
Clinical research study comparing anti-tumor acitivty of an investigational drug (neratinib) plus paclitaxel and a combination therapy of trastuzumab (Herceptin) plus paclitaxel in patients with erbB-2 positive locally recurrent or metastatic breast cancerEUCTR2008-007803-10-BEPuma Biotechnology, Inc.480
进行中（未招募）
1 期
Clinical research study comparing anti-tumor acitivty of an investigational drug (neratinib) plus paclitaxel and a combination therapy of trastuzumab (Herceptin) plus paclitaxel in patients with erbB-2 positive locally recurrent or metastatic breast cancerEUCTR2008-007803-10-LTPuma Biotechnology, Inc480
进行中（未招募）
1 期
Clinical research study comparing anti-tumor acitivty of an investigational drug (neratinib) plus paclitaxel and a combination therapy of trastuzumab (Herceptin) plus paclitaxel in patients with erbB-2 positive locally recurrent or metastatic breast cancerErbB2 Positive Locally Recurrent or Metastatic Breast CancerMedDRA version: 14.0Level: LLTClassification code 10027475Term: Metastatic breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2008-007803-10-LVWyeth Pharmaceuticals Inc., a wholly owened subsidiary of Pfizer Inc, 500 Arcola Road, collegeville, PA 19426 USA480
进行中（未招募）
1 期
Clinical research study comparing anti-tumor acitivty of an investigational drug (neratinib) plus paclitaxel and a combination therapy of trastuzumab (Herceptin) plus paclitaxel in patients with erbB-2 positive locally recurrent or metastatic breast cancerEUCTR2008-007803-10-DEPuma Biotechnology, Inc480