A Study of Neratinib Plus Paclitaxel VersusTrastuzumab Plus Paclitaxel as First-Line Treatment for ErbB-2-Positive Locally Recurrent or Metastatic BreastCancer
Phase 3
Completed
- Conditions
- Health Condition 1: null- ErbB-2-Positive Locally Recurrent or Metastatic BreastCancer
- Registration Number
- CTRI/2009/091/000942
- Lead Sponsor
- Wyeth Research Wyeth Pharmaceuticals India Private Limited A Subsidiary of Pfizer Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 480
Inclusion Criteria
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)
Exclusion Criteria
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method