Study Evaluating Neratinib Plus Paclitaxel VS Trastuzumab Plus Paclitaxel In ErbB-2 Positive Advanced Breast Cancer (NEFERTT)
Status and phase
Conditions
Treatments
Details and patient eligibility
About
This study is investigating the effects of an experimental drug (neratinib) in combination with paclitaxel versus trastuzumab in combination with paclitaxel for the treatment of women who have not received previous treatment for erbB-2-positive locally recurrent or metastatic breast cancer. The study will compare the effectiveness of each regimen in shrinking tumors and extending the lives of women with erbB-2 (HER2) positive breast cancer. The study will also compare the safety of the two regimens and as well as the quality of life of subjects receiving either regimen.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- ErbB-2 positive locally recurrent or metastatic breast cancer
- Eastern Cooperative Oncology Group (ECOG) 0-2
- Measurable disease
- Availability of tumor tissue for HER2 status confirmation
Exclusion criteria
- Prior systemic anti-cancer therapy other than endocrine therapy for locally recurrent or metastatic disease
- Prior erbB-2 inhibitor other than trastuzumab or lapatinib in the neoadjuvant or adjuvant setting
- Progression/recurrence within 12 months after completion of adjuvant or neoadjuvant therapy
- History of heart disease
- History of gastrointestinal disease
Trial design
Primary purpose
Allocation
Interventional model
Masking
479 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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