Phase 2
Completed N=479
Study Evaluating Neratinib Plus Paclitaxel VS Trastuzumab Plus Paclitaxel In ErbB-2 Positive Advanced Breast Cancer
Source: ClinicalTrials.gov NCT00915018 ↗Enrolled (actual)
479
Serious AEs
26.0%
Results posted
Nov 2017
Primary outcomePrimary: Progression-Free Survival — 12.9; 12.9 months — p=0.8934
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-Free Survival |
12.9; 12.9 | 0.8934 |
| SECONDARY Objective Response Rate |
74.8; 77.6 | 0.5219 |
| SECONDARY Duration of Response |
13.1; 12.9 | 0.8431 |
| SECONDARY Clinical Benefit Rate |
88.4; 85.2 | 0.2360 |
| SECONDARY Symptomatic or Progressive Central Nervous System (CNS) Lesions |
20; 41 | 0.0036 sig |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00915018). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.