Phase 2
N=136
Study Evaluating HKI-272 (Neratinib) In Subjects With Advanced Breast Cancer
Breast Neoplasms · Neoplasms
Bottom Line
View on ClinicalTrials.gov: NCT00300781 ↗Enrolled (actual)
136
Serious AEs
26.5%
Results posted
Sep 2017
Primary outcome: Primary: 16-week Progression Free Survival — 58.2; 77.8 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- neratinib (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Puma Biotechnology, Inc.
- Primary completion
- Apr 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 16-week Progression Free Survival |
58.2; 77.8 | — |
| SECONDARY Objective Response Rate |
24.2; 52.9 | — |
| SECONDARY Clinical Benefit Rate |
31.8; 62.9 | — |
| SECONDARY Duration of Response |
40.3; 60.0 | — |
Summary
The purpose of this study is to learn whether neratinib is safe and effective in treating women with advanced human epidermal growth factor receptor 2 (HER2) positive breast cancer.
Eligibility Criteria
Inclusion Criteria
- Pathologic diagnosis of breast cancer and current stage IIIB, IIIC, or IV
- Progression following at least 6 weeks of standard doses of Herceptin (Arm A only)
- Over-expression of HER2
- Tumor tissue available and adequate for analysis at screening
- At least one measurable lesion
Exclusion Criteria
- Prior treatment with Herceptin (Arm B only)
- More than 4 prior cytotoxic chemotherapy regimens
- Subjects with bone or skin as the only site of measurable disease
- Inadequate cardiac function
- Major surgery, chemotherapy, radiotherapy, investigational agents or other cancer therapy within 1 week of treatment day 1
- Active central nervous system metastases
- Pregnant or breastfeeding women
- Inability to swallow the HKI-272 capsules
Data sourced from ClinicalTrials.gov (NCT00300781). 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.