Phase 2 Study of HKI-272 In Subjects With Advanced Breast Cancer
18 Years
N/A
Female
Breast Neoplasms, Neoplasms
Trial Information
Phase 2 Study of HKI-272 In Subjects With Advanced Breast Cancer
Arm A: HER2 gene amplification and disease progression following at least 6 weeks of
standard doses of Herceptin; Arm B: HER2 gene amplification and no prior Herceptin or
HER2-targeted treatment.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
16 week progression-free survival (PFS) rate of neratinib in women with Her2+ b.c., either with prior Herceptin or no prior Herceptin therapy, evaluated by independent assessment of tumor scans collected at baseline and then every 8 weeks.
Outcome Time Frame:
16 weeks
Safety Issue:
Yes
Principal Investigator
Puma
Investigator Role:
Study Director
Investigator Affiliation:
Biotechnology
Authority:
United States: Food and Drug Administration
Study ID:
3144A1-201
NCT ID:
NCT00300781
Start Date:
August 2006
Completion Date:
December 2013
Related Keywords:
- Breast Neoplasms
- Neoplasms
- phase 2
- HER2+ breast cancer
- monotherapy neratinib
- Breast Neoplasms
- Neoplasms
Name | Location |
|---|---|
| Investigational site | Seattle, Washington 98166 |
| Investigational Site | Aurora, Colorado 80045 |
| Investigational Site | Zion, Illinois 60099 |
| Investigational Site | Shreveport, Louisiana 71103 |
| Investigational Site | Baltimore, Maryland 21204 |
| Investigational Site | Boston, Massachusetts 02118 |
| Investigational Site | Lebanon, New Hampshire 03756 |
| Investigational Site | New Brunswick, New Jersey 08901 |
| Investigational Site | Cleveland, Ohio 44195 |
