Study Evaluating HKI-272 (Neratinib) In Subjects With Advanced Breast Cancer

Launched by PUMA BIOTECHNOLOGY, INC. · Mar 7, 2006

Keywords

ClinConnect Summary

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.

Gender

FEMALE

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