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

• Status: Completed
• Trial end date: 2018-01-30
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Puma Biotechnology, Inc.

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