NCT00300781

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

Phase 2 Study of HKI-272 In Subjects With Advanced Breast Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 136 (actual)
• Sponsor: Puma Biotechnology, Inc. · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Breast Neoplasms
• Neoplasms

Interventions

Type	Name	Description
DRUG	neratinib

Timeline

• Start date: 2006-08-04
• Primary completion: 2008-04-01
• Completion: 2018-01-30
• First posted: 2006-03-09
• Last updated: 2018-08-14
• Results posted: 2017-09-13

Locations

33 sites across 7 countries: United States, Belgium, China, France, India, Mexico, Russia

Regulatory

• FDA-regulated drug study