A Phase 1/2 Study Of HKI-272 (Neratinib) in Combination With Trastuzumab (Herceptin) In Subjects With Advanced Breast Cancer

• Status: Completed
• Trial end date: 2018-03-02
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the safety and efficacy of HKI-272 (neratinib) in combination with trastuzumab in patients with advanced breast cancer.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Puma Biotechnology, Inc.
• Treatments: Trastuzumab

Criteria

Inclusion Criteria:

• Pathologic diagnosis of breast cancer with current stage IIIB, IIIC or IV not curable by available therapy

• Progression following at least one Herceptin-containing cytotoxic chemotherapy regimen (neoadjuvant, adjuvant, or metastatic setting)

• HER2 positive breast cancer

• At least one measurable target lesion

• Adequate performance status

• Adequate cardiac, kidney, and liver function

• Adequate blood counts

• Willingness of all subjects who are not surgically sterile or post menopausal to use acceptable methods of birth control

Exclusion Criteria:

• More than 3 prior cytotoxic chemotherapy regimens for locally advanced or metastatic disease

• Major surgery, chemotherapy, radiotherapy, investigational agents, Herceptin or other cancer therapy within 2 weeks of treatment day 1

• Prior treatment with anthracyclines with cumulative dose of >400 mg/m^2

• Extensive visceral disease

• Active central nervous system metastases

• Pregnant or breast feeding women

• Significant chronic or recent acute gastrointestinal disorder with diarrhea as a major symptom

• Prior exposure to HKI-272 or other HER2 targeted agents (except Herceptin and Tykerb)

• Significant cardiac disease or dysfunction

• History of life-threatening hypersensitivity to Herceptin

• Inability or unwillingness to swallow HKI-272 capsules

• Any other cancer within 5 years with the exception of contralateral breast cancer, adequately treated cervical carcinoma in situ, or adequately treated basal or squamous cell carcinoma of the skin