Status:
COMPLETED
A Phase 1/2 Study Of HKI-272 (Neratinib) in Combination With Trastuzumab (Herceptin) In Subjects With Advanced Breast Cancer
Lead Sponsor:
Puma Biotechnology, Inc.
Conditions:
Advanced Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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.
Detailed Description
Open label phase 1/2 study of ascending multiple oral doses of HKI-272 in combination with IV trastuzumab in subjects with advanced human epidermal growth factor receptor 2 positive (HER2+) breast can...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 4 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 2 2018
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT00398567
Start Date
April 4 2007
End Date
March 2 2018
Last Update
July 24 2018
Active Locations (14)
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1
City of Hope National Medical Center
Duarte, California, United States, 91010-3000
2
LAC/USC Medical Center, USC/Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
3
City of Hope National Medical Center
Pasadena, California, United States, 91105
4
University of Maryland, University of Maryland Medical Center
Baltimore, Maryland, United States, 21201