A Phase 1/2 Study Of HKI-272 (Neratinib) in Combination With Trastuzumab (Herceptin) In Subjects With Advanced Breast Cancer
Completed · Phase 1/Phase 2
Conditions studied: Advanced Breast Cancer
In brief
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.
Key facts
- Study ID
- NCT00398567
- Run by
- Puma Biotechnology, Inc.
- People needed
- 45
- Starts
- 2007-04-04
- Expected to finish
- 2018-03-02
- Last updated by the study team
- 2018-07-24
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- City of Hope National Medical Center — Duarte, California, United States
- LAC/USC Medical Center, USC/Norris Comprehensive Cancer Center — Los Angeles, California, United States
- City of Hope National Medical Center — Pasadena, California, United States
- University of Maryland, University of Maryland Medical Center — Baltimore, Maryland, United States
- Duke University, Duke University Medical Center — Durham, North Carolina, United States
- Fox Chase Cancer Center — Philadelphia, Pennsylvania, United States
- Chinese Nanjing Bayi Hospital — Nanjing, Jiangsu, China
- Tianjin Union Medicine Center — Tianjin, Tianjin Municipality, China
- Cancer Hospital, Academy of Med Science and Peking Union Med — Beijing, China
- 307 Hospital of Chinese People's Liberation Army — Beijing, China
- Chinese PLA General Hospital — Beijing, China
- Institut Curie — Paris, France
- Centre Rene Gauducheau — Saint-Herblain, France
- Centre Hospitalier Universitaire Vaudois — Lausanne, Switzerland
Full record on ClinicalTrials.gov
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