Study Evaluating HKI-272 (Neratinib) In Subjects With Advanced Breast Cancer
Status: | Completed |
---|---|
Conditions: | Breast Cancer, Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 8/16/2018 |
Start Date: | August 4, 2006 |
End Date: | January 30, 2018 |
Phase 2 Study of HKI-272 In Subjects With Advanced Breast Cancer
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.
women with advanced human epidermal growth factor receptor 2 (HER2) positive breast cancer.
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.
doses of Herceptin; Arm B: HER2 gene amplification and no prior Herceptin or HER2-targeted
treatment.
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
We found this trial at
14
sites
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Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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Cleveland Clinic Taussig Cancer Center At Taussig Cancer Institute, more than 250 highly skilled doctors,...
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One Medical Center Drive
Lebanon, New Hampshire 03756
Lebanon, New Hampshire 03756
(603) 653-9000
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center Norris Cotton Cancer Center at DHMC in...
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University of Colorado Hospital, Site Top medical professionals, superior medicine and progressive change make University...
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Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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1 Boston Medical Center Place
Boston, Massachusetts 02118
Boston, Massachusetts 02118
617.638.8000
Boston University Medical Center Boston Medical Center is an extraordinary community of health care providers...
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Virginia Mason Medical Center Established in 1920, Virginia Mason began as an 80-bed hospital with...
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