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

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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.

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.

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
Baltimore, Maryland 21204
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330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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Boston, MA
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2010 E 90th St
Cleveland, Ohio 44195
(866) 223-8100
Cleveland Clinic Taussig Cancer Center At Taussig Cancer Institute, more than 250 highly skilled doctors,...
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Cleveland, OH
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One Medical Center Drive
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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Lebanon, NH
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12605 East 16th Avenue
Aurora, Colorado 80045
720-848-0000
University of Colorado Hospital, Site Top medical professionals, superior medicine and progressive change make University...
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Aurora, CO
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2730 University Boulevard West
Bethesda, Maryland 20817
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Bethesda, MD
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Boston, MA
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1 Boston Medical Center Place
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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Boston, MA
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Boston, Massachusetts 02133
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Boston, MA
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121 Boulevard de Waterloo
Brussels, 1000
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Brussels,
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New Brunswick, New Jersey 08901
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New Brunswick, NJ
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Seattle, Washington 98101
(888) 862-2737
Virginia Mason Medical Center Established in 1920, Virginia Mason began as an 80-bed hospital with...
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Seattle, WA
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Shreveport, Louisiana 71103
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Shreveport, LA
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Zion, Illinois 60099
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Zion, IL
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