Breast Cancer Clinical Trial

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Study Evaluating HKI-272 (Neratinib) In Subjects With Advanced Breast Cancer

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Summary

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.

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Full Description

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.

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Eligibility Criteria

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

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

136

Study ID:

NCT00300781

Recruitment Status:

Completed

Sponsor:

Puma Biotechnology, Inc.

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There are 31 Locations for this study

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University of Colorado Hospital
Aurora Colorado, 80045, United States
Midwestern Regional Medical Center
Zion Illinois, 60099, United States
Louisiana State University
Shreveport Louisiana, 71103, United States
The Cancer Center at GBMC
Baltimore Maryland, 21204, United States
Oncology Care Associates
Bethesda Maryland, 20817, United States
Beth Israel Deaconess Medical Center
Boston Massachusetts, 02115, United States
Dana Farber Cancer Institute
Boston Massachusetts, 02115, United States
Boston University Medical Center
Boston Massachusetts, 02118, United States
Faulkner Hospital
Boston Massachusetts, 02130, United States
Norris Cotton Cancer Center Dartmouth Hitchcock Medical Center
Lebanon New Hampshire, 03756, United States
The Cancer Institute of New Jersey
New Brunswick New Jersey, 08901, United States
The Cleveland Clinic Taussig Cancer Center
Cleveland Ohio, 44195, United States
Virginia Mason Medical Center
Seattle Washington, 98101, United States
Institut Jules Bordet Unite du Chimiotherapie
Brussels , 1000, Belgium
University Hospital Gasthuisberg
Leuven , 3000, Belgium
St-Augustinus Ziekenhuis Oncology Department
Wilrijk , 2610, Belgium
The Hospital Affiliated Academy Military Medical Science, Chinese People's Liberation Army
Beijing Beijing, 10007, China
No. 81 Hospital of Chinese People's Liberation Army
Nanjing Jiangsu, 21000, China
Cancer Hospital Peking Union Medical College
Beijing , 10002, China
Chinese People's Liberation Army General Hospital
Beijing , 10085, China
Institut Gustave ROUSSY Service de Pathologie Mammaire
Villejuif Cedex , 94805, France
Jehangir Clinical Development Centre
Pune Maharashtra, 41100, India
Deenanath Mangeshkar Hospital
Pune Maharashtra, 41100, India
Nizam's Institute of Medical Sciences
Hyderabad Panjagutta, 50082, India
Tata Memorial Centre
Mumbai Parel, 40001, India
Hospital Regional Lic. Adolfo Lopez Mateos Oncología Médica
Mexico City , 01030, Mexico
Arke Estudios Clínicos S.A. de C.V.
Mexico City , 06700, Mexico
Hospital de Especialidades MIG
Mexico City , 07300, Mexico
N.N. Blokhin Russian Cancer Research Center of RAMS
Moscow , 11547, Russian Federation
Medical Radiological Research Center of RAMS, Department of Radiation and Surgical Methods
Obninsk , 24903, Russian Federation
City Oncology Dispensary
Saint Petersburg , 19702, Russian Federation
City Hospital N 31 Oncology Haematology Dept. For Adults
Saint Petersburg , 19711, Russian Federation
Breast Tumor Department, N.N. Petrov Research Institute of Oncology
Saint-Petersburg , 19775, Russian Federation
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How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

136

Study ID:

NCT00300781

Recruitment Status:

Completed

Sponsor:


Puma Biotechnology, Inc.

How clear is this clinincal trial information?

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