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

Completed · Phase 2

Conditions studied: Breast Neoplasms, Neoplasms

In brief

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.

Key facts

Study ID

NCT00300781

Run by

Puma Biotechnology, Inc.

People needed

136

Starts

2006-08-04

Expected to finish

2018-01-30

Last updated by the study team

2018-08-14

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Colorado Hospital — Aurora, Colorado, United States
• Midwestern Regional Medical Center — Zion, Illinois, United States
• Louisiana State University — Shreveport, Louisiana, United States
• The Cancer Center at GBMC — Baltimore, Maryland, United States
• Oncology Care Associates — Bethesda, Maryland, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Dana Farber Cancer Institute — Boston, Massachusetts, United States
• Boston University Medical Center — Boston, Massachusetts, United States
• Faulkner Hospital — Boston, Massachusetts, United States
• Norris Cotton Cancer Center Dartmouth Hitchcock Medical Center — Lebanon, New Hampshire, United States
• The Cancer Institute of New Jersey — New Brunswick, New Jersey, United States
• The Cleveland Clinic Taussig Cancer Center — Cleveland, Ohio, United States
• Virginia Mason Medical Center — Seattle, Washington, United States
• Institut Jules Bordet Unite du Chimiotherapie — Brussels, Belgium
• University Hospital Gasthuisberg — Leuven, Belgium
• St-Augustinus Ziekenhuis Oncology Department — Wilrijk, Belgium
• The Hospital Affiliated Academy Military Medical Science, Chinese People's Liberation Army — Beijing, Beijing Municipality, China
• No. 81 Hospital of Chinese People's Liberation Army — Nanjing, Jiangsu, China
• Cancer Hospital Peking Union Medical College — Beijing, China
• Chinese People's Liberation Army General Hospital — Beijing, China
• Institut Gustave ROUSSY Service de Pathologie Mammaire — Villejuif, France
• Jehangir Clinical Development Centre — Pune, Maharashtra, India
• Deenanath Mangeshkar Hospital — Pune, Maharashtra, India
• Nizam's Institute of Medical Sciences — Hyderabad, Panjagutta, India
• Tata Memorial Centre — Mumbai, Parel, India

Full record on ClinicalTrials.gov

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