Category: Cancer (Oncology) , Women's Health IRB-HSR# 14626
Title: A Phase 3, Randomized, Open-Label Study of Neratinib Versus Lapatinib Plus Capecitabine for the Treatment of ErbB-2-Positive Locally Advanced or Metastatic Breast Cancer
Contact:Mary Oliveri
Phone:(434)924-9496
E-mail:mc7m@virginia.edu

UVa Health System, Department of Medicine, Hematology/Oncology seeks: Women ages 18 and older with locally advanced or metastatic breast cancer for research study.

The purpose of this study is to compare an experimental drug called neratinib to the combination of two FDA approved drugs for the treatment of locally advanced or metastatic breast cancer. This study will also look at how your cancer responds to the study drugs. In addition, the study will look at the side effects of the study drugs, and it will examine how long neratinib stays in your blood. The study involves answering health questionnaires, blood draws, physical exams, pregnancy test, tests for heart function (electrocardiogram) and CT/MRI scans. Depending on the study treatment you receive, the study may involve taking the experimental drug or the FDA approved chemotherapy agents. Your participation in this study will require approximately 17 study visits over 34 months. Each visit will last 1 to 4 hours. Your medical condition is followed every 3 months until completion of the study.

Study drugs are provided free of charge.
Participants insurance company will be billed for non-experimental medication, tests and procedures.
No compensation is provided for this study.

Contact Information:
For more information please contact:
" Mary Oliveri, CRC
" Tel: 434-924-9496 Email: mc7m@Virginia.EDU
" IRB-HSR # 14626 (Wyeth 3144A2-3003)

Principal Investigator: Christiana Brenin, MD

Primary Investigator: Brenin Christiana,
Department: Internal Medicine
Division: 4W
Accepts adult enrollment :YES
Accepts minor enrollment :NO