A Phase 2, Randomized, Open-label Study of Bosutinib Administered in Combination With Exemestane Versus Exemestane Alone as Second Line Therapy in Postmenopausal Women With Locally Advanced or Metastatic ER+/PgR+/ErbB2- Breast Cancer

IRB-HSR# 14674
Service: Cancer | Category: Cancer (Oncology)
Adult Enrollment: Yes | Minor Enrollment: No
Primary Investigator: Christiana Brenin, M.D.

Contact Information

Contact: Mary Oliveri
Phone: 434.924.9496
E-mail: c7m@virginia.edu

Clinical Trial Description

UVA Health System, Department of Medicine, Hematology/Oncology seeks: Women ages 18 and older with locally advanced or metastatic breast cancer and are not eligible for surgery or radiation therapy to treat the cancer for research study.

The purpose of this study is to compare an experimental drug called bosutinib in combination with exemestane versus exemestane alone as possible treatment of locally advanced or metastatic breast cancer. 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 taking FDA approved chemotherapy agents, answering health questionnaires, blood draws, physical exams, tests for heart function (electrocardiogram, ECHO/MUGA) and CT/MRI scans. Depending on the study treatment you receive, the study may involve taking the experimental drug, bosutinib. Your participation in this study will require approximately 9-10 study visits over 25 months. Each visit will last 1 to 8 hours. Your medical condition is followed every 3 months for up to 2 years from when you first receive the study drug.

Compensation

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