A Double-Blind Phase III Trial of Doxorubicin and Cyclophosphamide followed by Paclitaxel with Bevacizumab or Placebo in Patients with Lymph Node Positive and High Risk Lymph Node Negative Breast Cancer

IRB-HSR# 13713
Service: Cancer | Category: Cancer (Oncology)
Adult Enrollment: Yes | Minor Enrollment: No
Primary Investigator: Christiana M. Brenin, M.D.

Contact Information

Contact: Mary Oliveri
Phone: 434.924.9496
E-mail: mc7m@virginia.edu

Clinical Trial Description

UVA Health System, Department of Medicine, Hematology/Oncology seeks: Women ages 18 and older with breast cancer with a significant risk of recurrence for a research study.

The purpose of the study is to determine if adding Bevacizumab to the current standard chemotherapy or cancer-reducing medications reduces the risk of recurrence compared to standard chemotherapy alone. Study involves taking an experimental medicine or a placebo, physical exams, blood draws, urine tests, x rays or CT scan, EKG and Echocardiogram or MUGA scan. Each visit will last approximately 4 hours. Initially visits occur once every 2 or 3 weeks dependent upon which chemotherapy agent is prescribed. After the first 4 doses are completed, visits will occur on a weekly basis for 12 doses. The total treatment period for the study is either 20-24 weeks or 50-54 weeks and your medical condition is followed for 15 years after.

• Study-related experimental medication provided free of charge. However, if bevacizumab becomes commercially available for this indication, there is a remote possibility you may be asked to purchase supplies
  
• Participant's insurance company will be billed for tests and procedures.

Compensation