Phase III Trial of Bisphosphonates as Adjuvant Therapy for Primary Breast Cancer

IRB-HSR# 13759
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: mc7m@virginia.edu

Clinical Trial Description

UVA Health System, Department of Medicine, Hematology/Oncology seeks Women with Stage I, II, or III Breast Cancer that is currently in remission for a research study.

The purpose of the study is to learn if adding a biophosphonate (clodronate, ibandronate or zoledronic acid) to hormone therapy or chemotherapy will help prevent breast cancer from spreading to the bones or other parts of the body. Study involves taking an experimental medicine, physical examinations, blood draws, CT scan, chest X-ray, dental examinations and bone scans. You may be required to take calcium and vitamin supplements. Initially visits occur on a monthly basis for six months. After the first six visits are complete, all remaining visits will occur every three months. Treatment is based upon randomization and will be given orally or intravenously. The treatment period is 36 months and your medical condition is followed for 10 years after. 

Compensation

• Study-related medication will be provided free of charge. However, if clodronate, ibandronate or zoledronic acid 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.
  
• No compensation is provided for this study.