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Protocol No. UW13060
Principal Investigator Wilke, Lee
Phase Pilot/Feasibility (Cancer Prevention)
Age Group Adult
Sponsor Type Institutional
Title Pilot study of short-term bisphosphonate administration as chemopreventive for breast cancer via engagement of gamma-delta T cells
Objective The purpose of this research study is to test whether alendronate (also known as Fosamax) produces changes in the immune system. A group of scientists at the University of Wisconsin has found that the drug alendronate can increase the number of cancer-fighting immune cells in research animals, and alendronate might increase the action of the immune system in the breast to fight pre-cancerous cells. Scientists will use breast tissue and blood samples collected from volunteer patients to learn how immune cells in health breast tissue are affected by taking alendronate.
Treatment If you decide to participate in this research, you will be asked to take alendronate for approximately one to three weeks. You will be asked to take 1 tablet by mouth, once a day, every day for 1 - 3 weeks before your breast surgery.
Description This study involves up to four study visits lasting approximately 30 minutes to 2 hours. You will be in the study for approximately 5 weeks. If your surgery is delayed, your participation will not last more than 8 weeks. You will be asked to take alendronate for approximately one to three weeks. The surgeon will perform two biopsies to the breast as well as two blood draws. We will give you a medication diary to write down when you take the study medication each day.
Patients referred for risk reduction mastectomy (for example, BRCA or other high risk gene mutations, strong family history of breast cancer, history of LCIS, ADH, ALH and those with DCIS undergoing bilateral mastectomy or prophylactic contralateral mastectomy)
Patients must be premenopausal (at least six menstrual cycles in past year)
Patients must agree to use ONE forms of birth control for the duration of the study
Patients of child-bearing potential must have a negative pregnancy test within the current menstrual cycle and within 7 days before starting drug
Patients must not have a previous diagnosis of invasive breast cancer can participate as long as it has been greater than 3 years ago
Pregnant or lactating women are excluded
Chronic steroid use not allowed during 2 years prior to surgery
Patients can not have received chemotherapy for a malignancy in the past 5 years
Patients excluded with current or previous bisphosphonate therapy
Applicable Disease Sites Breast
Therapies Involved Prevention
Drugs Involved Fosamax (alendronate); alendronate
Participating Institutions UW Hospital and Clinics