Digoxin as a Novel Inhibitor of Global Hypoxia Inducible Factor-1Î± (HIF-1Î±) Expression & Downstream Targets in Breast Cancer: DIG-HIF1 Pharmacodynamic Trial
The purpose of this study is to learn what effects digoxin may have on human breast cancer tissue. Breast cancer cells grow in a low oxygen environment called hypoxia. Your body normally controls the amount of oxygen in cells with what is known as HIF-1, hypoxia inducible factor 1. HIF-1 helps cancer cells grow in low oxygen environments; therefore, if are able to block its function, it may make it harder for breast cancer cells to grow. Digoxin is a drug that has been shown to block HIF-1 in lab studies. We want to learn if it blocks HIF-1 in human breast cancer tissue. We will do this by comparing the tumor tissue from your original diagnostic biopsy to tissue that is taken at the time of surgery. We will also be comparing tumor tissue of patients who are not randomized to take digoxin.
Women who have a known breast cancer and who are scheduled for surgery (lumpectomy or mastectomy) may join this study.
You will sign a consent and have some blood tests and an EKG (to look at the electrical activity of your heart) to make sure that it is safe for you to participate. After the blood tests and EKG you will be randomized to either receive the study drug digoxin or not (control). Randomized means chosen by chance, like the flipping of a coin. Neither you nor your doctor can choose whether you receive the study drug. If you are randomized to receive digoxin, you will take it twice daily for about 14 days prior to surgery. We will repeat the EKG and blood tests after one week of taking digoxin. Blood tests will also be done at the time of surgery and at your follow up visit (for a total of 3 times). We may ask you to have a biopsy of your breast tumor done for the study. This biopsy is optional and not required for you to take part in the study unless you were on hormones or hormonal therapy at the time of your diagnostic biopsy. Patients who are randomized to the control arm will be asked to have optional blood work on the day of surgery. For all participants, we will collect some of the leftover tumor tissue at the time of surgery (this will not change or affect your surgery).
05/22/2013 04:02 AM