DIG-HIF1 Pharmacodynamic Trial in Newly Diagnosed Operable Breast Cancer
The purpose of this study is to learn what effects digoxin may have on human breast cancer tissue.
|Study Design:||Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
|Official Title:||Digoxin as a Novel Inhibitor of Global Hypoxia Inducible Factor-1α (HIF-1α) Expression & Downstream Targets in Breast Cancer: DIG-HIF1 Pharmacodynamic Trial|
- Changes in HIF-1 protein expression [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]To evaluate whether two weeks of daily oral digoxin therapy, as compared to no study drug, reduces the expression of HIF-1α protein, measured by immunohistochemistry (IHC), in surgically resected breast cancer tissue obtained from women undergoing lumpectomy or mastectomy for invasive breast cancer.
- Adverse events with digoxin [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]To assess safety and tolerability of two weeks of digoxin therapy in the pre-surgical setting graded according to Common Terminology Criteria for Adverse Events (CTCAE), version 4.
|Study Start Date:||January 2013|
|Estimated Study Completion Date:||January 2018|
|Estimated Primary Completion Date:||January 2017 (Final data collection date for primary outcome measure)|
Digoxin administration for 2 weeks prior to surgery.
Digoxin once daily for 2 weeks prior to definitive breast surgery.
No Intervention: No drug administration prior to surgery
Group of participants who will not receive digoxin; however, tissue will be collected at time of definitive breast surgery.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01763931
|Contact: JHCCCRO (Central Contact)||firstname.lastname@example.org|
|Contact: Hopkins Breast Trials (Central Contact Backup)||HopkinsBreastTrials@jhmi.edu|
|United States, Maryland|
|Kimmel Cancer Center at Johns Hopkins||Recruiting|
|Baltimore, Maryland, United States, 21231|
|Contact: JHCCCRO (CRO) 410-955-8866 email@example.com|
|Contact: Hopkins Breast Trials (Back-up contact) HopkinsBreastTrials@jhmi.edu|
|Principal Investigator: Vered Stearns, M.D.|
|Study Chair:||Vered Stearns, M.D.||Sidney Kimmel Comprehensive Cancer Center|