NCT01763931

DIG-HIF-1 Pharmacodynamic Trial in Newly Diagnosed Operable Breast Cancer

Digoxin as a Novel Inhibitor of Global Hypoxia Inducible Factor-1α (HIF-1α) Expression & Downstream Targets in Breast Cancer: DIG-HIF-1 Pharmacodynamic Trial

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to learn what effects digoxin (DIG) may have on human breast cancer tissue.

Detailed description

Breast cancer cells grow in a low oxygen environment called hypoxia. The body normally controls the amount of oxygen in cells with what is known as Hypoxia-inducible factor (HIF)-1. HIF-1 helps cancer cells grow in low oxygen environments; therefore, if this function can be blocked, 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. The investigators want to learn if it blocks HIF-1 in human breast cancer tissue. This will be done by comparing the tumor tissue from the original diagnostic biopsy to tissue that is taken at the time of surgery. The investigators will also be comparing tumor tissue of patients who are not randomized to take digoxin.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Digoxin	Digoxin once daily for 2 weeks prior to definitive breast surgery.

Timeline

• Start date: 2013-01-01
• Primary completion: 2016-04-01
• Completion: 2016-04-01
• First posted: 2013-01-09
• Last updated: 2020-01-31
• Results posted: 2020-01-31

Locations

1 site across 1 country: United States