DIG-HIF1 Pharmacodynamic Trial in Newly Diagnosed Operable Breast Cancer
|ClinicalTrials.gov Identifier: NCT01763931|
Recruitment Status : Active, not recruiting
First Posted : January 9, 2013
Last Update Posted : September 14, 2017
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: Digoxin||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||64 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (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|
|Study Start Date :||January 2013|
|Estimated Primary Completion Date :||July 2018|
|Estimated Study Completion Date :||July 2018|
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.
- Changes in HIF-1 protein expression [ Time Frame: 2 weeks ]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 ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01763931
|United States, Maryland|
|Kimmel Cancer Center at Johns Hopkins|
|Baltimore, Maryland, United States, 21231|
|Study Chair:||Vered Stearns, M.D.||Sidney Kimmel Comprehensive Cancer Center|