Trial Outcomes & Findings for DIG-HIF-1 Pharmacodynamic Trial in Newly Diagnosed Operable Breast Cancer (NCT NCT01763931)

Last Updated: 2020-01-31

Results Overview

To assess whether two weeks of daily oral digoxin therapy, as compared to no study drug, reduces the expression of Hypoxia-inducible factor (HIF)-1α protein, measured by immunohistochemistry (IHC), in surgically resected breast cancer tissue obtained from women undergoing lumpectomy or mastectomy for invasive breast cancer.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

6 participants

Primary outcome timeframe

Baseline (biopsy prior to surgery) and at the end of 2 weeks digoxin treatment

Results posted on

2020-01-31

Participant Flow

Participant milestones

Participant milestones
Measure	Digoxin Digoxin administration for 2 weeks prior to surgery. Digoxin: Digoxin once daily for 2 weeks prior to definitive breast surgery.	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.
Overall Study STARTED	2	4
Overall Study COMPLETED	2	3
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Digoxin n=2 Participants Digoxin administration for 2 weeks prior to surgery. Digoxin: Digoxin once daily for 2 weeks prior to definitive breast surgery.	No Drug Administration Prior to Surgery n=4 Participants Group of participants who will not receive digoxin; however, tissue will be collected at time of definitive breast surgery.	Total n=6 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=99 Participants	4 Participants n=107 Participants	5 Participants n=206 Participants
Age, Categorical >=65 years	1 Participants n=99 Participants	0 Participants n=107 Participants	1 Participants n=206 Participants
Age, Continuous	65 years n=99 Participants	44 years n=107 Participants	51 years n=206 Participants
Sex: Female, Male Female	2 Participants n=99 Participants	4 Participants n=107 Participants	6 Participants n=206 Participants
Sex: Female, Male Male	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=99 Participants	1 Participants n=107 Participants	1 Participants n=206 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2 Participants n=99 Participants	3 Participants n=107 Participants	5 Participants n=206 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race/Ethnicity, Customized Race - White	2 Participants n=99 Participants	1 Participants n=107 Participants	3 Participants n=206 Participants
Race/Ethnicity, Customized Race - Black	0 Participants n=99 Participants	1 Participants n=107 Participants	1 Participants n=206 Participants
Race/Ethnicity, Customized Race - Other	0 Participants n=99 Participants	2 Participants n=107 Participants	2 Participants n=206 Participants

PRIMARY outcome

Timeframe: Baseline (biopsy prior to surgery) and at the end of 2 weeks digoxin treatment

Population: Not enough tissue samples were collected to be analyzed and so no data was generated for this outcome measure.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 weeks

Population: Adverse events with digoxin is not applicable to the group "no drug administration prior to surgery"

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.

Outcome measures

Outcome measures
Measure	Digoxin n=2 Participants Digoxin administration for 2 weeks prior to surgery. Digoxin: Digoxin once daily for 2 weeks prior to definitive breast surgery.	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.
Number of Participants With Adverse Events With Digoxin Treatment	2 Participants	0 Participants

Adverse Events

Digoxin

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

No Drug Administration Prior to Surgery

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Digoxin n=2 participants at risk Digoxin administration for 2 weeks prior to surgery. Digoxin: Digoxin once daily for 2 weeks prior to definitive breast surgery.	No Drug Administration Prior to Surgery n=4 participants at risk Group of participants who will not receive digoxin; however, tissue will be collected at time of definitive breast surgery.
Musculoskeletal and connective tissue disorders Hip Pain	50.0% 1/2 • Number of events 1	0.00% 0/4
Ear and labyrinth disorders Ear Pain	50.0% 1/2 • Number of events 1	0.00% 0/4
Surgical and medical procedures Incisional pain	100.0% 2/2 • Number of events 2	0.00% 0/4
Gastrointestinal disorders Dry mouth	50.0% 1/2 • Number of events 1	0.00% 0/4
Renal and urinary disorders Increased urine output	50.0% 1/2 • Number of events 1	0.00% 0/4
Musculoskeletal and connective tissue disorders Knee pain	50.0% 1/2 • Number of events 1	0.00% 0/4
Musculoskeletal and connective tissue disorders Neck spasms/pain	50.0% 1/2 • Number of events 1	0.00% 0/4
Infections and infestations Cellulitis	50.0% 1/2 • Number of events 1	0.00% 0/4

Additional Information

Vered Stearns, MD

SKCCC at Johns Hopkins

Phone: 410-614-1361

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place