Phase 2
Completed N=6
DIG-HIF-1 Pharmacodynamic Trial in Newly Diagnosed Operable Breast Cancer
Source: ClinicalTrials.gov NCT01763931 ↗Enrolled (actual)
6
Serious AEs
0.0%
Results posted
Jan 2020
Primary outcomePrimary: Change in HIF-1α Protein Expression
Summary
The purpose of this study is to learn what effects digoxin (DIG) may have on human breast cancer tissue.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in HIF-1α Protein Expression |
— | — |
| SECONDARY Number of Participants With Adverse Events With Digoxin Treatment |
2; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Female sex
- 18-70 years of age at time of consent.
- Histologically confirmed infiltrating carcinoma of the breast (Stage I-III)
- Unresected disease that meets scheduled to undergo definitive surgery; tumor size ≥ 1cm; grade 2 or 3 tumor or Ki-67 proliferation index of ≥ 10%; and, any estrogen receptor (ER), progesterone receptor (PR) or human epidermal growth factor receptor 2 (HER2) status
- Patients must not have received any prior treatment of any kind to treat the current breast cancer.
- Prior use of hormone contraceptives and replacement therapy is allowed, but must have been discontinued at least 30 days prior to the diagnostic biopsy.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (Karnofsky 80%-100%)
- Patients must have normal organ and marrow function: absolute neutrophil count (ANC) ≥ 1,500/mm3; platelet count ≥ 100,000/mm3; bilirubin (total) less than or equal to the upper limit of normal; creatinine ≤ 1.5 times the upper limit of normal with creatinine clearance ≥ 50 mL/min using the Modified Cockcroft-Gault method; and, all of the following within normal limits: thyroid stimulating hormone (TSH), magnesium, potassium, sodium, calcium.
- Heart rate > 60 beats/minute and 100 beats/minute; ventricular Fibrillation; ventricular tachycardia; premature ventricular contractions; Wolff-Parkinson-White syndrome. Note: Any questions on cardiac eligibility should be reviewed by the Study Cardiologist for approval in advance of enrollment.
- History of any of the following, unless approval is given by the Protocol Chair: heart disease, including acute myocardial infarction; cardiac arrhythmias, including sick sinus syndrome; pulmonary disease with a known forced expiratory volume (FEV) of <1.5 or on oxygen; gastrointestinal disease, surgery or malabsorption that could potentially impact the absorption of the study drug; patients requiring the use of a feeding tube; inability to swallow tablets
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that will limit compliance with study requirements
- Any medical condition which in the opinion of the investigator puts the patient at risk of potentially serious complications while on this therapy
Data sourced from ClinicalTrials.gov (NCT01763931). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.