Clinical trial · Interventional
Digoxin Induced Dissolution of CTC Clusters
Effect of Digoxin on Clusters of Circulating Tumor Cells (CTCs) in Breast Cancer Patients
NCT03928210CI-TRIAL-00072222completedEarly Phase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This single arm therapeutic exploratory study of digoxin in patients with advanced or metastatic breast cancer investigates whether cardiac glycosides are able to disrupt CTC clusters in breast cancer patients.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Circulating Tumor Cells (CTCs) | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Digoxin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Digoxin
- description
- Digoxin 0.125 mg or 0.25 mg administered once daily for 7 days or until symptoms of toxicity Generic e.g. DIGOXIN Juvisé or Lenoxin Mite
- interventionNames
- Drug: Digoxin
Primary outcomes (1)
- measure
- Change in mean CTC cluster size (in ng/ml)
- timeFrame
- Blood samples drawn at Screening, on day 0 (2 hours after first oral intake of digoxin), on day 3, on day 7, on day 10, on day 14, on day 17 and on day 21 after first oral intake of digoxin
- description
- mean CTC cluster size (in patients with a digoxin serum level above 0.7 ng/ml) after treatment will be compared to mean CTC-cluster size before treatment
Secondary outcomes (2)
- measure
- Change in mean CTC cluster number
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Informed Consent as documented by signature * Diagnosis of adenocarcinoma of the breast with evidence of locoregionally recurrent or metastatic disease not amenable to resection, radiation therapy or systemic therapy with curative intent * Adequate organ and marrow function Exclusion Criteria: * Patients on treatment with digoxin or digitoxin * Patients with atrial fibrillation or atrial flutter * Ventricular Fibrillation or ventricular tachycardia, * Atrioventricular heart block 2nd or 3rd degree, sick sinus syndrome or sinus bradycardia, * Wolff-Parkinson-White Syndrome * Hypokalemia, hypercalcemia, hypomagnesemia, hypoxia, * Hypertrophic cardiomyopathy, aortic aneurysm * Simultaneous intravenous application of calcium salts * Known hypersensitivity to Digoxin, other cardiac glycosides or included compounds * Known drug interactions of ongoing cancer therapy with digoxin * Women who are pregnant or breast feeding, * Intention to become pregnant during the course of the study, * Lack of safe contraception * Other clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease) * Known or suspected non-compliance, drug or alcohol abuse * Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant * Participation in another study with investigational drug within the 30 days preceding and during the present study, * Previous enrolment into the current study, * Enrolment of the investigator, his/her family members, employees and other dependent persons
References
Publications (1)
- DERIVEDKurzeder C, Nguyen-Strauli BD, Krol I, Ring A, Castro-Giner F, Nuesch M, Asawa S, Zhang YW, Budinjas S, Gvozdenovic A, Vogel M, Kohler A, Grasic Kuhar C, Schwab FD, Heinzelmann-Schwarz V, Weber WP, Rochlitz C, Vorburger D, Frauchiger-Heuer H, Witzel I, Wicki A, Kuster GM, Vetter M, Aceto N. Digoxin for reduction of circulating tumor cell cluster size in metastatic breast cancer: a proof-of-concept trial. Nat Med. 2025 Apr;31(4):1120-1124. doi: 10.1038/s41591-024-03486-6. Epub 2025 Jan 24. PMID 39856336