Digoxin Induced Dissolution of CTC Clusters

EARLY_PHASE1CompletedINTERVENTIONAL
Enrollment

58

Participants

Timeline

Start Date

July 8, 2020

Primary Completion Date

December 1, 2023

Study Completion Date

December 1, 2023

Conditions
Breast CancerCirculating Tumor Cells (CTCs)
Interventions
DRUG

Digoxin

Patients will receive a daily maintenance dose of digoxin. The daily dose of digoxin will be calculated according to the renal function and the target serum digoxin concentration and applied in an adjusted regimen based on the availability of 0.125 mg and 0.25 mg pills in the morning (before 10 am). Blood samples for analyses of mean CTC cluster size will be drawn at screening, on day 0 (2 hrs after first oral intake), on day 3 and on day 7. Depending on the digoxin serum level maintenance therapy with digoxin will be continued up to 3 weeks if the digoxin serum level on day 7 or day 14 is below 0.70 ng/ml. For the third week of maintenance therapy individual dose adjustments will be carried out as needed.

Trial Locations (3)

4031

Breast Cancer Center, University Hospital Basel, Basel

4410

Kantonspital Baselland (KSBL), Liestal

8091

University Hospital Zurich (USZ), Zurich

All Listed Sponsors
collaborator

ETH Zurich - The Aceto Lab

UNKNOWN

lead

University Hospital, Basel, Switzerland

OTHER

NCT03928210 - Digoxin Induced Dissolution of CTC Clusters | Biotech Hunter | Biotech Hunter