Effect of Digoxin on Clusters of Circulating Tumor Cells (CTCs) in Breast Cancer Patients

2019-00673; sp19Kurzeder

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.

2020-07-08

2023-12-01

2023-12-01

Completed

Early phase I

58

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

{'studyType': 'INTERVENTIONAL', 'phases': ['EARLY_PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Patients with at least one CTC cluster (if homotypic ≥ 2 CTCs, if heterotypic ≥ 1 CTC and ≥ 1 white blood cell (WBC)) at screening entered the treatment phase. During treatment phase, patients received a daily maintenance dose of digoxin for a total of seven days, with a digoxin target level of ≥ 0.7 ng/ml in serum during treatment. Blood draws for capture and enumeration of CTCs and CTC clusters were obtained on day 0 (pre- and 2 hours post digoxin), day 3 and day 7. Regular study visits included clinical and laboratory assessments such as vital signs, electrocardiogram (ECG), serious adverse events (SAE), and digoxin serum levels on day 0 and 7.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 58, 'type': 'ACTUAL'}}

2023-12-13