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Digoxin Induced Dissolution of CTC Clusters

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ClinicalTrials.gov Identifier: NCT03928210
Recruitment Status : Recruiting
First Posted : April 26, 2019
Last Update Posted : August 4, 2021
Sponsor:
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Breast Cancer Circulating Tumor Cells (CTCs) Drug: Digoxin Early Phase 1

Detailed Description:

Circulating tumor cells (CTCs) are considered to be precursors of metastasis in various cancer types and are found in the blood of cancer patients as single CTCs and CTC clusters, with the latter featuring a higher ability to seed metastasis.

CTC cluster share several properties that commonly feature stem cell biology which drive metastases formation. Preclinical data shows that CTC clusters can be disaggregated into single cells by the treatment with cardiac glycosides such as digoxin. 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.

Patients with advanced or metastatic breast cancer in whom CTC clusters could be identified will receive an individualized daily maintenance dose of digoxin adapted to their kidney function. Blood samples for analyses of digoxin serum level and mean CTC cluster size will be drawn at specified time points.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 9 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Digoxin on Clusters of Circulating Tumor Cells (CTCs) in Breast Cancer Patients
Actual Study Start Date : July 8, 2020
Estimated Primary Completion Date : May 2022
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Digoxin

Arms and Interventions
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Arm Intervention/treatment
Experimental: Digoxin 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.


Outcome Measures
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Primary Outcome Measures :
  1. Change in mean CTC cluster size (in ng/ml) [ Time Frame: 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 ]
    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 Outcome Measures :
  1. Change in mean CTC cluster number [ Time Frame: 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 ]
    number of CTC-clusters before and after treatment will be compared

  2. Average time to dissolution of CTC Clusters (in days) [ Time Frame: 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 ]
    average time to dissolution of CTC clusters


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03928210


Contacts
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Contact: Christian Kurzeder, PD Dr. med +41 61 26 52525 christian.kurzeder@usb.ch
Contact: Marcus Vetter, PD Dr. med +41 61 26 52525 marcus.vetter@usb.ch

Locations
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Switzerland
Breast Cancer Center, University Hospital Basel Recruiting
Basel, Switzerland, 4031
Contact: Christian Kurzeder, PD Dr. med    +41 61 265 2525    christian.kurzeder@usb.ch   
Principal Investigator: Marcus Vetter, PD Dr. med         
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
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Principal Investigator: Christian Kurzeder, PD Dr. med Breast Cancer Center, University Hospital Basel
More Information
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Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT03928210    
Other Study ID Numbers: 2019-00673; sp19Kurzeder
First Posted: April 26, 2019    Key Record Dates
Last Update Posted: August 4, 2021
Last Verified: August 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Basel, Switzerland:
cluster of circulating tumor cells (CTCs)
cardiac glycosides
digoxin
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplastic Cells, Circulating
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Neoplasm Metastasis
Neoplastic Processes
 Pathologic Processes
Digoxin
Anti-Arrhythmia Agents
Cardiotonic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs