Digoxin Induced Dissolution of CTC Clusters
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03928210|
Recruitment Status : Not yet recruiting
First Posted : April 26, 2019
Last Update Posted : July 18, 2019
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer Circulating Tumor Cells (CTCs)||Drug: Digoxin||Early Phase 1|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||9 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effect of Digoxin on Clusters of Circulating Tumor Cells (CTCs) in Breast Cancer Patients|
|Estimated Study Start Date :||August 2019|
|Estimated Primary Completion Date :||May 2021|
|Estimated Study Completion Date :||June 2021|
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.
- 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
- 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
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03928210
|Contact: Christian Kurzeder, PD Dr. med||+41 61 26 email@example.com|
|Contact: Marcus Vetter, PD Dr. med||+41 61 26 firstname.lastname@example.org|
|Breast Cancer Center, University Hospital Basel||Not yet recruiting|
|Basel, Switzerland, 4031|
|Contact: Christian Kurzeder, PD Dr. med +41 61 265 2525 email@example.com|
|Principal Investigator: Marcus Vetter, PD Dr. med|
|Principal Investigator:||Christian Kurzeder, PD Dr. med||Breast Cancer Center, University Hospital Basel|