At a glance
ClinicalIndex Comparison Record- ✓Stage IV breast cancer with metastases confirmed by imaging
- ✓Histologically or cytologically confirmed tumor
- ✓Age 18 years or older
- ✓ECOG performance status 0-2
- ✕Participation in another therapeutic drug trial within 14 days
- ✕Addiction to alcohol or drugs
- ✕Unable to ingest oral medications
- ✕Unable to undergo CT/SPECT scanning due to inability to lie recumbent
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase II Open Labeled Trial of Disulfiram With Copper in Metastatic Breast Cancer
In Brief
A Phase 2 clinical trial evaluating Disulfiram for Breast Neoplasm Female and Metastatic Breast Cancer. Completed, enrolled 9 participants across 1 site.
Detailed Summary
The aim of the study is to establish clinical evidence for introducing disulfiram and cooper as an active therapy for metastatic breast cancer upon failure of conventional systemic and/or locoregional therapies. Analyses of the following objectives will be performed in the population of patients with metastatic breast cancer: Primary efficacy objective: To evaluate the efficacy of the treatment by assessment of: * clinical response rate (RR) * clinical benefit rate (CBR) Secondary efficacy objectives: To evaluate the efficacy of the treatment by assessment of: * time to progression (TTP) * overall survival (OS) Pharmacokinetic objectives: • to determine pharmacokinetic parameters for disulfiram and its active metabolites administered in combination with copper supplements in cancer patient population Safety objectives: • to describe safety profile of disulfiram administered in combination with copper supplements Exploratory objectives: Parallel analysis to assess (identify) potential candidate surrogate biomarkers of disulfiram efficacy, as well as identification (using proteomic, biochemical and molecular genetic studies) of potential predictive biomarkers of disulfiram sensitivity or resistance will be performed. Surrogate biomarker analysis will focus on in vivo ubiquitin-proteosomal system inhibition, cell cycle and DNA damage.
Study Details
Timeline
Arms & Interventions
Patients will take one pill of disulfiram (Antabus) daily at a dose of 400 mg continually during the treatment phase (from day 0 till End of treatment Visit). In case of intolerance, lower dose up to 200 mg per day is allowed. Patients will take disulfiram after their evening meal. Patients will avoid alcohol and other disulfiram-drug interactions will be considered. Copper supplementation will be given separately from disulfiram; in the morning with patients´breakfast. Patients will take one pill of copper dietary supplement (for instance Copper Star, STARLIFE) corresponding to 2 mg of elementary copper.
Interventions
Patients will take one pill of disulfiram (Antabus) daily at a dose of 400 mg continually during the treatment phase (from day 0 till End of treatment Visit). In case of intolerance, lower dose up to 200 mg per day is allowed. Copper supplementation will be given separately from disulfiram; in the morning with patients´breakfast. Patients will take one pill of copper dietary supplement (for instance Copper Star, STARLIFE) corresponding to 2 mg of elementary copper.