Actively Recruiting
Phase II Trial of Disulfiram With Copper in Metastatic Breast Cancer
Led by The Institute of Molecular and Translational Medicine, Czech Republic · Updated on 2025-07-20
150
Participants Needed
1
Research Sites
430 weeks
Total Duration
On this page
Sponsors
T
The Institute of Molecular and Translational Medicine, Czech Republic
Lead Sponsor
U
University Hospital Olomouc
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Phase II Trial of Disulfiram With Copper in Metastatic Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with stage IV breast cancer with metastases shown by imaging
- Tumor confirmed by histology or cytology
- Age 18 years or older
- ECOG performance status of 0 to 2
- Failed, untolerated, or refused standard treatments
- No systemic anticancer therapy, radiation, or major surgery in last 2 weeks
- Not currently in another study
- Expected survival of at least 2 months
- Baseline AST and ALT no higher than 2.5 times upper limit
- Normal serum copper levels
- Serum ceruloplasmin greater than 17 mg/dL
- Able and willing to sign consent and follow study procedures
- Able to take oral medications
- No known allergy to disulfiram or copper
- Willing to avoid alcohol during the study
You will not qualify if you...
- Participation in another drug trial within past 14 days
- Addiction to alcohol or drugs
- Baseline AST or ALT greater than 2.5 times upper limit
- Unable to take oral medications
- Unable to lie still for CT/SPECT scans
- Currently receiving cytotoxic chemotherapy
- Expected survival less than 2 months
- Women of child-bearing potential not using effective contraception or without negative pregnancy test
- History of active liver disease including various hepatitis forms or jaundice with high bilirubin
- History of Wilson's disease or family history
- History of hemochromatosis or similar iron overload disorders
- Need for medications like metronidazole, warfarin, or theophylline affected by disulfiram
- Pregnant or nursing women
- Taking medications metabolized by cytochrome P450 2E1 such as chlorzoxazone or halothane derivatives
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
University Hospital Olomouc
Olomouc, Czechia, 77900
Actively Recruiting
Research Team
M
Marian Hajduch, MD., PhD.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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