NCT03323346CompletedPhase 2
Phase II Trial of Disulfiram With Copper in Metastatic Breast Cancer
Phase II Open Labeled Trial of Disulfiram With Copper in Metastatic Breast Cancer
Source: ClinicalTrials.gov · Last updated 26 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 9 (actual)
- First submitted
- 29 Sept 2017
- Start date
- 29 Sept 2017
- Primary completion date
- 30 Oct 2025
- Lead sponsor
- The Institute of Molecular and Translational Medicine, Czech Republic
- Diseases
- Metastatic breast cancer
- NCT number
- NCT03323346
- EU CT number
- 2024-514665-19-00
- EudraCT number
- 2016-001386-81
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 9
- From 29 Sept 2017 to the primary completion date, 30 Oct 2025
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participation in another clinical trial of a therapeutic drug during the past 14 days
- Addiction to alcohol or drugs
- Unable to ingest oral medications
- Actively receiving cytotoxic cancer chemotherapy agents
- Need for metronidazole, warfarin and/or theophylline medication, the metabolism of which is likely influenced by disulfiram
- Patients who are taking medications metabolized by cytochrome P450 2E1, including chlorzoxazone or halothane and its derivatives
Other illness
- History of Wilson's disease or family member with Wilson's disease
- History of hemochromatosis or family member with hemochromatosis
- History of other iron overload syndrome such as hemochromatosis
Lab values
- Baseline AST or ALT greater than 2.5 X upper institutional limit
- History of active liver disease, including chronic active hepatitis, viral hepatitis (hepatitis B, C and CMV), cholestatic jaundice of any etiology, toxic hepatitis, or cholestatic hepatitis or jaundice with bilirubin greater than 2.0 X upper institutional limit
Other
- Unable to undergo CT/SPECT scanning because of inability to lie recumbent in the scanner
- Anticipated survival of less than 2 months
- Women of child-bearing potential who are not using a commonly accepted effective means of contraception; women of child-bearing potential will have negative pregnancy test before enrollment
- Pregnant women and nursing mothers are not allowed to enroll on this study
Who the study is looking for
- Patients with stage IV breast cancer with metastases demonstrated by appropriate imaging techniques (computer tomography - CT, positron emission tomography - PET or PET/CT, MRI, ultrasound, etc.)
- Histologically or cytologically confirmed tumor
- Age of 18 years or more
- ECOG performance status of 0 - 2
- Patients have failed, untolerated or refused standard therapeutic modalities
- Not received systemic anticancer therapy or radiation or had major surgery in last 2 weeks
- Not currently participating in another study
- Anticipated survival of at least 2 months
- Baseline AST and ALT not greater than 2.5 X upper institutional limit
- Serum copper within normal limits
- Serum ceruloplasmin \> 17 mg/dL
- Able and willing to sign informed consent and to comply with study procedures
- Able to ingest oral medications
- No known allergy to disulfiram or copper
- Willing to refrain from ingestion of alcoholic beverages while on the study
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Masarykuv Onkologicky Ustav Coordinator of this site? Confirm its status | Brno-Stred | Czechia | Completed |
| Fakultni Nemocnice Hradec Kralove Coordinator of this site? Confirm its status | Novy Hradec Kralove | Czechia | Completed |
| University Hospital Olomouc Coordinator of this site? Confirm its status | Olomouc | Czechia | Completed |
| Fakultni nemocnice Ostrava Coordinator of this site? Confirm its status | Ostrava | Czechia | Completed |
| Fakultni nemocnice Kralovske Vinohrady Coordinator of this site? Confirm its status | Prague | Czechia | Completed |
This page is information, not medical advice. Discuss any trial with your doctor.