Actively Recruiting

Phase 2
Age: 18Years +
FEMALE
ID03323346

Phase II Open Label 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

N/A

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

Researchers are evaluating the use of disulfiram combined with copper supplements as a treatment for metastatic breast cancer in patients who have not responded to or tolerated conventional therapies. This Phase II trial aims to determine how well this treatment works by measuring clinical response and benefit rates, time to disease progression, overall survival, and pharmacokinetics. Safety and potential biomarkers related to treatment sensitivity or resistance will also be studied. Participants will take one daily pill of disulfiram at 400 mg after their evening meal, with a possible dose reduction to 200 mg if needed. Copper supplements providing 2 mg of elemental copper will be taken separately in the morning with breakfast. Patients must avoid alcohol and disulfiram-drug interactions during treatment. The treatment continues from the start until the end of the treatment visit. During the study, participants will undergo imaging tests to confirm metastases and regular assessments to track cancer progression and survival outcomes up to 60 months. Blood tests will monitor liver function and copper levels, while pharmacokinetic studies will evaluate the drug and its metabolites. Safety will be closely observed by recording adverse events. Participants must comply with study procedures and abstain from alcohol throughout the trial.

CONDITIONS

Brief Title

Phase II Trial of Disulfiram With Copper in Metastatic Breast Cancer

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with stage IV breast cancer with metastases confirmed by imaging techniques
  • Histologically or cytologically confirmed tumor
  • Age 18 years or older
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
  • Patients who have failed, not tolerated, or refused standard therapies
  • No systemic anticancer therapy, radiation, or major surgery in the last 2 weeks
  • Not currently enrolled in another study
  • Expected survival of at least 2 months
  • Baseline liver enzymes (AST and ALT) not exceeding 2.5 times the upper limit
  • Serum copper levels within normal limits
  • Serum ceruloplasmin greater than 17 mg/dL
  • Able and willing to give informed consent and follow study procedures
  • Able to take oral medications
  • No known allergies to disulfiram or copper
  • Willing to avoid alcohol during the study
Not Eligible

You will not qualify if you...

  • Participation in another therapeutic drug trial in the last 14 days
  • Addiction to alcohol or drugs
  • Baseline liver enzymes (AST or ALT) exceeding 2.5 times the upper limit
  • Unable to take oral medications
  • Unable to lie flat for CT or SPECT scans
  • Currently receiving cytotoxic chemotherapy
  • Expected survival less than 2 months
  • Women of childbearing potential not using effective contraception or with a positive pregnancy test
  • History of active liver disease or hepatitis with elevated bilirubin
  • History of Wilson's disease or family history
  • History of hemochromatosis or other iron overload disorders
  • Need for medications like metronidazole, warfarin, or theophylline affected by disulfiram
  • Pregnant or nursing women
  • Taking drugs metabolized by cytochrome P450 2E1, such as chlorzoxazone or halothane derivatives

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - From day 0 until the end of treatment

Participants take one pill of disulfiram daily at a dose of 400 mg, with dose reduction allowed if needed, along with a copper dietary supplement daily. Participants avoid alcohol during the treatment phase.

Regular visits during treatment as scheduled by the study

Trial Site Locations

Total: 1 location

1

University Hospital Olomouc

Olomouc, Czechia, 77900

Actively Recruiting

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Research Team

M

Marian Hajduch, MD., PhD.

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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Published Research Related To This Trial

Pharmacological profiling of disulfiram using human tumor cell lines and human tumor cells from patients.

Malin Wickström, Katarina Danielsson, Linda Rickardson...

https://pubmed.ncbi.nlm.nih.gov/17026967

Disulfiram inhibits activating transcription factor/cyclic AMP-responsive element binding protein and human melanoma growth in a metal-dependent manner in vitro, in mice and in a patient with metastatic disease.

Sukhdev S Brar, Claude Grigg, Kimberly S Wilson...

https://pubmed.ncbi.nlm.nih.gov/15367699

High-throughput screen identifies disulfiram as a potential therapeutic for triple-negative breast cancer cells: interaction with IQ motif-containing factors.

Tyler J W Robinson, Melody Pai, Jeff C Liu...

https://pubmed.ncbi.nlm.nih.gov/23974104

Ni(II), Cu(II), and Zn(II) diethyldithiocarbamate complexes show various activities against the proteasome in breast cancer cells.

Boris Cvek, Vesna Milacic, Jan Taraba...

https://pubmed.ncbi.nlm.nih.gov/18816109

Disulfiram, a clinically used anti-alcoholism drug and copper-binding agent, induces apoptotic cell death in breast cancer cultures and xenografts via inhibition of the proteasome activity.

Di Chen, Qiuzhi Cindy Cui, Huanjie Yang...

https://pubmed.ncbi.nlm.nih.gov/17079463