Using disulfiram with copper to treat metastatic breast cancer
Phase II Open Labeled Trial of Disulfiram With Copper in Metastatic Breast Cancer
This study is testing if a combination of disulfiram and copper can help people with advanced breast cancer who haven't had success with other treatments.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | The Institute of Molecular and Translational Medicine, Czech Republic Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Olomouc) |
| Trial ID | NCT03323346 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the efficacy of disulfiram combined with copper supplements in patients with metastatic breast cancer who have not responded to conventional therapies. The study will assess clinical response rates, time to progression, and overall survival among participants. Additionally, it will analyze the pharmacokinetics of disulfiram and its metabolites, as well as the safety profile of this treatment combination. The trial includes patients with confirmed stage IV breast cancer and specific eligibility criteria to ensure appropriate candidate selection.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 and older with stage IV metastatic breast cancer who have failed or refused standard therapies.
Not a fit: Patients with active alcohol or drug addiction, or those currently receiving cytotoxic chemotherapy, may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with metastatic breast cancer who have exhausted standard treatment options.
How similar studies have performed: While the combination of disulfiram and copper is a novel approach, previous studies have explored disulfiram's potential in cancer treatment, indicating some promise but limited established success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. 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.) 2. Histologically or cytologically confirmed tumor 3. Age of 18 years or more 4. ECOG performance status of 0 - 2 5. Patients have failed, untolerated or refused standard therapeutic modalities 6. Not received systemic anticancer therapy or radiation or had major surgery in last 2 weeks 7. Not currently participating in another study 8. Anticipated survival of at least 2 months 9. Baseline AST and ALT not greater than 2.5 X upper institutional limit 10. Serum copper within normal limits 11. Serum ceruloplasmin \> 17 mg/dL 12. Able and willing to sign informed consent and to comply with study procedures 13. Able to ingest oral medications 14. No known allergy to disulfiram or copper 15. Willing to refrain from ingestion of alcoholic beverages while on the study Exclusion Criteria: 1. Participation in another clinical trial of a therapeutic drug during the past 14 days 2. Addiction to alcohol or drugs 3. Baseline AST or ALT greater than 2.5 X upper institutional limit 4. Unable to ingest oral medications 5. Unable to undergo CT/SPECT scanning because of inability to lie recumbent in the scanner 6. Actively receiving cytotoxic cancer chemotherapy agents 7. Anticipated survival of less than 2 months 8. 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 9. 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 10. History of Wilson's disease or family member with Wilson's disease 11. History of hemochromatosis or family member with hemochromatosis 12. History of other iron overload syndrome such as hemochromatosis 13. Need for metronidazole, warfarin and/or theophylline medication, the metabolism of which is likely influenced by disulfiram 14. Pregnant women and nursing mothers are not allowed to enroll on this study 15. Patients who are taking medications metabolized by cytochrome P450 2E1, including chlorzoxazone or halothane and its derivatives
Where this trial is running
Olomouc
- University Hospital Olomouc — Olomouc, Czechia (Recruiting)
Study contacts
- Study coordinator: Marian Hajduch, MD., PhD.
- Email: marian.hajduch@upol.cz
- Phone: +420 585632111
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.