Phase II Trial of Disulfiram With Copper in Metastatic Breast Cancer (NCT03323346) | Clinical Trial Compass
CompletedPhase 2
Phase II Trial of Disulfiram With Copper in Metastatic Breast Cancer
Czechia9 participantsStarted 2017-09-29
Plain-language 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.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Clinical response rate (RR)
Timeframe: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months
2
Clinical benefit rate (CBR)
Timeframe: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months
Trial details
NCT IDNCT03323346
SponsorThe Institute of Molecular and Translational Medicine, Czech Republic
. Participation in another clinical trial of a therapeutic drug during the past 14 days
. Addiction to alcohol or drugs
. Baseline AST or ALT greater than 2.5 X upper institutional limit
. Unable to ingest oral medications
. Unable to undergo CT/SPECT scanning because of inability to lie recumbent in the scanner
. Actively receiving cytotoxic cancer chemotherapy agents
. 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