metastatic breast cancer
Conditions
Brief summary
effect of treatment with disulfiram and copper on clinical response rate (RR, percentage of patients whose cancer shrinks; termed a partial response, PR; or disappears after treatment; termed a complete response, CR; RR=PR+CR), effect of treatment with disulfiram and copper on clinical benefit rate (CBR=CR+PR+SD, where SD is defined as a stable disease - neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD for minimum 6-8 weeks)
Detailed description
Time to progression (TTP), Overall survival (OS), Pharmacokinetic - Total exposure (AUC0-τ), Pharmacokinetic - Maximum plasma concentrations (Cmax), Pharmacokinetic - Minimum plasma concentration (Cmin), Safety outcome measures - Nature, frequency, and severity of adverse events as graded using Common Terminology Criteria for Adverse Events (CTCAE), v5.0
Interventions
DRUGDISULFIRAM
Sponsors
Univerzita Palackeho V Olomouci
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| effect of treatment with disulfiram and copper on clinical response rate (RR, percentage of patients whose cancer shrinks; termed a partial response, PR; or disappears after treatment; termed a complete response, CR; RR=PR+CR), effect of treatment with disulfiram and copper on clinical benefit rate (CBR=CR+PR+SD, where SD is defined as a stable disease - neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD for minimum 6-8 weeks) | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to progression (TTP), Overall survival (OS), Pharmacokinetic - Total exposure (AUC0-τ), Pharmacokinetic - Maximum plasma concentrations (Cmax), Pharmacokinetic - Minimum plasma concentration (Cmin), Safety outcome measures - Nature, frequency, and severity of adverse events as graded using Common Terminology Criteria for Adverse Events (CTCAE), v5.0 | — |
Countries
Czechia
Outcome results
None listed