Study of Disulfiram and Copper for Patients with Metastatic Breast Cancer

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What is this study about?

This clinical trial is focused on studying the effects of a treatment for metastatic breast cancer, which is a type of breast cancer that has spread to other parts of the body. The treatment being tested involves the use of a medication called disulfiram, which is typically used as a drug for addiction therapy, combined with copper. The purpose of the study is to evaluate how effective this treatment is in managing the disease.

Participants in the study will receive the treatment and be monitored to see how their cancer responds. The study will look at the percentage of patients whose cancer shrinks or disappears after treatment, as well as those whose disease remains stable. The trial will also assess how long it takes for the cancer to progress and the overall survival of the participants. Additionally, the study will monitor the levels of disulfiram in the blood to understand how the body processes the drug and will keep track of any side effects experienced by the participants.

The trial is designed to provide valuable information about the potential benefits and safety of using disulfiram with copper for treating metastatic breast cancer. Participants will take the medication orally, and the study will continue for a period of time to gather comprehensive data on the treatment’s impact. The findings from this trial could contribute to developing new treatment options for individuals with this type of cancer.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria such as having stage IV breast cancer with metastases, appropriate serum copper levels, and the ability to ingest oral medications.

Participants must be willing to refrain from consuming alcoholic beverages during the study and must not have any known allergies to disulfiram or copper.

2 treatment initiation

The treatment involves the administration of disulfiram in combination with copper. The medication is taken orally.

The dosage and frequency of administration are determined by the study protocol and are tailored to each participant’s condition.

3 monitoring and assessment

Participants undergo regular monitoring to assess the clinical response rate (RR) and clinical benefit rate (CBR).

The primary focus is on the effect of the treatment on the cancer’s response, including any shrinkage or disappearance of the tumor.

4 safety evaluations

Safety is evaluated by monitoring the nature, frequency, and severity of any adverse events using established criteria.

Participants are observed for any side effects or reactions to the treatment.

5 progression and survival analysis

The study also measures the time to progression (TTP) and overall survival (OS) to understand the long-term effects of the treatment.

Pharmacokinetic analyses are conducted to determine the total exposure and plasma concentrations of the medication.

6 completion of the study

The study is estimated to conclude by December 31, 2030, with ongoing assessments and data collection throughout the trial period.

Participants will be informed of the study’s findings and any implications for their treatment.

Who Can Join the Study?

Patients must have stage IV breast cancer with cancer spread to other parts of the body, confirmed by imaging tests like CT, PET, MRI, or ultrasound.
Blood copper levels must be less than 40 micromoles per liter.
Blood ceruloplasmin levels must be more than 17 milligrams per deciliter but not more than 2.5 times the upper limit set by the institution.
Patients must be able and willing to sign a consent form and follow the study procedures.
Patients must be able to take medications by mouth.
Patients must not have any known allergy to disulfiram or copper.
Patients must agree not to drink alcoholic beverages during the study.
The presence of a tumor must be confirmed by examining tissue or cells under a microscope.
Patients must be 18 years old or older.
Patients must have an ECOG performance status of 0 to 2, which is a scale used to assess how a patient’s disease is affecting their daily living abilities.
Patients must have tried, not tolerated, or refused standard treatments, or have no other treatment options available.
Patients must not have received any cancer treatment, radiation, or had major surgery in the last 2 weeks.
Patients must not be currently participating in another study.
Patients must be expected to live for at least 2 more months.
AST and ALT levels, which are liver enzymes, must not be more than 2.5 times the upper limit for patients without liver cancer spread, or not more than 5 times the limit for those with liver cancer spread.

Who Cannot Join the Study?

Where you can join this trial?

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Other Sites

Site Name	City	Country
Masarykuv Onkologicky Ustav	Brno-Stred	Czechia
Fakultni Nemocnice Hradec Kralove	Novy Hradec Kralove	Czechia
Fakultni Nemocnice Kralovske Vinohrady	Prague	Czechia
University Hospital Olomouc	Olomouc	Czechia
University Hospital Ostrava	Ostrava	Czechia

Trial status

Country	Status	Recruitment Start
Czechia	Not recruiting	29.01.2019

Trial locations

Investigated drugs:

Disulfiram

Disulfiram is a medication traditionally used to support the treatment of chronic alcoholism by producing an acute sensitivity to ethanol. In this clinical trial, it is being investigated for its potential effectiveness in treating metastatic breast cancer. Researchers are exploring whether it can help slow down or stop the growth of cancer cells.

Copper is a mineral that is being used in combination with Disulfiram in this trial. The combination is being studied to see if it enhances the effectiveness of Disulfiram in treating metastatic breast cancer. Copper may play a role in the mechanism by which Disulfiram affects cancer cells.

Metastatic Breast Cancer – This is a type of breast cancer that has spread beyond the breast to other parts of the body, such as the bones, liver, lungs, or brain. It is considered an advanced stage of breast cancer, often referred to as stage IV. The disease progresses as cancer cells travel through the bloodstream or lymphatic system to form new tumors in other organs. Symptoms can vary depending on where the cancer has spread, but may include bone pain, difficulty breathing, or neurological symptoms. The progression of the disease can be slow or rapid, and it often requires ongoing management to control symptoms and maintain quality of life.

Trial ID:

2024-514665-19-00

Protocol code:

2016-1-DSF-MBC

NCT ID:

NCT03323346

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of Disulfiram and Copper for Patients with Metastatic Breast Cancer

What is this study about?

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