Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

Phase II Open Labeled Trial of Disulfiram with Copper in Metastatic Breast Cancer

This research is investigating a new approach to treating metastatic breast cancer, which is breast cancer that has spread to other parts of the body. The study uses a combination of two medications, disulfiram and copper, to see if they can effectively fight the cancer. Researchers are particularly interested in whether this treatment can make the cancer smaller or stop it from growing. We will also be looking at how long people live and their overall safety while taking these medicines. This is an early stage study, aiming to understand the potential benefits and any side effects of this treatment for patients aged 18 and over, regardless of gender.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Univerzita Palackeho V Olomouci

Enrolment target

150

Start

12 Sep 2024

metastatic breast cancer

What is this study about?

This study is a Phase II clinical trial, which means it's an important step in testing a new treatment for advanced breast cancer. Advanced, or 'metastatic,' breast cancer is when the cancer has spread from the breast to other areas of the body. The treatment being investigated combines two drugs that are already approved for other conditions: disulfiram, which is typically used to help people stop drinking alcohol, and copper, a mineral found in the body.

The main goal of this research is to see if giving disulfiram and copper together can shrink breast cancer or stop it from growing. Doctors will be carefully measuring the cancer to see if it responds to the treatment. They also want to understand if this treatment helps people live longer and if it is safe to use. This kind of study helps us learn more about potential new ways to treat cancer and improve patients' lives.

By combining existing drugs, researchers hope to find a new way to target cancer cells. This study is crucial for gathering more information about how this specific combination works in people with metastatic breast cancer, how much of the drugs stay in the body, and what side effects might appear.

Key takeaways

This study is testing a new treatment for advanced breast cancer.
It uses a combination of disulfiram and copper.
The main goals are to see if it shrinks cancer and if it's safe.
It's open to adults aged 18 and over, regardless of gender.
Participation involves taking medication and regular health check-ups.
You can stop participating at any time if you wish.

Who may be eligible?

This study is looking for volunteers who have been diagnosed with metastatic breast cancer. This means your breast cancer has spread to other parts of your body. Both men and women are welcome to take part in this research.

To be eligible, you need to be at least 18 years old. There's no upper age limit, so adults of any age, as long as they meet the other study requirements, can be considered for participation.

The full list of things that might make you suitable or unsuitable for the study is quite detailed. If you're interested, the study team will go through all the criteria with you to make sure it's safe and appropriate for you to take part.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

I am at least 18 years old.
I have been diagnosed with breast cancer that has spread to other parts of my body (metastatic breast cancer).
I am able to attend regular clinic visits.
I am able to or willing to take the study medication as directed.

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will receive the study medication, which is a combination of disulfiram and copper. You will have regular visits to the clinic so the doctors can monitor your health, check how your cancer is responding to the treatment, and manage any side effects you might experience. These visits will likely include physical examinations, blood tests, and scans to track the cancer’s size. You will be closely monitored for any health changes or side effects, and you'll have the opportunity to discuss these with the study team. The overall duration of your participation will depend on how you respond to the treatment, but you can choose to leave the study at any time.

Potential risks and benefits

Taking part in a clinical trial can have potential benefits, such as access to a new treatment before it's widely available, and you'll be closely monitored by a medical team. However, there are also potential risks; the treatment might not work for you, or you could experience side effects. These side effects will be carefully monitored and managed by the study team. It's really important to remember that you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Czechia

Common questions

What is metastatic breast cancer?

Metastatic breast cancer is breast cancer that has spread from the original breast area to other parts of the body, like the bones, lungs, or liver.

What are disulfiram and copper?

Disulfiram is a medicine normally used to help people with alcohol dependence. Copper is a natural mineral that is important for many body functions, but in this study, it's being tested alongside disulfiram for its potential cancer-fighting effects.

What does 'Phase II' mean?

Phase II means this is an early stage of testing where researchers are looking closely at whether the treatment works, how safe it is, and what side effects it might have in a larger group of people than in Phase I studies.

Will I know if the treatment is working?

The study team will regularly perform tests, like scans, to see how your cancer is responding. They will discuss these results with you and let you know if your cancer is shrinking, staying the same, or growing.

Can I stop participating if I want to?

Yes, absolutely. You have the right to leave the study at any point, for any reason, without needing an explanation. This will not affect the medical care you receive afterwards.