Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A study of the safety, tolerability, biological effect, and efficacy of allogenic natural killer cells in combination with trastuzumab and pertuzumab in adult patients with refractory metastatic Her2 positive breast cancer

This research study is investigating a new approach for women with advanced HER2-positive breast cancer that is no longer responding to current treatments. It combines a new type of cell therapy, using special immune cells called natural killer cells, with two well-known breast cancer drugs, trastuzumab and pertuzumab. The main goals of the study are to see how safe this combination treatment is, how well people can tolerate it, and if it has a positive effect on the cancer. It's an early-stage study, meaning researchers are cautiously exploring this new combination to understand its potential and safety for patients facing difficult-to-treat cancer.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Vall D Hebron Institute Of Oncology

Enrolment target

Start

21 Oct 2024

Refractory metastatic Her2 positive breast cancer

What is this study about?

This study is exploring a new way to fight a specific type of advanced breast cancer. This particular type is called 'HER2-positive' and has spread to other parts of the body (metastatic). Crucially, it's also 'refractory,' which means it hasn't responded to, or has stopped responding to, standard treatments. This can be a very challenging situation for patients, and doctors are always looking for new options.

The researchers are combining three different treatments. Two of these, trastuzumab and pertuzumab, are already approved medicines that target the HER2 protein on cancer cells. The new part of the treatment involves 'natural killer cells.' These are special cells from our immune system that can recognise and kill cancer cells. The idea is that by combining these natural killer cells with the existing medicines, they might work better together to fight the cancer more effectively.

This is an early-stage study, often called a Phase I study. In this phase, the main focus is on safety and understanding how the new treatment affects the body. Researchers want to find the right dose and make sure the treatment is something patients can tolerate well. If this study shows promise and is safe, it could lead to further research and potentially a new treatment option for women with this difficult-to-treat breast cancer.

Key takeaways

This study evaluates a new treatment for advanced HER2-positive breast cancer that has stopped responding to other therapies.
It combines existing drugs (trastuzumab and pertuzumab) with new immune cell therapy (natural killer cells).
The main goals are to check the treatment's safety and how well patients tolerate it.
It's an early-stage study, meaning researchers are carefully exploring this new approach.
Only women aged 18 or over with specific breast cancer types are eligible.
Participation involves regular hospital visits, treatments, and various medical tests.

Who may be eligible?

This study is specifically for women who are 18 years old or older. You would need to have a type of breast cancer that is HER2-positive and has spread to other parts of your body.

Importantly, your cancer must also be 'refractory', meaning it has not responded to or has stopped responding to other treatments you've received. This study is designed for patients where standard treatments are no longer working.

There will be other detailed medical criteria that your doctor will check to see if you are a good fit for this study. These might include things like your overall health, other medical conditions you have, and previous treatments you've had. Only your medical team can determine if this study is right for you.

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.

Are you a woman aged 18 years or older?
Do you have HER2-positive breast cancer?
Has your breast cancer spread to other parts of your body (metastatic)?
Has your breast cancer stopped responding to, or come back after, previous treatments?
Are you generally well enough to participate in a clinical study?
Are you able to travel to the study location for regular appointments?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will receive the new combination treatment, which includes natural killer cells, trastuzumab, and pertuzumab. The specific details of how often you'll receive these treatments and for how long will depend on the study plan, but you will have regularly scheduled hospital visits for your treatments and check-ups.

During your participation, you would have various tests and assessments. These might include blood tests, scans (like CT scans or MRI scans) to see how the cancer is responding, and physical examinations. These tests help the doctors monitor your health and how the treatment is affecting you. The total duration of your participation could vary, but clinical trials usually involve a period of treatment followed by a follow-up period to monitor your long-term health and the effects of the treatment.

Potential risks and benefits

Taking part in any clinical study comes with potential benefits and risks. A potential benefit of this study is that the new combination treatment might help to control your cancer when other treatments haven't worked. However, it's important to remember that this is an early-stage study, so it's not guaranteed to be effective, and there might be unknown side effects. Potential risks include side effects from the natural killer cell therapy or the combined medicines, which your care team will explain thoroughly. You have the right to withdraw from the study at any time, for any reason, without it affecting your 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
Spain

Common questions

What does 'HER2-positive' mean?

HER2-positive breast cancer means the cancer cells have too much of a protein called HER2, which helps them grow quickly.

What does 'refractory metastatic' mean?

'Refractory' means your cancer is no longer responding to standard treatments, and 'metastatic' means it has spread from the breast to other parts of your body.

What are 'natural killer cells'?

Natural killer cells are a type of immune cell in your body that can find and destroy unhealthy cells, including cancer cells.

Is this a new type of treatment?

Yes, while two of the medicines (trastuzumab and pertuzumab) are known, combining them with natural killer cell therapy in this way is a new approach being studied.

Will I get a placebo (dummy treatment)?

No, in this study, all participants will receive the active combination treatment, as it's an early-stage trial focusing on the new therapy's safety and effects.