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Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

Combination of Talimogene Laherparepvec (modified Herpes Virus) with atezolizumab (monoclonal antibody) in patients with residual breast cancer after conventional chemotherapy during the early stage of the disease.

This early-stage study is exploring a new way to treat breast cancer in women who still have some cancer cells left after their first round of chemotherapy. Researchers are testing a combination of two new treatments: a modified herpes virus and a drug called a monoclonal antibody. The modified virus is designed to specifically target and destroy cancer cells, while the antibody medicine helps your body's immune system fight the cancer. This study is mainly focused on checking if this combination is safe and what effects it might have. It's for adult women, both before and after menopause, with a specific type of breast cancer.

At a glance

Status
Ongoing, recruiting
Phase
Human Pharmacology (Phase I)- Other
Sponsor
Solti Group
Enrolment target
30
Start
26 Apr 2024

What is this study about?

This research study is investigating a new approach for women who have breast cancer remaining after their initial chemotherapy treatment. Sometimes, even after standard chemotherapy, a small amount of cancer called 'residual disease' can still be present. This study aims to find a new way to tackle these remaining cancer cells.

The study combines two different treatments that are designed to work together. One is a modified version of the herpes virus (don't worry, it's changed so it can't cause cold sores or infections in the usual way). This modified virus is designed to specifically infect and destroy cancer cells, while leaving healthy cells alone. The second treatment is a medicine called a monoclonal antibody. Antibodies are natural proteins in your body that help fight off infections. This special antibody medicine is designed to help your body's own immune system find and attack the cancer cells more effectively.

Because this is a very early stage study, the main goal is to see if combining these two treatments is safe for people and what effects they might have. Researchers are carefully monitoring participants to understand how the body reacts to these new medicines working together. It's hoped that this combination could eventually offer a new way to treat breast cancer more effectively.

Key takeaways

  • This is an early-stage study testing a new combination treatment for breast cancer.
  • It's for women who still have breast cancer after initial chemotherapy.
  • The treatment involves a modified virus and a special antibody medicine.
  • The main aim is to check the safety and effects of this new combination.
  • Participation is voluntary, and you can stop at any time.

Who may be eligible?

This study is specifically for women who have been diagnosed with breast cancer. You would need to be 18 years old or older to take part. It doesn't matter if you have gone through menopause or not; both pre- and post-menopausal women can be considered.

A key requirement is that you must have had chemotherapy for your breast cancer before surgery, and after this treatment, some cancer cells must still be present in your breast or lymph nodes. This is sometimes called 'residual disease'. The cancer must also be a type that can be removed by surgery.

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.

  1. Are you a woman aged 18 or over?
  2. Have you been diagnosed with breast cancer?
  3. Did you receive chemotherapy for your breast cancer before surgery?
  4. Do you still have some breast cancer cells remaining after that chemotherapy?
  5. Is your breast cancer a type that can be removed by surgery?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will have regular visits to the hospital or clinic. These visits will involve blood tests, physical examinations, and possibly scans to see how your body is responding to the treatment and to check for any side effects. You will receive the study medications as planned by the research team. The total duration of your participation in the study will be explained in detail by the study doctor, including how often you'll need to visit and for how long. There will be careful follow-up after your treatment to monitor your health.

Potential risks and benefits

Taking part in an early-stage study like this has potential benefits, though they are not guaranteed. You would have access to new treatments that are not yet widely available, and you would be helping researchers learn more about fighting cancer. However, there are also risks. The experimental treatments might not work for you, or they could cause unexpected side effects that range from mild to serious. The study doctors will explain all known potential risks in detail. Remember, your participation is completely voluntary, and you have the right to withdraw from the study at any time without affecting your future medical care.

Locations (1)

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

Common questions

What is a 'modified herpes virus'?

It's a herpes virus that has been changed in the lab so it can specifically target and destroy cancer cells without causing common cold sores or other herpes infections in the way a normal virus would.

What is a 'monoclonal antibody'?

It's a special type of medicine that acts like a natural antibody in your body. It helps your immune system find and fight cancer cells more effectively.

Why is this called an 'early stage' study?

This means it's one of the first times this combination treatment is being tested in people. The main goal at this stage is to check if it's safe and what effects it has, rather than just how well it cures cancer.

Who is funding this research?

The information provided does not specify the funding source. This would be something to ask the research team if you are interested in participating.

Will I know if I'm getting the active treatment?

In this type of study, all participants usually receive the experimental treatments. Your study doctor will explain the exact setup to you.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

Discussion

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