A randomized non-comparative open-label phase 1b/2 study of nadunolimab in combination with gemcitabine plus carboplatin in patients with advanced triple negative breast cancer “TRIFOUR study”
The 'TRIFOUR' study is looking into a new treatment for advanced triple-negative breast cancer. It combines a new drug called nadunolimab (also known as CAN04) with two commonly used chemotherapy drugs, gemcitabine and carboplatin. The first part of the study (Phase 1b) will focus on finding the safest dose of nadunolimab when given with these chemo drugs. The second part (Phase 2) will then check how well this combined treatment works at shrinking tumours. This is an 'open-label' study, meaning everyone involved will know which treatment is being given. Researchers hope to find an effective new option for patients.
At a glance
What is this study about?
This research study, known as the 'TRIFOUR study', is investigating a new way to treat a type of breast cancer called advanced triple-negative breast cancer. This condition can be difficult to treat, so doctors are always looking for new and better options.
The study combines a new investigational drug called nadunolimab (also known as CAN04) with two standard chemotherapy drugs you might have heard of: gemcitabine and carboplatin. The main goal is to see if this new combination is both safe and effective at tackling the cancer. The study is separated into two main parts. The first part will carefully assess the safety of the new drug combination and help find the right dose. The second part will then focus on how well the treatment shrinks tumours.
By taking part, you would be helping doctors learn more about this new treatment. The information gathered from this study could help future patients with triple-negative breast cancer, potentially offering a new treatment choice where options are currently limited. This type of research is vital for improving cancer care.
Key takeaways
- This study is for advanced triple-negative breast cancer.
- It tests a new drug (nadunolimab) with standard chemotherapy.
- The main goals are to check safety and if the treatment shrinks tumours.
- Taking part means regular hospital visits for treatment and checks.
- You can stop participating at any time if you wish.
Who may be eligible?
To join this study, you generally need to be at least 18 years old – there's no upper age limit. Both men and women can take part. You must have advanced triple-negative breast cancer. This means your cancer has spread to other parts of your body and it does not have certain features that other breast cancers might, making it 'triple negative'.
The study team will run several tests to make sure that the treatment is suitable for you and that you meet all the specific health requirements. They will check your general health, your cancer diagnosis, and previous treatments you may have had. It's important to discuss all your medical history with the study doctor.
Not everyone will be able to join, as there are specific health conditions or treatments that might mean this study isn't right for you. The study team will review your medical information carefully to determine if you are a good fit for this particular research alongside other patients.
- Are you 18 years old or older?
- Do you have advanced triple-negative breast cancer?
- Are you willing to have regular hospital visits for treatment and monitoring?
- Are you able to understand and sign a consent form for the study?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to take part, you will receive the study medication, which includes the new drug nadunolimab, along with gemcitabine and carboplatin. You will have regular visits to the hospital or clinic for these treatments and check-ups. These visits will involve blood tests, physical examinations, and scans (like CT or MRI scans) to see how your body is responding to the treatment and whether the cancer is shrinking.
The duration of your participation will depend on how you respond to the treatment and your health. If the treatment is helping and you are tolerating it well, you could continue for a longer period. There will also be a follow-up period after you stop treatment to monitor your health. The study team will explain the full schedule of visits and tests during the informed consent process.
Potential risks and benefits
Locations (1)
- —Spain
Common questions
What is 'triple-negative breast cancer'?
Triple-negative breast cancer is a type of breast cancer that doesn't have the three most common 'markers' or receptors found on breast cancer cells. This often means it won't respond to some targeted therapies that work for other types of breast cancer.
What is 'advanced' breast cancer?
Advanced breast cancer means the cancer has spread from where it started to other parts of the body. It is also sometimes called metastatic breast cancer.
What does 'open-label' mean?
Open-label means that both you and your study doctor will know which treatment you are receiving. There are no 'placebos' or 'dummy' treatments in this study.
Are nadunolimab, gemcitabine, and carboplatin chemotherapy drugs?
Gemcitabine and carboplatin are standard chemotherapy drugs. Nadunolimab is a new investigational drug that works differently from traditional chemotherapy, but it is being tested in combination with chemotherapy.
Will I have to pay to be part of the study?
No, you will not have to pay for the study treatment or the tests directly related to the research. Any travel expenses might be reimbursed; you should ask the study team about this.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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