DETERMINE Trial Treatment Arm 04: Trastuzumab in Combination With Pertuzumab in Adult, Paediatric and Teenage/Young Adult Patients With Cancers With HER2 Amplification or Activating Mutations
The DETERMINE trial is testing two drugs, trastuzumab and pertuzumab, which are already used together for some breast cancers. These drugs specifically target a feature called HER2, which can be found on certain cancer cells. Researchers want to see if this combination can also help people aged 12 and older with other types of cancer that have this same HER2 feature. This could include rarer cancers or common cancers that happen to have this specific 'HER2' change. If successful, this could lead to new treatment options available through the NHS. The study is part of a larger plan to match treatments to cancer types based on their unique cellular characteristics.
At a glance
What is this study about?
This study is called DETERMINE Treatment Arm 04, and its main goal is to find out if two medicines, trastuzumab and pertuzumab, can treat a wider range of cancers. These two drugs are already approved for treating some types of breast cancer in adults, particularly when the cancer cells have a specific feature called 'HER2 amplification' or an 'activating mutation'. This means the drugs are designed to target and block HER2, which can help stop cancer cells from growing.
Now, doctors want to see if these same drugs could help people with other types of cancer that also have this HER2 feature. This includes conditions like blood cancers, bowel cancers, bladder cancers, lung cancers, and even some rarer cancers, as long as they show the HER2 change. The idea is to match the treatment to the specific characteristics of the cancer, rather than just its location in the body.
If this study shows good results, it could mean that trastuzumab and pertuzumab become new treatment options for people with these other HER2-positive cancers. The study team would then work with the NHS and the Cancer Drugs Fund to try and make these treatments regularly available. This trial is part of a bigger programme, also called DETERMINE, which aims to find new uses for anti-cancer drugs by carefully matching them to specific cancer types or changes within cells.
Key takeaways
- This study tests two existing drugs, trastuzumab and pertuzumab, on new cancer types.
- It focuses on cancers with a specific change called 'HER2 amplification' or 'mutation'.
- It's open to people aged 12 and over with various cancer diagnoses.
- The goal is to find new treatment options for rare or specific cancer types.
- Participation involves tests, receiving the drugs, and regular follow-ups.
- You can stop participating at any time.
Who may be eligible?
To be considered for this study, your cancer needs to have a specific change called a 'HER2 amplification' or an 'activating mutation'. This is found through special tests on your cancer cells. The doctors will discuss your test results at a meeting with other experts to decide if this study might be right for you.
You also need to be at least 12 years old. If you're a woman who could become pregnant, you'll need to have a negative pregnancy test and agree to use effective birth control during and for several months after the study to prevent pregnancy. There are also specific criteria from the larger DETERMINE study that you would need to meet.
It's important to remember that if your doctor thinks you might be eligible, they will explain all the details and make sure the study rules are right for your specific situation. They'll also check if trastuzumab and pertuzumab are suitable for you, as these specific rules take priority over the general study rules if there's a difference.
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.
- Is my cancer known to have a HER2 amplification or activating mutation?
- Am I at least 12 years old?
- If I am a woman, am I able to use effective birth control during and after the study?
- Am I willing to have additional biopsies and blood tests for the study?
- Am I able to attend regular appointments for treatment and follow-up?
What does participation involve?
If you decide to take part, the first step is usually a 'screening' phase. This involves having detailed tests, including biopsies and blood samples. These tests help determine if your cancer has the specific HER2 changes needed for the study.
If you're eligible, you will receive the study drugs, trastuzumab and pertuzumab. You'll continue to receive these treatments for as long as they are working for you and not causing too many side effects. During this time, you'll have regular blood tests and check-ups to see how you're responding to the treatment and manage any side effects. After your treatment finishes, you'll be followed up by the study team every three months for two years to monitor your health.
Potential risks and benefits
Locations (27)
- Belfast City HospitalVerified postcodeBelfast, United Kingdom· Recruiting
- University Hospital BirminghamVerified postcodeBirmingham, United Kingdom· Recruiting
- Birmingham Children's HospitalVerified postcodeBirmingham, United Kingdom· Not yet recruiting
- Bristol Royal Hospital for ChildrenVerified postcodeBristol, United Kingdom· Recruiting
- Bristol Haematology and Oncology CentreVerified postcodeBristol, United Kingdom· Recruiting
- Addenbrooke's HospitalVerified postcodeCambridge, United Kingdom· Recruiting
- Velindre Cancer CentreVerified postcodeCardiff, United Kingdom· Recruiting
- Cardiff Children's HospitalVerified postcodeCardiff, United Kingdom· Not yet recruiting
- Western General HospitalVerified postcodeEdinburgh, United Kingdom· Recruiting
- The Beatson HospitalVerified postcodeGlasgow, United Kingdom· Recruiting
- Royal Hospital for Children GlasgowVerified postcodeGlasgow, United Kingdom· Recruiting
- Leicester Royal InfirmaryVerified postcodeLeicester, United Kingdom· Recruiting
Common questions
What is 'HER2'?
HER2 is a protein on the outside of some cancer cells. When there's too much HER2, or it's changed, it can make cancer grow faster. These drugs are designed to block HER2.
Are these drugs new?
Trastuzumab and pertuzumab are already approved and used for some types of breast cancer. This study is exploring if they can help with other types of cancer too.
What kinds of cancer are being studied?
This study is looking at many different cancer types, including blood cancers, bowel cancers, bladder cancers, lung cancers, and others, as long as they have the specific HER2 change.
Will I have to pay for the treatment?
No, if you are accepted into the study, all study-related treatments and tests would be provided as part of the research.
What happens if the treatment doesn't work for me?
If the treatment isn't working or causes too many side effects, you would stop taking the study drugs, and your doctors would discuss other treatment options with you.
How to find out more
Aida Sarmiento Castro
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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