Early Detection of Triple Negative Breast Cancer Relapse (CUPCAKE)
The CUPCAKE study aims to find out if closely monitoring women who have had triple-negative breast cancer can help detect a recurrence (the cancer coming back) earlier. Triple-negative breast cancer can be aggressive, and finding it early might improve treatment options. This study uses frequent blood tests to look for tiny traces of cancer DNA (ctDNA) in the blood. If these traces are found, the study then uses advanced scans (like PET-CT scans) to try and locate where the cancer might be. The goal is to see if finding the cancer sooner makes a difference for patients, compared to the usual follow-up care.
At a glance
What is this study about?
The CUPCAKE study is a clinical trial focusing on women who have previously been treated for triple-negative breast cancer that hadn't spread to other parts of the body. Unfortunately, triple-negative breast cancer has a higher chance of coming back, and finding it early is very important. This study wants to see if new, very sensitive tests can spot the cancer returning earlier than our usual methods currently allow.
Here’s how it works: after you've finished your initial treatment, you would have regular blood tests, about every four months. These blood tests look for tiny fragments of cancer DNA, called circulating tumour DNA (ctDNA), which can be shed by cancer cells into your bloodstream. If these special blood tests find any ctDNA, it suggests the cancer might be returning at a very early stage.
If ctDNA is detected, you would then be randomly assigned to one of two groups. In one group, you and your doctor would be told about this early finding, and you would have advanced scans (like certain PET-CT scans) to try and find where the cancer is. In the other group, you and your doctor wouldn't be told about the ctDNA detection yet, and your care would continue as usual until the cancer was found by standard methods. The main goal is to compare outcomes in these two groups to understand if finding these early signs makes a meaningful difference.
Key takeaways
- The study explores early detection of breast cancer recurrence using blood tests.
- It's for women treated for triple-negative breast cancer that hasn't spread.
- Regular blood tests look for tiny cancer DNA fragments (ctDNA).
- If ctDNA is found, advanced scans may be used to locate the cancer.
- Treatments are only started after cancer is confirmed by standard methods.
- You can leave the study at any time without affecting your care.
Who may be eligible?
This study is looking for women who are 18 years or older and have had triple-negative breast cancer that was successfully treated with surgery and any necessary follow-up treatments, and has not yet spread. Your original breast cancer must have been classed as 'non-metastatic' (meaning it hadn't spread widely in the body) and was considered to be at a higher risk of coming back.
You would need to have had your breast cancer surgery between 3 to 9 months before joining the study, and any other treatments like chemotherapy must have been completed at least 12 weeks prior. You should be generally well, without any serious uncontrolled health problems that would make taking part difficult.
The research team will also need to check your original tumour tissue samples to ensure they have enough information about your specific cancer. You must also be able to understand and agree to all the study procedures and have health insurance.
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 or older?
- Have you been diagnosed and treated for triple-negative breast cancer that hadn't spread?
- Did you complete your surgery for breast cancer 3 to 9 months ago, and any other treatments like chemotherapy at least 12 weeks ago?
- Are you generally well and fit enough to take part in the study procedures?
- Do you have no signs of your cancer having come back currently?
- Are you able to attend regular appointments for blood tests?
What does participation involve?
If you join the CUPCAKE study, your participation will mainly involve regular blood tests. These blood tests will happen about every four months for up to two years. The purpose of these tests is to look for tiny pieces of cancer DNA in your blood. If these special blood tests do not find any cancer DNA, you and your doctor will not be told the results, and you will continue with your usual follow-up care. Your participation in this part of the study would be considered 'blinded' to the ctDNA results.
However, if the blood tests do find cancer DNA, you would then be randomly placed into one of two groups. In one group, you and your doctor would be informed immediately, and you would be offered advanced scans (like a specific type of PET-CT scan) to help locate where the cancer might be. In the other group, you and your doctor would continue with your regular follow-up without being told about the ctDNA detection until the cancer is found through standard methods. No treatments would start based solely on the blood test; doctors would always need imaging to confirm the cancer's return. The total duration of your involvement could be up to two years.
Potential risks and benefits
Locations (13)
- Sainte-Catherine Institut du Caner Avignon-ProvenceVerified postcodeAvignon, France· Not yet recruiting
- Institut BergoniéVerified postcodeBordeaux, France· Not yet recruiting
- Centre Jean PerrinVerified postcodeClermont-Ferrand, France· Not yet recruiting
- Centre Leon BérardVerified postcodeLyon, France· Not yet recruiting
- Institut Paoli-CalmettesVerified postcodeMarseille, France· Not yet recruiting
- Institut du cancer de MontpellierVerified postcodeMontpellier, France· Not yet recruiting
- CHU NîmesVerified postcodeNîmes, France· Not yet recruiting
- Hôpital Saint-LouisVerified postcodeParis, France· Not yet recruiting
- Hôpital TenonVerified postcodeParis, France· Not yet recruiting
- Centre Eugène MarquisVerified postcodeRennes, France· Not yet recruiting
- Institut CurieVerified postcodeSaint-Cloud, France· Recruiting
- ONCOPOLE Claudius RegaudVerified postcodeToulouse, France· Not yet recruiting
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 'receptors' (ER, PR, and HER2). This means certain common treatments don't work for it, making it harder to treat and more likely to come back.
What are 'ctDNA' blood tests?
'ctDNA' stands for circulating tumour DNA. These are tiny fragments of DNA released by cancer cells into your bloodstream. Detecting them can be an early sign that cancer might be present, even before it causes symptoms or shows up on scans.
Will I receive treatment if ctDNA is found?
No, treatments will not be started based only on a positive ctDNA test. Doctors will still need to confirm a relapse using scans and other tests before starting any anti-cancer treatments.
What are the PET-CT scans used for?
The PET-CT scans (like the 68Ga-FAPI-46-PET-CT) are special imaging tests that can help doctors find areas where cancer cells might be growing anywhere in the body, which isn't always visible on standard scans.
How long will I be in the study?
Your participation in the study, mainly involving the regular blood tests, could last for up to two years.
How to find out more
Anne-Claire COYNE
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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