RecruitingNAINTERVENTIONAL

Safe De-escalation of Chemotherapy for Stage 1 Breast Cancer

This study investigates a new blood test for people with certain types of early-stage breast cancer (HER2 positive or triple-negative). Some patients currently receive strong chemotherapy after surgery, even though many are cured by surgery alone. This research uses a test called circulating tumour DNA (ctDNA) to check if any tiny cancer cells remain in the body after surgery. If no ctDNA is found, it might mean patients can have less intense chemotherapy, or perhaps avoid it altogether. The goal is to make treatment kinder and more tailored, helping doctors decide who truly needs full chemotherapy and who can safely receive a gentler approach. This could lead to a better quality of life for patients after breast cancer treatment.

At a glance

Status

Recruiting

Phase

Sponsor

Royal Marsden NHS Foundation Trust

Enrolment target

400

Start

05 Jun 2023

Estimated completion

05 Dec 2028

Breast Cancer

What is this study about?

When someone is diagnosed with early-stage breast cancer, particularly HER2 positive or triple-negative types, doctors often recommend chemotherapy after surgery. While this treatment is very effective for many, some patients might receive more intense chemotherapy than they actually need to be cured. The problem is knowing who these patients are. This study is exploring a clever new blood test that could help make this decision much clearer.

This blood test looks for something called 'circulating tumour DNA' (ctDNA). Imagine that as cancer cells grow and die, they release tiny bits of their unique DNA into your bloodstream. This test is designed to find those specific bits of cancer DNA. If we can't find any ctDNA in a patient's blood after surgery, it suggests they might not have any remaining cancer cells in their body. On the other hand, if ctDNA is found, it means there might still be some cancer present, even if it's too small to see with other scans.

The main idea behind this research is to use the ctDNA test results to guide treatment. For patients who test negative for ctDNA, it might be possible to reduce the amount or strength of chemotherapy they receive. This could mean fewer side effects and a much better recovery experience. For those who test positive, it helps doctors understand that more treatment might be needed. Ultimately, this study aims to make breast cancer treatment more personal and less harsh when possible, improving the long-term well-being of patients.

Key takeaways

A blood test (ctDNA) is being studied to guide breast cancer treatment.
Aims to reduce strong chemotherapy for early-stage HER2 positive or triple-negative breast cancer.
Could mean fewer side effects and better recovery for some patients.
Participation involves blood samples taken around the time of surgery.
The study follows participants for five years to track results.
Could lead to more tailored and kinder cancer treatments in the future.

Who may be eligible?

This study is looking for people aged 18 or over who have been diagnosed with a specific type of early-stage breast cancer. This includes breast cancers that are either 'HER2 positive' or 'triple-negative.' Your doctor will confirm which type you have based on your tests.

Your cancer must be considered 'Stage 1,' which means it's still quite small and hasn't spread widely. This typically applies to tumours between 6mm and 20mm in size, and usually without spread to many lymph nodes. You can join the study either before or shortly after your breast cancer surgery.

However, you can't join if your cancer has already spread to distant parts of your body. You also can't join if you have multiple cancer sites in the breast, or if you've had another cancer diagnosis in the last five years (unless it was a very common and safely removed skin cancer or a specific type of cervical change). You also shouldn't have had any chemotherapy for your current breast cancer before joining this study.

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 18 years old or older?
Do you have early-stage breast cancer that is either HER2 positive or triple-negative?
Is your tumour between 6mm and 20mm, and usually without spread to many lymph nodes?
Have you NOT had any chemotherapy for your current breast cancer yet?
Do you NOT have cancer that has spread to distant parts of your body?
Are you able to provide blood samples and attend follow-up appointments for five years?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll need to provide blood samples. These will be taken either before and after your surgery, or if you join after surgery, you'll just have blood taken after your operation. During your regular follow-up appointment after surgery, the results from your blood tests will be shared with your doctors. These results will help them decide the best way forward for your chemotherapy treatment, aiming to make it as effective but gentle as possible.

You'll be followed by the study team for five years. This involves keeping in touch and attending any necessary follow-up appointments as advised by your medical team so they can monitor your health and the outcomes of your treatment. There are no extra medications given as part of this study.

Potential risks and benefits

A potential benefit of taking part is that the ctDNA test might help your doctors tailor your chemotherapy specifically for you, possibly leading to less intense treatment if your risk is low. This could mean fewer side effects and a better quality of life post-treatment. The main risk involved is having blood samples taken, which might cause some minor discomfort or bruising. There's also the chance that the ctDNA test might not provide a clear answer for your treatment. Remember, joining any study is completely voluntary, and you are free to withdraw at any time without affecting your medical care.

Locations (2)

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

The Royal Marsden NHS Foundation Trust, Chelsea
Verified postcode
London, United Kingdom· Recruiting
The Royal Marsden NHS Foundation Trust, Sutton
Verified postcode
Sutton, United Kingdom· Recruiting

Common questions

What is 'ctDNA'?

ctDNA stands for 'circulating tumour DNA.' It's tiny bits of cancer cells' DNA that can be found in your blood. This test helps doctors check if any cancer cells might still be in your body.

What kind of breast cancer is this study for?

This study is for people with early-stage breast cancer that is either 'HER2 positive' or 'triple-negative.' Your doctor will know if your cancer fits this criteria.

Will I have to have more tests if I join?

You will need to give blood samples for the ctDNA test. These happen around the time of your surgery (either before and after, or just after surgery).

Could this study change my treatment?

Yes, potentially. The results of the ctDNA test could help your doctors decide if you can have a gentler chemotherapy plan, or if a more standard approach is still needed.

How long will I be involved in the study?

You will be followed by the study team for five years to see how you are doing, usually through your regular hospital appointments.

How to find out more

Project Manager

safe-de@rmh.nhs.uk 020 7808 2887 Official trial record

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