RecruitingNAINTERVENTIONAL

Standard Surveillance vs. Intensive Surveillance in Early Breast Cancer

This research is looking at two ways to monitor people who have had early breast cancer and are at medium or high risk: standard check-ups or more intensive monitoring. The intensive monitoring involves extra blood tests that look for very small signs of cancer using special markers (like CA27.29) and tiny fragments of cancer cells (like ctDNA). If these blood tests show something unusual, doctors will do more scans to check if the cancer has returned. The main goal is to find out if this more intensive approach helps people live longer and if it can spot any returning cancer earlier than standard care. All participants will have regular blood draws and quality of life assessed.

At a glance

Status

Recruiting

Phase

Sponsor

Prof. Wolfgang Janni

Enrolment target

3,500

Start

07 Dec 2022

Estimated completion

01 Dec 2035

Breast Cancer

What is this study about?

When you've been treated for early breast cancer, especially if your risk is considered medium or high, doctors want to keep a close eye on you to make sure the cancer doesn't come back. This study is designed to explore the best way to do that. Currently, there are standard check-ups that everyone receives, but this study also introduces a more 'intensive' way of watching patients. It's like having a regular MOT for your car versus one that also checks for very tiny, early signs of wear and tear.

Participants in this study will be split into two groups. One group will receive the usual follow-up care that doctors recommend. The other group will get those standard check-ups plus some additional, advanced blood tests. These extra blood tests look for specific markers and very small pieces of cancer material that might be circulating in your blood, even if you feel completely fine. If these advanced tests show anything unusual, it will prompt doctors to do more detailed scans to investigate further. The study aims to see if catching potential issues earlier with these intensive blood tests can ultimately lead to better health outcomes, like living longer, compared to standard follow-up.

It’s important to understand that this is a research study to compare these two approaches. The blood samples from both groups will be collected regularly. For those in the intensive group, the samples will be tested right away. For the standard group, the samples will be stored safely for future research, but won't be tested during the study itself unless the cancer returns. The study plans to involve 3,500 people and will follow them for many years to get a clear picture of which approach works best.

Key takeaways

Compares two ways of monitoring breast cancer patients after treatment.
One group gets standard check-ups, the other gets standard plus advanced blood tests.
Aims to see if earlier detection from blood tests leads to better outcomes.
Involves regular blood tests and doctor visits over 5 years.
Helps researchers understand the best follow-up care for early breast cancer.

Who may be eligible?

This study is for people who have been treated for early breast cancer. You might be able to join if you had cancer that was considered medium to high risk. This generally means your doctor recommended (or you had) chemotherapy, or if your original tumour was large, had spread to your lymph nodes, or was a faster-growing type.

You must have completed your main cancer treatments (like surgery, chemotherapy, or radiotherapy) at least 4 weeks ago, but no longer than 24 months ago. This means you've finished the major part of your initial treatment. You can still be on some ongoing treatments like hormone therapy or other newer medications for your breast cancer.

Finally, you need to be between 18 and 75 years old, and there must be no current signs that your cancer has spread to other parts of your body. Doctors will also need to be able to access some of your original tumour tissue (from a biopsy or surgery) for research purposes.

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.

Have you been treated for early breast cancer (medium to high risk)?
Did you finish your main treatments (surgery, chemo, or radio) between 4 weeks and 24 months ago?
Are you between 18 and 75 years old?
Do you currently show no signs of cancer having spread?
Is some of your original tumour tissue available for research?

Answer every question to see your result.

What does participation involve?

If you choose to join this study, it will run for about 12 years in total, though your active involvement with blood tests and doctor visits will be for 5 years. You'll be randomly assigned to one of two groups. Both groups will have regular check-up appointments with doctors every 3 months for the first 3 years, and then every 6 months for the next 2 years.

At each of these appointments, you'll have blood samples taken. Your quality of life will also be checked. If you're in the 'intensive' group, your blood samples will be tested immediately for special cancer markers. If any of these markers are high, your doctors will arrange for further scans to investigate. If you're in the 'standard' group, your blood samples will be stored safely for future research, but won't be tested during the study itself. If at any point cancer is found to have spread, your participation in the surveillance part of the study will end, and you'll receive treatment as normal.

Potential risks and benefits

Taking part in a study like this means you'll be contributing to important research that could improve care for future breast cancer patients. If you're in the intensive monitoring group, there's a potential benefit that any returning cancer might be detected earlier, which could lead to earlier treatment. However, earlier detection doesn't always lead to better outcomes. There's also a chance that some of the extra blood tests might show something unusual that turns out not to be cancer (a 'false alarm'), which could cause worry and lead to extra scans or appointments. For everyone, the main risk is simply the discomfort of regular blood tests. You are free to stop participating in the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

University Hospital Ulm Gynecology/Obstetrics
Verified postcode
Ulm, Germany· Recruiting

Common questions

What is the main purpose of this study?

It's to compare if intensive monitoring with extra blood tests works better than standard check-ups for people treated for early breast cancer.

What does 'intensive monitoring' involve?

It means having extra blood tests that look for specific cancer markers and tiny pieces of cancer DNA in your blood, in addition to your usual check-ups.

Will I know if my blood tests in the intensive group show something unusual?

Yes, if an intensive blood test shows an abnormal result, your doctor will arrange further scanning tests to follow up.

How long will I need to be in the study?

The active part of your participation, with appointments and blood tests, will be for 5 years. The study will track outcomes for participants for many years afterwards.

Can I choose which monitoring group I'm in?

No, participants are randomly assigned to either the standard or intensive monitoring group, like flipping a coin, to ensure a fair comparison.

How to find out more

Sophia Huesmann, Dr.

sophia.huesmann@uniklinik-ulm.de +4973150058577 Official trial record

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