Not yet recruitingPHASE2INTERVENTIONAL

Evaluation of [68Ga]Ga-NOTA-anti-HER2-sdAb PET/CT for Predicting Pathological Complete Response After Neoadjuvant Chemotherapy in HER2 Positive Early Breast Cancer

This study, called GATHER, is investigating a new type of scan for early breast cancer. The scan, a PET/CT, uses a special marker ([68Ga]Ga-NOTA-anti-HER2-sdAb) that sticks to HER2-positive cancer cells, making them show up brightly. Doctors want to see if this scan can accurately predict how well chemotherapy and other treatments will work before surgery. The main goal is to find out if this prediction is reliable enough to help doctors decide if some patients might be able to avoid surgery in the future, or at least have a less intensive operation. This could lead to more personalised treatment plans, reducing the side effects and impact of breast cancer treatment for many.

At a glance

Status

Not yet recruiting

Phase

PHASE2

Sponsor

Centre Henri Becquerel

Enrolment target

Start

01 Sep 2026

Estimated completion

01 Mar 2028

Breast Cancer

What is this study about?

When someone has early HER2-positive breast cancer, they often receive chemotherapy and other treatments before surgery. Doctors call this ‘neoadjuvant chemotherapy’. For many patients, these treatments work so well that all the cancer cells in the breast and lymph nodes are destroyed before surgery. Doctors call this a ‘pathological complete response’ (pCR), and it's a very good sign for a patient's health long-term.

Currently, it's hard to know for sure if the treatment has worked completely without surgery. This means almost everyone has surgery, even if their cancer might have fully disappeared. Surgery can have a big impact on how someone looks, how their arm and shoulder move, and their emotional well-being. So, scientists are looking for a better way to tell if the cancer has gone without needing an operation.

This study is testing a new kind of scan that uses a special substance, or ‘tracer’, which attaches specifically to HER2-positive cancer cells. When it attaches, it lights up on a PET/CT scan. The hope is that if the scan shows no cancer cells lighting up after chemotherapy, it means the treatment has been fully successful. If this scan works well, it could mean that in the future, some patients might not need surgery at all, or could have a much smaller operation, making their recovery easier.

Key takeaways

This study uses a new type of scan to predict how well breast cancer treatment works.
It aims to help doctors personalise treatment for HER2-positive breast cancer.
The goal is to see if surgery can be avoided or reduced for some patients.
The study involves special PET/CT scans before and after chemotherapy.
It's for women with early HER2-positive breast cancer planning neoadjuvant chemotherapy.
Participation will not change your planned cancer treatment.

Who may be eligible?

This study is looking for women aged 18 or older who have been diagnosed with early HER2-positive breast cancer. This type of breast cancer is specifically identified by certain tests on the cancer cells. You must be planning to have chemotherapy combined with anti-HER2 treatments before any surgery, and this plan must have been decided by a team of cancer doctors.

You should generally be in good health and able to carry out your daily activities without much difficulty, as measured by a health score called ECOG status (0 or 1). You also need to be part of a social protection scheme, like the NHS in the UK, and be able to understand the study information and give your written permission to take part.

There are also some reasons why you might not be able to join. For example, if you are pregnant or breastfeeding, or if you have had breast cancer on the same side before that was treated with surgery or radiotherapy. Also, if you have a specific type of breast cancer called lobular histology, or if you are already taking part in another study involving special scans, you wouldn't be eligible. Some allergies to the scanning substances would also prevent participation, as would specific legal or cognitive reasons that might make it hard to understand the 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 a woman aged 18 or over?
Do you have HER2-positive early breast cancer?
Are you going to have chemotherapy and anti-HER2 treatment before surgery?
Are you generally in good health and able to go about your daily life?
Are you NOT pregnant or breastfeeding?
Are you NOT taking part in another study using special scans?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would undergo a special type of scan called a PET/CT. This scan uses a small amount of a special tracer ([68Ga]Ga-NOTA-anti-HER2-sdAb) that helps doctors see your cancer more clearly. You would receive this scan once before starting your main cancer treatment (chemotherapy and anti-HER2 therapy) and then again after your treatment is finished, but before any surgery. These scans are in addition to your standard medical care and would be scheduled at specific times during your treatment journey. The study itself doesn't involve new medications for your cancer; it's focused solely on the diagnostic scans. The total duration of your participation would cover the period from your first scan until after your chemotherapy and surgery, allowing researchers to compare the scan results with the actual outcome of your treatment.

Potential risks and benefits

Taking part in this study might not directly benefit you, as it's primarily designed to help doctors learn more for future patients. However, the information gathered from your scans could potentially help doctors understand your specific response to treatment better. There are some minor risks associated with the PET/CT scans, mainly from the small amount of radiation involved, similar to that of routine medical imaging. You might also experience mild discomfort from the injection of the tracer. It's important to remember that you can choose to leave the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Centre Henri Becquerel
Verified postcode
Rouen, France

Common questions

What is HER2-positive breast cancer?

HER2-positive breast cancer is a type of breast cancer where the cancer cells have too much of a protein called HER2, which helps them grow. Specific treatments target this protein.

What is a PET/CT scan?

A PET/CT scan is a type of imaging test that combines two scans. It helps doctors see how well your body's cells are working and where cancer might be.

What does 'neoadjuvant chemotherapy' mean?

This is chemotherapy given before surgery to shrink a tumour and make surgery more effective, or even avoid it in some cases.

Will taking part in this study change my cancer treatment?

No, this study is about evaluating a new type of scan, not about changing your planned cancer treatment. You will still receive your standard chemotherapy and other treatments.

What is 'pathological complete response' (pCR)?

This means that after treatment, no cancer cells are found in the breast or lymph nodes when examined under a microscope, which is a very good sign.

How to find out more

Florian Clatot, MD, PhD

florian.clatot@chb.uncancer.fr +33232082981 Official trial record

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