AuthorisedPhase I and Phase II (Integrated)- OtherInterventional

Evaluation of a [68Ga] Ga-HER2 single domain antibody PET/CT for predicting pathological complete response (pCR) after neoadjuvant chemotherapy (NACT) in HER2-positive early breast cancer

This research is investigating a new way to check how well treatment is working for women with HER2-positive early breast cancer. Doctors use chemotherapy before surgery to shrink the tumour, called neoadjuvant chemotherapy. This study uses a special type of scan called a PET/CT with a low-dose radioactive tracer to see if the cancer has completely gone away before surgery. We want to see if this scan can accurately predict if the chemotherapy has successfully removed all the cancer cells. This could help doctors understand sooner if the treatment is effective and tailor future care. It's for women aged 18 and above.

At a glance

Status

Authorised

Phase

Phase I and Phase II (Integrated)- Other

Sponsor

Centre Henri Becquerel

Enrolment target

Start

26 Jan 2026

Breast Cancer

What is this study about?

When someone has HER2-positive early breast cancer, doctors often give chemotherapy before surgery. This is called 'neoadjuvant chemotherapy' and its aim is to shrink the tumour or even make it disappear completely before the operation. We call it a 'pathological complete response' (pCR) if all the cancer cells are gone after this treatment and before surgery.

Currently, the only way to know for sure if the cancer has completely disappeared is after surgery, by looking at the removed tissue under a microscope. This study is trying to find a new, earlier way to tell if the chemotherapy has worked completely, even before surgery takes place. We're doing this using a special type of scan called a PET/CT scan.

This PET/CT scan uses a tiny amount of a special tracer liquid that helps us see specific features of the cancer. The research aims to see if this scan can accurately predict whether the chemotherapy has made the cancer completely disappear. If it can, this information could help doctors make more informed decisions about future treatment steps for patients.

Key takeaways

This study evaluates a special scan to predict treatment success for HER2-positive breast cancer.
It aims to see if chemotherapy has worked completely before surgery.
The study involves a PET/CT scan with a tracer.
It could help doctors make more informed treatment decisions sooner.
Participants must be women aged 18 or older with HER2-positive early breast cancer.

Who may be eligible?

This study is looking for women who have been diagnosed with HER2-positive early breast cancer. The most important thing is that participants must be 18 years old or older—there's no upper age limit.

Because this study is about how well chemotherapy works before surgery, participants will need to be receiving this type of 'neoadjuvant chemotherapy' as part of their standard care.

More specific details about your health and cancer type will be checked by the study team to make sure this is the right study for you.

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 female?
Are you 18 years old or older?
Have you been diagnosed with HER2-positive early breast cancer?
Are you expected to receive chemotherapy before your surgery (neoadjuvant chemotherapy)?

Answer every question to see your result.

What does participation involve?

The information provided is very brief, so we can't give a full picture of what taking part involves. Generally, clinical trials like this will require a few extra visits to the hospital in addition to your standard cancer care appointments.

During these visits, you would likely have one or more of the special PET/CT scans. This would involve a small, temporary injection of a tracer liquid before the scan. There would also be checks to see how you are feeling and standard blood tests. The study would likely follow you through your chemotherapy treatment and up to your surgery. The total duration of your participation would depend on your treatment plan.

Potential risks and benefits

Taking part in a study like this might offer the benefit of having an advanced scan that could provide more information about your cancer's response to treatment. While the special PET/CT scan uses a low dose of radiation, similar to other medical scans, there's always a very small risk associated with radiation exposure. There might also be a slight risk or discomfort from the injection. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

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

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Unverified
France

Common questions

What is HER2-positive early breast cancer?

This is a type of breast cancer where the cells have too much of a protein called HER2, which helps the cancer grow. 'Early' means it hasn't spread beyond the breast or nearby lymph nodes yet.

What is 'neoadjuvant chemotherapy'?

It's chemotherapy given before surgery to shrink the cancer and make the operation easier, or sometimes to make the cancer disappear completely.

What is a PET/CT scan?

It's a special type of scan that combines two powerful imaging techniques. It helps doctors see how your organs and tissues are working and find areas of concern.

What does 'pathological complete response' mean?

This means that after treatment, when doctors examine the removed tissue, there are no remaining cancer cells found. It's a very positive outcome.

Will I still have my regular cancer treatment if I join this study?

Yes, this study is about adding a new scan to your existing care; it doesn't replace your standard, planned cancer treatments.