Testing 68Ga-NOTA-ABSCINT-HER2 Imaging to Predict Treatment Response in Patients with HER2-Positive Early Breast Cancer Receiving Chemotherapy

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What is this study about?

This study involves patients with Breast Cancer that is HER2-positive, which means the cancer cells have high levels of a protein called HER2 on their surface. The treatment being studied is a new imaging agent called 68Ga-ABS011, which is a radioactive tracer that can be detected by special imaging scans. This substance is given as a solution for injection through a vein, which means it is administered directly into the bloodstream. Patients in this study will also receive standard treatment that includes chemotherapy combined with anti-HER2 targeted therapy before surgery, which is called neoadjuvant chemotherapy.

The purpose of this study is to see if the new radioactive tracer can predict whether the cancer will completely disappear after neoadjuvant chemotherapy. The imaging method used is called PET/CT, which stands for positron emission tomography combined with computed tomography, a type of scan that creates detailed pictures of the inside of the body. The study aims to determine if this imaging technique can accurately show when patients have achieved a complete response to treatment, meaning no invasive cancer cells remain in the breast or lymph nodes after chemotherapy.

During the study, patients will receive the radioactive tracer injection and undergo PET/CT scans to see how well the tracer binds to the cancer cells. After completing the neoadjuvant chemotherapy treatment, patients will have surgery as planned by their doctors. The results from the imaging scans will then be compared with the actual findings from the tissue examination after surgery to see if the new imaging method was able to correctly predict whether the cancer had completely responded to the chemotherapy treatment.

1 Signing consent and enrollment

Your participation will begin after signing an informed consent document.

This study involves patients with HER2-positive early breast cancer, which means the cancer cells have high levels of a specific protein called HER2.

Your doctor will have confirmed that your cancer is HER2-positive through laboratory tests before you enter the study.

2 First imaging scan before treatment

You will receive an injection of a radioactive tracer called [68Ga] Ga-NOTA-anti-HER2-sdAb.

This substance will be administered through a vein (intravenous administration) as a solution for injection.

After the injection, you will undergo a PET/CT scan, which is a special imaging procedure that combines two types of scans to create detailed pictures of your body.

This scan will help doctors see how the HER2 protein is distributed in your cancer before treatment starts.

3 Receiving standard treatment

You will receive neoadjuvant chemotherapy, which is chemotherapy given before surgery to shrink the tumor.

Along with chemotherapy, you will receive anti-HER2 targeted therapy, which is a treatment specifically designed to target the HER2 protein on cancer cells.

This treatment phase will follow the standard plan determined by your medical team.

The specific medications, doses, and duration will be determined according to standard treatment protocols for HER2-positive breast cancer.

4 Second imaging scan after treatment

After completing the neoadjuvant chemotherapy and anti-HER2 therapy, you will receive another injection of the radioactive tracer [68Ga] Ga-NOTA-anti-HER2-sdAb.

The injection will again be given through a vein (intravenous administration).

You will undergo another PET/CT scan to see how your cancer has responded to the treatment.

This scan will help doctors predict whether the treatment has eliminated all invasive cancer cells.

5 Surgery

Following the completion of neoadjuvant treatment, you will undergo surgery as planned by your medical team.

During surgery, the tumor and possibly nearby lymph nodes will be removed.

The removed tissue will be examined in a laboratory to determine the exact response to treatment.

6 Analysis of results

After surgery, pathologists will examine the removed tissue under a microscope.

They will determine whether a pathological complete response has been achieved, which means no invasive cancer cells remain in the breast or lymph nodes.

The results from the PET/CT scans will be compared with the pathology results to evaluate how well the imaging predicted the treatment response.

This comparison is the main goal of the study.

Who Can Join the Study?

You must sign a document showing that you agree to take part in the study after being informed about it, which is called informed consent.
You must have a performance status of 0 to 1, which means you are able to carry out normal daily activities without major limitations.
You must be a woman.
You must be over 18 years old.
You must have early breast cancer that has been confirmed by examining tissue under a microscope, which is called histologically proven.
Your breast cancer must be HER2 positive, which means the cancer cells have high levels of a protein called HER2 that makes them grow. This is determined by specific laboratory tests showing either IHC 3+ or IHC 2+ and ISH positive results.
Your medical team at a Breast Tumor Board, which is a group of cancer specialists who discuss treatment plans, must have decided that you need neoadjuvant treatment. This means treatment given before surgery that includes chemotherapy, which are drugs that kill cancer cells, and anti-HER2 targeted therapy, which are drugs that specifically target the HER2 protein on cancer cells.
After this treatment before surgery, you must be scheduled to have surgery to remove the cancer.

Who Cannot Join the Study?

Male patients cannot participate in this study, as it is only open to female patients
Patients who are under 18 years old cannot participate in this study
Patients with breast cancer that is not HER2-positive cannot participate, where HER2 is a protein that can promote the growth of cancer cells
Patients with advanced or late-stage breast cancer cannot participate, as the study focuses on early breast cancer

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Centre Henri Becquerel	Rouen	France

Trial status

Country	Status	Recruitment Start
France	Not yet recruiting	01.01.2026

Trial locations

Investigated drugs:

68Ga-Nota-Abscint-Her2

[68Ga] Ga-NOTA-anti-HER2-sdAb is an imaging agent used during a PET/CT scan. This medication contains a radioactive tracer that is designed to attach to HER2 proteins, which are found in certain breast cancer cells. The scan helps doctors see how much HER2 is present in the tumor and may help predict how well the cancer will respond to treatment. This imaging medication is given before the scan to create detailed pictures that show where HER2-positive cancer cells are located in the body.

Investigated diseases:

HER2 positive breast cancer

Breast Cancer – Breast cancer is a disease where abnormal cells in the breast tissue grow uncontrollably and form a tumor. The cancer typically begins in the milk ducts or milk-producing glands of the breast. As the disease progresses, cancer cells can multiply and spread to nearby breast tissue. In more advanced stages, the cancer may spread to lymph nodes under the arm or near the collarbone. If left unchecked, cancer cells can travel through the bloodstream or lymphatic system to other parts of the body. HER2-positive breast cancer is a specific type where cancer cells have too much of a protein called HER2 on their surface, which makes them grow faster.

Trial ID:

2025-523286-23-00

Trial Phase:

Human Pharmacology (Phase I) – Other

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Testing 68Ga-NOTA-ABSCINT-HER2 Imaging to Predict Treatment Response in Patients with HER2-Positive Early Breast Cancer Receiving Chemotherapy

What is this study about?

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