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Study on Early Detection of Triple-Negative Breast Cancer Relapse Using [68Ga]Ga-FAPI-46 for Patients at High Risk

Verified siteInvestigationalNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on the early detection of relapse in patients with triple-negative breast cancer (TNBC), a type of breast cancer that lacks three common receptors known to fuel most breast cancer growth. The study aims to evaluate a new method of monitoring patients who are at high risk of their cancer returning. This method involves using a special imaging technique called 68Ga-FAPI-46 PET-CT and a blood test that looks for tiny pieces of cancer DNA, known as ctDNA, in the bloodstream. The goal is to see if this approach can help detect cancer returning earlier than current methods.

Participants in the study will receive the 68Ga-FAPI-46 through an intravenous infusion, which means it will be delivered directly into a vein. This substance helps highlight areas in the body where cancer might be present during the PET-CT scan. The study will compare the results of this new method with standard imaging techniques to determine its effectiveness. The trial will also monitor the overall survival rate of participants over a period of 24 months after they are randomly assigned to different groups within the study.

The study will track several outcomes, including the number of cancer sites detected at the time of relapse, the time patients remain free from cancer returning, and the overall response to treatment. Additionally, the study will explore the quality of life of participants and any side effects related to the use of 68Ga-FAPI-46 and ctDNA analysis. The trial is expected to continue until early 2028, with the aim of improving the way TNBC relapses are detected and managed in the future.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, you will be required to sign a written informed consent form. This document confirms your understanding and agreement to participate in the trial.

    You must have health insurance coverage and be at least 18 years old. Additionally, you should have been diagnosed with a specific type of breast cancer known as triple-negative breast cancer (TNBC) and have undergone surgery with the intent to cure.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to ensure there are no signs of cancer relapse. This assessment will be performed by a healthcare professional.

    You will need to provide a tumor sample, which will be used for further analysis. This sample should have a certain level of cellularity, meaning it contains enough cells for the study.

  3. Step 3

    Treatment and monitoring

    During the trial, you will receive a medication administered through an intravenous infusion. This means the medication will be delivered directly into your bloodstream through a vein.

    The medication used in this trial is a specialized compound designed to help detect cancer relapse early. The frequency and duration of administration will be determined by the study protocol.

  4. Step 4

    Follow-up assessments

    Regular follow-up assessments will be conducted to monitor your health and the effectiveness of the treatment. These assessments may include imaging tests and blood tests.

    You will be asked to complete quality of life questionnaires at various points during the trial to help evaluate the impact of the treatment on your daily life.

  5. Step 5

    End of trial

    The trial is expected to conclude by January 31, 2028. At the end of the trial, a final assessment will be conducted to evaluate your overall health and the outcomes of the treatment.

    Results from the trial will be analyzed to determine the effectiveness of the treatment in detecting early cancer relapse and improving survival rates.

Who can join the trial?

12 criteria

  • Patients must have signed a written informed consent before joining the study.
  • Patients must be covered by health insurance.
  • Patients must be female and at least 18 years old.
  • Patients must have been diagnosed with a non-metastatic triple-negative breast cancer (TNBC). This means the cancer has not spread to other parts of the body. The cancer must have been evaluated using specific imaging tests like a 18F-FDG PET-CT or a bone scan combined with a CT scan of the chest, abdomen, and pelvis with contrast.
  • Patients must have had surgery intended to cure their non-metastatic TNBC. The surgery must have been done between 1 to 18 months before joining the study. Patients must have started any additional therapy, if needed, at least 4 weeks before joining. If patients are receiving an experimental treatment as part of another clinical trial, that treatment must be completed before joining this study.
  • Patients must have a high-risk primary tumor, which can be defined in several ways:
    • Lack of complete response to chemotherapy given before surgery (known as neoadjuvant chemotherapy), with specific criteria for response levels.
    • If no chemotherapy was given before surgery, the cancer must be at a certain stage (Stage IIB-III).
    • Any local recurrence of cancer after previous treatment of TNBC on the same side.
    • There must be no signs of cancer returning, either locally or in other parts of the body, as assessed by the study doctor.
    • Patients must have a performance status of less than 2, which means they are able to carry out daily activities with little or no assistance.
    • Patients must have an available tumor sample with more than 10% of the sample made up of cancer cells.
    • Patients must be able to follow the study requirements.

Who cannot join the trial?

3 criteria

  • Patients who do not have triple-negative breast cancer (TNBC) at high risk of coming back cannot participate. Triple-negative breast cancer is a type of breast cancer that does not have three common receptors known to fuel most breast cancer growth.
  • Patients who are not within the specified age range cannot participate. The age range includes young adults and adults.
  • Patients who are part of a vulnerable population cannot participate. A vulnerable population includes groups who may have limited ability to protect their interests in a clinical trial.
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Investigated drugs

68Ga-FAPI is a radioactive tracer, not a treatment, that is given as a single small injection into a vein before a PET scan. It consists of a molecule that seeks out a protein found on the supporting cells of tumours, linked to a tiny amount of the radioactive substance gallium-68. After the injection, the tracer travels through the body and collects in places where cancer tissue may be present, and the PET camera then makes these areas light up on the pictures. In this trial the tracer is used to look for early signs that triple-negative breast cancer has come back in women whose blood tests show traces of tumour DNA, so that any relapse can be found and treated as early as possible. The radiation dose from the injection is very small and the tracer leaves the body quickly.

What is already known about the treatment

Medication Name – This medication is administered orally in the form of tablets, making it easy for patients to take at home. It is currently being studied in clinical trials and is not yet widely available in medical practice. The main use of this medication is to help prevent the return of triple-negative breast cancer, especially in patients who are at a high risk of the cancer coming back. It works by targeting specific molecules in cancer cells, which helps to stop the cancer from growing and spreading. This medication is classified as a targeted therapy, which means it specifically attacks cancer cells without affecting normal cells.

Investigated diseases

Triple-negative breast cancer – Triple-negative breast cancer is a type of breast cancer that lacks three common receptors known to fuel most breast cancer growth: estrogen, progesterone, and the HER-2/neu gene. This cancer is more aggressive and tends to grow and spread faster than other types of breast cancer. It is more likely to have spread at the time it is found and is more likely to come back after treatment. The progression of this disease involves the rapid growth of cancer cells, which can invade nearby tissues and spread to other parts of the body. It often presents as a lump or mass in the breast, and due to its aggressive nature, it may quickly advance to involve lymph nodes and distant organs. The absence of targeted receptors makes it challenging to treat with hormone therapies or drugs that target HER-2.
Trial detailsLast updated 22 Oct 2026
Age18+ yearsPhasePhase IITrial ID2022-501562-22-00Protocol codeIC 2022-02Estimated enrolment450 patientsSponsorInstitut Curie

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