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Study on Early Detection of Triple-Negative Breast Cancer Relapse Using 68Ga-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 patients with triple-negative breast cancer (TNBC), a type of breast cancer that lacks three common receptors known to fuel most breast cancer growths. The study aims to detect early signs of cancer returning, known as a relapse, in patients who are at high risk. The treatment being studied involves a special imaging technique using a substance called 68Ga-FAPI-46, which is given through an intravenous infusion. This substance helps to highlight cancer cells during a scan, making it easier to see if the cancer has returned.

The purpose of the study is to evaluate a new way of monitoring patients using a method called ctDNA-based surveillance. This involves checking for tiny pieces of cancer DNA in the blood, which can indicate if the cancer is coming back. The study will compare this new method with standard monitoring techniques to see if it can help detect relapses earlier and improve survival rates. Participants will undergo regular scans and blood tests over a period of time to monitor their condition.

Throughout the study, researchers will collect information on how well the new monitoring method works, including any side effects from the 68Ga-FAPI-46 PET-CT scans. The study will also look at how the new method compares to existing imaging procedures, such as 18F-FDG PET-CT, in terms of detecting cancer spread. The trial is expected to run until 2028, with the goal of improving early detection and treatment strategies for patients with high-risk triple-negative breast cancer.

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, the patient must have signed a written informed consent.

    The patient must be covered by health insurance and meet specific eligibility criteria, including being female and at least 18 years old.

    The patient must have been diagnosed with non-metastatic triple-negative breast cancer (TNBC) and have undergone surgery with curative intent.

  2. Step 2

    Initial assessment

    The patient will undergo an initial assessment to confirm there are no signs of local or distant relapse.

    The assessment includes a review of the patient's performance status, which must be less than 2.

  3. Step 3

    Treatment administration

    The patient will receive an intravenous infusion of 68Ga-FAPI-46.

    This medication is administered through a vein and is part of the study's imaging procedures.

  4. Step 4

    Monitoring and follow-up

    The patient will be monitored for any adverse effects related to the 68Ga-FAPI-46 PET-CT and ctDNA analysis.

    Regular follow-up appointments will be scheduled to assess the patient's condition and response to the treatment.

  5. Step 5

    Completion of study

    The study is expected to continue until June 30, 2028.

    Upon completion, the patient's overall survival rate and other outcomes will be evaluated.

Who can join the trial?

12 criteria

  • Patients must have signed a written informed consent before joining the study. This means they agree to participate after understanding the details of the study.
  • Patients must have health insurance coverage.
  • Patients must be female and at least 18 years old.
  • Patients must have been diagnosed with a type of breast cancer called triple-negative breast cancer (TNBC), which is not spread to other parts of the body. This type of cancer does not have certain receptors, which are proteins that can affect cancer growth. The diagnosis should have been confirmed using specific imaging tests like a PET-CT scan or a bone scan combined with a CT scan of the chest, abdomen, and pelvis.
  • Patients must have had surgery aimed at curing their non-metastatic TNBC. The surgery should have been done between 1 to 18 months before joining the study. Patients should have started any additional treatment, if needed, at least 4 weeks before joining. If they are part of another clinical trial for additional treatment, that treatment must be finished before joining this study.
  • Patients must have a high-risk primary tumor, which means:
    • The cancer did not completely respond to chemotherapy given before surgery, or
    • The cancer is at a certain stage (IIB-III), or
    • The cancer has returned in the same area after being treated before.
    • There should be no signs of the cancer returning locally or spreading to other parts of the body, as assessed by the doctor.
    • Patients must have a performance status of less than 2, which means they are able to carry out daily activities without significant limitations.
    • There must be a sample of the tumor available with more than 10% of the sample made up of cancer cells. This can be either a block of tissue or 11 sections of the tumor.
    • Patients must be able to follow the study's requirements and procedures.

Who cannot join the trial?

4 criteria

  • Patients who do not have triple-negative breast cancer (TNBC) at high risk of relapse cannot participate. TNBC 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 is not specified here, but it is important for eligibility.
  • Only female patients are eligible, so male patients cannot participate.
  • Patients who are considered part of a vulnerable population cannot participate. A vulnerable population includes groups who may have limited ability to protect their interests, such as children or those with certain disabilities.
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Investigated drugs

ctDNA-based surveillance strategy is a method used in this trial to monitor patients for early signs of cancer relapse. This approach involves analyzing circulating tumor DNA (ctDNA) in the blood, which can provide information about the presence of cancer cells in the body. The goal is to detect any recurrence of triple negative breast cancer at an early stage, potentially improving the chances of successful treatment and reducing the risk of early death.

What is already known about the treatment

ctDNA-based Surveillance Strategy – This approach involves a non-invasive method of monitoring patients through blood tests to detect circulating tumor DNA (ctDNA), which can indicate the presence of cancer cells. It is currently being evaluated in clinical trials for its effectiveness in early detection of relapse in patients with triple-negative breast cancer, a type of cancer that lacks three common receptors known to fuel most breast cancer growth. The main therapeutic indication is to monitor high-risk patients for early signs of cancer returning, potentially improving survival rates by allowing for earlier intervention. The mechanism of action involves detecting small fragments of DNA released by cancer cells into the bloodstream, providing a molecular-level insight into the presence and progression of cancer. This strategy is classified under diagnostic and monitoring tools in oncology.

Investigated diseases

Triple-negative breast cancer – This is a type of breast cancer that does not have any of the three common receptors known to fuel most breast cancer growth: estrogen, progesterone, and the HER-2/neu gene. It is considered more aggressive and has fewer treatment options compared to other breast cancer types. The disease often grows and spreads more quickly than other forms of breast cancer. Patients with this condition are at a higher risk of relapse, meaning the cancer can return after treatment. The progression of the disease can vary, but it often involves the cancer spreading to other parts of the body, known as metastasis. Monitoring and managing the disease can be challenging due to its aggressive nature and limited targeted therapies.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2022-501562-22-01Protocol codeIC 2022-02Estimated enrolment450 patientsSponsorInstitut Curie

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