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Study on Edotreotide for Detecting Somatostatin Receptors in Patients with Metastatic Breast Cancer

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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 studying Breast Cancer, specifically in patients with metastatic breast cancer. The study will use a special imaging technique called DOTATOC-68Ga PET scans to evaluate the presence of certain receptors known as somatostatin receptors in the cancer cells. The treatment involves a radiopharmaceutical preparation called SomaKit TOC, which contains the active substance edotreotide. This substance is used to help visualize the cancer cells during the PET scan.

The purpose of the study is to assess how well these somatostatin receptors are expressed in the cancer cells of patients with metastatic breast cancer. During the study, patients will undergo a PET scan using the SomaKit TOC to detect these receptors. The study will compare the results of this scan with previous scans to understand the extent and intensity of the cancer spread. This will help in understanding the behavior of the cancer and potentially guide future treatment options.

Participants in the study will have their cancer evaluated through these specialized PET scans, which are designed to provide detailed images of the cancer's activity. The study aims to gather important information about the cancer's characteristics and how it responds to the imaging process. This information could be valuable for developing new strategies to manage metastatic breast cancer in the future.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying age, diagnosis of metastatic breast cancer, and previous treatment history.

    Eligibility criteria require the presence of identifiable liver and/or bone metastases and at least ten secondary lesions detectable by a specific type of scan called 18F-FDG PET.

  2. Step 2

    First scan

    A scan using 18F-FDG PET is performed to identify and assess the extent of cancerous lesions. This scan helps in understanding the current state of the disease.

  3. Step 3

    Second scan preparation

    Preparation for the second scan involves ensuring no changes in treatment occur between the first and second scans. This is crucial for accurate comparison.

  4. Step 4

    Second scan

    A second scan using 68Ga-DOTATOC PET is conducted within 21 days of the first scan. This scan evaluates the expression of somatostatin receptors in the lesions.

    The scan uses a solution for injection called SomaKit TOC 40 micrograms, administered intravenously.

  5. Step 5

    Data analysis

    Data from both scans are analyzed to assess the intensity of lesion uptake and compare the volume of disease between the two types of scans.

    The analysis includes evaluating the expression of specific receptors and comparing metabolic volumes.

  6. Step 6

    Follow-up

    Follow-up involves collecting clinical and imaging data to monitor the progression of the disease and the effectiveness of the scans in identifying receptor expression.

Who can join the trial?

9 criteria

  • Must be over 18 years old.
  • Must have **metastatic breast cancer**, which means the cancer has spread to other parts of the body, and have already received at least one type of **systemic treatment** for this condition. Systemic treatment is a therapy that travels through the bloodstream to reach and affect cells all over the body.
  • The original breast cancer tumor must be labeled as **ER+HER2-**. ER+ means the cancer cells grow in response to the hormone estrogen, and HER2- means the cancer does not have high levels of the protein HER2.
  • Must have **metastatic lesions** in the liver and/or bones that can be identified using a special imaging test called **PET scan** with a substance called **18F-FDG**.
  • Must have at least 10 secondary lesions that can be identified using the PET scan with 18F-FDG.
  • No changes in treatment should occur between the PET scan with 18F-FDG and another PET scan with a different substance called **68Ga-DOTATOC**.
  • The PET scan with 68Ga-DOTATOC must be done within 21 days after the PET scan with 18F-FDG.
  • Must be affiliated with social security or have a similar type of coverage.
  • Must have given written **informed consent**, which means agreeing to participate in the study after being fully informed about it.

Who cannot join the trial?

4 criteria

  • Patients who do not have **breast cancer** cannot participate.
  • Only **female** patients are eligible; male patients cannot participate.
  • Patients who are not within the specified **age range** cannot participate. The age range is not specified here, but it is important for eligibility.
  • Patients who are part of a **vulnerable population** are not eligible. A vulnerable population includes groups like children, pregnant women, or those unable to give consent.
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Investigated drugs

DOTATOC-68Ga is a radiopharmaceutical used in PET scans to help visualize certain types of cancer cells. In this trial, it is used to detect the presence of somatostatin receptors in patients with metastatic breast cancer. This helps doctors understand how the cancer is behaving and whether it is likely to respond to certain treatments.

What is already known about the treatment

DOTATOC-68Ga – This medication is administered through an intravenous injection and is used in PET scans to detect certain types of cancer, such as metastatic breast cancer. It is currently being studied in clinical trials to evaluate its effectiveness in identifying tumors that overexpress somatostatin receptors. The main therapeutic indication is for imaging in cancer diagnosis, particularly in cases where tumors have specific receptor characteristics. At the molecular level, DOTATOC-68Ga binds to somatostatin receptors, allowing for the visualization of tumors during PET scans. It is classified as a radiopharmaceutical used in diagnostic imaging.

Investigated diseases

Breast Cancer – Breast cancer is a disease where cells in the breast grow uncontrollably, forming a tumor. It often begins in the ducts or lobules of the breast. As the disease progresses, it can spread to nearby lymph nodes and other parts of the body, a process known as metastasis. The progression can vary greatly among individuals, with some experiencing rapid growth and others having a slower course. Symptoms may include a lump in the breast, changes in breast shape, or skin dimpling. Early detection is crucial for managing the disease effectively.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-504458-36-02Protocol code38RC21.0432Estimated enrolment25 patientsSponsorCentre Hospitalier Universitaire Grenoble Alpes

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