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Study of Atezolizumab, Pertuzumab, and Trastuzumab for Patients with HER2 Positive Early High-Risk and Locally Advanced 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 treatments for HER2-positive breast cancer, which is a type of breast cancer that tests positive for a protein called human epidermal growth factor receptor 2 (HER2). This protein promotes the growth of cancer cells. The study involves several medications, including Atezolizumab, Pertuzumab, and Trastuzumab, which are used in combination with chemotherapy. These medications are designed to target and block the HER2 protein, helping to slow or stop the growth of cancer cells.

The purpose of the study is to compare the effectiveness of different treatment combinations in improving the 5-year event-free survival of patients. Event-free survival refers to the length of time after treatment during which a patient remains free from certain complications or events that the study is measuring. Participants will receive treatment over a period of time, and their health will be monitored to assess the outcomes. Some participants may receive a placebo, which is a substance with no active medication, to help compare the effects of the actual treatments.

Throughout the study, participants will undergo regular health assessments to monitor their response to the treatment. The study aims to provide valuable information on the best treatment strategies for patients with HER2-positive breast cancer, potentially leading to improved outcomes and survival rates. The trial is expected to conclude by the end of 2026, with results helping to guide future treatment approaches for this type of 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, participation is confirmed through written informed consent. This consent is necessary before any study-specific procedures begin.

  2. Step 2

    Initial assessments

    Initial assessments include confirming the diagnosis of HER2 positive invasive breast cancer and ensuring eligibility criteria are met. This involves reviewing medical history and performing necessary tests.

  3. Step 3

    Treatment phase

    The treatment phase involves receiving medications as part of the study. The medications include trastuzumab emtansine, pertuzumab, atezolizumab, and chemotherapy.

    Medications are administered either intravenously or subcutaneously, depending on the specific drug. The frequency and dosage are determined by the study protocol.

  4. Step 4

    Monitoring and follow-up

    Regular monitoring is conducted to assess the response to treatment and manage any side effects. This includes blood tests and imaging studies.

    Follow-up visits are scheduled to evaluate the effectiveness of the treatment and to ensure the patient's well-being.

  5. Step 5

    End of treatment

    At the end of the treatment phase, a final assessment is conducted to determine the overall response to the therapy.

    The study aims to compare the 5-year Event-Free Survival (EFS) between different treatment groups.

Who can join the trial?

10 criteria

  • Female patients aged 18 years or older with early high-risk or locally advanced and inflammatory breast cancers that are suitable for treatment before surgery.
  • Willing and able to follow the study's rules and procedures.
  • Confirmed diagnosis of invasive breast cancer in one breast.
  • HER2 positive disease according to current guidelines. HER2 is a protein that can affect the growth of cancer cells.
  • Known levels of estrogen receptor (ER) and progesterone receptor (PgR). These are proteins that can influence how breast cancer behaves.
  • A sample of the tumor, preserved in a special way, must be available for testing to confirm HER2 status and to check other markers.
  • Agree to give blood samples at specific times during the study, including before starting treatment, after the first cycle, before surgery, six months after surgery, and at the end of all treatments.
  • ECOG performance status of 0 or 1, which means the patient is fully active or has some symptoms but can carry out light work.
  • For women who are not postmenopausal or surgically sterile, they must agree to use effective birth control methods during the study and for at least 7 months after the last dose of study drugs. Abstinence is only acceptable if it is the patient's usual lifestyle. Certain methods like periodic abstinence and withdrawal are not acceptable.
  • Written informed consent to participate in the trial must be obtained before any study-specific procedures begin. This means the patient agrees to join the study after understanding all the details.

Who cannot join the trial?

4 criteria

  • Patients who do not have invasive breast cancer cannot participate. Invasive breast cancer is a type of cancer that has spread from the original site in the breast to other parts of the body.
  • Only female patients are eligible, so 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 considered part of a vulnerable population may not be eligible. A vulnerable population includes groups who may have difficulty giving informed consent or are at higher risk of harm.
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Investigated drugs

  • Atezolizumab

    is a medication used to help the immune system attack cancer cells. It works by blocking a protein that stops the immune system from working properly, allowing it to better target and destroy cancer cells.

  • Pertuzumab

    is a medication that targets a specific protein on the surface of cancer cells. It helps to stop the growth and spread of cancer by blocking signals that tell the cancer cells to grow.

  • Trastuzumab

    is a medication used to treat certain types of breast cancer. It works by attaching to a protein on the surface of cancer cells, which helps to stop the cells from growing and dividing.

  • Chemotherapy

    involves the use of drugs to kill or slow the growth of cancer cells. It is often used in combination with other treatments to increase its effectiveness in treating cancer.

What is already known about the treatment

  • Atezolizumab

    Atezolizumab is administered intravenously and is currently being studied in clinical trials for its effectiveness in treating invasive breast cancer. It is an immunotherapy drug that works by blocking the PD-L1 protein, helping the immune system to detect and attack cancer cells. Atezolizumab is classified as a monoclonal antibody and is primarily used for certain types of cancer, including breast cancer.

  • Pertuzumab

    Pertuzumab is given through an intravenous infusion and is used in the treatment of HER2-positive breast cancer. It is approved for use in combination with other medications and works by targeting the HER2 receptor, preventing cancer cell growth. Pertuzumab is a monoclonal antibody and is part of targeted cancer therapies.

  • Trastuzumab

    Trastuzumab is administered via intravenous infusion and is widely used in the treatment of HER2-positive breast cancer. It functions by binding to the HER2 receptor on cancer cells, inhibiting their growth and survival. Trastuzumab is a monoclonal antibody and is a well-established treatment in oncology for HER2-positive cancers.

Investigated diseases

Invasive Breast Cancer – This is a type of breast cancer that has spread from the original site in the breast ducts or lobules into surrounding breast tissue. It can further progress by spreading to nearby lymph nodes and potentially to other parts of the body. The disease often begins as a lump or mass in the breast, which may be detected through physical examination or imaging tests. As it advances, symptoms can include changes in breast shape, skin dimpling, or nipple discharge. The progression of invasive breast cancer can vary, with some cases growing slowly while others may spread more rapidly. Understanding the specific characteristics of the cancer, such as hormone receptor status, is crucial in determining its behavior and potential progression.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-518026-32-00Protocol codeFM-17-B01Estimated enrolment661 patientsSponsorFondazione Michelangelo

sourced from the EU Clinical Trials Register and site verification

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