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Study of Atezolizumab, Trastuzumab, and Vinorelbine for Patients with Advanced HER2-Positive Breast Cancer

Verified siteRegistered drugNo 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 studying a type of breast cancer known as HER2-positive advanced or metastatic breast cancer. This type of cancer is characterized by the presence of a protein called HER2, which promotes the growth of cancer cells. The study is specifically for patients whose cancer has progressed despite previous treatments with medications like trastuzumab and other anti-HER2 therapies. The trial will explore the effectiveness of a combination treatment using three medications: atezolizumab, trastuzumab, and vinorelbine. Atezolizumab, also known by its code name RO5541267, is a type of medication that helps the immune system fight cancer cells. Trastuzumab is a targeted therapy that attaches to the HER2 protein on cancer cells, and vinorelbine is a chemotherapy drug that helps stop the growth of cancer cells.

The purpose of this study is to evaluate how well this combination of medications works in treating patients with this specific type of breast cancer. Participants in the study will receive the treatment over a period of time, and their response to the treatment will be monitored. The study will look at how the cancer responds to the treatment, including whether it shrinks or stops growing, and how long these effects last. The study will also monitor the overall health and survival of the participants during and after the treatment period.

Throughout the study, participants will receive regular check-ups and assessments to track their progress and any side effects they may experience. The study aims to provide valuable information on the potential benefits of this treatment combination for patients with HER2-positive breast cancer, particularly those who have not responded to previous treatments. This research could lead to new treatment options for patients with this challenging form of cancer.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Enrollment

    Eligibility is confirmed by a member of the study team. This includes a review of medical history and current health status.

    A signed informed consent form is required before any study-specific procedures begin.

  2. Step 2

    Initial assessment

    A baseline assessment is conducted, including tests to measure heart function and a pregnancy test for women of childbearing potential.

    A tumor sample is collected for biomarker analysis to confirm eligibility.

  3. Step 3

    Treatment initiation

    Treatment begins with the administration of atezolizumab, trastuzumab, and vinorelbine.

    Atezolizumab is given as a solution for infusion. The specific dosage and frequency are determined by the study protocol.

  4. Step 4

    Ongoing treatment

    Regular infusions of the medications continue as per the study schedule.

    Participants are monitored for response to treatment and any side effects.

  5. Step 5

    Follow-up assessments

    Periodic assessments are conducted to evaluate the effectiveness of the treatment.

    These assessments include imaging tests and other evaluations as per the study protocol.

  6. Step 6

    End of treatment

    The treatment phase concludes as per the study timeline or if the participant experiences significant side effects or disease progression.

    A final assessment is conducted to evaluate the overall response to the treatment.

  7. Step 7

    Post-treatment follow-up

    Participants are monitored for a specified period after the end of treatment to assess long-term effects and overall survival.

    Follow-up visits may include additional tests and assessments.

Who can join the trial?

13 criteria

  • Must be a man or woman, either premenopausal or postmenopausal, with advanced **HER2-positive breast cancer**. This means the cancer has spread beyond the breast and is not curable with surgery.
  • Must have previously received treatment with **trastuzumab** and other anti-HER2 therapies.
  • Must be 18 years or older.
  • Must have a **performance status** of 0 to 2, which means the patient is fully active or has some limitations but can still take care of themselves.
  • Must have a confirmed diagnosis of **HER2-positive breast cancer** that is either metastatic (spread to other parts of the body) or cannot be surgically removed.
  • Must have a **baseline LVEF** (a measure of heart function) of 50% or higher.
  • Must not have any psychological, family, or geographical issues that would prevent them from following the study procedures.
  • If a woman of childbearing potential, must have a negative pregnancy test before starting the study and agree to use effective birth control during the study and for a specified time after the last dose of study drugs.
  • Participants with a history of **CNS metastases** (cancer spread to the brain) are eligible if certain conditions are met, such as stable brain lesions or having received treatment for brain lesions.
  • Must have **measurable disease** according to specific criteria, meaning the cancer can be measured and tracked during the study.
  • Must have adequate organ function, which includes specific levels of blood cells, liver enzymes, and kidney function.
  • Must provide a sample of tumor tissue for analysis, which helps in understanding the cancer better and determining eligibility.
  • Must have signed a written informed consent form, agreeing to participate in the study and understanding all procedures involved.

Who cannot join the trial?

4 criteria

  • Patients who have not progressed to trastuzumab-based chemotherapy and AntiHER2-ADC cannot participate. This means if the cancer has not worsened after these treatments, the patient is not eligible.
  • Patients with breast cancer that is not HER2-positive are excluded. HER2-positive means the cancer has a protein that promotes the growth of cancer cells.
  • Patients with breast cancer that is ER-positive or luminal are not eligible. ER-positive means the cancer grows in response to the hormone estrogen. Luminal refers to a subtype of breast cancer that is hormone receptor-positive.
  • Patients who have breast cancer that can be treated with surgery are not eligible. This trial is for those whose cancer cannot be removed by surgery.
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Investigated drugs

  • Atezolizumab

    is an immunotherapy drug that helps the body's immune system attack cancer cells. It works by blocking a protein that prevents the immune system from effectively targeting and destroying cancer cells.

  • Trastuzumab

    is a targeted therapy used to treat HER2-positive breast cancer. It attaches to the HER2 protein on the surface of cancer cells, which can help slow or stop the growth of the cancer.

  • Vinorelbine

    is a chemotherapy medication that works by interfering with the growth and spread of cancer cells. It is used to treat various types of cancer, including breast cancer, by stopping cancer cells from dividing and growing.

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 certain types of advanced breast cancer. It is primarily used for patients with HER2-positive breast cancer that has not responded to other treatments. Atezolizumab works by blocking a protein called PD-L1, which helps cancer cells evade the immune system, thereby allowing the immune system to better attack the cancer. It is classified as an immune checkpoint inhibitor.

  • Trastuzumab

    Trastuzumab is given through an intravenous infusion and is well-established in medical practice for treating HER2-positive breast cancer. It is used for patients whose cancer has progressed despite previous treatments. Trastuzumab targets the HER2 protein on cancer cells, inhibiting their growth and survival. It belongs to the class of monoclonal antibodies.

  • Vinorelbine

    Vinorelbine is administered intravenously and is used in combination with other medications for treating advanced breast cancer. It is indicated for patients with HER2-positive breast cancer that has not responded to other therapies. Vinorelbine works by interfering with the formation of microtubules, which are essential for cell division, thus inhibiting cancer cell growth. It is classified as a vinca alkaloid.

Investigated diseases

HER2-positive breast cancer – This is a type of breast cancer characterized by the overexpression of the human epidermal growth factor receptor 2 (HER2) protein, which promotes the growth of cancer cells. It can occur in both pre- and post-menopausal women, as well as men. The disease may present as locally advanced or metastatic, meaning it has spread beyond the original site to other parts of the body. Patients with this type of cancer may initially respond to treatments like trastuzumab-based chemotherapy, but the disease can progress despite these therapies. The progression involves the cancer becoming resistant to initial treatments, necessitating alternative therapeutic strategies. HER2-positive breast cancer is known for its aggressive nature compared to other types of breast cancer.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-508829-28-00Protocol codeSOLTI-1907Estimated enrolment55 patientsSponsorSolti Group

sourced from the EU Clinical Trials Register and site verification

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