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Study on Avelumab for Patients with High-Risk Triple Negative 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 a type of breast cancer known as triple negative breast cancer. This form of cancer is called "triple negative" because the cancer cells do not have three common receptors known to fuel most breast cancer growth: estrogen, progesterone, and HER2/neu. The treatment being tested in this study is a medication called Avelumab, which is an anti-PD-L1 antibody. This medication is given as a solution through an infusion, which means it is administered directly into the bloodstream through a vein.

The purpose of the study is to find out if taking Avelumab for one year can help improve the time patients remain free from cancer after they have already received surgery and chemotherapy aimed at curing the cancer. The study will compare patients who receive Avelumab with those who are just observed without additional treatment. Patients participating in the study will have completed their initial treatment, which includes surgery to remove the tumor and chemotherapy to kill any remaining cancer cells.

Participants in the study will be randomly assigned to either receive the Avelumab treatment or be part of the observation group. The study will last for about a year, during which time the health of the participants will be closely monitored. The main goal is to see if Avelumab can help prevent the cancer from coming back. The study will also look at overall survival, which means how long patients live after starting the study, whether or not the cancer returns. This research aims to provide more information on whether Avelumab can be an effective additional treatment for patients with high-risk triple negative breast cancer.

The research process

The trial runs in 4 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 will be randomly assigned to one of two groups: one receiving the medication avelumab and the other under observation without the medication.

    The patient must have completed surgery and chemotherapy for high-risk triple negative breast cancer before joining the study.

  2. Step 2

    Treatment phase

    If assigned to the treatment group, the patient will receive avelumab, which is administered as an intravenous infusion.

    The dosage is 20 mg/mL of avelumab in a solution for infusion.

    The treatment will last for one year, with infusions given every two weeks.

  3. Step 3

    Observation phase

    Patients in the observation group will not receive avelumab but will be monitored regularly to assess their health status.

    Both groups will have regular check-ups to monitor for any recurrence of cancer or other health issues.

  4. Step 4

    End of study

    The study aims to determine if one year of avelumab treatment improves disease-free survival compared to observation.

    The primary endpoint is disease-free survival, which measures the time until any recurrence of cancer or the occurrence of a new cancer.

Who can join the trial?

22 criteria

  • Participants must be **18 years or older**.
  • Participants must have had **adjuvant chemotherapy** after surgery. This means chemotherapy given after the main treatment to lower the risk of the cancer coming back. It should include at least 3 courses of an **anthracycline agent** and 3 courses of a **taxane agent**. If participants couldn't complete all planned treatment cycles, they are still eligible.
  • No more than **10 weeks** should pass between finishing adjuvant chemotherapy and starting the trial.
  • Participants must have **normal organ and marrow function**. This includes:
    • White blood count (WBC) at a certain level.
    • Absolute neutrophil count (ANC) at a certain level.
    • Absolute lymphocyte count at a certain level.
    • Platelet count at a certain level.
    • Hemoglobin at a certain level.
    • Estimated creatinine clearance at a certain level, which measures kidney function.
    • Adequate liver function, with specific levels of bilirubin and liver enzymes.
    • Participants must use **highly effective contraception** if there is a risk of pregnancy. This is because the effects of the trial treatment on a developing fetus are unknown.
    • Participants must be able to understand and be willing to sign a **written informed consent**. This means they agree to participate in the trial after being informed about it.
    • Participants must have a **performance status** of 0 or 1 according to the Eastern Cooperative Oncology Group (ECOG). This is a scale that measures how well a person can perform ordinary tasks.
    • Participants must have **non-metastatic** breast cancer, meaning the cancer has not spread to other parts of the body.
    • Participants must have **triple negative breast cancer**, which means the cancer cells do not have estrogen or progesterone receptors and do not have excess HER2 protein.
    • Participants must have completed treatment with the intent to cure, including **surgery and chemotherapy**.
    • Participants must have had **adequate tumor excision**, meaning the tumor was properly removed during surgery.
    • Participants must have had **axillary lymph node dissection** to check the status of lymph nodes. Eligibility depends on the number of metastatic lymph nodes and the size of the tumor.
    • Participants must have **pathologic evidence** of remaining invasive cancer in the breast or lymph nodes after preoperative therapy.
    • Participants must have a **clinical stage** of T1-4, N0-3, M0 at presentation, which describes the size and extent of the cancer.
    • Participants must have completed **neoadjuvant chemotherapy** before surgery, which is chemotherapy given before the main treatment to shrink the tumor.
    • Participants must provide a **tumor tissue sample** from before chemotherapy.

Who cannot join the trial?

6 criteria

  • Patients who have not completed treatment with the intent to cure, including surgery and chemotherapy, cannot participate.
  • Patients who have not undergone surgery of the primary tumor followed by chemotherapy, or chemotherapy followed by surgery, are excluded.
  • Patients who do not have high-risk primary **triple negative breast cancer** are not eligible. **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 for the study cannot participate.
  • Patients who do not meet the gender requirements for the study are excluded.
  • Patients who are considered part of a vulnerable population, which may include those unable to give informed consent, are not eligible.
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Investigated drugs

Avelumab: Avelumab is a type of medication known as an anti-PD-L1 antibody. It is used in this clinical trial as an adjuvant treatment for patients with high-risk triple negative breast cancer. The goal of using Avelumab is to improve disease-free survival in patients who have already undergone surgery and chemotherapy. Avelumab works by helping the immune system recognize and attack cancer cells, potentially reducing the risk of cancer returning after initial treatment.

What is already known about the treatment

Avelumab – Avelumab is administered as an intravenous infusion, typically given in a clinical setting. It is currently being studied in clinical trials for its effectiveness in treating high-risk triple-negative breast cancer. The main therapeutic indication for Avelumab is to improve disease-free survival in patients who have completed surgery and chemotherapy. At the molecular level, Avelumab works by blocking the PD-L1 protein, which helps the immune system recognize and attack cancer cells. It is classified as an immune checkpoint inhibitor, a type of immunotherapy.

Investigated diseases

Breast Cancer – Breast cancer is a disease where cells in the breast grow uncontrollably, forming a tumor that can often be felt as a lump or seen on an X-ray. It typically begins in the ducts or lobules of the breast and can spread to other parts of the body if not managed. The progression of breast cancer can vary, with some types growing slowly and others more rapidly. Triple-negative breast cancer is a subtype that lacks three common receptors known to fuel most breast cancer growths, making it more challenging to treat. This type of cancer is often more aggressive and has a higher chance of recurrence after initial treatment. Understanding the specific characteristics of the cancer is crucial for determining the best approach to management.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-514515-10-00Protocol codeA-BRAVE-TrialEstimated enrolment474 patientsSponsorUniversita Degli Studi Di Padova

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