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Study of Nivolumab After Initial Treatment in Patients with Metastatic Triple-Negative Breast Cancer

Registered 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 triple-negative breast cancer (TNBC), which is a form of cancer that does not have three common receptors known to fuel most breast cancer growth. The study is investigating the effects of a treatment called nivolumab, also known by its code names BMS936558 and ABP 206. Nivolumab is a medication that is given through an infusion into the vein and is designed to help the immune system fight cancer cells.

The purpose of this study is to determine how effective nivolumab is after patients with metastatic TNBC receive one of four different initial treatments. These initial treatments include radiation therapy and three chemotherapy drugs: doxorubicin, cyclophosphamide, and cisplatin. The idea is that these initial treatments might help the immune system respond better to nivolumab.

Participants in the study will first receive one of the initial treatments to potentially boost their immune response. After this, they will receive nivolumab. The study will monitor how the cancer responds to the treatment and how long patients live without the cancer getting worse. The study will also look at the overall survival of patients and any side effects they experience. The trial is expected to continue until June 2026.

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

    Joining the trial

    Upon joining the trial, you will be required to provide a signed written informed consent. This document confirms your understanding and agreement to participate in the study.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to confirm eligibility. This includes verifying that you have metastatic ER and HER2 negative breast cancer, are 18 years or older, and meet other specific criteria such as having evaluable disease and a WHO performance status of 0 or 1.

  3. Step 3

    Induction treatment

    You will undergo one of four different short-term induction treatments. These treatments are designed to prepare your immune system and may include radiation, doxorubicin, cyclophosphamide, or cisplatin.

  4. Step 4

    Nivolumab treatment

    Following the induction treatment, you will receive nivolumab. This medication is administered as a solution for infusion through an intravenous (IV) line. The dosage and frequency will be determined by the study protocol.

  5. Step 5

    Monitoring and follow-up

    Throughout the trial, your health and response to the treatment will be closely monitored. This includes regular check-ups and assessments to track progression-free survival and other health indicators.

  6. Step 6

    Completion of trial

    The trial is expected to continue until June 15, 2026. Upon completion, you will have a final assessment to evaluate the overall impact of the treatment.

Who can join the trial?

9 criteria

  • Must have metastatic ER and HER2 negative breast cancer. Metastatic means the cancer has spread to other parts of the body.
  • Must be 18 years or older.
  • Must have metastatic lesions that can be accessed for a histological biopsy. This means the areas where the cancer has spread can be sampled for examination under a microscope.
  • Must have received a maximum of three different chemotherapy treatments for the metastatic disease.
  • Must have disease that can be measured according to RECIST 1.1, which is a standard way to measure how well a cancer treatment is working.
  • Must have a WHO performance status of 0 or 1. This is a scale that measures how well you can perform daily activities, with 0 being fully active and 1 being restricted in physically strenuous activity but able to carry out light work.
  • If there are brain metastases (cancer spread to the brain), they must have been treated, and there should be no signs of progression on an MRI scan for at least 4 weeks after treatment. An MRI is a type of scan that uses magnetic fields to create detailed images of the inside of the body.
  • Must not require high doses of systemic corticosteroids (more than 10 mg/day of prednisone equivalents) for at least 2 weeks before starting the study drug. Systemic corticosteroids are medications that reduce inflammation and affect the immune system.
  • Must provide signed written informed consent, which means you agree to participate in the study after being informed about all aspects of the trial.

Who cannot join the trial?

3 criteria

  • Patients who do not have triple negative breast cancer (TNBC) with metastatic disease. Metastatic disease means that the cancer has spread to other parts of the body.
  • Patients who are not within the specified age range for the study.
  • Patients who are part of a vulnerable population, which means they might need special protection or care.
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Investigated drugs

  • Nivolumab

    is a type of medication known as an immune checkpoint inhibitor. It works by helping your immune system recognize and attack cancer cells more effectively. In this trial, nivolumab is being tested to see if it can help treat triple-negative breast cancer after other treatments have been used to prepare the immune system.

  • Radiation Therapy

    is a treatment that uses high-energy rays to target and kill cancer cells. In this trial, radiation is used as an induction treatment, which means it is given before nivolumab to help stimulate the immune system to fight cancer more effectively.

  • Doxorubicin

    is a chemotherapy drug that is used to kill cancer cells. It works by interfering with the DNA inside cancer cells, preventing them from growing and dividing. In this trial, doxorubicin is used as an induction treatment to help boost the immune response before giving nivolumab.

  • Cyclophosphamide

    is another chemotherapy medication that helps destroy cancer cells by damaging their DNA. It is used in this trial as an induction treatment to enhance the immune system's ability to respond to cancer when nivolumab is administered.

  • Cisplatin

    is a chemotherapy drug that kills cancer cells by causing damage to their DNA. In this trial, cisplatin is used as an induction treatment to help prepare the immune system to work better with nivolumab in fighting cancer.

What is already known about the treatment

Nivolumab – Nivolumab is administered as an intravenous infusion, meaning it is given directly into the bloodstream through a vein. It is currently being studied in clinical trials for its effectiveness in treating triple-negative breast cancer (TNBC) that has spread to other parts of the body. The main use of nivolumab is to help the immune system recognize and attack cancer cells. It works by blocking a protein called PD-1 on immune cells, which can help the immune system to better fight cancer. Nivolumab is classified as an immune checkpoint inhibitor, a type of drug that helps the body's immune system fight cancer.

Investigated diseases

Triple Negative Breast Cancer – Triple Negative Breast Cancer (TNBC) is a type of breast cancer that lacks three common receptors known to fuel most breast cancer growth: estrogen, progesterone, and the HER-2/neu gene. This absence makes TNBC distinct from other breast cancer types, as it does not respond to hormonal therapy or therapies that target HER-2 receptors. TNBC tends to be more aggressive and has a higher likelihood of spreading and recurring compared to other breast cancer types. The progression of TNBC can vary, but it often grows and spreads more quickly than other forms of breast cancer. It is typically diagnosed at a later stage due to its rapid progression. TNBC is more common in younger women and those with a BRCA1 gene mutation.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-520487-18-00Protocol codeN15TONEstimated enrolment84 patientsSponsorHet Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting

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