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Study of BNT327 and a drug combination for patients with untreated metastatic or locally recurrent 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 study focuses on individuals with Triple-negative breast cancer, which is a type of breast cancer that lacks certain common receptors typically used to guide treatment. The research is specifically looking at patients whose cancer has returned in the same area and cannot be removed by surgery, or has spread to other parts of the body, and who are not candidates for certain other therapies due to the absence of a specific protein called PD-L1. The purpose of the study is to compare the effectiveness of a new medication called BNT327 combined with chemotherapy against a combination of chemotherapy and a placebo.

The treatment involves several different medications used as chemotherapy, which are drugs designed to kill fast-growing cancer cells. These drugs include paclitaxel, gemcitabine, carboplatin, and eribulin. Participants will receive these medications through an intravenous infusion, a process where medicine is delivered directly into a vein. Some participants will receive BNT327 along with the drugs, while others will receive the placebo along with the drugs. This is a double-blind study, meaning neither the participants nor the researchers know which specific treatment is being administered during the course of the trial.

During the study, researchers will monitor how long patients live and how long they remain stable without the cancer growing further. The study also tracks how well the tumors shrink or disappear in response to the medicine. Changes in the patient's overall health and how they feel physically will also be observed to ensure the safety of the treatments provided.

The research process

The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    <b>study entry</b> and <b>randomization</b>

    After joining the study, a process called randomization occurs. this means a method similar to flipping a coin is used to assign the treatment group without any knowledge of the assignment.

    One group receives a medication called bnt327 (also known as pumitamig) at a dose of 95.2 mg via intravenous infusion (a liquid passed into a vein).

    The other group receives a placebo, which is a substance that looks like the medication but contains no active medicine, administered alongside chemotherapy.

  2. Step 2

    <b>chemotherapy</b> administration

    The treatment includes chemotherapy, which is medicine used to treat cancer. the specific drugs used depend on the assigned group.

    One possible treatment combination involves paclitaxel at a dose of 3.8 mg/m2, gemcitabine at a dose of 47.62 mg/m2, and carboplatin at a dose of 10.5 mg/m2, administered through intravenous infusion.

    Another possible treatment combination involves abraxane (a form of paclitaxel) at a dose of 3.57 mg/m2, gemcitabine at a dose of 47.62 mg/m2, and carboplatin at a dose of 10.5 mg/m2, administered through intravenous infusion.

    Another possible combination involves eribulin at a dose of 0.06 mg/m2, administered through intravenous infusion.

  3. Step 3

    <b>monitoring</b> and <b>evaluation</b>

    During the study, the effectiveness of the treatment is monitored by looking at overall survival, which is the time from randomization until death from any cause.

    The progression-free survival is also tracked, which measures the time from randomization until the cancer starts growing again or until death occurs.

    The response of the tumor to the medicine is assessed through objective response rate, which determines if the tumor has shrunk or disappeared.

    The quality of life, including physical functioning and general health, is regularly checked to see how the treatment affects daily living.

Who can join the trial?

13 criteria

  • You must be an adult, meaning you are 18 years of age or older.
  • Men who are sterile or could potentially have children must agree to use condoms and ensure their partners use highly effective contraception (methods used to prevent pregnancy) from the time they join the study until 6 months after the final dose.
  • Participants must agree not to donate or freeze any germ cells (sperm or eggs) for use in fertility treatments during the study and for 6 months after the last dose.
  • You must be able to understand the study and provide informed consent, which is a written agreement to participate after being told all the details.
  • You must be willing and able to follow the study schedule, attend all planned visits, and complete any required diaries or instructions.
  • You must be ineligible for a specific type of immunotherapy (a treatment that helps the immune system fight cancer) based on your tumor's PD-L1 expression (a specific marker on the surface of cancer cells).
  • You must have a confirmed diagnosis of locally recurrent inoperable (cancer that has returned in the same area and cannot be removed by surgery), metastatic (cancer that has spread to other parts of the body), or ER-low, HER2-negative breast cancer.
  • You must have at least one measurable lesion (a tumor or area of cancer that can be clearly seen and measured on scans) as defined by standard medical rules.
  • You must provide a tissue sample (a small piece of body tissue) during the screening period.
  • Your ECOG performance status must be 0 or 1, which means you are able to carry out daily activities and most work activities with little or no restriction.
  • You must have healthy organ function, specifically regarding your blood counts, liver function, kidney function, and coagulation (your blood's ability to clot).
  • People of child-bearing potential must have a negative serum beta hCG pregnancy test (a blood test to confirm pregnancy is not occurring) within 7 days before starting treatment.
  • People of child-bearing potential must agree to use highly effective contraception and require male partners to use barrier methods (such as condoms) from the time they join the study until 6 months after the final dose.

Who cannot join the trial?

27 criteria

  • People who have previously received systemic anticancer therapy, which refers to medicine that travels through the whole body to treat cancer, for advanced stages of the disease.
  • People who have used a PD(L)-1/VEGF bispecific antibody, a specific type of targeted drug therapy, before the study.
  • People who have taken systemic corticosteroids, which are powerful anti-inflammatory medicines, within 7 days before the study starts.
  • People who have received a live attenuated vaccine, which is a type of vaccine using a weakened form of a germ, within 4 weeks before the study starts.
  • People who have received broad-spectrum intravenous antibiotics, which are strong medicines used to fight a wide range of bacteria delivered through a vein, within 2 weeks before the study starts.
  • People with hepatitis B that requires active antiviral medicine.
  • People with any medical, psychological, or social condition that the study doctor believes could harm their well-being or prevent them from following the study rules.
  • People who are pregnant, breastfeeding, or planning to become pregnant or father children during the study or within 6 months after the last dose.
  • People who have had major organ surgery, significant physical injury, or invasive dental procedures, such as dental implants, within 28 days before the study starts, or those planning elective surgery during the trial.
  • People who have had a hematopoietic stem cell transplantation (a procedure to replace blood-forming cells) or an organ transplant.
  • People with spinal cord compression (pressure on the spinal cord) or central nervous system metastases (cancer that has spread to the brain or spinal cord) that are untreated or causing symptoms.
  • People with an active autoimmune disease, a condition where the body's immune system attacks its own healthy cells, that required whole-body medicine in the last 2 years.
  • People who have had other malignant tumors, which are cancerous growths, within the last 2 years.
  • People with certain heart conditions as defined by the study within the last 6 months.
  • People with an active hepatitis C virus infection.
  • People with hypertension (high blood pressure) or diabetic conditions before the study starts.
  • People considered vulnerable, meaning their ability to make a free choice to participate might be influenced by expectations of benefits or fear of consequences.
  • People with superior vena cava syndrome (a blockage of the main vein in the chest) or symptoms of spinal cord pressure.
  • People with pneumonitis (inflammation of the lung tissue) or interstitial lung disease (conditions that cause scarring of lung tissue) that are active or have a history of requiring steroid treatment.
  • People with a history of tuberculosis that was not successfully treated.
  • People with serious non-healing wounds, ulcers, or bone fractures.
  • People with coagulation disorders, which are problems with how the blood clots, or a high risk of hemorrhage (heavy bleeding).
  • People receiving therapeutic anticoagulation or antiplatelet therapy, which are medicines used to thin the blood or prevent clots.
  • People with pleural effusion (fluid around the lungs), pericardial effusion (fluid around the heart), or ascites (fluid buildup in the abdomen) that requires repeated drainage.
  • People who had serious immune-related adverse events (irAEs), which are side effects caused by the immune system, that were severe enough to stop previous treatment, or those still experiencing side effects from previous cancer therapy.
  • People with a known hypersensitivity, or allergic reaction, to the study medicines or any of their ingredients.
  • People with human immunodeficiency virus (HIV) who have low CD4+ T-cell counts (a type of white blood cell that helps the immune system) below 350 cells/µL or a history of AIDS-defining opportunistic infections.
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Investigated drugs

  • Paclitaxel

    is a chemotherapy medication used to treat cancer by stopping cancer cells from growing and dividing.

  • Gemcitabine

    is a chemotherapy drug that works by interfering with the DNA of cancer cells, which helps to slow down or stop their growth.

  • Carboplatin

    is a type of chemotherapy medication that is used to kill cancer cells by damaging their ability to repair themselves.

  • BNT327

    is an investigational therapy being studied in this trial to see if it can work together with chemotherapy to better fight cancer cells.

  • Abraxane

    is a form of chemotherapy that contains a cancer-fighting drug attached to a protein to help it reach the cancer cells more effectively.

  • Eribulin

    is a chemotherapy medication used to treat certain types of cancer by preventing cancer cells from being able to move and divide.

What is already known about the treatment

  • Paclitaxel

    This medication is a chemotherapy drug used to treat various types of cancer and is typically administered through injection or infusion. It is a well-established treatment that works by stopping cancer cells from dividing, which prevents the tumor from growing. As a taxane-class drug, it stabilizes the internal structure of cells to freeze their growth process.

  • Gemcitabine

    Gemcitabine is a chemotherapy agent used to treat several types of solid tumors and is delivered into the body via an intravenous infusion. It is widely used in medical practice and functions by mimicking the building blocks of DNA. When the cancer cell tries to use this medication to replicate its genetic material, the process is interrupted, causing the cell to die. This drug belongs to a group known as antimetabolites.

  • Carboplatin

    Carboplatin is a widely used chemotherapy drug administered through an intravenous infusion to treat various cancers. It works by attaching itself to the DNA of cancer cells, creating links that prevent the cells from copying their genetic information. This action stops the cells from multiplying and eventually leads to cell death. It is classified as a platinum-based antineoplastic agent.

  • BNT327

    BNT327 is an experimental immunotherapy drug currently being studied in clinical trials and is administered as a solution through an intravenous infusion. It is designed to target specific proteins on cancer cells to help the body's immune system recognize and attack the tumor more effectively. This substance belongs to a class of targeted therapies aimed at modulating immune responses.

  • Paclitaxel albumin-bound

    This is a specialized form of chemotherapy delivered through an intravenous infusion that uses a protein called albumin to carry the medicine directly to the cancer cells. It is a recognized treatment for certain cancers and works by interfering with the structural framework of the cell to prevent division. This medication is classified as a taxane and is specifically designed for improved delivery to the tumor site.

  • Eribulin mesylate

    Eribulin mesylate is a chemotherapy medication used for certain types of advanced cancer and is given through an intravenous infusion. It is an established treatment that works by disrupting the movement of proteins required for a cell to divide and multiply. This drug is categorized as a microtubule inhibitor, which helps prevent the spread of cancer cells.

Investigated diseases

Triple-negative breast cancer - This is a type of breast cancer that lacks estrogen receptors, progesterone receptors, and human epidermal growth factor receptor 2. Because it does not have these specific receptors, the cancer cells do not respond to hormone therapies or drugs targeting the HER2 protein. This condition often involves fast-growing cells that can spread to other parts of the body. As the disease progresses, the tumor cells multiply and may move from the breast to lymph nodes or distant organs.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-521884-12-00Protocol codeBNT327-05Estimated enrolment583 patientsSponsorBioNTech SE

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).