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Study of Izalontamab Brengitecan Compared to Standard Chemotherapy in Untreated Triple-negative or ER-low, HER2-negative Breast Cancer Patients Not Eligible for Anti-PD1/PD-L1 Treatment

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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 Triple-negative Breast Cancer and ER-low, HER2-negative Breast Cancer that cannot be removed by surgery or has spread to other parts of the body. The study compares a new medicine called izalontamab brengitecan (also known as BL-B01D1) with standard chemotherapy treatments including paclitaxel, paclitaxel albumin-bound, capecitabine, or a combination of carboplatin and gemcitabine.

The main purpose of this research is to determine if izalontamab brengitecan works better than standard chemotherapy treatments in patients who cannot receive certain types of immunotherapy treatments (anti-PD1/PD-L1). The study will measure how long patients live without their cancer getting worse and their overall survival time. During treatment, some patients may also receive pegfilgrastim, a supportive care medicine that helps the body make white blood cells.

The medications will be given in different ways - some through an intravenous infusion directly into a vein, while others, like capecitabine, are taken by mouth as tablets. The study will continue for several years to gather information about how well the treatments work and how safe they are for patients.

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

    Initial assessment

    Your doctor will confirm if you have triple-negative breast cancer (TNBC) or ER-low, HER2-negative breast cancer that cannot be removed by surgery or has spread.

    Your previous treatments must be completed at least 2 weeks before starting the study.

    A brain scan (MRI or CT) will be performed within 28 days before starting.

  2. Step 2

    Treatment assignment

    You will be randomly assigned to receive either the new medicine izalontamab brengitecan (iza-bren) or one of these standard treatments:

    - Paclitaxel (given through a vein)

    - Paclitaxel albumin-bound (given through a vein)

    - Capecitabine (taken by mouth)

    - Carboplatin plus gemcitabine (both given through a vein)

  3. Step 3

    Treatment period

    Your treatment will continue as long as it is helping and you are not experiencing serious side effects.

    Regular scans will be performed to check if the cancer is stable or getting better or worse.

    Your doctor will monitor your health status throughout the treatment.

  4. Step 4

    Follow-up period

    After treatment ends, your health will continue to be monitored.

    The study will track how long you live without the cancer getting worse (progression-free survival).

    The study will also track overall survival time.

  5. Step 5

    Study completion

    The study is expected to run until February 2031.

    Your participation may end earlier if the treatment stops working or you experience serious side effects.

Who can join the trial?

10 criteria

  • You must have advanced triple-negative breast cancer or ER-low, HER2-negative breast cancer that cannot be surgically removed or has spread to other parts of the body
  • You must not have received any previous treatments for this stage of cancer
  • You must have completed any previous local cancer treatments (such as radiation therapy or major surgery) at least 2 weeks before starting the study
  • Your cancer must be measurable through CT scan or MRI (special imaging tests that create detailed pictures of your body)
  • You must have had a brain MRI (or CT scan if you cannot have an MRI) within 28 days before starting the study
  • You must be able to receive at least one of these chemotherapy treatments: paclitaxel, nab-paclitaxel, capecitabine, or carboplatin plus gemcitabine
  • You must have an ECOG performance status of 0 or 1 (this means you must be able to perform most daily activities on your own)
  • Any side effects from previous treatments must have improved to mild levels or disappeared (except for hair loss or nerve problems, which can be moderate)
  • If you have triple-negative breast cancer, you must not be eligible for first-line treatment with medications like pembrolizumab or atezolizumab
  • If you have ER-low, HER2-negative breast cancer, your doctor must determine that hormone therapy is not suitable for you

Who cannot join the trial?

14 criteria

  • Age below 18 years
  • Pregnancy or breastfeeding
  • History of severe allergic reactions to similar medications
  • Active brain metastases (cancer that has spread to the brain) that are not treated
  • Serious heart conditions, including heart failure or uncontrolled high blood pressure
  • Severe liver problems (liver function tests more than 3 times the normal limit)
  • Severe kidney problems (creatinine clearance less than 30 mL/min)
  • Active infections requiring treatment
  • Other types of cancer within the last 3 years (except for successfully treated non-melanoma skin cancer or cervical cancer in situ)
  • Major surgery within 4 weeks before starting the study
  • Current participation in other clinical trials
  • Inability to swallow oral medications
  • Any condition that, in the opinion of the study doctor, would make participation unsafe
  • Unable to follow study procedures or attend scheduled visits
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Investigated drugs

  • Izalontamab Brengitecan

    (also known as iza-bren) is a new investigational medication being tested for treating breast cancer. It's being studied as a potential treatment for patients who have breast cancer that has spread or cannot be removed by surgery.

  • Paclitaxel

    is a commonly used chemotherapy medication that works by stopping cancer cells from dividing and growing. It's often used to treat various types of cancer, including breast cancer.

  • Nab-paclitaxel

    is a form of paclitaxel that is bound to protein particles, making it easier for the body to deliver the medication to cancer cells. It's commonly used in treating breast cancer.

  • Capecitabine

    is an oral chemotherapy medication that the body converts into a substance that interferes with cancer cell growth. It's used to treat various cancers, including breast cancer.

  • Carboplatin

    is a platinum-based chemotherapy medication that works by damaging the DNA of cancer cells, preventing them from multiplying. It's often used in combination with other chemotherapy medications.

  • Gemcitabine

    is a chemotherapy medication that works by preventing cancer cells from making and repairing DNA, which stops them from growing and dividing. It's commonly used in combination with other cancer treatments.

What is already known about the treatment

  • Izalontamab Brengitecan (BMS-986507)

    A novel investigational medication administered intravenously that is currently being studied in clinical trials for treating triple-negative breast cancer (TNBC) and ER-low, HER2-negative breast cancer. This drug is being evaluated as a potential first-line treatment option for patients with locally advanced, recurrent inoperable, or metastatic breast cancer who cannot receive anti-PD1/PD-L1 therapy. The medication is being compared to standard chemotherapy options such as paclitaxel, nab-paclitaxel, capecitabine, and carboplatin plus gemcitabine combination to determine its effectiveness and optimal dosing in treating these aggressive forms of breast cancer.

  • Paclitaxel

    A widely used chemotherapy medication administered intravenously that belongs to the taxane class of drugs. It works by preventing cancer cell division by targeting tubulin, a protein essential for cell growth, making it effective in treating various types of cancer, including breast cancer. This established treatment is commonly used as a standard therapy option for breast cancer patients and serves as one of the comparison treatments in clinical trials evaluating new medications.

  • Nab-paclitaxel

    An albumin-bound form of paclitaxel administered intravenously that delivers the chemotherapy drug more effectively to cancer cells. This formulation combines paclitaxel with human albumin protein, which helps to reduce some side effects associated with standard paclitaxel and potentially improves its effectiveness in treating breast cancer. It represents a more refined version of traditional paclitaxel and is frequently used as a standard treatment option for breast cancer patients.

  • Capecitabine

    An oral chemotherapy medication that converts to 5-fluorouracil in the body, specifically targeting rapidly dividing cancer cells. This drug belongs to the fluoropyrimidine class and is taken by mouth in tablet form, making it more convenient for patients compared to intravenous treatments. It is commonly used in breast cancer treatment and serves as one of the standard therapy options against which new treatments are compared.

  • Carboplatin

    A platinum-based chemotherapy drug administered intravenously that works by binding to DNA in cancer cells, preventing them from dividing and growing. This medication belongs to the platinum compounds class and is often used in combination with other chemotherapy drugs, particularly gemcitabine, to treat various types of cancer, including breast cancer. It represents one of the established treatment options in breast cancer therapy.

  • Gemcitabine

    An intravenous chemotherapy medication that belongs to the antimetabolite class of drugs, working by interfering with cancer cell DNA synthesis and replication. This medication is often used in combination with other chemotherapy drugs, particularly carboplatin, to enhance treatment effectiveness in breast cancer patients. It is a well-established treatment option that serves as one of the standard therapies against which new medications are compared.

Investigated diseases

  • Breast cancer

    A disease that starts when cells in the breast tissue begin to grow out of control. These abnormal cells usually form a tumor that can often be seen on an x-ray or felt as a lump. The cancer typically begins either in the cells of the lobules, which are the milk-producing glands, or in the ducts that drain milk from the lobules to the nipple. Over time, cancer cells can invade nearby healthy breast tissue and make their way into the underarm lymph nodes. If cancer cells get into the lymph nodes, they then have a pathway into other parts of the body.

  • Triple-negative breast cancer

    A specific type of breast cancer that lacks three common types of receptors known to fuel most breast cancer growth: estrogen receptors, progesterone receptors, and HER2 protein. This cancer tends to be more aggressive than other types of breast cancer. It develops from cells in the breast ducts and grows when abnormal cells divide rapidly. The disease affects breast tissue similarly to other types of breast cancer but has distinct biological characteristics.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IVTrial ID2024-519871-24-00Protocol codeCA244-0008Estimated enrolment500 patientsSponsorBristol-Myers Squibb Services Unlimited Company

sourced from the EU Clinical Trials Register and site verification

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