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Study of sacituzumab tirumotecan, pembrolizumab and chemotherapy combination for early-stage triple-negative breast cancer or hormone receptor-low positive/HER2-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 studies the treatment of triple-negative breast cancer and hormone receptor-low positive/HER2-negative breast cancer in its early stages. The study evaluates a new treatment approach using sacituzumab tirumotecan (also known as MK-2870) followed by carboplatin and paclitaxel, compared to standard chemotherapy. Both treatment options will be combined with pembrolizumab (Keytruda), a medication that helps the immune system fight cancer cells.

The treatment plan involves giving medications before surgery (neoadjuvant therapy) to shrink the tumor. The study medications are given through an intravenous infusion directly into the bloodstream. Some participants will receive the new combination with sacituzumab tirumotecan, while others will receive standard chemotherapy which may include doxorubicin, epirubicin, or cyclophosphamide. All participants will also receive dexamethasone to help manage side effects, and some may receive capecitabine as part of their treatment.

The main purpose of this research is to determine whether the new treatment combination is more effective at eliminating cancer cells before surgery compared to standard chemotherapy. The study will also track how long participants remain free of cancer after treatment and monitor their overall survival. Researchers will carefully watch for any side effects and evaluate how the treatments affect participants' quality of life.

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

    Initial treatment assignment

    You will be randomly assigned to one of two treatment groups for breast cancer therapy

    Both groups will receive pembrolizumab (given through intravenous infusion)

  2. Step 2

    Treatment Group A

    If assigned to Group A, you will receive:

    First phase: sacituzumab tirumotecan (MK-2870) through intravenous infusion

    Second phase: Combination of carboplatin and paclitaxel through intravenous infusion

  3. Step 3

    Treatment Group B

    If assigned to Group B, you will receive standard chemotherapy which may include:

    Doxorubicin through intravenous infusion

    Epirubicin through intravenous infusion

    Cyclophosphamide through intravenous infusion

    Capecitabine taken by mouth

    Dexamethasone taken by mouth

  4. Step 3

    Surgery evaluation

    After completing the treatment phase, you will undergo surgery

    The medical team will evaluate how well the treatment worked by examining the breast tissue removed during surgery

  5. Step 4

    Follow-up assessments

    Regular check-ups to monitor your health status

    Completion of quality of life questionnaires about your physical functioning and treatment side effects

    Monitoring for any side effects or adverse events

  6. Step 5

    Study duration

    The study is planned to run from July 2025 to December 2034

    Your individual participation duration will be determined by your treatment plan and follow-up schedule

Who can join the trial?

10 criteria

  • You must have early-stage breast cancer that has not spread to other parts of the body (non-metastatic) and has not been treated before. The cancer must be either:
    • A tumor size larger than 2 cm but less than 5 cm with or without lymph node involvement, or
    • A tumor smaller than 2 cm with lymph node involvement
    • Your breast cancer must be confirmed by central testing as either:
      • Triple-negative breast cancer (cancer that does not have receptors for estrogen, progesterone, and HER2), or
      • Hormone receptor-low positive/HER2 negative breast cancer (cancer with low levels of hormone receptors and no HER2)
      • You must have good physical function, rated as ECOG 0 or 1 (able to perform daily activities with minimal assistance) within 28 days before starting treatment
      • Your heart function test must show a left ventricle ejection fraction (measurement of heart pumping ability) of 50% or higher
      • If you have previous exposure to anthracycline medications (a type of chemotherapy), your total lifetime doses must not exceed:
        • Doxorubicin: less than 100 mg/m²
        • Epirubicin: less than 180 mg/m²
        • Mitoxantrone: less than 40 mg/m²
        • Idarubicin: less than 22.5 mg/m²

Who cannot join the trial?

15 criteria

  • Previous cancer treatment with pembrolizumab (a type of immunotherapy drug) or similar medications
  • Active, untreated brain metastases (cancer that has spread to the brain)
  • Severe autoimmune disease (when your immune system attacks your own body)
  • History of pneumonitis (lung inflammation) requiring steroid treatment
  • Active infection requiring systemic treatment (medication that affects your whole body)
  • Uncontrolled high blood pressure
  • Unstable heart disease
  • History of organ transplant
  • Known HIV infection
  • Active hepatitis B or C infection
  • Pregnant or breastfeeding women
  • Unable to take oral medications
  • Any condition that would make participation unsafe
  • Participation in another clinical trial within the last 30 days
  • Unable to undergo required medical procedures
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Investigated drugs

  • Sacituzumab Tirumotecan

    is a medication that combines an antibody that targets breast cancer cells with a drug that helps kill these cells. It's specifically designed to treat triple-negative breast cancer and certain types of hormone receptor-low breast cancers.

  • Carboplatin

    is a chemotherapy medication that works by interfering with cancer cell DNA, helping to stop cancer cells from growing and dividing.

  • Paclitaxel

    is a chemotherapy drug that works by stopping cancer cells from dividing and growing. It's commonly used in the treatment of various types of cancer, including breast cancer.

  • Pembrolizumab

    is an immunotherapy medication that helps your immune system fight cancer cells. It works by blocking a protein that prevents your immune system from attacking cancer cells, allowing your body's natural defenses to work better against the cancer.

What is already known about the treatment

  • Sacituzumab Tirumotecan (Sac-TMT)

    An investigational antibody-drug conjugate administered intravenously that specifically targets Trop-2 expressing cancer cells, being studied for the treatment of triple-negative breast cancer (TNBC) and hormone receptor-low positive/HER2-negative breast cancer. It combines a humanized antibody with a potent topoisomerase I inhibitor, delivering targeted chemotherapy to cancer cells while potentially minimizing effects on healthy tissue.

  • Pembrolizumab

    An immunotherapy medication administered through intravenous infusion that works by helping the immune system detect and fight cancer cells. It belongs to a class of drugs called PD-1 inhibitors and is being studied in combination with other treatments for early-stage breast cancer, particularly in neoadjuvant therapy settings.

  • Carboplatin

    A platinum-based chemotherapy drug administered intravenously that works by binding to DNA and interfering with cell division, commonly used in various cancer treatments including breast cancer. It belongs to the alkylating agents class of chemotherapy drugs and is often used in combination therapy protocols.

  • Paclitaxel

    A chemotherapy medication given through intravenous infusion that works by stopping cancer cell division by targeting tubulin, a protein essential for cell division. It belongs to the taxane class of drugs and is widely used in breast cancer treatment protocols, often in combination with other anti-cancer medications.

Investigated diseases

  • Triple-negative breast cancer (TNBC)

    A type of breast cancer where the cancer cells lack receptors for estrogen, progesterone, and HER2 protein. This cancer develops in the breast tissue and can grow quickly. The disease begins when breast cells start to multiply uncontrollably, forming a tumor. TNBC accounts for about 10-15% of all breast cancers.

  • Hormone receptor-low positive breast cancer

    A form of breast cancer characterized by cells that have a low expression of hormone receptors (estrogen or progesterone) and are HER2 negative. This cancer develops when breast cells with low levels of hormone receptors begin to multiply abnormally. The disease represents a distinct subtype of breast cancer with unique biological characteristics.

  • Ductal carcinoma in situ (DCIS)

    A non-invasive breast cancer that starts in the milk ducts of the breast. In this condition, abnormal cells are contained within the ducts and haven't spread to surrounding breast tissue. DCIS is considered an early form of breast cancer. The abnormal cells look similar to invasive cancer cells when viewed under a microscope.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-520190-12-00Protocol codeMK-2870-032Estimated enrolment2 514 patientsSponsorMerck Sharp & Dohme LLC

sourced from the EU Clinical Trials Register and site verification

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