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Evaluating sacituzumab tirumotecan alone or with pembrolizumab compared to standard treatment in untreated patients with metastatic triple-negative breast cancer with low PD-L1 expression

Verified siteRegistered drugNo placebo
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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 that has spread to other parts of the body or cannot be surgically removed. The study tests a new drug called sacituzumab tirumotecan (also known as MK-2870), both alone and in combination with another drug called pembrolizumab (KEYTRUDA). These treatments will be compared to standard treatment options which include paclitaxel, albumin-bound paclitaxel, or a combination of gemcitabine and carboplatin.

The purpose of this research is to determine how well sacituzumab tirumotecan works, both by itself and when combined with pembrolizumab, compared to standard treatments. The study will look at how these treatments affect cancer growth and patient survival. All medications will be given through intravenous infusion, which means they are delivered directly into the bloodstream through a vein.

During the study, patients will be randomly assigned to receive either sacituzumab tirumotecan alone, sacituzumab tirumotecan with pembrolizumab, or one of the standard treatment options. The study will monitor how the cancer responds to treatment and track any side effects that may occur. Patients will also complete questionnaires about their quality of life during treatment.

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 treatment assignment

    You will be randomly assigned to one of three treatment groups:

    - Group 1: sacituzumab tirumotecan alone

    - Group 2: sacituzumab tirumotecan combined with pembrolizumab

    - Group 3: physician's choice treatment (either paclitaxel, albumin-bound paclitaxel, or gemcitabine with carboplatin)

  2. Step 2

    Treatment administration

    All medications will be given through an intravenous infusion (directly into your vein)

    Treatment will continue until either:

    - Your disease shows signs of progression

    - You experience unacceptable side effects

    - Your doctor decides to stop the treatment

    Regular visits to the clinic will be required for treatment administration

  3. Step 3

    Monitoring and assessments

    Your health status will be regularly monitored through:

    - Physical examinations

    - Imaging tests to check how your disease responds to treatment

    You will complete quality of life questionnaires about:

    - Your overall health status

    - Physical functioning

    - Emotional well-being

    - Fatigue levels

    - Digestive symptoms

  4. Step 4

    Side effect monitoring

    Any side effects will be carefully tracked and documented

    Your doctor will monitor and manage any side effects that may occur

    You may stop treatment if serious side effects develop

  5. Step 5

    Study duration

    The study is planned to run from March 2025 to February 2030

    Your individual participation length will depend on how your body responds to the treatment

Who can join the trial?

10 criteria

  • Must have triple-negative breast cancer (TNBC) that has spread locally and cannot be surgically removed, or has spread to other parts of the body, and cannot be cured
  • Must not have received any previous treatments for advanced or spreading TNBC
  • If previously treated for early-stage breast cancer, all treatments must have been completed at least 6 months before the cancer came back
  • Must be suitable to receive pembrolizumab (an immunotherapy drug) and one of these chemotherapy options:
    • paclitaxel
    • nab-paclitaxel
    • gemcitabine with carboplatin
    • Must have recovered from side effects of previous cancer treatments to mild level or baseline condition, except for hair loss or skin pigment changes
    • If living with HIV, the infection must be well-controlled with antiviral medications
    • If positive for hepatitis B, must have been receiving antiviral treatment for at least 4 weeks with undetectable virus levels
    • If having a history of hepatitis C, virus levels must be undetectable

Who cannot join the trial?

12 criteria

  • Patients who have PD-L1 expression (a protein marker) below CPS score of 10 in their tumor tissue
  • Patients under 18 years of age
  • Patients who have previously received treatment with pembrolizumab (an immunotherapy medication)
  • Patients with active brain metastases (cancer that has spread to the brain) that are not stable
  • Patients with active autoimmune disease requiring systemic treatment
  • Patients who have received live vaccines within 30 days before starting the study treatment
  • Patients with active infections requiring systemic therapy
  • Patients who are pregnant or breastfeeding
  • Patients with known history of severe allergic reactions to study medications
  • Patients who have received other investigational drugs within 4 weeks before starting this study
  • Patients with inadequate organ function (including liver, kidney, or bone marrow problems)
  • Patients with uncontrolled high blood pressure or heart disease
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Investigated drugs

Sacituzumab Tirumotecan (sac-TMT) is a medication designed to target and treat breast cancer cells. It works by delivering an anti-cancer drug directly to cancer cells, helping to destroy them while limiting damage to healthy cells. Pembrolizumab is an immunotherapy medication that helps your immune system fight cancer cells. It works by blocking a protein called PD-L1, which can prevent your immune system from attacking cancer cells effectively. Treatment of Physician's Choice (TPC) refers to standard treatment options that your doctor may select based on your specific situation. This typically includes established cancer treatments that are currently available and approved for treating triple-negative breast cancer.

What is already known about the treatment

  • Sacituzumab Tirumotecan

    An investigational antibody-drug conjugate administered intravenously, specifically designed for treating triple-negative breast cancer (TNBC). This medication works by combining an antibody that targets Trop-2 (a protein commonly found on breast cancer cells) with a potent topoisomerase I inhibitor, delivering targeted chemotherapy to cancer cells. It is currently being studied in clinical trials for patients with locally recurrent unresectable or metastatic TNBC, particularly in cases where PD-L1 expression is low.

  • Pembrolizumab

    An FDA-approved immunotherapy medication administered through intravenous infusion that belongs to the class of PD-1 inhibitors. This medication works by helping the immune system recognize and attack cancer cells by blocking the PD-1 pathway, which cancer cells often use to hide from immune detection. It has shown effectiveness in various types of cancer and is being studied in combination with other treatments for triple-negative breast cancer, particularly in patients with specific PD-L1 expression levels.

Investigated diseases

Triple-negative breast cancer (TNBC) - A type of breast cancer where cancer cells lack three common receptors: estrogen, progesterone, and HER2 protein. This cancer typically develops in breast tissue and can spread to nearby tissues and other parts of the body. TNBC tends to grow and spread more quickly than other types of breast cancer. The term "locally recurrent" means the cancer has returned to the same area after previous treatment, while "metastatic" indicates the cancer has spread to other parts of the body. This type of cancer is characterized by the presence of PD-L1 proteins on tumor cells, which can be measured using a scoring system called CPS (Combined Positive Score).
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-516834-36-00Protocol codeMK-2870-011Estimated enrolment1 000 patientsSponsorMerck Sharp & Dohme LLC

sourced from the EU Clinical Trials Register and site verification

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