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Study of Sacituzumab Tirumotecan and Pembrolizumab for Patients with Triple-Negative Breast Cancer Post-Surgery

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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). The study will explore the effectiveness and safety of a new treatment combination. The treatment involves a medication called MK-2870, which is a powder for solution for injection, used together with another medication called pembrolizumab, also known as Keytruda. Pembrolizumab is a concentrate for solution for infusion. The purpose of the study is to compare this combination treatment to other treatments chosen by doctors for patients who have undergone surgery for TNBC but did not achieve a complete response to their initial therapy.

Participants in the study will receive the treatment over a period of up to 24 months. The study will involve regular visits to the clinic for treatment administration and monitoring. The treatment will be given through an intravenous infusion, which means it will be delivered directly into the bloodstream through a vein. The study will also include the use of other medications such as capecitabine, dexamethasone, and paracetamol as needed, depending on the treatment plan chosen by the doctors. Some participants may receive a placebo instead of the active treatment to help compare the effects.

The main goal of the study is to assess how well the treatment works in preventing the return of cancer, known as invasive disease-free survival (iDFS). The study will also look at other important outcomes, such as overall survival and quality of life. Participants will be closely monitored for any side effects or adverse events during the study. The study aims to provide valuable information on the potential benefits of the new treatment combination for people with TNBC who have not fully responded to their initial therapy.

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

    Joining the study

    Upon joining the study, the participant is confirmed to have triple negative breast cancer (TNBC) and has undergone surgery without achieving a complete response.

    The participant must have completed neoadjuvant therapy and surgery according to guidelines and be ready to start the trial within 12 weeks post-surgery.

  2. Step 2

    Randomization

    The participant is randomly assigned to receive either the combination of MK-2870 and pembrolizumab or the treatment of the physician's choice, which may include pembrolizumab alone or with capecitabine.

  3. Step 3

    Treatment administration

    If assigned to the MK-2870 and pembrolizumab group, the participant receives MK-2870 as a powder for solution for injection and pembrolizumab as a solution for infusion.

    If assigned to the treatment of physician's choice, the participant may receive pembrolizumab as a solution for infusion, possibly combined with capecitabine taken orally.

  4. Step 4

    Monitoring and assessments

    Throughout the trial, the participant's health and response to treatment are monitored regularly.

    Assessments include checking for invasive disease-free survival and overall survival, as well as monitoring for any adverse events.

  5. Step 5

    Completion of the trial

    The trial is estimated to end by December 14, 2037, with the participant's involvement concluding upon completion of the treatment and final assessments.

Who can join the trial?

15 criteria

  • Has been diagnosed with triple negative breast cancer (TNBC), confirmed by specific medical guidelines.
  • If capable of producing sperm, agrees to use effective birth control during the study and for a certain period after the last dose of the study medication. Also agrees not to donate sperm during this time.
  • For females, is not pregnant or breastfeeding. If of childbearing potential, uses effective birth control during the study and for a specified time after the last dose of the study medication. Agrees not to breastfeed during the study and for a certain period afterward.
  • Has recovered from any side effects of previous cancer treatments to a mild level or back to normal, except for hair loss.
  • If living with HIV, the condition is well controlled with medication.
  • Has a good general health status, as measured by a specific performance scale, within 7 days before starting the study treatment.
  • If positive for hepatitis B, has been on antiviral therapy for at least 4 weeks and has no detectable virus in the blood before starting the study.
  • Has no signs of cancer returning in the local area or spreading to other parts of the body, as checked by the doctor.
  • Has received a specific type of pre-surgery treatment for TNBC, followed by surgery, and completed at least 5 doses of a particular medication and chemotherapy.
  • Has had all visible cancer removed from the breast and/or lymph nodes through surgery and has recovered well from the surgery.
  • Did not have a complete response to treatment at the time of surgery.
  • Is able to continue receiving a specific medication after surgery.
  • Is randomized to the study within 12 weeks after surgery.
  • If needed, has completed radiation therapy after surgery and has recovered before starting the study.
  • Has provided a tissue sample from the surgery for specific laboratory testing.

Who cannot join the trial?

4 criteria

  • Patients who have a different type of breast cancer other than triple negative breast cancer cannot participate. Triple negative breast cancer is a type of breast cancer that does not have three common receptors known to fuel most breast cancer growth.
  • Patients who are not within the specified age range for the study cannot participate. The age range is determined by the study organizers.
  • Patients who are part of a vulnerable population, which means they might need special protection or care, cannot participate.
  • Patients who do not meet other specific health criteria set by the study organizers cannot participate. These criteria are designed to ensure the safety and effectiveness of the study.
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Investigated drugs

  • MK-2870

    is an investigational medication being studied for its potential to help treat triple-negative breast cancer. It is being tested in combination with another medication to see if it can improve outcomes for patients who have not achieved a complete response to previous treatments.

  • Pembrolizumab

    is a medication used to help the immune system fight cancer cells. It is being used in this study to see if it can improve the effectiveness of treatment for patients with triple-negative breast cancer.

  • Capecitabine

    is a chemotherapy drug that is used to treat various types of cancer, including breast cancer. In this study, it is being combined with pembrolizumab to see if the combination can provide better results for patients who have not fully responded to earlier treatments.

What is already known about the treatment

  • MK-2870

    This medication is administered intravenously and is currently being studied in clinical trials for its effectiveness in treating triple-negative breast cancer. It is not yet widely used in standard medical practice, as it is still under investigation. The main therapeutic indication is for patients with triple-negative breast cancer who have not achieved a complete response after initial therapy. MK-2870 works by targeting specific proteins on cancer cells, helping the immune system to recognize and attack these cells. It is classified as an immunotherapy agent.

  • Pembrolizumab

    This medication is given through an intravenous infusion and is approved for use in various cancers, including triple-negative breast cancer. It is well-documented in medical literature and is used to help the immune system detect and fight cancer cells. Pembrolizumab is indicated for patients with triple-negative breast cancer who have not fully responded to initial treatments. It works by blocking a protein that prevents the immune system from attacking cancer cells, thus enhancing the body's immune response. It belongs to the class of drugs known as immune checkpoint inhibitors.

  • Capecitabine

    This medication is taken orally in pill form and is used in the treatment of various types of cancer, including breast cancer. It is well-established in medical practice and literature. Capecitabine is indicated for patients with triple-negative breast cancer as part of combination therapy. It works by interfering with the DNA production of cancer cells, which inhibits their growth and division. It is classified as an antimetabolite chemotherapy drug.

Investigated diseases

Triple Negative Breast Cancer – This is a type of breast cancer that does not have any of the three common receptors known to fuel most breast cancer growth: estrogen, progesterone, and the HER-2/neu gene. It is considered more aggressive and difficult to treat than other types of breast cancer. The cancer cells in triple negative breast cancer do not respond to hormonal therapy medicines or medicines that target HER2 protein receptors. It tends to grow and spread more quickly than other types of breast cancer. This type of cancer is more likely to affect younger women and those with a BRCA1 gene mutation. It is often diagnosed at a higher grade and stage, which can influence the approach to treatment.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-504962-52-00Protocol codeMK-2870-012Estimated enrolment1 501 patientsSponsorMerck Sharp & Dohme LLC

sourced from the EU Clinical Trials Register and site verification

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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).