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Study of Patritumab Deruxtecan and Pembrolizumab for Patients with High-Risk Early-Stage Triple-Negative or Hormone Receptor-Low Positive Breast Cancer

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 clinical trial is focused on studying treatments for a type of breast cancer known as high-risk early-stage triple-negative breast cancer or hormone receptor-low positive/HER2-negative breast cancer. The study involves several medications, including patritumab deruxtecan (also known as MK-1022), pembrolizumab (also known as Keytruda), carboplatin, paclitaxel, epirubicin hydrochloride, doxorubicin hydrochloride, cyclophosphamide, capecitabine, and olaparib. These medications are used in different combinations to explore their safety and effectiveness in treating the specified types of breast cancer.

The purpose of the study is to evaluate the safety and effectiveness of these treatments when given in different sequences. Participants will receive these medications through intravenous infusion, which means the medicine is given directly into a vein, or orally, which means the medicine is taken by mouth. The study will compare the effects of these treatments when given before or after surgery, as well as their impact on the cancer's response to treatment.

Throughout the study, participants will be monitored for any side effects and the overall response of their cancer to the treatment. The study aims to determine the best treatment sequence to improve outcomes for patients with these specific types of breast cancer. The trial will continue for several years to gather comprehensive data on the effectiveness and safety of the treatments being tested.

The research process

The trial runs in 7 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 will be informed about the trial's objectives and procedures. The participant will be required to provide informed consent, acknowledging understanding of the study and agreeing to participate.

  2. Step 2

    Initial assessment

    The participant will undergo an initial assessment to confirm eligibility. This includes a review of medical history, a physical examination, and necessary tests to ensure the participant meets the study criteria.

  3. Step 3

    Treatment phase 1

    The participant will receive **patritumab deruxtecan** and **pembrolizumab** through an intravenous infusion. The frequency and dosage will be determined by the study protocol and communicated to the participant by the medical team.

  4. Step 4

    Treatment phase 2

    Following the initial treatment, the participant will receive **carboplatin** and **paclitaxel** along with **pembrolizumab** through intravenous infusion. The medical team will provide specific instructions regarding the schedule and dosage.

  5. Step 5

    Surgery

    After completing the treatment phases, the participant will undergo surgery to remove any remaining cancerous tissue. The timing and specifics of the surgery will be discussed with the participant by the surgical team.

  6. Step 6

    Adjuvant treatment

    Post-surgery, the participant will receive additional **pembrolizumab** treatment to help prevent cancer recurrence. This will be administered through intravenous infusion as per the study protocol.

  7. Step 7

    Follow-up assessments

    The participant will attend regular follow-up appointments to monitor health and assess the effectiveness of the treatment. These assessments will include physical exams and necessary tests as determined by the medical team.

Who can join the trial?

7 criteria

  • Must have locally advanced, non-metastatic (M0) breast cancer. This means the cancer has not spread to other parts of the body.
  • Must have a confirmed diagnosis of either triple-negative breast cancer (TNBC) or hormone receptor low positive/human epidermal growth factor receptor 2 negative (HR-low+/HER2-) breast cancer.
  • If positive for Hepatitis B, must have been on antiviral therapy for at least 4 weeks and have an undetectable viral load.
  • If there is a history of Hepatitis C infection, the viral load must be undetectable.
  • Must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. This is a scale used to assess how the disease affects daily living abilities, where 0 means fully active and 1 means some symptoms but nearly fully active.
  • Must have a left ventricular ejection fraction (LVEF) of 50% or higher, or at least the lower limit of normal. This is a measure of how well the heart is pumping blood, assessed by an echocardiogram (ECHO) or a multigate acquisition scan (MUGA).
  • Open to both female and male participants.

Who cannot join the trial?

10 criteria

  • Patients with a history of severe allergic reactions to any of the study drugs.
  • Patients who have received any other cancer treatment within the last 4 weeks.
  • Patients with uncontrolled illnesses such as heart disease, high blood pressure, or diabetes.
  • Patients who are pregnant or breastfeeding.
  • Patients with active infections that require treatment.
  • Patients with a history of another type of cancer within the last 5 years, except for certain skin cancers or in situ cervical cancer.
  • Patients with known brain metastases, which means cancer that has spread to the brain.
  • Patients with a history of autoimmune diseases, which are conditions where the immune system attacks the body.
  • Patients who have received a live vaccine within 30 days before the first dose of the study drug.
  • Patients with a history of drug or alcohol abuse within the last 12 months.
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Investigated drugs

  • Patritumab Deruxtecan

    is a type of targeted cancer therapy. It works by attaching to a specific protein on cancer cells called HER3. Once attached, it delivers a powerful anti-cancer drug directly into the cancer cells, which helps to kill them. This medication is being studied to see if it can help treat certain types of breast cancer by stopping the growth of cancer cells.

  • Pembrolizumab

    is an immunotherapy drug. It helps your immune system fight cancer by blocking a protein called PD-1. This protein can stop the immune system from attacking cancer cells. By blocking PD-1, pembrolizumab allows the immune system to better recognize and destroy cancer cells. It is used in this trial to see if it can improve the treatment of breast cancer when used with other therapies.

  • Carboplatin

    is a chemotherapy drug. It works by damaging the DNA of cancer cells, which stops them from dividing and growing. This helps to kill the cancer cells. In this trial, carboplatin is used to see if it can help treat breast cancer when combined with other medications.

  • Paclitaxel

    is another chemotherapy drug. It works by interfering with the normal function of microtubules during cell division, which prevents cancer cells from dividing and growing. This helps to kill the cancer cells. The trial is testing paclitaxel to see if it can be effective in treating breast cancer when used with other treatments.

What is already known about the treatment

  • Patritumab Deruxtecan

    This medication is administered intravenously, meaning it is given through a vein. It is currently being studied in clinical trials for its effectiveness and safety in treating certain types of breast cancer, specifically high-risk early-stage triple-negative breast cancer or hormone receptor low positive/HER2-negative breast cancer. The main purpose of this medication is to help the immune system target and destroy cancer cells. It works by attaching to a specific protein on cancer cells and delivering a toxic substance directly to them, which helps to kill the cancer cells. Patritumab Deruxtecan is classified as an antibody-drug conjugate, a type of targeted cancer therapy.

  • Pembrolizumab

    This medication is also administered intravenously and is being studied in combination with other drugs for treating certain breast cancers. It is already widely used in medicine for various cancers, including melanoma and lung cancer. Pembrolizumab helps the immune system recognize and attack cancer cells by blocking a specific pathway that cancer cells use to hide from the immune system. It is classified as an immune checkpoint inhibitor, which is a type of immunotherapy that boosts the body's natural defenses to fight cancer.

Investigated diseases

  • Triple Negative Breast Cancer (TNBC)

    Triple Negative Breast Cancer is a type of breast cancer that lacks three common receptors known to fuel most breast cancer growth: estrogen, progesterone, and the HER2 protein. This cancer tends to grow and spread more quickly than other types of breast cancer. It is more likely to be diagnosed in younger women and is often more aggressive. TNBC can spread to other parts of the body, including the brain, liver, and bones. The progression of TNBC can vary, but it often requires more intensive treatment due to its aggressive nature.

  • Hormone Receptor Low Positive/Human Epidermal Growth Factor Receptor 2 Negative (HR-low+/HER2-) Breast Cancer

    This type of breast cancer is characterized by low levels of hormone receptors and the absence of the HER2 protein. It behaves differently from other breast cancers, often showing a slower progression compared to triple negative types. The cancer cells may still respond to hormone signals, but to a lesser extent, which can influence their growth and spread. This type of cancer can affect various parts of the body, including lymph nodes and distant organs. The progression can be variable, with some cases showing a more indolent course. Understanding the specific receptor status is crucial for determining the appropriate management approach.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-514376-40-00Protocol codeMK-1022-010Estimated enrolment46 patientsSponsorMerck Sharp & Dohme LLC

sourced from the EU Clinical Trials Register and site verification

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