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Study of Pembrolizumab with Chemotherapy for Patients with HER2-Negative Inflammatory 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 a type of breast cancer known as HER2-negative inflammatory breast cancer. The study is investigating the effects of a treatment combination that includes Pembrolizumab, also known by its code name MK-3475, along with a chemotherapy regimen called EC-Paclitaxel. The purpose of the study is to evaluate how well this combination works in treating the cancer and to observe any potential side effects.

Participants in the study will receive the treatment through an intravenous infusion, which means the medication is delivered directly into the bloodstream through a vein. The study will take place over several months, during which participants will receive the treatment and be monitored for their response to it. The study aims to see if the cancer can be reduced or eliminated before surgery, which is known as a pathological complete response. Additionally, the study will assess the safety of the treatment by monitoring for any significant side effects.

The medications involved in this study include Pembrolizumab, Cyclophosphamide, Epirubicin, and Paclitaxel. These are commonly used in cancer treatment and work in different ways to target and destroy cancer cells. The study is designed to provide valuable information on the effectiveness and safety of this treatment combination for patients with HER2-negative inflammatory breast cancer.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial treatment phase

    The treatment begins with the administration of pembrolizumab, a medication given through an intravenous infusion. This phase is designed to assess the body's response to the treatment and any potential side effects.

    The dosage and frequency of pembrolizumab are determined by the medical team based on individual health conditions and response to the treatment.

  2. Step 2

    Combination chemotherapy phase

    Following the initial phase, a combination of chemotherapy drugs is administered. These include cyclophosphamide, epirubicin hydrochloride, and paclitaxel, all given through intravenous infusion.

    The chemotherapy regimen is designed to work alongside pembrolizumab to enhance the treatment's effectiveness against breast cancer.

  3. Step 3

    Monitoring and assessment phase

    Throughout the trial, regular monitoring is conducted to assess the treatment's effectiveness and any side effects. This includes blood tests, imaging studies, and physical examinations.

    The primary goal is to evaluate the absence of any residual invasive cancer in the breast and lymph nodes after the treatment.

  4. Step 4

    Completion and follow-up phase

    Upon completion of the treatment regimen, a final assessment is conducted to determine the overall response to the therapy.

    Long-term follow-up is scheduled to monitor for any recurrence of cancer and to assess overall survival and quality of life.

Who can join the trial?

20 criteria

  • Participants must be at least 18 years old on the day they sign the consent form.
  • Participants must have good organ function, with tests done within 10 days before starting the study treatment.
  • Participants must have good blood health, meaning:
    • Enough white blood cells (absolute neutrophil count) and platelets.
    • Hemoglobin (Hb) levels must be high enough without needing extra help like blood transfusions or certain medications.
    • Participants must have good liver function, meaning:
      • Normal levels of bilirubin, a substance made by the liver.
      • Normal levels of liver enzymes called ASAT and ALAT.
      • Participants must have good kidney function, meaning:
        • Normal levels of creatinine, a waste product filtered by the kidneys.
        • Creatinine clearance, a measure of kidney function, must be high enough.
        • Participants must have normal blood clotting, measured by tests called International Normalized Ratio (INR) or Prothrombin Time (PT), unless they are on blood-thinning medication.
        • Participants must have good heart function, with a left ventricular ejection fraction (LVEF) of at least 50%. This measures how well the heart pumps blood.
        • Female participants must not be pregnant or breastfeeding and must follow specific birth control guidelines if they can have children.
        • Male participants must agree to use birth control and not donate sperm during the study and for a certain time after.
        • Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1, which means they are fully active or have some symptoms but can still do light work.
        • Participants must be able to follow the study rules.
        • Participants must be part of a social security system or have similar coverage.
        • Participants or their legal representatives must provide written consent to join the study.
        • Participants must have a new diagnosis of breast cancer that is confirmed by a lab test and must have inflammatory breast cancer, which includes symptoms like redness, swelling, or skin changes on the breast.
        • The cancer must be HER2 negative, which is a specific type of breast cancer.
        • The status of hormone receptors in the cancer must be known.
        • The cancer must not have spread to other parts of the body (no metastases).

Who cannot join the trial?

10 criteria

  • Patients who have a different type of cancer other than breast cancer.
  • Patients who are not within the specified age range for the study.
  • Patients who are not able to follow the study procedures or attend the required visits.
  • Patients who have other serious health conditions that might interfere with the study.
  • Patients who are pregnant or breastfeeding.
  • Patients who have had a recent heart attack or other serious heart problems.
  • Patients who have an active infection that requires treatment.
  • Patients who have a history of severe allergic reactions to the study medications.
  • Patients who are currently participating in another clinical trial.
  • Patients who have a history of drug or alcohol abuse that might affect their ability to participate in the study.
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Investigated drugs

  • Pembrolizumab

    is a medication used in this trial to help the body's immune system fight cancer. It works by blocking a specific protein that can stop the immune system from attacking cancer cells. This medication is being tested in combination with chemotherapy to see if it improves the treatment of HER2-negative inflammatory breast cancer.

  • Paclitaxel

    is a type of chemotherapy drug used in this trial. It works by stopping cancer cells from dividing and growing, which can help to shrink tumors. In this study, it is used as part of a combination treatment to see if it is more effective when given with other medications.

  • EC Regimen

    refers to a combination of two chemotherapy drugs, epirubicin and cyclophosphamide, used in this trial. These drugs work together to kill cancer cells and are given before surgery to try to reduce the size of the tumor. The trial is testing if adding pembrolizumab to this regimen improves outcomes for patients with HER2-negative inflammatory breast cancer.

What is already known about the treatment

Pembrolizumab – Pembrolizumab is administered intravenously and is currently being studied in clinical trials for its effectiveness in treating HER2-negative inflammatory breast cancer. It is an approved medication in the field of oncology and is well-documented in medical literature. The main therapeutic indication for pembrolizumab in this trial is breast cancer, specifically in combination with chemotherapy. At the molecular level, pembrolizumab works by blocking the PD-1 pathway, which helps the immune system recognize and attack cancer cells. It is classified as an immune checkpoint inhibitor.

Investigated diseases

Breast Cancer – Breast cancer is a disease where cells in the breast grow uncontrollably, forming a tumor that can often be felt as a lump. It typically begins in the ducts or lobules of the breast and can spread to other parts of the body if not treated. The progression of breast cancer can vary, with some types growing slowly and others more rapidly. It is often categorized by stages, which describe the size of the tumor and the extent of its spread. Early stages may not show symptoms, but as it progresses, symptoms like changes in breast shape, lumps, or skin changes may occur. Regular screenings and awareness of changes in the breast are important for early detection.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-514899-41-00Protocol codePELICAN-IPC 2015-016Estimated enrolment72 patientsSponsorInstitut Paoli Calmettes

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