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Study on Preoperative Treatment for HER2-Negative Breast Cancer Using Pembrolizumab, Paclitaxel, and Carboplatin in Patients Not Responding to Initial Chemotherapy

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 breast cancer. The study is investigating the effectiveness and safety of combining a specific type of immunotherapy with radiation therapy and standard chemotherapy. The immunotherapy being tested is called pembrolizumab, which is compared to a placebo. Pembrolizumab is a medication that helps the immune system fight cancer cells. The trial aims to see if this combination can improve treatment outcomes for patients whose cancer has not responded well to initial chemotherapy.

Participants in the study will receive a combination of treatments before surgery. This includes a boost of radiation therapy, a short course of immunotherapy with either pembrolizumab or a placebo, and standard chemotherapy. The chemotherapy drugs used in this study include paclitaxel and carboplatin, which are commonly used to treat breast cancer. The study will monitor how well the cancer responds to these treatments and assess any side effects experienced by the participants.

The trial is designed to help researchers understand if adding pembrolizumab to the treatment plan can lead to better outcomes for patients with HER2-negative breast cancer. The study will also evaluate the quality of life of participants and the time it takes for the cancer to return, if it does. By comparing the results of those receiving pembrolizumab with those receiving a placebo, the study aims to provide valuable insights into the potential benefits of this treatment approach.

The research process

The trial runs in 10 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, you will be informed about the trial's purpose, procedures, and potential risks and benefits. You will be required to provide written consent to participate.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to confirm eligibility. This includes a review of your medical history, physical examination, and necessary laboratory tests to ensure you meet the study criteria.

  3. Step 3

    First chemotherapy cycle

    You will receive a standard chemotherapy treatment, which includes medications such as paclitaxel and carboplatin. These are administered through an intravenous (IV) infusion. The specific dosage and frequency will be determined by the study team.

  4. Step 4

    PET/CT scan

    After the first chemotherapy cycle, a PET/CT scan will be performed. This scan helps assess the metabolic response of the cancer to the initial treatment.

  5. Step 5

    Randomization

    Based on the PET/CT scan results, you will be randomly assigned to receive either pembrolizumab (an immunotherapy drug) or a placebo. This process is double-blind, meaning neither you nor the study team will know which treatment you are receiving.

  6. Step 6

    Immunotherapy and radiotherapy

    You will receive a short course of immunotherapy with pembrolizumab or placebo, combined with a stereotactic radiation therapy boost. These treatments are administered preoperatively to enhance the effectiveness of the chemotherapy.

  7. Step 7

    Ongoing assessments

    Throughout the trial, regular assessments will be conducted to monitor your health and the cancer's response to treatment. This includes physical exams, blood tests, and imaging studies as needed.

  8. Step 8

    Surgery

    Following the completion of the preoperative treatments, surgery will be performed to remove the tumor. The surgical procedure will be planned based on the response to the treatments.

  9. Step 9

    Postoperative evaluation

    After surgery, a histopathological examination of the removed tissue will be conducted to assess the extent of tumor regression. This evaluation helps determine the effectiveness of the preoperative treatments.

  10. Step 10

    Follow-up

    Regular follow-up visits will be scheduled to monitor your recovery and check for any signs of cancer recurrence. These visits will include physical exams and possibly additional imaging tests.

Who can join the trial?

18 criteria

  • Must be a woman or man over 18 years of age at the time of signing the consent form for the study.
  • No contraindications to radiation treatment, which means no medical reasons that would prevent you from safely receiving radiation therapy.
  • ECOG PS performance status 0 or 1, which means you are fully active or have some symptoms but do not need bed rest during the day.
  • Healthy bone marrow function, shown by specific blood test results: hemoglobin concentration of at least 9 g/dL, neutrophil count of at least 1500/μL, and platelet count of at least 100,000/μL.
  • Bilirubin concentration should be no more than 1.5 times the normal upper limit, unless you have Gilbert's syndrome, a mild liver condition.
  • AST and ALT levels should be no more than 3 times the normal upper limit. These are liver enzymes measured in blood tests.
  • Creatinine level should be within normal limits, or creatinine clearance should be at least 50 mL/min. This measures kidney function.
  • Left ventricular ejection fraction (EF) should be at least 50%. This is a measure of how well your heart pumps blood.
  • No contraindications for breast MRI, meaning you can safely undergo a breast magnetic resonance imaging scan.
  • If you can have children, you must agree to use effective contraception before, during, and after the study for a specified time (12 months for women, 14 weeks for men).
  • Must provide written informed consent to participate in the study, meaning you agree to join the study after understanding all the details.
  • Must have a diagnosis of invasive breast cancer.
  • Must be eligible for standard preoperative breast cancer chemotherapy with specific drugs, as determined by the study doctor.
  • Must have breast cancer at a specific stage, with certain conditions for metastatic disease (cancer that has spread to other parts of the body).
  • Must have a triple negative or HER2-negative tumor, which are specific types of breast cancer based on certain protein expressions.
  • Multiple tumors are allowed if they are all HER2-negative, except for small satellite tumors.
  • No prior chemotherapy for the current breast cancer diagnosis and no prior anthracycline chemotherapy for any reason, with some exceptions for previous treatments.
  • Previous cancer treatment is allowed if it was completed at least 1 year ago and did not include radiation to the same chest area as the current breast cancer.

Who cannot join the trial?

5 criteria

  • Patients who have a type of breast cancer that is not HER2 negative. HER2 is a protein that can affect the growth of cancer cells.
  • Patients who are not resistant to classical chemotherapy. This means their cancer must not have responded well to standard chemotherapy treatments.
  • Patients who are not within the specified age range for the study.
  • Patients who are not eligible based on gender requirements, as the study includes both male and female participants.
  • Patients who belong to a vulnerable population, which means they might need special protection or care.
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Investigated drugs

Pembrolizumab is a type of immunotherapy used in this clinical trial. It works by helping your immune system recognize and attack cancer cells. Pembrolizumab is known as a checkpoint inhibitor, which means it blocks a specific protein on the surface of immune cells, allowing them to better fight cancer. In this study, it is being used in combination with other treatments to see if it can improve outcomes for patients with a specific type of breast cancer.

Stereotactic radiation therapy is a highly precise form of radiation treatment. It targets the cancerous area with high doses of radiation while minimizing exposure to the surrounding healthy tissue. In this trial, it is used as a preoperative treatment, meaning it is given before surgery, to try to shrink the tumor and make it easier to remove.

Standard chemotherapy refers to the use of drugs to kill cancer cells or stop them from growing. In this trial, chemotherapy is part of the treatment plan for patients with breast cancer. It is used alongside other therapies to try to improve the effectiveness of the overall treatment strategy.

What is already known about the treatment

Pembrolizumab – Pembrolizumab is administered as an injection into a vein, typically given in a hospital or clinic setting. It is currently being studied in clinical trials for its effectiveness in treating HER2-negative breast cancer that does not respond well to standard chemotherapy. The main therapeutic use of pembrolizumab is to help the immune system fight cancer by blocking a specific protein called PD-1, which can prevent immune cells from attacking cancer cells. Pembrolizumab is classified as an anti-PD-1 immunotherapy, a type of treatment that enhances the body's natural defenses to combat cancer.

Investigated diseases

HER2-negative breast cancer – HER2-negative breast cancer is a type of breast cancer that does not have an excess of the HER2 protein on the surface of its cells. This form of cancer is typically driven by other factors, such as hormone receptors or genetic mutations. It can begin as a localized tumor in the breast tissue and may spread to nearby lymph nodes. Over time, if not managed, it can progress to other parts of the body. The growth rate and pattern can vary, with some tumors growing slowly and others more rapidly. The progression is influenced by various factors, including the cancer's specific characteristics and the patient's overall health.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-504145-31-00Protocol codeBREAST-BOOSTEREstimated enrolment78 patientsSponsorNarodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie-Panstwowy Instytut Badawczy

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