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Study of Pembrolizumab, Carboplatin, and Paclitaxel for Patients with Stage I Triple-Negative 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 triple-negative breast cancer (TNBC), specifically in its early stage, referred to as stage I. The study aims to evaluate the effectiveness of a treatment combination that includes three medications: pembrolizumab, carboplatin, and paclitaxel. Pembrolizumab, also known by its code name MK-3475, is a medication that helps the immune system fight cancer cells. Carboplatin and paclitaxel are chemotherapy drugs that work by stopping the growth of cancer cells.

The purpose of this study is to assess how well this combination of medications can eliminate cancer cells before surgery. Participants will receive these medications over a period of time, and their response to the treatment will be closely monitored. The study will involve regular check-ups and assessments to see how the cancer responds to the treatment. The ultimate goal is to see if the cancer can be completely removed by the time of surgery.

Throughout the study, participants will undergo various tests and provide samples to help researchers understand the treatment's effects. The study will also monitor any side effects that may occur during the treatment. This research is important for finding more effective ways to treat early-stage triple-negative breast cancer and improve outcomes for patients with this type of cancer.

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 phase

    Upon joining the study, the first phase involves receiving three medications: pembrolizumab, carboplatin, and paclitaxel. These medications are administered through an intravenous infusion, which means they are given directly into a vein.

    Pembrolizumab is provided as a 25 mg/mL concentrate for solution for infusion. Carboplatin is given as a 10 mg/mL concentrate for solution for infusion. Paclitaxel is administered as a 6 mg/mL concentrate for solution for infusion.

    The frequency and dosage of these medications will be determined by the study protocol and the healthcare team overseeing the trial.

  2. Step 2

    Monitoring and assessment

    Throughout the treatment phase, regular monitoring and assessments are conducted to evaluate the response to the medications. This includes providing blood samples and undergoing imaging tests as required by the study protocol.

    After two cycles of treatment, an assessment is performed to determine the progress and any changes in the condition.

  3. Step 3

    End of treatment evaluation

    At the end of the treatment phase, a final evaluation is conducted before surgery. This involves providing additional blood samples and undergoing imaging tests to assess the effectiveness of the treatment.

    The main objective is to evaluate the pathological complete response, which is the absence of invasive cancer in both the breast and lymph nodes following the treatment.

  4. Step 4

    Surgery

    Following the completion of the treatment phase and final evaluation, surgery is performed to remove any remaining cancerous tissue.

    The success of the treatment is measured by the absence of invasive cancer in the tissue removed during surgery.

  5. Step 5

    Follow-up

    After surgery, follow-up appointments are scheduled to monitor recovery and any long-term effects of the treatment.

    These appointments are important to ensure the continued health and well-being of the patient.

Who can join the trial?

15 criteria

  • Sign a written informed consent form before starting any specific study procedures.
  • The tumor size must be between more than 10 mm and 20 mm by mammogram or ultrasound, or 25 mm or less after a biopsy by breast MRI. Note: Up to 25 mm is allowed if the MRI is done within 2 weeks after the biopsy due to tissue inflammation.
  • No cancer spread to lymph nodes, confirmed by clinical exam and local imaging tests.
  • Having tumors in both breasts or multiple tumors in one or both breasts is allowed. The most advanced tumor will be used to check eligibility, and TNBC must be confirmed for each tumor. Both armpits need to be checked for cancer spread.
  • No signs of cancer spreading to other parts of the body based on imaging tests.
  • No previous major surgery on the same side of the breast for the current cancer.
  • Agree to provide tumor tissue samples at the start and during surgery, and blood samples at the start, after two treatment cycles, and at the end of treatment before surgery.
  • No previous chemotherapy, targeted therapy, or radiation therapy for this cancer.
  • Females of childbearing potential must have a negative pregnancy test and agree to use effective birth control during treatment and for at least 4 months after the last dose of the study drug. They must not donate eggs or breastfeed during this time.
  • Male patients and females of childbearing potential who have heterosexual intercourse must agree to use effective birth control and not donate sperm or eggs during treatment and for at least 4 months after the last dose of the study drug.
  • Have adequate bone marrow, liver, and kidney function, as shown by specific blood test results.
  • Must be available for treatment and follow-up visits.
  • Must be 18 years of age or older.
  • Have an ECOG performance status of 0-1, which means being fully active or restricted in physically strenuous activity but able to carry out light work.
  • Have a confirmed diagnosis of TNBC based on local laboratory results, meaning the tumor has less than 1% expression of certain receptors and specific results for HER2 testing.

Who cannot join the trial?

7 criteria

  • Patients with any other type of cancer besides HR-negative/HER2-negative resectable stage I TNBC cannot participate. This means the study is only for a specific type of breast cancer.
  • Patients who have had previous treatment for this type of cancer are not eligible.
  • Patients with serious heart conditions cannot participate.
  • Patients with uncontrolled infections are not allowed to join the study.
  • Pregnant or breastfeeding women cannot take part in the study.
  • Patients who are unable to follow the study procedures for any reason are not eligible.
  • Patients with any other medical condition that the study doctors think would make it unsafe for them to participate cannot join.
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Investigated drugs

  • Pembrolizumab

    is a type of medication known as an immunotherapy. It works by helping your immune system recognize and attack cancer cells. In this study, pembrolizumab is used to help your body fight against triple-negative breast cancer by boosting your immune response to the cancer cells.

  • Carboplatin

    is a chemotherapy drug that is used to treat various types of cancer, including breast cancer. It works by damaging the DNA of cancer cells, which prevents them from growing and dividing. In this study, carboplatin is used to help shrink the tumor before surgery by stopping the cancer cells from multiplying.

  • Paclitaxel

    is another chemotherapy medication used in the treatment of cancer. It works by interfering with the normal function of microtubules during cell division, which stops cancer cells from growing and spreading. In this study, paclitaxel is used alongside other treatments to help reduce the size of the tumor before surgery.

What is already known about the treatment

  • Pembrolizumab

    Pembrolizumab is administered as an intravenous infusion, meaning it is given directly into a vein through a drip. It is currently being studied in clinical trials for its effectiveness in treating certain types of breast cancer, specifically HR-negative/HER2-negative resectable stage I triple-negative breast cancer (TNBC). The main therapeutic indication is to help the immune system recognize and attack cancer cells. At the molecular level, pembrolizumab works by blocking a protein called PD-1 on immune cells, which helps the immune system to better detect and fight cancer cells. It is classified as an immune checkpoint inhibitor, a type of immunotherapy.

  • Carboplatin

    Carboplatin is administered as an intravenous infusion, delivered directly into the bloodstream through a vein. It is a well-established chemotherapy drug used in the treatment of various cancers, including breast cancer, and is currently being studied in combination with other drugs for stage I triple-negative breast cancer (TNBC). Its main therapeutic indication is to kill cancer cells or stop them from growing. At the molecular level, carboplatin works by binding to DNA in cancer cells, causing damage that prevents the cells from dividing and growing. It is classified as a platinum-based chemotherapy agent.

  • Paclitaxel

    Paclitaxel is given as an intravenous infusion, meaning it is administered directly into a vein. It is a widely used chemotherapy medication for treating different types of cancer, including breast cancer, and is being studied in combination with other drugs for stage I triple-negative breast cancer (TNBC). The main therapeutic indication is to stop cancer cells from dividing and growing. At the molecular level, paclitaxel works by stabilizing the structure of microtubules, which are part of the cell's skeleton, thereby preventing cancer cells from dividing. It is classified as a taxane, a type of chemotherapy drug.

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 subtype of breast cancer is more aggressive and tends to grow and spread more quickly than other types. It is often diagnosed at a higher stage and is more likely to recur after treatment. TNBC is more common in younger women and those with a BRCA1 gene mutation. The progression of TNBC can vary, but it typically involves rapid growth and potential spread to other parts of the body. It is important to monitor for changes and manage symptoms as the disease progresses.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-513511-27-00Protocol codeMEDOPP599Estimated enrolment30 patientsSponsorMedica Scientia Innovation Research S.L.

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