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Study of Pembrolizumab and Chemotherapy for Patients with Triple Negative Breast Cancer

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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 Triple Negative Breast Cancer (TNBC), a type of breast cancer that does not have any of the three common receptors known to fuel most breast cancer growth. The study is evaluating the effectiveness of a medication called Pembrolizumab, also known by its code name MK-3475, in combination with chemotherapy drugs. The chemotherapy drugs being used in this study include Doxorubicin, Cyclophosphamide, Paclitaxel, Carboplatin, Epirubicin, and Filgrastim. A Placebo is also used for comparison purposes.

The purpose of the study is to determine how well Pembrolizumab, when combined with chemotherapy, works as a treatment before surgery (neoadjuvant therapy) and after surgery (adjuvant therapy) for patients with TNBC. Participants in the study will receive either Pembrolizumab plus chemotherapy or a placebo plus chemotherapy before surgery. After surgery, they will continue to receive either Pembrolizumab or a placebo. The study aims to see if this treatment can help reduce the cancer in the breast and lymph nodes, and improve the time patients remain free from cancer events.

The study will take place over a period of time, with participants receiving treatments and undergoing evaluations to monitor their response to the therapy. The goal is to assess the rate of complete response, meaning no remaining cancer in the breast or lymph nodes, and to evaluate the overall survival and quality of life of the participants. This research is important for understanding how Pembrolizumab and chemotherapy can be used effectively to treat TNBC and improve outcomes for patients with this challenging type of breast 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 patient will begin the initial treatment phase. This phase involves receiving a combination of medications designed to treat triple negative breast cancer.

    The patient will receive pembrolizumab as a solution for infusion. This medication is administered at a concentration of 25 mg/mL. The frequency and duration of administration will be determined by the study protocol.

    In addition to pembrolizumab, the patient will receive chemotherapy drugs, including paclitaxel and carboplatin, both administered as solutions for infusion. The specific dosage and schedule will be provided by the healthcare team.

  2. Step 2

    Neoadjuvant therapy

    During the neoadjuvant therapy phase, the patient will continue to receive the combination of pembrolizumab and chemotherapy. This phase aims to reduce the size of the tumor before surgery.

    The patient will be monitored regularly to assess the response to the treatment. This may involve imaging tests and other assessments as determined by the healthcare team.

  3. Step 3

    Surgery

    After completing the neoadjuvant therapy, the patient will undergo surgery to remove any remaining tumor tissue. The timing of the surgery will be based on the response to the initial treatment phase.

    The surgery aims to achieve a pathological complete response, meaning no invasive cancer remains in the breast or lymph nodes.

  4. Step 4

    Adjuvant therapy

    Following surgery, the patient will enter the adjuvant therapy phase. This phase involves additional treatment to help prevent the cancer from returning.

    The patient will continue to receive pembrolizumab or a placebo, depending on the study group assignment. The frequency and duration of this treatment will be specified by the study protocol.

  5. Step 5

    Follow-up

    After completing all treatment phases, the patient will enter a follow-up period. This involves regular check-ups to monitor for any signs of cancer recurrence and to assess overall health.

    The follow-up period will include scheduled visits with the healthcare team and may involve imaging tests and other assessments as needed.

Who can join the trial?

6 criteria

  • The patient must have a newly diagnosed, locally advanced, and centrally confirmed case of Triple Negative Breast Cancer (TNBC). This is a specific type of breast cancer.
  • The patient must not have received any previous treatment for their locally advanced, non-metastatic TNBC. Non-metastatic means the cancer has not spread to other parts of the body.
  • The patient must provide a core needle biopsy, which is a procedure where a small sample of the tumor is taken using a needle. At least two separate samples from the primary tumor are needed for the study.
  • The patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. This is a scale used to assess how the disease affects the daily living abilities of the patient, with 0 meaning fully active and 1 meaning some symptoms but nearly fully active.
  • The patient must have adequate organ function, meaning their organs are working well enough to participate in the study.
  • Both male and female patients of childbearing potential must agree to use an adequate method of contraception during the study and for a period after the last dose of study treatment. This is to prevent pregnancy during the study.

Who cannot join the trial?

10 criteria

  • Patients with any other type of cancer besides Triple Negative Breast Cancer (TNBC) cannot participate.
  • Patients who have had a different type of cancer in the past are not eligible.
  • Patients with serious heart problems are excluded.
  • Patients with uncontrolled high blood pressure cannot join the study.
  • Patients with severe liver or kidney disease are not allowed to participate.
  • Patients who are pregnant or breastfeeding cannot take part in the trial.
  • Patients who have an active infection that requires treatment are excluded.
  • Patients who have received another experimental treatment within the last 4 weeks are not eligible.
  • Patients with a known allergy to the study medication cannot participate.
  • Patients who are unable to follow the study procedures for any reason are excluded.
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Investigated drugs

  • Pembrolizumab

    is a type of medication known as an immunotherapy. It works by helping your immune system fight cancer cells. In this trial, pembrolizumab is being tested to see if it can help treat triple-negative breast cancer when used alongside chemotherapy before surgery and on its own after surgery. The goal is to see if it can reduce the cancer or prevent it from coming back.

  • Chemotherapy

    is a treatment that uses drugs to kill cancer cells. In this trial, chemotherapy is used in combination with pembrolizumab before surgery to try to shrink the cancer and make it easier to remove. The specific drugs used in chemotherapy can vary, but they generally work by targeting and destroying rapidly dividing cancer cells.

What is already known about the treatment

Pembrolizumab – Pembrolizumab is administered as an intravenous infusion, meaning it is given directly into the bloodstream through a vein. It is currently being studied in clinical trials for its effectiveness in treating Triple Negative Breast Cancer (TNBC), a type of breast cancer that lacks three common receptors known to fuel most breast cancer growth. Pembrolizumab works by helping the immune system recognize and attack cancer cells, specifically by blocking a protein called PD-1 on the surface of immune cells, which can otherwise prevent the immune system from attacking cancer. It is classified as an immune checkpoint inhibitor, a type of drug that helps the immune system fight cancer.

Investigated diseases

Triple Negative Breast Cancer – Triple Negative Breast Cancer (TNBC) is a type of breast cancer that lacks the presence of estrogen receptors, progesterone receptors, and excess HER2 protein. This means it does not respond to hormonal therapy or medicines that target HER2 protein receptors. TNBC 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 more common in women with a BRCA1 gene mutation. The progression of TNBC can vary, but it often involves the rapid growth of cancer cells and potential spread to other parts of the body. The absence of targeted receptors makes it challenging to treat with conventional hormone therapies.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-501382-49-00Protocol codeMK-3475-522Estimated enrolment1 174 patientsSponsorMerck Sharp & Dohme LLC

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