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Study on Pembrolizumab for Patients with Early Triple-Negative Breast Cancer Responding Well to Initial Treatment

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 patients with early-stage triple-negative breast cancer who have shown a strong response to initial treatments. The study is examining the use of a medication called pembrolizumab, which is given as a solution through an intravenous infusion. Pembrolizumab is a type of treatment that helps the immune system fight cancer cells. The trial aims to determine if simply observing patients after surgery is as effective as continuing treatment with pembrolizumab for six months in preventing the cancer from coming back.

Participants in the study will have already received standard chemotherapy and pembrolizumab before surgery and achieved a complete response, meaning no signs of cancer were found in the breast or lymph nodes. The study will compare two groups: one group will continue to receive pembrolizumab after surgery, while the other group will be closely monitored without further treatment. The goal is to see if both approaches offer similar protection against the cancer returning.

The trial will also look at the safety and side effects of pembrolizumab, as well as the overall quality of life of the participants. This includes monitoring for any new symptoms or health issues that may arise during the study. The study is expected to continue for several years to gather enough information to make a clear comparison between the two approaches. Participants will be regularly checked to ensure their health and well-being throughout the study period.

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

    Randomization

    Randomization occurs within 12 weeks after breast surgery. This step determines whether observation or additional treatment with pembrolizumab will be followed.

  2. Step 2

    Treatment or observation

    If assigned to the treatment group, pembrolizumab is administered. The medication is given intravenously, which means it is delivered directly into a vein.

    The treatment lasts for 6 months. The frequency and specific dosage are determined by the healthcare provider based on individual needs and responses.

  3. Step 3

    Monitoring and follow-up

    Regular follow-up visits are scheduled to monitor health status and any potential side effects. These visits include physical examinations and possibly imaging tests.

    Health-related quality of life and emotional well-being are assessed using questionnaires. These assessments help understand the impact of the treatment or observation on daily life.

  4. Step 4

    End of trial participation

    The trial concludes with a final evaluation. This includes a comprehensive review of health status and any changes experienced during the trial.

    The primary goal is to assess recurrence-free survival, which is the time from randomization to any recurrence of cancer or death from any cause.

Who can join the trial?

14 criteria

  • The patient must have signed a written informed consent before any trial-related procedures. If the patient cannot sign, a trusted person can confirm the patient's consent in writing.
  • The patient must have a specific type of breast cancer called triple-negative breast cancer (TNBC) or low estrogen/progesterone receptor breast cancer. This means the cancer does not have certain receptors that some other breast cancers have.
  • The patient must have been treated with a combination of chemotherapy and a drug called pembrolizumab before surgery, for at least 6 cycles.
  • After the treatment, there should be no remaining invasive cancer in the breast or lymph nodes. However, a non-invasive type called ductal carcinoma in situ (DCIS) is allowed.
  • The patient must have had surgery to remove all visible cancer in the breast and lymph nodes. This can be either breast-conserving surgery or a total mastectomy, with no cancer left at the edges of the removed tissue.
  • The patient must have received or have plans to receive adequate radiation therapy to the breast area.
  • The patient must have normal functioning of organs and bone marrow, as shown by specific blood tests done within 28 days before starting the trial.
  • The patient must be randomized into the study no more than 12 weeks after breast surgery. Radiation therapy is allowed and can be given with pembrolizumab if the doctor decides.
  • The patient must not be pregnant or breastfeeding. Women who can have children must have a negative pregnancy test within 7 days before starting the trial.
  • Women who can have children and male patients must agree to use effective birth control during the study and for up to 4 months after the last dose of study drugs.
  • The patient must be able and willing to attend study visits and follow the procedures outlined in the study.
  • The patient must be part of a Social Security System or an equivalent system.
  • The patient must be 18 years or older.
  • The patient must have an ECOG performance status of 0-2, which is a scale used to assess how well a patient can perform daily activities.

Who cannot join the trial?

5 criteria

  • Patients who have not achieved a pathologic complete response (pCR) after receiving chemotherapy and pembrolizumab before surgery. Pathologic complete response means that after treatment, no signs of cancer are found in tissue samples.
  • Patients who have not been diagnosed with early triple-negative breast cancer (TNBC). This is a type of breast cancer that does not have three common receptors known to fuel most breast cancer growth.
  • Patients who have not received neoadjuvant systemic chemotherapy and pembrolizumab. Neoadjuvant chemotherapy is treatment given before the main treatment, which is usually surgery, to shrink a tumor.
  • Patients who are not within the specified age range for the study.
  • Patients who are part of a vulnerable population, which means they might need special protection or care.
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Investigated drugs

Pembrolizumab is a medication used in this clinical trial. It is an immunotherapy drug that helps the body's immune system fight cancer cells. In this study, it is being tested to see if it can help prevent the return of cancer in patients with early-stage triple-negative breast cancer who have already responded well to initial treatments.

What is already known about the treatment

Pembrolizumab – Pembrolizumab is administered as an intravenous infusion, typically given in a clinical setting. It is currently a well-established medication in the field of oncology, with extensive documentation in medical literature. The primary therapeutic indication for pembrolizumab is the treatment of various cancers, including early-stage triple-negative breast cancer, particularly in patients who have achieved a pathologic complete response after neoadjuvant chemotherapy. At the molecular level, pembrolizumab works by blocking the PD-1 pathway, which enhances the immune system's ability to detect and destroy cancer cells. It is classified as an immune checkpoint inhibitor, a type of immunotherapy that helps the body's immune system fight cancer.

Investigated diseases

Triple-Negative Breast Cancer (TNBC) – This is a type of breast cancer that does not have any of the three common receptors known to fuel most breast cancer growth: estrogen, progesterone, and the HER-2/neu gene. TNBC is often more aggressive and has fewer treatment options compared to other breast cancer types. It is more likely to spread and recur, especially within the first few years after diagnosis. TNBC is typically diagnosed through a biopsy and is characterized by the absence of hormone receptors. It is more common in younger women and those with a BRCA1 gene mutation. The progression of TNBC can vary, but it often requires a combination of surgery, chemotherapy, and sometimes radiation therapy.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-515787-31-00Protocol codeUC-BCG-2401Estimated enrolment1 000 patientsSponsorUnicancer

sourced from the EU Clinical Trials Register and site verification

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