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Study on Pembrolizumab and Paclitaxel for Early Triple-Negative Breast Cancer in Patients with High Tumor-Infiltrating Lymphocytes

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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 Triple Negative Breast Cancer, a type of breast cancer that does not have hormone receptors or the HER2 protein receptor. The study will explore the effects of a treatment involving a combination of two medications: pembrolizumab and paclitaxel. Pembrolizumab is a type of immunotherapy that helps the immune system fight cancer, while paclitaxel is a chemotherapy drug that works by stopping cancer cells from growing. The purpose of the study is to understand how effective this combination treatment is in preventing the return of cancer in patients who have had early-stage triple-negative breast cancer removed surgically.

Participants in the study will be divided into two groups. One group will receive the combination of pembrolizumab and paclitaxel, while the other group will be under standard surveillance, meaning they will not receive additional treatment after surgery. The study will monitor participants over a period of time to see how well the treatment works in preventing cancer from coming back. The study will also look at the safety and tolerability of the treatment, as well as its impact on the quality of life of the participants.

The trial will assess the outcomes over several years, focusing on whether the cancer returns, if new cancers develop, and overall survival rates. The study aims to provide valuable information on the effectiveness of using pembrolizumab and paclitaxel together in treating early-stage triple-negative breast cancer, potentially offering new insights into managing this challenging type of cancer.

The research process

The trial runs in 7 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, the patient will be required to understand, sign, and date a written informed consent form. This is necessary before any specific procedures related to the study are performed.

    Women of childbearing potential must agree to use specified methods of contraception for 3 years after joining the study. Men who engage in heterosexual intercourse must agree to use specified methods of contraception during the trial treatments and for at least 6 months after the last dose.

  2. Step 2

    Initial assessment

    The patient will undergo an initial assessment to confirm eligibility. This includes verifying the patient's age, performance status, and medical history related to triple-negative breast cancer.

    For cohort 1, the patient must demonstrate adequate organ function and a left ventricular ejection fraction of at least 50%.

  3. Step 3

    Treatment initiation for cohort 1

    Patients in cohort 1 will receive a combination of pembrolizumab and paclitaxel. Pembrolizumab is administered as a concentrate for solution for infusion, known as KEYTRUDA 25 mg/mL.

    Paclitaxel is also administered as a concentrate for solution for infusion. The treatment is given every 3 weeks.

  4. Step 4

    Surveillance for cohort 2

    Patients in cohort 2 will undergo standard surveillance without receiving adjuvant systemic treatments. This involves regular monitoring and follow-up visits to assess the patient's condition.

  5. Step 5

    Follow-up and monitoring

    Throughout the trial, patients will have scheduled visits and examinations to monitor their health and the effectiveness of the treatment.

    For cohort 1, safety and tolerability of the treatment will be assessed every 3 weeks while on treatment and every 6 months thereafter for 5 years.

  6. Step 6

    Quality of life assessment

    Quality of life will be evaluated using specific questionnaires, including EORTC QLQ-C30, EORTC QLQ-B23, EORTC QLQ-FA12, and the HADS anxiety subscale.

  7. Step 7

    End of study

    The study is estimated to end on December 1, 2031. Patients will continue to be monitored for outcomes such as distant recurrence of breast cancer, second primary non-breast cancer, and overall survival.

Who can join the trial?

14 criteria

  • Understand, sign, and date the written informed consent form before any specific procedures are done.
  • Women who can have children must agree to use specific methods of birth control for 3 years after joining the study. Men who have sex with women must agree to use specific birth control methods during the study and for at least 6 months after the last treatment. Women who can have children are those who have not had surgery to prevent pregnancy or have not stopped having periods for more than 1 year.
  • Patients must be part of the social security system or an equivalent system in France.
  • Patients must be willing and able to follow the study rules for the entire duration, including treatments, scheduled visits, and follow-up exams.
  • For cohort 1: Have a left ventricular ejection fraction (LVEF) of at least 50%, which is a measure of heart function, checked by an echocardiogram or a heart scan.
  • For cohort 1: Show that organs are working well within 7 days of joining the study.
  • Men and women must be at least 18 years old.
  • Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, which means being fully active or having some symptoms but being able to do light work.
  • Have a confirmed diagnosis of pT1b/c N0M0 triple negative breast cancer (TNBC) that has been completely removed, according to specific cancer staging guidelines.
  • Have had breast cancer surgery that either conserves the breast or removes the breast, including nipple- or skin-sparing mastectomy.
  • Have had a sentinel lymph node biopsy (SLNB) and/or axillary lymph node dissection (ALND) to check the status of lymph nodes. The dissection should include at least six lymph nodes.
  • There should be at least 4 weeks but no more than 12 weeks between the final breast surgery and the start of treatment for cohort 1, and no more than 12 weeks for cohort 2.
  • Have a centrally assessed tumor-infiltrating lymphocytes (TILs) rate from a surgical tumor sample, using a specific type of slide, according to the latest guidelines.
  • Women who can have children must have a negative pregnancy test within 72 hours before the first dose of study medication for cohort 1 and within 7 days of joining for cohort 2.

Who cannot join the trial?

5 criteria

  • Patients who do not have triple negative breast cancer cannot participate. This type of cancer does not have three common receptors known to fuel most breast cancer growth.
  • Patients who are not within the specified age ranges cannot participate. The study includes certain age groups, so if you are outside these, you may not be eligible.
  • Patients who do not meet the specific sTILs criteria cannot participate. sTILs stands for stromal tumor-infiltrating lymphocytes, which are immune cells present in the tumor area. The study requires certain levels of these cells.
  • Patients who are not female cannot participate, as the study is focused on female subjects.
  • Patients who are considered part of a vulnerable population may not be eligible. This includes groups who might need special protection in research settings.
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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 on cancer cells, allowing the immune system to better recognize and attack these cells. In this study, it is given to patients with early triple-negative breast cancer to see if it can improve their chances of staying cancer-free.

  • Paclitaxel

    is a type of chemotherapy used in this trial. It works by stopping cancer cells from dividing and growing, which can help to shrink tumors and slow the spread of cancer. In this study, it is used in combination with pembrolizumab to treat patients with early triple-negative breast cancer.

What is already known about the treatment

Pembrolizumab – This medication is administered through an intravenous infusion, typically in a clinical setting. It is currently well-established in medical literature as an immunotherapy used for various cancers, including triple-negative breast cancer. Pembrolizumab works by blocking a specific protein on immune cells, allowing them to better detect and attack cancer cells. It is classified as a monoclonal antibody and is part of the immune checkpoint inhibitor class of drugs.

Investigated diseases

Triple Negative Breast Cancer – 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. It is considered more aggressive and difficult to treat than other types of breast cancer. The cancer cells in triple negative breast cancer do not respond to hormonal therapy medicines or medicines that target HER2 protein receptors. It tends to grow and spread more quickly than other types of breast cancer. This type of cancer is more likely to affect younger women and those with a BRCA1 gene mutation. It is often diagnosed at a higher grade and stage, indicating a more advanced disease.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-504620-26-00Protocol codeUC-BCG-2213Estimated enrolment364 patientsSponsorInstitut Gustave Roussy

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