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Study of Sacituzumab Govitecan and Pembrolizumab for Patients with Triple Negative Breast Cancer with Residual Disease After Surgery and Therapy

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). This form of cancer is characterized by the absence of three common receptors known to fuel most breast cancer growths. The study will explore the effectiveness of a combination of treatments, specifically Sacituzumab Govitecan and Pembrolizumab, compared to other treatments chosen by doctors. Sacituzumab Govitecan is a type of medication called an antibody-drug conjugate, which is designed to target and kill cancer cells. Pembrolizumab is a monoclonal antibody that helps the immune system detect and fight cancer cells.

The purpose of this study is to compare how well patients do without the cancer coming back after receiving these treatments. Participants in the study will be randomly assigned to receive either the combination of Sacituzumab Govitecan and Pembrolizumab or a treatment chosen by their doctor. The study will follow participants over a period of time to monitor their health and any changes in their condition. Some participants may receive a placebo, which is a substance with no active medication, to help compare the effects of the treatments being studied.

Throughout the study, participants will receive regular check-ups and monitoring to ensure their safety and to track the progress of their treatment. The study aims to provide valuable information on the effectiveness of these treatments in preventing the return of cancer in patients with Triple Negative Breast Cancer who have already undergone surgery and initial therapy. This research could potentially lead to new treatment options for patients with this challenging form 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

    Joining the study

    Upon joining the study, you will be randomly assigned to one of two groups. One group will receive a combination of sacituzumab govitecan and pembrolizumab, while the other group will receive a treatment chosen by your doctor.

    You will be informed about the specific treatment plan you will follow, including the medications, their dosages, and the schedule for taking them.

  2. Step 2

    Treatment administration

    If you are in the group receiving sacituzumab govitecan and pembrolizumab, you will receive these medications through an intravenous infusion. This means the medication will be given directly into your vein.

    Sacituzumab govitecan is administered as a 200 mg solution for infusion, and pembrolizumab is given as a 25 mg/mL concentrate for infusion. The exact schedule and frequency will be explained to you by the medical team.

  3. Step 3

    Oral medication

    If your treatment plan includes capecitabine, you will take this medication orally in the form of 500 mg film-coated tablets.

    The dosage and frequency of capecitabine will be determined by your doctor based on your specific needs and condition.

  4. Step 4

    Monitoring and follow-up

    Throughout the study, regular monitoring will be conducted to assess your health and the effectiveness of the treatment. This may include physical exams, blood tests, and imaging studies.

    You will be required to attend scheduled follow-up visits to ensure your safety and to track the progress of your treatment.

  5. Step 5

    Completion of the study

    At the end of the study period, a final evaluation will be conducted to assess the outcomes of the treatment.

    You will receive information about the results of the study and any further steps or treatments that may be recommended based on your condition.

Who can join the trial?

7 criteria

  • Patients must be 18 years of age or older and able to understand and give written consent to participate.
  • Patients must have a performance status score of 0 or 1, which means they are fully active or have some symptoms but do not need bed rest during the day.
  • Patients must have a history of Triple Negative Breast Cancer (TNBC) with certain stages and confirmed by a doctor. TNBC is a type of breast cancer that does not have certain receptors. Patients should have remaining cancer in the breast or lymph nodes after initial treatment and surgery. There should be no signs of cancer spread to other parts of the body.
  • Patients must have received neoadjuvant chemotherapy, which is treatment given before surgery, for at least 6 cycles or 18 weeks. This treatment may include specific drugs like taxane, anthracycline, or pembrolizumab.
  • Patients must have had adequate surgery to remove all visible cancer in the breast and/or lymph nodes. This includes either a total mastectomy or breast-conserving surgery with no cancer at the edges of the removed tissue. If cancer is found at the edges, more surgery may be needed.
  • Patients must have received appropriate radiotherapy and recovered before starting the study treatment. This includes radiation to the whole breast or chest wall and possibly the regional lymph nodes, depending on the initial cancer stage.
  • Patients must have adequate liver function, meaning their liver is working well enough to participate in the study.

Who cannot join the trial?

4 criteria

  • Patients who do not have Triple Negative Breast Cancer cannot participate.
  • Only female patients can participate; male patients are excluded.
  • Patients who are not within the specified age range cannot participate. The age range is not specified here, but it is important to check if you meet the age criteria.
  • Patients who are part of a vulnerable population may be excluded. This typically refers to groups who may need special protection or care.
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Investigated drugs

  • Sacituzumab Govitecan

    is a type of medication used in cancer treatment. It is designed to target and attach to specific proteins found on cancer cells, helping to deliver a powerful drug directly to the cancer cells. This can help to kill the cancer cells while causing less harm to normal cells in the body.

  • Pembrolizumab

    is a medication that helps the immune system fight cancer. It works by blocking a specific protein that prevents the immune system from attacking cancer cells. By blocking this protein, pembrolizumab allows the immune system to better recognize and destroy cancer cells.

What is already known about the treatment

  • Sacituzumab Govitecan

    Sacituzumab Govitecan 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, particularly in patients who have remaining invasive disease after surgery and initial therapy. This medication works by delivering a toxic substance directly to cancer cells, helping to kill them while sparing most healthy cells. It is classified as an antibody-drug conjugate, which combines an antibody with a chemotherapy drug to target cancer cells more precisely.

  • Pembrolizumab

    Pembrolizumab is also administered as an intravenous infusion. It is a well-established medication in the medical field, often used to treat various types of cancer, including triple negative breast cancer. Pembrolizumab works by helping the immune system recognize and attack cancer cells more effectively. It is classified as an immune checkpoint inhibitor, which blocks certain proteins that prevent the immune system from attacking cancer cells.

Investigated diseases

Triple Negative Breast Cancer – 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 HER-2/neu gene. This absence makes it distinct from other breast cancer types, as it does not respond to hormonal therapy or therapies that target HER-2 receptors. The disease often progresses more aggressively than other types of breast cancer. It can spread to other parts of the body, including the lymph nodes, lungs, liver, and brain. The progression involves the growth of cancerous cells in the breast tissue, which can invade surrounding tissues and organs. This type of cancer is more likely to occur in younger women and those with a BRCA1 gene mutation.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-512279-10-00Protocol codeGS-US-595-6184Estimated enrolment1 537 patientsSponsorGilead Sciences Inc.

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