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Study of Sacituzumab Govitecan and Pembrolizumab for Patients with Untreated Advanced 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 treatments for Triple-Negative Breast Cancer that has spread to other parts of the body or cannot be removed by surgery. The study involves the use of a medication called Sacituzumab Govitecan in combination with Pembrolizumab, a type of treatment known as a monoclonal antibody. The trial will compare this combination to other treatments chosen by doctors, also combined with Pembrolizumab. The purpose of the study is to evaluate the effectiveness of these treatments in patients whose tumors express a protein called PD-L1.

Participants in the study will receive their assigned treatment through an intravenous infusion, which means the medication is given directly into a vein. The study will follow participants over a period to observe how the cancer responds to the treatment and to monitor any side effects. The trial aims to understand how long the treatment can prevent the cancer from getting worse and to assess the overall survival of the participants.

Throughout the study, participants will undergo regular check-ups and tests, such as imaging scans, to track the progress of their treatment. The study will also collect information on the quality of life of participants, including their physical functioning and any symptoms they experience. This information will help researchers determine the best treatment options for patients with Triple-Negative Breast Cancer in the future.

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

    Initial treatment phase

    Upon joining the study, the patient will begin the initial treatment phase. This involves receiving medications through an intravenous infusion.

    The medications include sacituzumab govitecan and pembrolizumab. Sacituzumab govitecan is administered as a 200 mg powder for solution, and pembrolizumab is given as a 25 mg/mL concentrate for solution.

    The frequency and duration of these infusions will be determined by the study protocol and the treating physician.

  2. Step 2

    Treatment of physician's choice

    In addition to the initial medications, the patient may receive treatment of the physician's choice, which could include other medications such as paclitaxel, carboplatin, or gemcitabine.

    Paclitaxel is provided as a 6 mg/mL concentrate, carboplatin as a 10 mg/mL concentrate, and gemcitabine as a 38 mg/mL concentrate, all for intravenous infusion.

    The specific choice of medication and its administration schedule will be tailored to the patient's condition and response to treatment.

  3. Step 3

    Ongoing assessment

    Throughout the trial, the patient's progress will be monitored through regular assessments. These assessments will evaluate the effectiveness of the treatment and any side effects experienced.

    The primary goal is to measure progression-free survival, which is the time from the start of treatment until the disease progresses or the patient passes away.

    Secondary assessments will include overall survival, response rates, and the duration of response, among other health and quality of life measures.

  4. Step 4

    Completion of trial

    The trial is expected to continue until February 2027, with the patient's participation lasting as long as the treatment is beneficial and safe.

    Upon completion, the patient's overall health and treatment outcomes will be reviewed to determine the next steps in their care.

Who can join the trial?

16 criteria

  • Participants must be **18 years of age or older** and able to understand and give written consent.
  • Participants must have a blood test result called **INR/PT and PTT or aPTT** that is less than or equal to 1.5 times the normal limit, unless they are receiving treatment to prevent blood clots.
  • Participants who can have children and are sexually active must agree to use specific methods of birth control.
  • Participants with **HIV** must be on medication for HIV and have a well-controlled infection, meaning their **CD4+ T-cell count** is 350 or higher, and their **HIV RNA level** is very low for at least 12 weeks before the study.
  • Participants must have **triple-negative breast cancer (TNBC)** that is advanced or has spread to other parts of the body, and their tumors must be **PD-L1 positive**. They should not have received previous treatment for advanced disease.
  • Participants must have completed treatment for earlier stages of breast cancer at least 6 months before joining the study.
  • Participants with newly diagnosed metastatic TNBC are eligible.
  • Participants must have a tumor sample tested to confirm TNBC and PD-L1 status.
  • Participants must have measurable disease as seen on a **CT or MRI scan**.
  • Participants must provide a tumor sample for testing, either from a recent biopsy or stored tissue.
  • Participants must have a **performance status score** of 0 or 1, which indicates they are fully active or have some symptoms but can still do light work.
  • Participants must have a life expectancy of at least 3 months.
  • Participants must have recovered from major surgery for at least 2 weeks.
  • Participants must have adequate blood counts without needing transfusions or growth factor support.
  • Participants must have adequate liver function, with specific blood test results within certain limits.
  • Participants must have a **creatinine clearance** of 30 mL/min or higher, which is a measure of kidney function.

Who cannot join the trial?

10 criteria

  • Patients who have a different type of cancer than the one being studied.
  • Patients who have received certain treatments that might interfere with the study.
  • Patients with serious health conditions that could make participation unsafe.
  • Patients who are unable to follow the study procedures or attend required visits.
  • Patients who are pregnant or breastfeeding.
  • Patients who have participated in another clinical trial recently.
  • Patients with allergies to the study medications.
  • Patients with infections that are not well controlled.
  • Patients with a history of certain heart conditions.
  • Patients who have had a recent surgery that could affect the study.
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Investigated drugs

  • Sacituzumab Govitecan

    is a medication used in this trial to treat patients with a specific type of breast cancer known as triple-negative breast cancer. It is designed to target and deliver chemotherapy directly to cancer cells, helping to destroy them while minimizing damage to healthy cells.

  • Pembrolizumab

    is an immunotherapy drug used in this trial. It works by helping the immune system recognize and attack cancer cells. Pembrolizumab is often used in combination with other treatments to enhance its effectiveness in fighting cancer.

What is already known about the treatment

  • Sacituzumab Govitecan

    This medication is administered intravenously and is currently being studied in clinical trials for its effectiveness in treating PD-L1 positive metastatic triple-negative breast cancer. It is an antibody-drug conjugate that targets the Trop-2 protein on cancer cells, delivering a chemotherapy agent directly to the tumor. Sacituzumab Govitecan is classified as an antineoplastic agent and is being evaluated for its potential to improve progression-free survival in patients.

  • Pembrolizumab

    Administered through intravenous infusion, pembrolizumab is an established medication in the treatment of various cancers, including PD-L1 positive metastatic triple-negative breast cancer. It works by blocking the PD-1 pathway, which helps the immune system recognize and attack cancer cells. Pembrolizumab is classified as an immune checkpoint inhibitor and is widely used in oncology for its ability to enhance the body's immune response against tumors.

Investigated diseases

PD-L1 Positive Metastatic Triple-Negative Breast Cancer – This is a type of breast cancer characterized by the absence of estrogen and progesterone receptors and the lack of excess HER2 protein. It is termed "triple-negative" because it does not express these three common receptors, making it more challenging to treat. The cancer is considered metastatic when it has spread beyond the breast to other parts of the body. PD-L1 positivity indicates that the cancer cells express the PD-L1 protein, which can help them evade the immune system. This type of cancer tends to grow and spread more quickly than other forms of breast cancer. It is often diagnosed at a later stage due to its aggressive nature.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-504194-21-00Protocol codeGS-US-592-6173Estimated enrolment443 patientsSponsorGilead Sciences Inc.

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