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Study Comparing Sacituzumab Govitecan to Physician's Choice Treatment for Patients with 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 a type of breast cancer known as triple-negative breast cancer (TNBC). This form of cancer does not have the three common receptors known to fuel most breast cancer growth: estrogen, progesterone, and HER2. The study is specifically looking at patients with advanced stages of this cancer, either locally advanced, inoperable, or metastatic, meaning it has spread to other parts of the body. The trial involves a medication called sacituzumab govitecan, which is being compared to other treatments chosen by doctors. Sacituzumab govitecan is a type of treatment known as an antibody-drug conjugate, which combines an antibody with a drug to target cancer cells more precisely.

The purpose of the study is to compare the effectiveness of sacituzumab govitecan with other treatments in patients who have not received previous treatment for their advanced cancer or who have been treated with certain immune therapies. The study will involve administering the treatments through an intravenous infusion, which means the medication is given directly into a vein. Patients will be monitored over a period to see how their cancer responds to the treatment. The study will also look at how long patients live and how their quality of life is affected by the treatment.

Participants in the study will receive either sacituzumab govitecan or a treatment chosen by their doctor, which may include medications like paclitaxel, gemcitabine, or carboplatin. These are all chemotherapy drugs that work by stopping the growth of cancer cells. The study aims to provide more information on the best treatment options for patients with this challenging type of breast cancer. The trial is expected to continue until 2027, allowing researchers to gather comprehensive data on the effectiveness and safety of the treatments being studied.

The research process

The trial runs in 6 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, eligibility is confirmed based on specific criteria, including age, health status, and previous treatments.

    A baseline biopsy may be required if archival tissue is not available. This procedure must be performed before the first dose of study treatment.

  2. Step 2

    Randomization

    Participants are randomly assigned to receive either sacituzumab govitecan or a treatment chosen by the physician from a list of approved options.

  3. Step 3

    Treatment administration

    The treatment involves intravenous infusions of the assigned medication.

    Medications include paclitaxel, gemcitabine, sacituzumab govitecan, carboplatin, and paclitaxel albumin-bound.

    The specific dosage, frequency, and duration depend on the treatment plan determined by the physician.

  4. Step 4

    Monitoring and assessments

    Regular monitoring is conducted to assess the response to treatment and any side effects.

    Assessments include imaging tests like CT or MRI to measure disease progression.

  5. Step 5

    End of treatment

    The treatment continues until disease progression, unacceptable side effects, or other criteria for discontinuation are met.

    Final assessments are conducted to evaluate the overall response to the treatment.

  6. Step 6

    Follow-up

    After the treatment phase, follow-up visits are scheduled to monitor long-term health and any delayed effects of the treatment.

Who can join the trial?

15 criteria

  • Must be a female or male patient, 18 years or older, able to understand and give written consent.
  • Blood clotting tests (INR/PT and PTT or aPTT) should be within normal limits unless on blood-thinning medication.
  • If sexually active, must agree to use specific birth control methods.
  • Patients with HIV must be on HIV medication, have a stable and well-controlled infection, and meet specific health criteria.
  • Must have a specific type of breast cancer called **triple-negative breast cancer (TNBC)**, which means the cancer does not have certain receptors (ER, progesterone receptor, and HER2).
  • Must have a tumor that is either **PD-L1 negative** or **PD-L1 positive** and previously treated with a specific type of medication if applicable.
  • Must have completed treatment for earlier stages of breast cancer, with a certain time elapsed since treatment.
  • Must have measurable disease as determined by specific imaging tests like CT or MRI.
  • Must provide a tumor sample for testing, either from a recent biopsy or stored tissue.
  • Must have a good general health status, as measured by a specific performance score.
  • Must have a life expectancy of at least 3 months.
  • Must have recovered from any major surgery for at least 2 weeks.
  • Must have adequate blood cell counts without recent support from transfusions or growth factors.
  • Must have proper liver function, with specific limits on liver enzymes and proteins.
  • Must have a certain level of kidney function, measured by creatinine clearance.

Who cannot join the trial?

1 criterion

  • Patients who have not been diagnosed with **PD-L1-negative metastatic triple-negative breast cancer** or **PD-L1-positive metastatic triple-negative breast cancer** that was previously treated with an **anti-PD-(L)1 agent** in a curative setting. **Metastatic** means the cancer has spread to other parts of the body. **PD-L1** is a protein that can affect the immune system's ability to fight cancer. **Triple-negative breast cancer** is a type of breast cancer that does not have three common receptors known to fuel most breast cancer growth.
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Investigated drugs

Sacituzumab Govitecan is a medication being studied for its effectiveness in treating patients with a specific type of breast cancer known as triple-negative breast cancer. This type of cancer does not have certain receptors, making it more challenging to treat. Sacituzumab Govitecan is designed to target and deliver chemotherapy directly to the cancer cells, potentially reducing the cancer's growth and spread. The trial aims to see how well this medication works compared to other treatments chosen by doctors.

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 certain types of breast cancer. It is specifically being tested for use in patients with metastatic triple-negative breast cancer, either PD-L1-negative or PD-L1-positive, who have been previously treated with anti-PD-(L)1 agents. Sacituzumab Govitecan works by delivering a chemotherapy drug directly to cancer cells, using an antibody that targets a specific protein on the surface of these cells. It is classified as an antibody-drug conjugate, combining targeted therapy with chemotherapy to attack cancer cells more precisely.

Investigated diseases

Metastatic Triple-Negative Breast Cancer – This 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. It is considered more aggressive and difficult to treat than other types of breast cancer. The disease can spread to other parts of the body, such as the bones, liver, or lungs, which is referred to as metastasis. Patients with this cancer may experience symptoms like lumps in the breast or underarm, changes in breast shape, or skin dimpling. The progression of the disease can vary, with some experiencing rapid advancement while others may have a slower progression. Treatment typically focuses on managing symptoms and slowing the spread of the disease.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-504195-14-00Protocol codeGS-US-592-6238Estimated enrolment729 patientsSponsorGilead Sciences Inc.

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