Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not recruiting

Study Comparing Sacituzumab Govitecan with Other Treatments for Patients with HR+/HER2- Metastatic Breast Cancer After Endocrine Therapy

Verified siteRegistered drugNo placebo
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

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 hormone receptor-positive (HR+)/human epidermal growth factor receptor 2 negative (HER2-) breast cancer. This type of cancer is characterized by the presence of hormone receptors and the absence of a protein called HER2. The study involves patients who have advanced or metastatic breast cancer, meaning the cancer has spread beyond the breast to other parts of the body, and who have already received treatment with hormone therapy.

The main treatment being studied is a medication called sacituzumab govitecan, which is also known by its code name IMMU-132. This medication is an antibody-drug conjugate, which means it combines an antibody with a drug to target cancer cells more precisely. The study will compare the effects of sacituzumab govitecan with other treatments chosen by the patient's doctor, which may include medications like capecitabine, nab-paclitaxel, or paclitaxel. These are all types of chemotherapy drugs used to treat cancer.

The purpose of the study is to evaluate how well sacituzumab govitecan works compared to the other treatments in terms of delaying the progression of the disease. Patients participating in the study will receive either sacituzumab govitecan or one of the other treatments, and their health will be monitored over time to assess the effects of the treatment. The study will involve regular check-ups and assessments to track the progress of the cancer and any side effects of the treatments. The study aims to provide valuable information that could help improve treatment options for patients with this type of 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

    Joining the study

    Upon joining the study, you will be randomly assigned to receive either sacituzumab govitecan or a treatment chosen by your physician. This is to compare the effects of the different treatments on your condition.

  2. Step 2

    Treatment administration

    If assigned to sacituzumab govitecan, you will receive it as an intravenous infusion. This means the medication will be given through a vein in your arm. The specific dosage and frequency will be determined by the study protocol and your healthcare provider.

    If assigned to the treatment of your physician's choice, you may receive medications such as capecitabine or paclitaxel. Capecitabine is taken orally in the form of film-coated tablets, while paclitaxel is administered as an intravenous infusion.

  3. Step 3

    Monitoring and assessments

    Throughout the study, regular monitoring and assessments will be conducted to evaluate your response to the treatment. This may include physical examinations, blood tests, and imaging studies such as CT or MRI scans.

    Your healthcare team will assess the progression of your disease and any side effects you may experience. This information is crucial for determining the effectiveness and safety of the treatment.

  4. Step 4

    Completion of the study

    The study is expected to continue until December 2028. Your participation may end earlier if you experience significant side effects, if your disease progresses, or if you choose to withdraw from the study.

    Upon completion, you will have a final assessment to evaluate your overall health and the outcomes of the treatment you received.

Who can join the trial?

21 criteria

  • Must be assigned male or female at birth and be 18 years of age or older.
  • Must be able to understand and give written informed consent.
  • Must have completed any cancer treatment at least 14 days before joining the study. Any side effects from previous treatment should be resolved or stable.
  • If you have HIV, you must be on antiretroviral therapy (ART) and have a well-controlled infection. This means:
    • Your CD4+ T-cell count should be at least 350 cells/mm3.
    • Your HIV RNA level should be below 50 copies/mL for at least 12 weeks before joining the study.
    • You should have been on a stable ART regimen for at least 4 weeks before joining the study.
    • Your ART regimen should not interfere with the study medication.
    • Must meet organ function requirements as per the study protocol.
    • Male and female patients of childbearing potential who engage in heterosexual intercourse must agree to use specified methods of contraception.
    • Must have an ECOG performance status of 0 or 1, which means you are fully active or have some symptoms but do not need bed rest.
    • Must have a life expectancy of at least 3 months.
    • Must be willing and able to follow the study requirements and restrictions.
    • Must have measurable disease according to specific criteria used in the study.
    • Must provide a tumor tissue sample for testing, preferably from a locally recurrent or metastatic site.
    • Must have documented evidence of HR+ metastatic breast cancer, confirmed by a recent tumor biopsy.
    • Must have documented evidence of HER2- status according to specific guidelines.
    • Must have documented disease progression by CT or MRI during or after the most recent therapy.
    • Must be a candidate for the first chemotherapy in the locally advanced or metastatic setting.
    • Must be eligible for specific chemotherapy drugs like capecitabine, nab-paclitaxel, or paclitaxel.
    • Must have experienced disease progression on at least two previous lines of endocrine therapy (ET) in the metastatic setting.
    • May have received prior targeted therapies but can no longer be candidates for additional endocrine treatment.

Who cannot join the trial?

10 criteria

  • Patients with other types of cancer that are not the specific type being studied.
  • Patients who have not received a treatment based on hormones for their breast cancer.
  • Patients with severe or uncontrolled medical conditions that could interfere with the study.
  • Patients who are pregnant or breastfeeding.
  • Patients who have had another cancer treatment within a certain time frame before the study starts.
  • Patients who have allergies to the study medication or similar drugs.
  • Patients who are unable to follow the study procedures or attend the required visits.
  • Patients who have participated in another clinical trial recently.
  • Patients with certain infections that are not well controlled.
  • Patients with a history of drug or alcohol abuse that could affect their participation.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

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 the surface of cancer cells. Once attached, it delivers a powerful drug directly into the cancer cell, which can help to stop the cancer from growing and spreading. This medication is being studied to see how well it works compared to other treatments chosen by doctors for patients with a specific type of breast cancer.

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 certain types of breast cancer, specifically those that are hormone receptor-positive and HER2-negative, in patients who have already received hormone-based treatments. This medication works by delivering a powerful anti-cancer drug directly to cancer cells, using a special antibody that targets these cells. It belongs to a class of drugs known as antibody-drug conjugates, which are designed to specifically attack cancer cells while minimizing damage to healthy cells.

Investigated diseases

Hormone Receptor-Positive, HER2-Negative Breast Cancer – This type of breast cancer is characterized by the presence of hormone receptors for estrogen or progesterone, but lacks the human epidermal growth factor receptor 2 (HER2). It typically progresses by using hormones to fuel its growth, which can lead to the cancer spreading to nearby tissues or other parts of the body. The disease may initially respond to hormone-blocking treatments, but over time, it can become resistant and continue to grow. As it advances, the cancer can invade local structures such as the chest wall or lymph nodes. In metastatic cases, it can spread to distant organs like the bones, liver, or lungs. The progression of this cancer is often monitored through imaging and clinical evaluations to assess changes in tumor size and spread.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-502593-17-00Protocol codeGS-US-598-6168Estimated enrolment867 patientsSponsorGilead Sciences Inc.

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.