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Study of Sacituzumab Govitecan compared to standard therapy in HER2-negative breast cancer patients with high risk of relapse after neoadjuvant treatment

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 study focuses on patients with HER2-negative breast cancer who still have residual disease after receiving standard neoadjuvant chemotherapy and are at high risk of cancer returning. The main treatment being investigated is sacituzumab govitecan, which is a specialized medication that combines an antibody with an anti-cancer drug, designed to target specific cancer cells.

The study compares two treatment approaches: patients will receive either sacituzumab govitecan or a standard treatment chosen by their doctor from several options including carboplatin, cisplatin, or capecitabine. The purpose is to determine if sacituzumab govitecan is more effective at preventing the cancer from returning compared to standard treatments.

Treatment will continue for up to 24 months. The medications are given either through an intravenous infusion directly into the bloodstream or as tablets taken by mouth, depending on which treatment the patient receives. All patients must have completed their previous treatments, including surgery and radiation therapy, before starting the study medication.

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

    Initial assessment

    Your eligibility for the study will be confirmed through medical tests and examination after completing standard neoadjuvant treatment and surgery

    Laboratory tests will check your blood counts, liver and kidney function

    A heart function test will be performed according to standard procedures

  2. Step 2

    Treatment assignment

    You will be randomly assigned to receive either sacituzumab govitecan or a standard treatment chosen by your doctor

    The assignment must occur within 16 weeks after your final surgery or within 10 weeks after completing radiation therapy (whichever comes last)

  3. Step 3

    Treatment administration

    If assigned to sacituzumab govitecan, you will receive the medication through an intravenous infusion

    If assigned to standard treatment, you may receive one of the following:

    - Carboplatin through intravenous infusion

    - Cisplatin through intravenous infusion

    - Capecitabine tablets taken by mouth

  4. Step 4

    Monitoring during treatment

    Regular assessments will check for any side effects

    Side effects will be measured using standardized criteria

    Your quality of life will be evaluated using specific questionnaires

  5. Step 5

    Follow-up period

    You will be monitored for signs of disease return or spread

    Regular check-ups will continue until 2027

    The main focus will be on tracking how long you remain free of invasive disease

Who can join the trial?

16 criteria

  • Must be at least 18 years old, both men and women can participate
  • Must agree to use effective birth control methods during treatment and for a period after the last dose if able to have children
  • Must have breast cancer confirmed by tissue examination that is HER2-negative (a specific type of breast cancer)
  • Must have remaining cancer tissue after initial chemotherapy treatment, with specific risk factors for cancer return
  • Must have undergone proper surgical removal of the cancer and lymph nodes
  • Must have completed at least 16 weeks of chemotherapy containing taxane (a type of cancer drug)
  • Must have no evidence of cancer spread during or after initial chemotherapy
  • Must start the study within 16 weeks after final surgery or within 10 weeks after completing radiation therapy
  • Must have completed radiation therapy before starting the study treatment
  • Must have good physical function (ECOG score 0 or 1, meaning able to perform daily activities)
  • Must have normal heart function
  • Must have acceptable blood test results, including:
    • Adequate blood cell counts
    • Normal liver function
    • Normal kidney function
    • Must have a negative pregnancy test if able to become pregnant
    • Must have recovered from side effects of previous treatments

Who cannot join the trial?

14 criteria

  • Previous diagnosis of HER2-positive breast cancer (HER2 is a protein that promotes cancer cell growth)
  • Age below 18 years old
  • Pregnant or breastfeeding women
  • Active or untreated brain metastases (cancer that has spread to the brain)
  • Severe heart conditions including heart failure or recent heart attack
  • Ongoing serious infections requiring treatment
  • Previous treatment with sacituzumab govitecan
  • Known allergies to the study medications
  • Participation in another clinical trial within the last 30 days
  • Significant liver or kidney dysfunction
  • Uncontrolled high blood pressure
  • Active autoimmune disease requiring systemic treatment (conditions where the immune system attacks healthy cells)
  • History of other cancers within the past 3 years (except for successfully treated non-melanoma skin cancer or cervical cancer in situ)
  • Any condition that, in the opinion of the study doctor, would make participation unsafe
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Investigated drugs

Sacituzumab Govitecan is an antibody-drug conjugate medication used to treat breast cancer. It works by combining an antibody that targets cancer cells with a drug that can kill these cells. The antibody part helps the medication find and attach to specific proteins on cancer cells, while the drug part works to destroy the cancer cells. This medication is being studied as a treatment for patients with HER2-negative breast cancer who have completed standard neoadjuvant treatment (treatment given before surgery) but still have a high risk of cancer returning. Treatment of Physician's Choice refers to the standard treatment options that doctors typically prescribe for this type of cancer. This allows the doctor to select the most appropriate treatment for each patient based on their specific situation and medical history.

What is already known about the treatment

Sacituzumab Govitecan - An antibody-drug conjugate (ADC) administered intravenously that represents a targeted therapy approach in cancer treatment. This medication combines a monoclonal antibody targeting the Trop-2 protein with a potent chemotherapy drug, specifically designed for treating HER2-negative breast cancer patients who have a high risk of relapse after standard neoadjuvant treatment. The mechanism of action involves the antibody specifically binding to cancer cells expressing Trop-2, followed by the release of the chemotherapy component inside these cells, leading to their destruction while minimizing damage to healthy tissue. This innovative therapeutic agent belongs to the class of targeted cancer therapies and has shown promising results in clinical trials for treating aggressive forms of breast cancer.

Investigated diseases

HER2-negative breast cancer – A type of breast cancer characterized by the absence of excess HER2 protein on the surface of cancer cells. This cancer begins in the breast tissue when cells start growing abnormally and uncontrollably. The disease can develop in different parts of the breast, including the ducts, lobules, or other breast tissues. The term "HER2-negative" indicates that the cancer cells don't have high levels of a protein called human epidermal growth factor receptor 2, which distinguishes it from other types of breast cancer. This form of breast cancer typically develops gradually, with cancer cells potentially spreading to nearby tissues over time.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-510390-33-00Protocol codeGBG102-SASCIAEstimated enrolment1 391 patientsSponsorGBG Forschungs GmbH

sourced from the EU Clinical Trials Register and site verification

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