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A Study of Disitamab Vedotin for Adults with HER2 Expressing Advanced Breast Cancer

Verified siteInvestigationalNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study is looking at advanced breast cancer that expresses a protein called HER2. Breast cancer can have different levels of HER2 protein on the cancer cells, ranging from high levels (called HER2-positive) to low levels (called HER2-low or HER2-ultralow). The study will also look at whether the cancer has hormone receptors, which are proteins that can be found on some breast cancer cells. The treatment being tested is called Disitamab Vedotin, also known by its code name SGN-DV, which is given through a vein as an infusion. This medication is designed to target cancer cells that have HER2 on their surface.

The purpose of this study is to see how well Disitamab Vedotin works against advanced breast cancer in different groups of patients based on their HER2 and hormone receptor levels, particularly in patients who have already received other HER2-targeted treatments like trastuzumab deruxtecan. The study will look at several groups including patients with HER2-positive breast cancer, patients with hormone receptor-positive and HER2-low breast cancer, patients with hormone receptor-positive and HER2-ultralow breast cancer, and patients with hormone receptor-negative and HER2-low breast cancer, which is also called triple-negative breast cancer.

During the study, patients will receive Disitamab Vedotin and doctors will monitor how the cancer responds to the treatment by checking if tumors shrink or stop growing. The study will also track how long any positive responses last, how long patients live without their cancer getting worse, and overall survival. Blood samples will be taken to measure how the medication moves through the body and whether the immune system develops a response to the medication. Doctors will carefully watch for any side effects and will record any health problems that occur during treatment, including whether any changes need to be made to the treatment plan because of these side effects.

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

    Treatment administration

    You will receive disitamab vedotin as a treatment during this study. This medication is designed to target HER2, a protein that may be present on your breast cancer cells.

    The medication will be given to you through an intravenous infusion, which means it will be delivered directly into your vein through a needle or catheter.

    The medication comes as a powder that will be mixed into a solution before being infused into your body.

    The specific dose, how often you receive the treatment, and how long each infusion takes will be determined by the study protocol and your medical team.

  2. Step 2

    Regular monitoring visits

    Throughout the study, you will have regular visits where your condition will be monitored.

    During these visits, your doctor will assess how your cancer is responding to the treatment using imaging scans and physical examinations.

    The response to treatment will be evaluated using RECIST v1.1, which is a standard method for measuring changes in tumor size.

  3. Step 3

    Blood sample collection

    Blood samples will be taken at specific times during the study to measure the levels of the medication in your bloodstream.

    These samples will help determine how your body processes the drug, including disitamab vedotin, the total antibody, and unconjugated MMAE (a component of the medication).

    Blood tests will also check whether your body develops anti-drug antibodies, which are substances your immune system might create in response to the medication.

  4. Step 4

    Safety assessments

    Your health will be closely monitored for any side effects or adverse reactions to the treatment.

    Laboratory tests will be performed regularly to check for any abnormalities in your blood counts or organ function.

    Your doctor will record any side effects you experience, including their type, severity, and whether they are related to the study medication.

    If necessary, your treatment schedule may be adjusted, the dose may be reduced, or treatment may be paused based on how you tolerate the medication.

  5. Step 5

    Ongoing disease assessment

    Your doctor will continue to assess whether your cancer is responding to treatment, staying stable, or progressing.

    This assessment will help determine the duration of response, which is how long your cancer responds to the treatment.

    The study will also track progression-free survival, which measures how long you live without your cancer getting worse.

    Your overall health and survival will be monitored throughout the study period.

  6. Step 6

    Continuation of treatment

    You will continue receiving the study medication as long as your cancer is not progressing and you are tolerating the treatment acceptably.

    The study is expected to continue until approximately June 2028, though your individual participation may be shorter or longer depending on your response to treatment and overall health.

Who can join the trial?

9 criteria

  • You must have breast cancer that has been confirmed by laboratory testing of tissue samples, either through a biopsy (removal of a small piece of tissue) or cytology (examination of cells)
  • Your breast cancer must be locally-advanced (has grown beyond where it started but has not spread to distant parts of the body), unresectable (cannot be removed by surgery), or metastatic (has spread to other parts of the body)
  • Your cancer must have specific characteristics related to HER2 (a protein found on some breast cancer cells) and hormone receptors (proteins that respond to hormones) that match one of the study groups
  • Your HER2 status must be determined by the most recent test done at your local hospital or clinic, following standard medical guidelines for measuring HER2 levels in breast cancer cells
  • If your cancer is hormone receptor positive, this means that either your estrogen receptor (a protein that responds to the hormone estrogen) or progesterone receptor (a protein that responds to the hormone progesterone) test shows at least 1% positive cells
  • If your cancer is hormone receptor negative, this means that both your estrogen receptor and progesterone receptor tests show less than 1% positive cells
  • If you have had multiple hormone receptor tests for your advanced breast cancer, the most recent test result will be used to confirm if you can join the study
  • Both female and male patients may participate in this study
  • Adult and elderly patients may participate in this study

Who cannot join the trial?

1 criterion

  • No exclusion criteria have been provided in the available study information
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Investigated drugs

  • Disitamab vedotin

    is an investigational cancer medication being studied for the treatment of advanced breast cancer. It is designed to target and attach to a protein called HER2 that is found on the surface of some cancer cells. Once attached, the medication delivers a powerful drug directly into the cancer cells to help destroy them. This medication is being tested in patients whose cancer shows different levels of HER2 protein expression and who may have received other treatments in the past.

  • Trastuzumab deruxtecan

    (also known as Enhertu) is an approved cancer medication that is mentioned in this trial as a treatment that some patients may have received before joining this study. Like disitamab vedotin, it also targets the HER2 protein on cancer cells and delivers medication directly to them. This drug is used as a comparison point to understand how patients respond to the new medication being tested.

What is already known about the treatment

Disitamab Vedotin – This is an injectable medication given directly into the bloodstream that is currently being studied in clinical trials for treating advanced breast cancer that shows HER2 protein expression. It is designed for patients with different levels of HER2 in their cancer cells, including those who have already received other HER2-targeted treatments, and works by delivering a cell-killing substance directly to cancer cells through an antibody that recognizes and attaches to the HER2 protein on the surface of tumor cells. This medication belongs to a class of drugs called antibody-drug conjugates, which combine targeted therapy with chemotherapy to specifically attack cancer cells while minimizing damage to healthy tissues.

Investigated diseases

  • HER2 Positive Advanced Breast Cancer

    This is a type of breast cancer that has spread beyond the original tumor site to other parts of the body and tests positive for a protein called HER2. HER2 is a growth-promoting protein found on the outside of all breast cells. In this form of cancer, the cancer cells have higher than normal levels of HER2, which causes the cells to grow and divide more quickly. The disease progresses as cancer cells continue to multiply and spread to distant organs and tissues. This condition represents an advanced stage where the cancer is no longer confined to the breast or nearby lymph nodes.

  • Hormone Receptor Positive HER2-Low Advanced Breast Cancer

    This is an advanced form of breast cancer where the tumor cells have receptors for hormones such as estrogen or progesterone and show low levels of HER2 protein expression. The presence of hormone receptors means the cancer cells can use hormones to fuel their growth. The HER2-low classification indicates that while some HER2 protein is present, it is not at high enough levels to be considered HER2 positive. As the disease progresses, cancer cells spread beyond the breast to other parts of the body. The combination of hormone receptor positivity and low HER2 expression defines the specific biological behavior of this cancer type.

  • Hormone Receptor Positive HER2-Ultralow Advanced Breast Cancer

    This is an advanced breast cancer subtype where tumor cells contain hormone receptors but have extremely minimal levels of HER2 protein expression, even lower than HER2-low cancers. The cancer cells can respond to hormones like estrogen or progesterone, which promote their growth and division. The ultralow HER2 expression represents a very specific biological characteristic that distinguishes this cancer from other breast cancer types. As with other advanced breast cancers, the disease has spread beyond its original location to distant sites in the body. This classification helps identify patients based on the very limited presence of HER2 protein on cancer cells.

  • HER2-Low Triple-Negative Breast Cancer

    This is an advanced form of breast cancer that lacks receptors for estrogen and progesterone and does not overexpress HER2 protein, but shows low levels of HER2 expression. Triple-negative refers to the absence of the three most common receptors typically found in breast cancer cells. Despite being classified as triple-negative, these tumors have detectable low levels of HER2 protein. The disease progresses as cancer cells multiply and spread to other organs and tissues throughout the body. This subtype is particularly challenging because it does not respond to hormone therapies or standard HER2-targeted treatments.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase ITrial ID2025-521003-52-00Protocol codeC5731006/SGNDV-006Estimated enrolment90 patientsSponsorPfizer Inc.

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