Cork University Hospital
Cork, Ireland
Recruiting
Study of Trastuzumab Deruxtecan for Patients with Early Stage HER2-Positive Breast Cancer
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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 early stage HER2-positive breast cancer. The treatment being tested is called trastuzumab deruxtecan, also known by its code name DS-8201a. This medication is a special kind of drug that combines an antibody, which targets the HER2 protein on cancer cells, with a chemotherapy agent that helps kill these cells. The purpose of the study is to see how effective this treatment is when given before surgery, with the hope of reducing the need for traditional chemotherapy.
Participants in the study will receive the treatment as a solution through an intravenous infusion, which means it is given directly into the bloodstream. The study will follow a single group of patients who will receive this treatment before undergoing surgery. The researchers will monitor how well the cancer responds to the treatment and whether it can help avoid the use of standard chemotherapy. The study will also look at the long-term outcomes of patients who receive this treatment, such as their survival rates and whether the cancer returns.
Throughout the study, various aspects will be observed, including changes in the tumor and the body's response to the treatment. The study will also explore the potential of using new technologies to analyze tumor samples and the role of the immune system in responding to the treatment. The goal is to gather information that could lead to more effective and less toxic treatment options for patients with HER2-positive breast cancer.
The research process
The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.
Who can join the trial?
21 criteria
- Adults, both women and men, who are 18 years of age or older.
- Must have recent laboratory test results that meet specific criteria, including:
- Absolute neutrophil count (ANC) of at least 1.5 x 109/L. Neutrophils are a type of white blood cell important for fighting infections.
- Platelet count of at least 100 x 109/L. Platelets help with blood clotting.
- Hemoglobin level of at least 9.0 g/dL. Hemoglobin is a protein in red blood cells that carries oxygen.
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels no more than 3 times the upper limit of normal. These are liver enzymes.
- Total bilirubin no more than 1.5 times the upper limit of normal, or less than 3 times if you have Gilbert's syndrome, a mild liver condition.
- Serum albumin of at least 25 g/L. Albumin is a protein made by the liver.
- Creatinine clearance (CrCL) of at least 30 ml/min. This measures kidney function.
- Prothrombin time and partial thromboplastin time no more than 1.5 times the upper limit of normal. These tests measure how well your blood clots.
- Women must either be post-menopausal or have a negative pregnancy test if they are of childbearing potential and sexually active with a non-sterilized male partner.
- Women of childbearing potential must agree to use a highly effective method of contraception during the study and for at least 7 months after the last dose of the study drug.
- Non-sterilized male participants must use a condom with spermicide if sexually active with a female partner of childbearing potential, from the start of the study until 4 months after the last dose of the study drug.
- Female participants must not donate or retrieve eggs for their own use during the study and for at least 7 months after the last dose of the study drug. They should also not breastfeed during this time.
- Must have a confirmed diagnosis of HER2-positive breast cancer, which means the cancer has a high level of a protein called HER2.
- Must have newly diagnosed breast cancer that is planned for treatment before surgery.
- Must have stage 2 or 3 breast cancer.
- Must not have received any previous treatment for breast cancer.
- Must be willing to have a tumor biopsy at a specific time during the study.
- Must have an ECOG performance status of 0-1, which means you are fully active or have some symptoms but can still carry out light work.
- Must have available tissue from a previous tumor biopsy for screening.
- Must have a left ventricular ejection fraction (LVEF) of at least 50%, which measures how well the heart pumps blood.
Who cannot join the trial?
5 criteria
- Patients who do not have HER2-positive breast cancer. This means the cancer cells have a protein called HER2 on their surface, which makes them grow.
- Patients who are not in the early stage of breast cancer. This refers to the initial stages where the cancer is usually smaller and has not spread extensively.
- Patients who are not within the specified age range for the study. The study may have specific age limits for participants.
- Patients who are not female. This study is specifically for female patients.
- Patients who are part of a vulnerable population. This means groups of people who might need special protection or care, such as children or those unable to give consent.
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Verified sites
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Verified Verified St Vincent's University Hospital
Dublin, IrelandVerified University Hospital Limerick
Limerick, Ireland
Trial locations
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Investigated drugs
Trastuzumab Deruxtecan (T-DXd) is a medication used in this clinical trial to treat early-stage HER2-positive breast cancer. It is given before surgery to shrink the tumor and is part of a treatment plan aimed at curing the cancer. This medication works by targeting and attaching to the HER2 protein on cancer cells, delivering chemotherapy directly to the cells to help destroy them. The goal of using this medication in the trial is to see how well it can eliminate cancer cells before surgery, potentially allowing patients to avoid more extensive chemotherapy treatments.
What is already known about the treatment
Trastuzumab Deruxtecan – This medication is administered intravenously and is currently being studied in clinical trials for its effectiveness in treating early-stage HER2-positive breast cancer. It is a promising treatment option that aims to reduce the need for traditional chemotherapy. Trastuzumab Deruxtecan works by targeting and binding to the HER2 protein on cancer cells, delivering a cytotoxic agent directly to the cells, which helps to inhibit their growth and survival. It is classified as an antibody-drug conjugate, combining targeted therapy with chemotherapy to enhance its therapeutic effects.
Investigated diseases
Early stage HER2-positive breast cancer – This is a type of breast cancer characterized by the overexpression of the HER2 protein, which promotes the growth of cancer cells. It is considered an early stage when the cancer is confined to the breast or nearby lymph nodes and has not spread to distant parts of the body. The disease progresses as cancer cells grow and potentially spread to surrounding tissues. HER2-positive breast cancer tends to grow and spread more aggressively than other types of breast cancer. Early detection and intervention are crucial to managing the disease effectively.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IVTrial ID2024-516582-36-00Protocol codeCTRIAL‐IE-22‐01Estimated enrolment77 patientsSponsorCancer Trials Ireland
sourced from the EU Clinical Trials Register and site verification
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