Study of Trastuzumab Deruxtecan for Patients with Early Stage HER2-Positive Breast Cancer

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What is this study about?

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.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria, including age, laboratory values, and medical history.

Participants must have early stage HER2-positive breast cancer and meet other health requirements.

2 initial treatment phase

The treatment involves the administration of trastuzumab deruxtecan (T-DXd), a medication given through an intravenous infusion.

The medication is provided in a solution form and is administered according to the study’s schedule.

3 treatment monitoring

Regular monitoring is conducted to assess the response to the treatment.

A mandatory tumor biopsy is performed at Cycle 2 Day 14, with a possible additional biopsy before surgery.

4 surgery preparation

After completing the initial treatment cycles, preparation for surgery is undertaken.

The goal is to achieve a pathological complete response, meaning no invasive cancer is found in the breast or lymph nodes during surgery.

5 surgery and follow-up

Surgery is performed to remove any remaining cancerous tissue.

Follow-up assessments are conducted to evaluate the long-term outcomes, including event-free survival and overall survival over a three-year period.

Who Can Join the Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country
University Hospital Limerick	Limerick	Ireland
Beaumont Hospital	Dublin	Ireland
Cwut Uukqnyunxd Hyvengox	Cork	Ireland
Sr Vbmwodyakbwwykz Ucwtzxrwec Hubuemtg	Dublin	Ireland

Trial status

Country	Status	Recruitment Start
Ireland	Recruiting	26.10.2023

Trial locations

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.

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 ID:

2024-516582-36-00

Protocol code:

CTRIAL‐IE-22‐01

NCT ID:

NCT05710666

Trial Phase:

Therapeutic use (Phase IV)

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Study of Trastuzumab Deruxtecan for Patients with Early Stage HER2-Positive Breast Cancer

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?