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Study on Trastuzumab Deruxtecan for Patients with Metastatic HER2-Positive Breast Cancer

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 clinical trial is focused on studying a type of breast cancer known as metastatic HER2-positive breast cancer. This is a form of cancer where the cancer cells have spread to other parts of the body and have a high level of a protein called HER2, which promotes the growth of cancer cells. The treatment being tested in this study is called Trastuzumab Deruxtecan, which is a medication given as an injection into a vein. It is designed to target and destroy cancer cells that have high levels of the HER2 protein.

The purpose of the study is to explore how changes in the cancer cells' genetic material, which can lead to resistance to the treatment, can be detected using a new method called liquid biopsy. This involves taking blood samples to look for changes in the cancer cells' DNA that are circulating in the blood. The study will monitor these changes over time to understand how they relate to the effectiveness of the treatment.

Participants in the study will receive the treatment and have regular blood tests to check for changes in the cancer cells' DNA. The study will last for a period of time, during which the safety and effects of the treatment will be closely monitored. The goal is to better understand how to tailor treatments for patients with this type of breast cancer and improve outcomes by using advanced diagnostic methods like liquid biopsy.

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

    Enrollment

    Upon joining the study, the patient must meet specific criteria, including a confirmed diagnosis of metastatic HER2-positive breast cancer and a life expectancy greater than 12 weeks.

    The patient must provide informed consent and agree to periodic blood sample collection for liquid biopsy.

  2. Step 2

    Initial assessment

    Before starting treatment, the patient undergoes a series of assessments to confirm eligibility, including tests to ensure adequate organ and bone marrow function and a negative pregnancy test for women of childbearing potential.

  3. Step 3

    Treatment administration

    The patient receives trastuzumab deruxtecan intravenously. The dosage and frequency are determined by the study protocol and the patient's specific medical condition.

  4. Step 4

    Monitoring and follow-up

    Throughout the study, the patient is monitored for any changes in their condition, including the presence of circulating genomic alterations associated with resistance to the treatment.

    Regular assessments are conducted to evaluate the patient's response to the treatment and to monitor for any side effects.

  5. Step 5

    Progress evaluation

    The patient's progress is evaluated using medical imaging and liquid biopsy to assess the presence of circulating tumor DNA and any genomic alterations.

    The study aims to compare the progression of the disease as detected by imaging and by liquid biopsy.

  6. Step 6

    Completion

    The study is estimated to conclude by May 31, 2027. The patient's participation continues until the study's end or until they meet criteria for discontinuation.

Who can join the trial?

17 criteria

  • Must be able to understand, sign, and date a consent form before any study procedures.
  • Expected to live for more than 12 weeks.
  • Can have brain metastases (cancer spread to the brain) if they are not active.
  • If brain metastases were treated and are no longer causing symptoms, and no longer need treatment with steroids or seizure medications, you can join the study after recovering from radiation side effects. At least 2 weeks should pass after brain radiation before joining.
  • Heart function must be at least 50% within 28 days before joining the study. This is measured by a test called LVEF (Left Ventricular Ejection Fraction).
  • Organs and bone marrow must be working well within 14 days before joining the study. All test results must meet the study requirements on the same day and be the most recent results.
  • Must have a break from previous treatments before joining the study, as defined in the study protocol.
  • Women who can have children must show they are not pregnant with a blood test at the start and before each treatment. Women are considered unable to have children if they have had certain surgeries or have not had a period for 12 months without another reason.
  • Must agree to have blood samples taken regularly for a test called a liquid biopsy.
  • Must be 18 years or older.
  • Must have a confirmed diagnosis of a type of breast cancer called adenocarcinoma, which is either advanced and cannot be removed or treated with radiation to cure, or has spread to other parts of the body and cannot be cured.
  • Must have a confirmed HER2-positive breast cancer, as determined by specific guidelines, with any status of other hormone receptors (ER and/or PgR).
  • Must have had no more than one previous treatment for advanced/metastatic cancer, which may include certain drugs like trastuzumab and taxane, or cancer that progressed within 6 months after treatment.
  • Must show cancer progression through imaging tests during or after the most recent treatment, or within 6 months after completing therapy.
  • Must have at least one measurable tumor according to specific criteria (RECIST version 1.1).
  • If cancer is only in the bones, it must include at least one type of bone lesion that can be evaluated. If radiation was done on bones, there must be at least one lesion in an area that was not treated. Lesions seen only on a bone scan are not eligible.
  • Must have a performance status of 0 or 1 on a scale used to assess how the disease affects daily living (ECOG performance status).

Who cannot join the trial?

3 criteria

  • Patients who do not have metastatic HER2-positive breast cancer. This means the cancer must have spread to other parts of the body and have a specific protein called HER2.
  • Patients who are not within the specified age range for the study. The study may have specific age requirements.
  • Patients who are part of a vulnerable population. This means people who might need special protection or care, like children or those unable to make decisions for themselves.
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Investigated drugs

Trastuzumab Deruxtecan (T-DXd) is a medication used in this clinical trial to treat certain types of cancer. It is designed to target and attach to cancer cells that have a protein called HER2 on their surface. Once attached, it delivers a chemotherapy drug directly into the cancer cells to help destroy them. This medication is being studied to understand how it can be more effectively used and to identify any changes in the cancer cells that might make them resistant to the treatment.

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 metastatic HER2-positive breast cancer. It is a targeted therapy that combines an antibody with a chemotherapy drug, specifically designed to deliver the chemotherapy directly to cancer cells that express the HER2 protein. The mechanism of action involves binding to the HER2 receptor on cancer cells, allowing the chemotherapy component to enter and kill the cancer cells. Trastuzumab Deruxtecan is classified as an antibody-drug conjugate and is being explored for its potential to overcome resistance in patients who have previously been treated with other HER2-targeted therapies.

Investigated diseases

Metastatic 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. In its metastatic form, the cancer has spread beyond the breast to other parts of the body, such as the bones, liver, or brain. The progression of this disease involves the continuous growth and spread of cancer cells, often leading to the development of new tumors in distant organs. HER2-positive breast cancer tends to grow and spread more aggressively than other types of breast cancer. The disease is often monitored through imaging and blood tests to track changes in HER2 status and detect any resistance to treatments. Understanding the genetic alterations in circulating tumor DNA can provide insights into the disease's progression and potential resistance to therapies.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-518017-26-00Protocol codeESR-21-21447Estimated enrolment22 patientsSponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS

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