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A Study of Trastuzumab Deruxtecan Treatment for Patients with Early-Stage HER2-Positive or HER2-Low Breast Cancer Who Show Signs of Molecular Relapse

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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-positive or HER2-low early breast cancer. The research evaluates a medication called trastuzumab deruxtecan (also known as Enhertu), which is given through intravenous infusion. This medicine is being studied as a treatment option for patients who show signs of disease activity through blood tests, even though there are no visible signs of cancer spread on scans.

The purpose of this research is to determine how effectively the treatment clears disease markers from the blood. The study involves comparing two groups of patients - one group receiving trastuzumab deruxtecan and another group receiving standard care treatment. During the study, patients will receive regular infusions of the medication and undergo blood tests to monitor their response to treatment.

The treatment may continue for up to one year, with a maximum dose of 5.4 milligrams per kilogram of body weight. Throughout the study period, patients will have regular check-ups to monitor their health and complete quality of life questionnaires. The medical team will pay special attention to monitoring the heart and lungs, as these are important aspects of patient safety during treatment.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
A medical evaluation will confirm your eligibility within 28 days before starting the treatment
Tests will include heart function check to confirm left ventricular ejection fraction is 50% or higher
Blood tests will be performed to check organ and bone marrow function
Step 2
Treatment assignment
You will be randomly assigned to one of the treatment groups
If assigned to group A, you will receive trastuzumab deruxtecan through an intravenous infusion
Any current breast cancer treatments will need to be stopped before starting the new treatment, except for hormone therapy which can continue
Step 3
Treatment period
Treatment will be given in cycles
Regular blood tests will be taken to monitor your response to treatment
Scans will be performed to check for any signs of cancer
You will need to complete quality of life questionnaires before the first treatment and at 3, 6, 9, 12, 15, 18, and 24 months
Step 4
Monitoring
Your health will be closely monitored throughout the study
Special attention will be paid to monitoring for side effects, particularly those affecting the lungs and heart
Regular assessments will check for any signs of cancer return
Step 5
Follow-up
You will continue to be monitored after completing treatment
Follow-up visits will include regular health checks and scans
The total study duration is expected to continue until October 2031

Who can join the trial?

13 criteria

Age between 18 and 75 years
Must provide written informed consent before starting study procedures
Must have a heart function test showing left ventricular ejection fraction of 50% or higher within 28 days before starting the study
Must have good physical performance status (ECOG score of 0 or 1, meaning able to perform daily activities with minimal assistance)
Must have adequate organ and bone marrow function within 28 days before starting the study
Must have breast cancer that is either: - HER2-positive (showing high levels of HER2 protein), or - HER2-low (showing low levels of HER2 protein)
Must have had complete surgical removal of the tumor with clear margins (no cancer cells at the edges)
Must be participating in the SURVIVE study with evidence of early signs of disease return in blood tests
Must have no evidence of cancer spread as shown by CT scan and bone scan within 8 weeks before starting
Must have completed surgery, chemotherapy, and radiation therapy (if received) at least 6 months before starting
For women who can become pregnant: - Must have negative pregnancy test - Must use effective birth control during study and for 7 months after - Must not breastfeed during study and for 7 months after
For men: - Must use contraception during study and for 4 months after if sexually active - Must not father children during study and for 4 months after
Must have known hormone receptor status (positive or negative) for the breast cancer

Who cannot join the trial?

14 criteria

Age under 18 years old
Known metastatic disease (cancer that has spread to other parts of the body)
Previous treatment with anti-HER2 therapy (medications targeting HER2 protein)
Pregnancy or breastfeeding
Serious heart conditions, including congestive heart failure (when heart cannot pump blood effectively)
Active or uncontrolled infections
History of other cancers within the past 5 years (except successfully treated non-melanoma skin cancer or cervical cancer in situ)
Significant liver problems or abnormal liver function tests
Severe kidney disease requiring dialysis
Uncontrolled high blood pressure
Known psychiatric or substance abuse disorders that would interfere with study participation
Participation in another clinical trial within 30 days before starting this study
Unable to follow study procedures or attend scheduled visits
Known allergies to study medications or their components

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
Charite Universitaetsmedizin Berlin KöR
Berlin, Germany
Verified
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH
Ulm, Germany
Verified
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)
Munich, Germany

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Investigated drugs

Trastuzumab-Deruxtecan is a targeted cancer medication that combines two active components. It works by attaching to specific proteins on cancer cells (called HER2) and delivering chemotherapy directly to these cells. This medication is designed to treat breast cancer while potentially causing less damage to healthy cells compared to traditional chemotherapy. Standard of Care (SOC) therapy refers to the current best-known treatment that doctors regularly use to treat breast cancer patients. The specific medications used as SOC may vary depending on individual patient factors and local treatment guidelines.

Trastuzumab Deruxtecan

What is already known about the treatment

Trastuzumab Deruxtecan - A targeted antibody-drug conjugate administered through intravenous infusion, specifically designed for treating HER2-positive and HER2-low breast cancer. This innovative medication combines a HER2-targeted antibody with a potent chemotherapy agent, delivering the cancer-fighting drug directly to tumor cells that express HER2 proteins while minimizing damage to healthy tissues. The medication belongs to the class of targeted cancer therapies and works by attaching to HER2 receptors on cancer cells, then releasing its cytotoxic payload inside the cells to destroy them. Currently, it represents one of the most advanced treatments in breast cancer therapy, showing promising results in clinical trials for early-stage breast cancer treatment, particularly in cases where cancer cells can be detected through circulating tumor DNA.

Investigated diseases

HER2-positive breast cancer
A type of breast cancer where cancer cells have high levels of a protein called HER2 on their surface. The cancer cells grow and divide more rapidly than those without the HER2 protein. This form of breast cancer typically starts in the breast ducts or lobules and can spread to surrounding tissues.
HER2-low breast cancer
A type of breast cancer characterized by low levels of HER2 protein expression on cancer cells. This cancer develops when breast cells with lower amounts of HER2 protein begin to grow uncontrollably. The cancer originates in breast tissue and can develop in either the ducts or the lobules of the breast.