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 study about?

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.

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

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

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

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

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 Study?

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 Study?

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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Technische Universitaet Dresden	Dresden	Germany
Universitaetsmedizin Goettingen	Goettingen	Germany
Universitaetsklinikum Heidelberg AöR	Heidelberg	Germany

Other Sites

Site Name	City	Country
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)	Munich	Germany
Universitaetsklinikum Aachen AöR	Aachen	Germany
Klinikum Ernst von Bergmann gGmbH	Potsdam	Germany
Romed Klinikum Rosenheim	Rosenheim	Germany
Klinikverbund Allgaeu gGmbH	Kempten (Allgau)	Germany
Marienhospital Bottrop gGmbH	Bottrop	Germany
Universitaetsklinikum Schleswig-Holstein AöR	Kiel	Germany
Universitaetsklinikum Regensburg AöR	Regensburg	Germany
Universitaetsklinikum Erlangen AöR	Erlangen	Germany
Universitaetsklinikum Tuebingen AöR	Tuebingen	Germany
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany
SLK-Kliniken Heilbronn GmbH	Heilbronn	Germany
St. Elisabeth Krankenhaus GmbH	Cologne	Germany
Klinikum Chemnitz gGmbH	Chemnitz	Germany
Rheinische Friedrich-Wilhelms-Universitaet Bonn	Bonn	Germany
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH	Ulm	Germany
Universitaetsklinikum Leipzig AöR	Leipzig	Germany
Mys Sid Prviik Gajh	Schwerte	Germany
Upterrmozc Mspfril Cqhgup Hwmcsfhwjwzjwdiay	Hamburg	Germany
Uqbpsjfhpgckbtaunmekt Eaxxv Aps	Essen	Germany
Kmcwzebr Ruuhlo	Rheine	Germany
Hlrhhjwmifdngmsz iy Mrnmvsz	Bremen	Germany
Unihcdvsnfsueebkmvdsn Dmtvjmmqmbs Ail	Duesseldorf	Germany
Kjweqzkc dxk Uboujycegumy Mihbkbgw Atk	Munich	Germany

Trial status

Country	Status	Recruitment Start
Germany	Recruiting	21.10.2024

Trial locations

Investigated drugs:

Trastuzumab Deruxtecan

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.

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.

Trial ID:

2024-516173-76-01

Protocol code:

ESR-22-21837

Trial Phase:

Therapeutic confirmatory (Phase III)

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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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?