RecruitingPHASE3INTERVENTIONAL

A Randomized Secondary Adjuvant Treatment Intervention Study Comparing Trastuzumab-Deruxtecan to SOC Therapy in eBC Patients With Molecular Relapse

This study is for people aged 18-75 with early breast cancer that has either HER2-positive or HER2-low features. These are people who have already taken part in the SURVIVE trial and have shown a sign called 'molecular relapse' in their blood, meaning tiny traces of cancer have been detected, even if there are no visible tumours. The study will compare a new medicine, Trastuzumab-Deruxtecan, given every three weeks, with other standard treatments chosen by their doctor. The main goal is to find out if Trastuzumab-Deruxtecan can help prevent the cancer from coming back or spreading compared to current treatments.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Prof. Wolfgang Janni

Enrolment target

180

Start

22 Apr 2025

Estimated completion

22 Apr 2032

Breast Cancer

What is this study about?

You might be reading this because you or someone you know has been diagnosed with breast cancer. This study is for people who have already had treatment for early breast cancer and have joined another study called SURVIVE. In the SURVIVE study, a blood test for something called 'circulating tumour DNA' (ctDNA) is used. If this test shows a positive result, it means tiny signs of cancer cells have been found in the blood. This is called 'molecular relapse'. It doesn't mean the cancer has visibly returned or spread, but it's an early warning sign.

The purpose of this study is to see if a new medicine, Trastuzumab-Deruxtecan, can help prevent the cancer from fully returning or spreading after molecular relapse, compared to the standard treatments doctors usually offer. The study wants to find out which approach is better at keeping people well. Half of the people in the study will be given Trastuzumab-Deruxtecan, and the other half will receive treatment chosen by their doctor.

This is a 'Phase 3' study, which means it's one of the final steps before a new treatment might become widely available. Doctors and scientists are carefully comparing this new medicine with existing ones to understand its benefits and risks for patients with these specific breast cancer characteristics.

Key takeaways

Compares a new drug (Trastuzumab-Deruxtecan) to standard care.
For specific types of early breast cancer (HER2-positive or HER2-low).
Only for people already in the SURVIVE study with 'molecular relapse' (early signs of cancer in blood).
Aims to prevent cancer from returning or spreading.
Requires regular hospital visits, blood tests, and scans.
You have a 2 in 3 chance of receiving the new drug.

Who may be eligible?

This study is looking for both women and men between 18 and 75 years old who have been diagnosed with an early form of breast cancer. This cancer must be either 'HER2-positive' or 'HER2-low', which are specific types of breast cancer identified by lab tests.

To join, your breast cancer must have been completely removed by surgery, and you must have completed any chemotherapy or radiation therapy at least six months before starting this study. A very important part of joining is that you must already be part of the SURVIVE study and have had a positive ctDNA test result, showing signs of molecular relapse. You also cannot have any visible cancer spread to other parts of your body, which will be checked with scans.

If you are currently taking certain other breast cancer medicines like Trastuzumab or Olaparib, you might need to stop those treatments for a short time before joining this study, though some hormone therapies can continue alongside the study treatment.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 18 and 75 years old?
Do you have HER2-positive or HER2-low breast cancer?
Have you already had your breast cancer surgery, and any chemotherapy or radiation therapy finished at least 6 months ago?
Are you currently participating in the SURVIVE study and have had a positive ctDNA (molecular relapse) blood test?
Do scans show no visible signs of cancer spread?
Are you willing to discuss potential changes to your current medications (e.g., stopping some temporarily)?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be randomly assigned to one of two groups. Two out of three people will receive Trastuzumab-Deruxtecan, given through a drip into your vein every three weeks. If your cancer is hormone-sensitive, you will also continue with your hormone therapy. The other group will receive treatment chosen by your doctor, which could be a variety of established breast cancer medicines. The study treatment will continue for 16 cycles (about a year) or until your cancer shows signs of returning, whichever comes first.

Throughout the study, you will have regular clinic visits, blood tests, and scans to monitor your health and see how the treatment is working. These assessments are important to track your progress and any side effects. The total duration of active treatment and follow-up will vary depending on your group and how you respond to treatment.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. You might benefit from receiving a new treatment, Trastuzumab-Deruxtecan, which could be more effective than standard care in preventing your breast cancer from fully returning. However, like all medicines, Trastuzumab-Deruxtecan has potential side effects, and your doctor will discuss these with you in detail. The risks of standard treatments are also well-known. You will be closely monitored by a medical team, and you are free to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (1)

University Clinic Ulm
Verified postcode
Ulm, Germany· Recruiting

Common questions

What is 'molecular relapse'?

It means a blood test has found tiny traces of cancer DNA in your body, even if scans don't show any visible tumours yet. It's an early warning sign.

What does HER2-positive or HER2-low mean?

These are categories that describe a specific protein found on breast cancer cells, which helps doctors decide the best treatment. Your doctor can explain your specific type.

Will I definitely get the new drug?

No, you have a two-in-three chance of receiving the new drug, Trastuzumab-Deruxtecan. The other group will receive standard treatment chosen by your doctor.

How long will I be on the study treatment?

You will receive treatment for about a year (16 cycles) or until your cancer shows signs of returning, whichever happens first.

Can I stop participating in the study at any time?

Yes, you can choose to leave the study at any point without it affecting your regular medical care.

How to find out more

Wolfgang Janni, Prof. Dr. med.

studienzentrale.ufk@uniklinik-ulm.de +49731 500 58536 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.