RecruitingPHASE2INTERVENTIONAL

Trastuzumab Deruxtecan in First-Line HER2-Positive Metastatic Breast Cancer With Proactive Toxicity Management

This study is testing a new treatment for advanced HER2-positive breast cancer that has spread to other parts of the body. The treatment uses a drug called Trastuzumab Deruxtecan (T-DXd) along with another drug called Pertuzumab. Doctors want to see how well this combination works and if it's safe as a first treatment. A special part of this study involves using digital tools, like phone apps and other devices, to help patients and their doctors keep track of any side effects. The goal is to spot potential problems, especially lung issues, early so they can be managed quickly. This study is for people who haven't had chemotherapy or HER2-targeted therapy for their advanced cancer yet.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

SOLTI Breast Cancer Research Group

Enrolment target

300

Start

18 Feb 2026

Estimated completion

01 Jul 2030

Breast Cancer Stage IV

What is this study about?

This clinical trial is looking at a new way to treat advanced HER2-positive breast cancer that has spread. HER2-positive means that the cancer cells have a lot of a protein called HER2, which can make the cancer grow faster. The study is testing a combination of two drugs: Trastuzumab Deruxtecan (often called T-DXd) and Pertuzumab. These drugs are given through a drip (IV infusion).

The main aim of this study is to see how effective this combination is as a very first treatment for this type of advanced breast cancer and to understand its safety. It's hoped that this treatment could offer a good option for patients. An important and innovative part of this study is the use of digital health tools, like mobile phone apps and special devices. These tools are designed to help patients and their care team monitor health and potential side effects from home.

By using these digital tools, the study hopes to spot any side effects, especially a lung condition called pneumonitis (inflammation of the lungs), much earlier than usual. Catching side effects early means they can be managed more quickly, potentially making the treatment safer and more comfortable for patients. The study is open to both men and women aged 18 and over who have this type of breast cancer.

Key takeaways

This study tests a new drug combination for advanced HER2-positive breast cancer.
It's for people who haven't had prior treatment for their spread cancer.
Digital tools (apps, devices) are used to monitor side effects, especially lung issues.
Treatment is given via IV drip and continues as long as it's effective and safe.
You will be closely monitored by a medical team.

Who may be eligible?

To join this study, you need to be at least 18 years old and have advanced HER2-positive breast cancer that has spread. This means your cancer cells have a lot of the HER2 protein. Your cancer must also be considered "evaluable," which means doctors can measure its size.

It's important that you haven't had chemotherapy or other HER2-targeted treatments specifically for your advanced or spread breast cancer before. However, if you had these treatments in the past for earlier-stage breast cancer (before it spread), you might still be able to join. Your doctors will check if your overall health is good enough for you to participate.

You also need to be willing and able to use the digital health tools, like a mobile app and other devices, that are part of the study. Even if your cancer has spread to your brain (CNS metastases), you might still be able to join if it's being managed and doesn't need urgent 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 at least 18 years old?
Do you have HER2-positive breast cancer that has spread?
Have you *not* had chemotherapy or HER2-targeted treatment for your *spread* cancer before?
Are you willing and able to use a mobile app and other digital devices for monitoring?
Is your overall health generally good enough for a clinical trial?

Answer every question to see your result.

What does participation involve?

If you take part in this study, you will receive the study drugs, Trastuzumab Deruxtecan and Pertuzumab, through a drip (IV infusion) in cycles. This treatment will continue for as long as it's helping you and you're not experiencing bad side effects, or until your doctor decides to stop it. For some patients with hormone-sensitive tumours, you might also take standard hormone therapy at the same time.

A key part of your participation will be using digital health tools. This includes a mobile app on your phone and other devices that will help you and your care team keep an eye on your health and any side effects between hospital visits. This is designed to help detect and manage any problems early. You will have regular appointments and tests to check how the treatment is working and to monitor your health. The total duration of your participation will depend on how you respond to the treatment and your health.

Potential risks and benefits

Taking part in a clinical trial offers the chance to access a new treatment that might be more effective than standard options, and you'll receive very close monitoring from a medical team. However, like all medications, the study drugs can have side effects, which could be serious. The digital tools are in place to help spot side effects early, but they don't prevent them. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (27)

Gustave Roussy
Verified postcode
Villejuif, France· Not yet recruiting
Klinikum der Universitaet Muenchen AöR
Verified postcode
München, Germany· Not yet recruiting
Hospital Universitari Vall d'Hebrón
Verified postcode
Barcelona, Spain· Recruiting
Complexo Hospitalario Universitario A Coruna
Verified postcode
A Coruña, Spain· Not yet recruiting
Hospital General Universitario Dr. Balmis
Verified postcode
Alicante, Spain· Recruiting
Hospital Universitario de Badajoz
Verified postcode
Badajoz, Spain· Recruiting
Hospital Clínic de Barcelona
Verified postcode
Barcelona, Spain· Recruiting
Hospital Universitario de Basurto
Verified postcode
Bilbao, Spain· Not yet recruiting
Institut Català d'Oncologia (ICO) Girona
Verified postcode
Girona, Spain· Not yet recruiting
Hospital Universitario Clínico San Cecilio
Verified postcode
Granada, Spain· Recruiting
Institut Català d'Oncologia (ICO) Hospitalet
Verified postcode
L'Hospitalet de Llobregat, Spain· Not yet recruiting
Hospital Universitario Leon
Verified postcode
León, Spain· Recruiting

Common questions

What is HER2-positive breast cancer?

HER2-positive breast cancer means the cancer cells have a lot of a protein called HER2, which acts like a signal for the cancer to grow.

What are 'digital health tools'?

These are things like phone apps and wearable devices that help you and your doctors keep track of your health and any side effects from home.

Can I join if I've had breast cancer treatment before?

You can join if you've had treatment for early-stage breast cancer, but not if you've already had chemotherapy or HER2-targeted therapy for your *advanced* spread cancer.

What is 'ILD/pneumonitis'?

These are medical terms for serious inflammation in the lungs, which the digital tools in this study aim to detect early.

How long will I be on the treatment?

You will continue treatment for as long as it is working for you and not causing unacceptable side effects, or until your doctor advises otherwise.

How to find out more

Mariana Paes Dias, PhD

info@gruposolti.org +34 933 436 302 Official trial record

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