RecruitingPHASE2INTERVENTIONAL

Safety and Efficacy of T-DXd vs. CDK4/6i-based ET as First-line Therapy of HR-positive and HER2-low/Ultralow Advanced Breast Cancer Patients Classified as Non-luminal Subtype

This study is for people with advanced breast cancer that is hormone receptor-positive and classified as 'HER2-low/ultralow' and 'non-luminal.' Researchers want to see how well a new treatment called trastuzumab deruxtecan (T-DXd) works compared to a standard treatment involving CDK4/6 inhibitors plus hormone therapy. The main goal is to find out if T-DXd can prevent the cancer from growing or spreading for longer. This is a Phase 2 study, meaning it's still in the earlier stages of testing, after the very first safety tests. The hope is to improve treatment options for this specific type of breast cancer.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

MedSIR

Enrolment target

200

Start

30 Jun 2025

Estimated completion

01 Jan 2028

Advanced Breast Cancer Advanced Breast Carcinoma Hormone Receptor Positive Breast Carcinoma

What is this study about?

This research study is looking for better ways to treat a specific type of advanced breast cancer. This cancer is described as 'hormone receptor-positive,' which means its growth is affected by hormones. It's also classified as 'HER2-low' or 'HER2-ultralow,' which refers to the amount of a protein called HER2 on the cancer cells, and 'non-luminal,' which is a way of further classifying the cancer based on its genetic makeup. These classifications help doctors understand how a cancer might behave and which treatments could work best.

The study will compare a new treatment called trastuzumab deruxtecan (T-DXd) with a standard treatment that doctors often use. The standard treatment combines a CDK4/6 inhibitor (a drug that stops cancer cells from growing) with hormone therapy. Researchers want to see if T-DXd can be more effective at stopping the cancer from growing or spreading for a longer time when used as a first treatment for new patients.

It's important to find effective first-line treatments because they can make a big difference in how well patients do. This study hopes to understand if T-DXd could become a new, better option for people with this particular kind of advanced breast cancer.

Key takeaways

This study is for advanced, HR-positive, HER2-low/ultralow, non-luminal breast cancer.
It compares a new drug (T-DXd) with a standard treatment.
The main goal is to see if T-DXd can stop cancer growth for longer.
You will be randomly assigned to one of the two treatment groups.
Participation involves regular hospital visits, tests, and medication.
You can stop participating in the study at any time.

Who may be eligible?

To join this study, you need to be at least 18 years old and have advanced breast cancer that has come back or spread, and cannot be removed by surgery. Your cancer must be 'hormone receptor-positive' and also fall into specific categories called 'HER2-low/ultralow' and 'non-luminal.' These are determined by special tests on your tumor tissue.

You also need to be generally well enough to take part, with a good level of activity in your daily life. Your doctors will check that you are expected to live for at least 12 weeks and that your cancer is suitable for this research. They will also need to review your tumor tissue samples to confirm these specific characteristics.

There will be other detailed health checks to make sure the study is safe for you. If you meet these main points, your doctor can review the full list of requirements to see if this study might be a good fit.

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 advanced breast cancer that has spread or returned?
Has your doctor confirmed your cancer is 'Hormone Receptor-positive'?
Have tests shown your cancer is 'HER2-low' or 'HER2-ultralow' and 'non-luminal'?
Are you generally well and active enough for daily activities?
Are you willing to have regular hospital visits for treatment and monitoring?

Answer every question to see your result.

What does participation involve?

If you join this study, you will first have some tests to confirm you meet all the requirements. Once confirmed, you will be randomly assigned to one of two groups: one group will receive trastuzumab deruxtecan (T-DXd) and the other will receive a CDK4/6 inhibitor plus hormone therapy. You won't get to choose which treatment you receive; it's decided by chance, like flipping a coin.

The trastuzumab deruxtecan is given as an infusion into your vein every 21 days. The CDK4/6 inhibitor and hormone therapy are usually taken by mouth daily, with possible infusions for some hormone therapies, but this will vary based on what your doctor chooses for you. You will have regular check-ups, scans (like CT or MRI), and blood tests to monitor your health and how the treatment is working. This will continue for as long as the treatment is helping you and you are tolerating it well. The study will also follow up on your health over a longer period. The total duration of active treatment and follow-up will depend on your individual response.

Potential risks and benefits

Taking part in a clinical trial may offer potential benefits, such as access to a new treatment before it's widely available, and careful monitoring by a medical team. However, there are also potential risks. New treatments can have side effects, and it's possible that the treatment might not work for you, or could even cause serious problems. Your doctors will explain all known side effects and help manage them. You can withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (72)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Kepler Universitäts Klinikum
Verified postcode
Linz, Austria· Recruiting
Medical University of Vienna
Verified postcode
Vienna, Austria· Recruiting
Algemeen Ziekenhuis Klina
Verified postcode
Brasschaat, Belgium· Recruiting
Ghent University Hospital
Verified postcode
Ghent, Belgium· Recruiting
CHU Helora - Hopital de Mons
Verified postcode
Mons, Belgium· Recruiting
Cliniques universitaires Saint-Luc
Verified postcode
Woluwe-Saint-Lambert, Belgium· Recruiting
Centre Francois Baclesse
Verified postcode
Caen, France· Recruiting
CHU Lyon Sud
Verified postcode
Lyon, France· Recruiting
Institute Paoli Calmettes
Verified postcode
Marseille, France· Recruiting
Institut Curie
Verified postcode
Paris, France· Recruiting
CHU Saint Etienne
Verified postcode
Saint-Priest-en-Jarez, France· Recruiting
MVZ Klinikum Aschaffenburg
Verified postcode
Aschaffenburg, Germany· Recruiting

Common questions

What does 'advanced breast cancer' mean?

Advanced breast cancer means the cancer has spread beyond the breast to other parts of the body, or it has come back in the breast area after previous treatment and cannot be removed by surgery.

What does 'HR-positive' mean?

HR-positive (Hormone Receptor-positive) means the cancer cells have receptors that attach to hormones like oestrogen, which can help the cancer grow. Hormone therapies can block these effects.

What is 'HER2-low/ultralow'?

HER2-low/ultralow refers to a small amount of a protein called HER2 on the cancer cells. This is different from 'HER2-positive' where there's a lot of this protein.

What is trastuzumab deruxtecan (T-DXd)?

Trastuzumab deruxtecan is a targeted drug designed to deliver chemotherapy directly to cancer cells that have the HER2 protein, even in low amounts.

What is a 'CDK4/6 inhibitor plus ET'?

This is a common treatment for HR-positive advanced breast cancer. It combines a drug that blocks certain proteins that help cancer cells grow (CDK4/6 inhibitor) with hormone therapy (ET, or endocrine therapy).

How to find out more

MEDSIR

contact.trials@medsir.org + 34 932 214 135 Official trial record

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