Not yet recruitingPHASE2INTERVENTIONAL

Testing Two Different Drugs (Sacituzumab-govitecan and Trastuzumab-deruxtecan) Combinations Prescribed in an Alterning Pattern to Patients With Metastatic or Locally Advanced Triple-negative Breast Cancer

This study is for people with advanced triple-negative breast cancer, where the cancer has spread or is locally advanced. It's a Phase 2 trial, meaning researchers are looking at how well new treatments work and if they are safe. The trial is comparing two ways of giving treatment: some patients will receive sacituzumab govitecan and trastuzumab deruxtecan in an alternating pattern, while others will receive sacituzumab govitecan alone. Both drugs are already approved for use. The main goal is to find out if the alternating treatment helps people live longer compared to using just one of the drugs.

At a glance

Status

Not yet recruiting

Phase

PHASE2

Sponsor

UNICANCER

Enrolment target

260

Start

01 Oct 2025

Estimated completion

01 Oct 2029

Triple Negative Breast Neoplasms Neoplasm Metastasis HER 2 Low-expressing Breast Cancer

What is this study about?

When breast cancer is described as 'advanced triple-negative,' it means the cancer has spread to other parts of the body (metastatic) or has grown into nearby tissues and cannot be removed by surgery (locally advanced). This type of breast cancer can be challenging to treat because it doesn't respond to some of the common hormone or HER2-targeted therapies.

This study is testing two medicines, sacituzumab govitecan and trastuzumab deruxtecan, which are a type of drug called 'antibody-drug conjugates.' Think of them like a guided missile: they're designed to find cancer cells and deliver a cancer-fighting medicine directly to them, hopefully causing less harm to healthy cells. Both of these drugs are already approved and used for this type of breast cancer, and they have shown better results than traditional chemotherapy for many patients. However, cancer can sometimes become resistant to treatment over time.

Researchers are wondering if using these two drugs in a different way might be even more effective. Instead of using one until it stops working and then switching to the other, they want to see if giving them in an alternating pattern – swapping between them throughout treatment – could help prevent the cancer from becoming resistant and improve how long people live. The study will compare this alternating approach to using sacituzumab govitecan by itself, which is a standard treatment option.

Key takeaways

This study is for advanced triple-negative breast cancer that is HER2-low.
It compares two approved drugs, sacituzumab govitecan and trastuzumab deruxtecan, given in an alternating pattern versus sacituzumab govitecan alone.
The main goal is to see if alternating treatments can improve how long patients live.
This is a Phase 2 trial, focused on how well the treatments work and their safety.
Participation involves regular hospital visits for treatment, blood tests, and scans.

Who may be eligible?

To join this study, people need to be 18 years or older and have locally advanced or metastatic triple-negative breast cancer. Importantly, their cancer must be classified as 'HER2-low,' which is a specific characteristic found when looking at cancer cells under a microscope. This means the cancer cells have a low level of a protein called HER2.

Your doctors will check your general health to make sure you're well enough to take part. This includes reviewing your recent blood tests to confirm your organs and bone marrow are working properly. You also need to have a good performance status, which broadly means you are able to carry out most of your normal daily activities.

If you are a woman who could become pregnant, or a man, you will need to agree to use effective contraception throughout the study and for several months after your last treatment. This is to prevent pregnancy while the study drugs might still be in your system.

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 18 years or older?
Do you have locally advanced or metastatic triple-negative breast cancer?
Has your cancer been confirmed as 'HER2-low'?
Are your doctors happy with your overall health (e.g., blood tests, daily activity level)?
Are you willing to use contraception if you could become pregnant or start a pregnancy?

Answer every question to see your result.

What does participation involve?

This study is a Phase 2 trial, meaning we are looking closely at how well the new treatment approach works and its safety. If you join, you will be randomly assigned to one of two groups: one group will receive sacituzumab govitecan and trastuzumab deruxtecan in an alternating pattern, and the other group will receive sacituzumab govitecan alone. You won't be able to choose which group you are in.

The specific schedule for your treatments and how often you'll need to visit the hospital for tests and check-ups will be explained in detail by the study team. This will likely involve regular appointments for infusions of the study drugs, blood tests, and scans to monitor your cancer and overall health. The total duration of your participation will depend on how you respond to the treatment, but you will be monitored throughout your treatment journey and beyond to track your progress.

Potential risks and benefits

Taking part in this study could offer a potential benefit by exploring a new way to treat your cancer that might be more effective than current standard approaches, particularly if the alternating treatment strategy proves to be beneficial. However, like all medicines, the drugs used in this study can have side effects. While both drugs are approved treatments, combining or alternating them might lead to different or more pronounced side effects, which the study will carefully monitor. You will be fully informed about all known side effects before you decide to join. It is very important to remember that participating in any clinical trial is entirely voluntary, and you are free to withdraw at any time, for any reason, without it affecting your future medical care.

Locations (2)

institut Paoli calmette
Verified postcode
Marseille, France
Gustave Roussy
Verified postcode
Villejuif, France

Common questions

What is 'triple-negative breast cancer'?

Triple-negative breast cancer is a type of breast cancer that doesn't have certain hormone receptors (estrogen and progesterone) or a high amount of the HER2 protein. This means it doesn't respond to treatments that target these features.

What does 'HER2-low' mean for my cancer?

HER2-low means your cancer cells have some, but not a lot, of the HER2 protein on their surface. This is important because certain drugs, like those in this study, can specifically target cancer cells with low HER2 levels.

What are sacituzumab govitecan and trastuzumab deruxtecan?

These are 'smart' drugs that act like guided missiles. They find cancer cells and deliver a powerful medicine directly to them, aiming to kill the cancer cells while limiting harm to healthy cells.

Why are researchers looking at an 'alternating pattern' of treatment?

Researchers hope that by switching between these two drugs, they can prevent the cancer from getting used to one drug and becoming resistant, potentially making the treatment work better and for longer.

Will I know which treatment I'm getting?

No, you will be randomly assigned to one of two groups and will not know which specific treatment plan you are receiving. This is a common way to ensure the study results are fair and unbiased.

How to find out more

GERALD BAGOE

g-bagoe@unicancer.fr +337714415 82 Official trial record

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