AuthorisedTherapeutic exploratory (Phase II)Interventional

ALTER : A Phase 2, Multicenter, Randomized, Open-label trial assessing sacituzumab-govitecan and trastuzumab-deruxtecan combinaison in an ALTERnating regimen for patients with metastatic or locally advanced Her2-low triple-negative breast Cancer

This research study, called ALTER, is for people with advanced HER2-low triple-negative breast cancer that has spread or is locally advanced. It's a Phase 2 trial, meaning it's still an earlier stage of testing, to see how well a new treatment approach works and if it's safe. The study compares giving two medicines, sacituzumab govitecan and trastuzumab deruxtecan, one after the other in an alternating way. Doctors want to see if this combination helps people live longer. They will also look at how many people respond to the treatment, how long they stay well without their cancer getting worse, and their quality of life. The aim is to find better ways to treat this specific type of breast cancer.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Unicancer

Enrolment target

260

Start

23 Oct 2025

Patients with metastatic or locally advanced HER2-low triple-negative breast cancer and eligible to receive sacituzumab-govitecan and T-Dxd according to their indication.

What is this study about?

This study, called ALTER, is exploring a new treatment approach for a specific type of breast cancer called HER2-low triple-negative breast cancer. 'Metastatic or locally advanced' means the cancer has spread from where it started or has grown into nearby tissues. This can be a challenging type of breast cancer to treat, so doctors are always looking for better options.

The study combines two medicines that are already available: sacituzumab govitecan and trastuzumab deruxtecan. Both of these are 'targeted therapies,' meaning they are designed to attack cancer cells more specifically than traditional chemotherapy. The idea behind this study is to give these medicines in an alternating pattern, rather than one after the other or at the same time, to see if this new schedule works better. Being a Phase 2 study means researchers are mainly looking to see if the treatment is effective and safe enough to continue testing in larger studies.

The main goal of SWITCH is to see if this alternating treatment helps people live longer. They will also carefully watch other things, like how much the tumours shrink, how long people stay well without the cancer getting worse, and how the treatment affects their daily life and general well-being. This research is important because it could lead to new and more effective ways to treat this particular form of breast cancer.

Key takeaways

This study is for advanced HER2-low triple-negative breast cancer.
It tests an alternating schedule of two existing targeted medicines.
The main goal is to see if this new approach helps people live longer.
Researchers will also track side effects and quality of life.
It's a Phase 2 study, an early stage of testing new treatments.
Participation involves regular treatments and health checks.

Who may be eligible?

This study is looking for adults who have a specific type of breast cancer. This is called HER2-low triple-negative breast cancer, and it must be either 'metastatic' (meaning it has spread to other parts of the body) or 'locally advanced' (meaning it has grown significantly into nearby tissues).

To join, participants must also be suitable to receive both of the medicines being tested in the study, sacituzumab govitecan and trastuzumab deruxtecan. Your doctor will be able to tell you if these medications are typically recommended for your specific cancer and health situation.

The study is open to both men and women, and you must be at least 18 years old. Your doctors will check other health details to make sure the study treatment is safe for you.

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 old or older?
Do you have metastatic or locally advanced HER2-low triple-negative breast cancer?
Has your doctor confirmed that you are generally healthy enough to receive treatments like sacituzumab govitecan and trastuzumab deruxtecan?
Are you willing and able to attend regular hospital visits for treatment and check-ups?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you would receive treatment with two different medicines, trastuzumab deruxtecan and sacituzumab govitecan, given one after the other in an alternating pattern over time. You would have regular visits to the hospital or clinic for these treatments and for check-ups. These check-ups will include blood tests and scans, such as CT or MRI, to see how the treatment is working and to monitor for any side effects.

You'll also be asked questions about how you are feeling and your quality of life, which helps doctors understand the overall impact of the treatment. The total length of your participation would depend on how your cancer responds and how well you tolerate the treatment. Your doctors will explain the full schedule and expected duration during the consent process.

Potential risks and benefits

Participating in this study might offer a potential benefit of accessing an experimental treatment approach that could be more effective than standard options for advanced HER2-low triple-negative breast cancer. However, there are also potential risks involved. The medicines used, trastuzumab deruxtecan and sacituzumab govitecan, are known to have side effects, which can range from mild to severe, and they will be carefully monitored. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

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

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Unverified
France

Common questions

What does HER2-low triple-negative breast cancer mean?

This is a specific type of breast cancer that doesn't have high levels of HER2 protein and doesn't have receptors for oestrogen or progesterone. This means certain common targeted treatments won't work, making it harder to treat.

What are sacituzumab govitecan and trastuzumab deruxtecan?

These are both targeted chemotherapy medicines. They are designed to specifically find and kill cancer cells, which can be more effective and sometimes have different side effects than traditional chemotherapy.

Why are they being given in an 'alternating regimen'?

Researchers want to see if giving these two medicines one after the other, in a specific order, is more effective at fighting the cancer and helps people live longer than giving them separately or in a different way.

What is a 'Phase 2' study?

A Phase 2 study means it's an earlier stage of drug testing. Doctors are looking to see if the treatment works well enough and is safe enough to be tested in larger groups of people later on.

What is 'overall survival'?

In this study, 'overall survival' means how long people live after starting the treatment. It's an important way to measure how effective a new cancer treatment is.