RecruitingPHASE3INTERVENTIONAL

Safety and Efficacy Analysis of an Antibody Associated With a Chemotherapy for Patients With a Triple Negative Metastatic Breast Cancer

This study, called ISIdE, is looking at a new treatment called sacituzumab govitecan for people with an advanced form of breast cancer known as triple-negative breast cancer. This is for patients whose cancer has progressed after previous chemotherapy, or within six months of finishing curative treatments. Researchers want to see how effective this drug is, especially in patients who haven’t had many prior treatments. They also hope to find markers in the body that can predict who will respond well to the drug and who might not. This could help doctors choose the best treatment for each person in the future.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

UNICANCER

Enrolment target

Start

05 Oct 2023

Estimated completion

06 May 2028

Triple Negative Breast Cancer Metastatic Breast Cancer

What is this study about?

The ISIdE study is designed to learn more about a new treatment called sacituzumab govitecan for a specific type of breast cancer. This cancer is called 'triple-negative breast cancer' because it doesn't have the three common features (receptors for oestrogen, progesterone, or HER2 protein) that other breast cancers might have. When this cancer has spread to other parts of the body or can't be removed with surgery, it's called metastatic or locally advanced, inoperable triple-negative breast cancer.

Researchers want to see how effectively sacituzumab govitecan works in patients whose cancer has grown despite having chemotherapy before, or has returned quite quickly after other treatments. They are interested in patients who haven't had many previous treatments, as this might show the drug's true potential. By understanding this, doctors can get a better idea of when and how to best use this treatment.

Another important goal is to find 'biomarkers'. These are like clues in the body (such as specific substances or genetic features) that can help predict if a treatment will work for someone. If they can find such clues, it could mean that in the future, doctors can test a patient's tumour to see if sacituzumab govitecan is likely to be a good option for them, making treatments more personalised and effective.

Key takeaways

This study tests a new drug for advanced triple-negative breast cancer.
It's for people whose cancer has grown despite previous chemotherapy.
Researchers want to see how well the drug works and find clues to predict who it will help.
Taking part means receiving the study drug and having regular check-ups and biopsies.
You can stop participating at any time if you wish.

Who may be eligible?

This study is for adults aged 18 and over, both men and women, who have triple-negative breast cancer that is advanced, has spread, or can't be removed by surgery. Critically, your cancer must have continued to grow after previous chemotherapy, or it must have returned within six months of your last curative treatment (like surgery, radiotherapy, or other medical treatments).

You must have had a chemotherapy drug called a 'taxane' before, and your cancer must be measurable, meaning doctors can track its size. Also, researchers need to be able to take small tissue samples (biopsies) from your cancer during the study to learn more about it. If you have any questions about whether this applies to your specific situation, it's best to speak with your doctor.

It's important that you are able to give your informed consent, which means you fully understand what the study involves and agree to take part. If you can't write your consent, a trusted person chosen by you (who is not part of the research team) can confirm your agreement.

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 advanced triple-negative breast cancer?
Has your cancer progressed after previous chemotherapy, or within 6 months of finishing other treatments?
Have you previously had a 'taxane' chemotherapy drug?
Are you able to have small tissue samples (biopsies) taken from your cancer?
Are you able to provide consent to participate?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you will receive the study drug, sacituzumab govitecan. This treatment will continue as long as your cancer is not getting worse, you are not experiencing significant side effects, or you choose to stop. During the study, you will have regular visits for assessments, which will include checks to see if the treatment is working and to monitor any side effects. You will also need to have biopsies (small tissue samples) taken from your cancer during the treatment. The total duration of your participation will depend on how you respond to the treatment and your health.

Potential risks and benefits

Potential benefits of joining this study include access to a new treatment that might help control your cancer, particularly if other treatments haven't worked or are no longer effective. It also contributes to medical knowledge, which could help future patients. However, like all medications, sacituzumab govitecan can have side effects. These will be explained in detail by the study team. There's also no guarantee the treatment will work for you. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual care.

Locations (1)

Gustave Roussy
Verified postcode
Villejuif, France· Recruiting

Common questions

What is 'triple-negative breast cancer'?

It's a type of breast cancer that doesn't have the three common features (receptors) often found in other breast cancers, which means it responds to different types of treatment.

What does 'metastatic' mean?

It means the cancer has spread from where it started to other parts of the body.

What is sacituzumab govitecan?

It's an antibody-drug conjugate, which is like a 'smart bomb' that delivers chemotherapy directly to cancer cells.

Will I have to pay to be in this study?

No, you will not have to pay for the study drug or for the study-related medical care you receive as part of the trial.

What if the treatment doesn't work for me?

The study team will continuously monitor your progress, and if the treatment isn't helping or if side effects are too severe, they will discuss other treatment options with you.

How to find out more

Clara GUYONNEAU, PharmD

c-guyonneau@unicancer.fr 0685167111 Official trial record

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