Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

"TOPOLOGY" : A phase II study to evaluate the efficacy and toxicities of PLX038, in patients with locally advanced or metastatic triple-negative breast cancer

This research study, named "TOPOLOGY," is looking into a new treatment called PLX038 for people who have advanced triple-negative breast cancer. This type of breast cancer can be harder to treat, so doctors are always searching for new options. The main goal of this study is to see if PLX038 can make tumours smaller or disappear completely within the first six months of treatment. Researchers will also be carefully watching for any side effects the medicine might cause. They also want to understand things like how long the treatment works and how it affects patients' lives overall. It’s an important step in finding new ways to help people with this condition.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Institut Curie, Institut Curie

Enrolment target

Start

27 Oct 2023

Advanced or metastatic triple-negative breast cancer

What is this study about?

This study, called "TOPOLOGY," is focused on a specific type of breast cancer known as triple-negative breast cancer. This type can be challenging to treat because it doesn't respond to some common hormone or targeted therapies. Finding new and effective treatments for advanced cases of triple-negative breast cancer is a high priority for doctors and researchers.

The main purpose of this study is to test a new medicine called PLX038. It's an early-stage study, meaning doctors are still learning about how well it works and what side effects it might have. Researchers want to see if PLX038 can shrink the tumour or make it disappear in patients within the first six months of treatment. They will also be looking at how safe the medicine is by tracking any side effects carefully.

Beyond just shrinking tumours, the study will also look at how long the treatment keeps the cancer from growing (this is called 'progression-free survival'), how long people live overall, and how quickly the treatment starts to work. They will also investigate if certain features of a person's cancer, like changes in their genes, might predict how well PLX038 works. This information helps doctors understand who might benefit most from this new medicine in the future.

Key takeaways

This study tests a new medicine (PLX038) for advanced triple-negative breast cancer.
The main aim is to see if the treatment shrinks tumours.
Researchers will also carefully track any side effects.
It's a Phase II study, meaning it's an early investigation into the treatment's effectiveness and safety.
Understanding who might benefit most from PLX038 is also a key goal.
Participation involves receiving the medicine, regular check-ups, and scans.

Who may be eligible?

To join this study, you must have advanced triple-negative breast cancer that has either spread to other parts of your body (metastatic) or is locally advanced. Your care team will be able to confirm if your cancer fits this description.

You also need to be at least 18 years old. Both men and women can take part in this research.

There might be other specific medical requirements or tests you need to pass to ensure the treatment is safe for you. Your doctor will discuss all of these details with you if you're interested in participating.

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.

I am at least 18 years old.
I have been diagnosed with advanced or metastatic triple-negative breast cancer.
My illness is considered locally advanced or has spread (metastatic).
I am able to attend regular hospital appointments for tests and treatment.
I am comfortable with receiving an investigational new medicine.

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will receive the new medicine, PLX038. The study involves regular visits to the clinic, where you will have check-ups, blood tests, and scans (like CT or MRI scans) to see how your body is responding to the treatment and to monitor for any side effects. These assessments will help the doctors understand if the tumour is shrinking. You will also be asked to share information about how you are feeling. Doctors will collect samples, such as blood or tumour tissue, to look for specific markers that might help predict how well the treatment works. The total duration of the study participation will vary depending on how you respond to the treatment, but monitoring for the main effects will be within the first six months.

Potential risks and benefits

Participating in a clinical trial might offer potential benefits, such as receiving a new investigational treatment that isn't yet widely available, and closely monitored medical care. However, new treatments like PLX038 can have unknown side effects, some of which might be serious. There's also no guarantee that 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 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 is 'triple-negative breast cancer'?

Triple-negative breast cancer is a type of breast cancer that doesn’t have three common features (receptors) that other breast cancers might have. This means it doesn't respond to some standard treatments, so new medicines are really important.

What does 'Phase II study' mean?

A Phase II study means it's an early stage of testing a new medicine. Researchers are mainly looking to see if the treatment works well enough to consider more testing, and what types of side effects it might cause, in a small group of patients.

Will I get a placebo (dummy medicine) in this study?

The information provided suggests that everyone in this study will receive the active investigational medicine, PLX038. There is no mention of a placebo group in this specific trial.

What are 'side effects'?

Side effects are any unwanted or unexpected effects caused by a medicine. Doctors in this study will carefully monitor you for all types of side effects, from mild to more serious ones.

How long will I be in the study?

The time you spend in the study can vary. It depends on how you respond to the treatment and whether you experience any side effects. The main period for checking if the tumour shrinks is within the first six months. Your doctor can give you a more personalised idea.