Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

"DEMETER": Milademetan and fulvestrant in GATA3-mutant, ER-positive, HER2-negative advanced or metastatic breast cancer patients: a multicenter phase II trial

This clinical trial, called "DEMETER", is looking at a new treatment called milademetan when given with an existing breast cancer drug, fulvestrant. It's for people with a specific type of advanced breast cancer that has spread to other parts of the body or can't be removed with surgery. This type of cancer is identified by certain markers: it's GATA3-mutant, ER-positive, and HER2-negative. The main goal is to see how many patients respond well to the treatment. This means checking if their tumours completely disappear, shrink, or stay stable for at least 24 weeks (about six months). The study is also looking at side effects, how long patients live without their cancer getting worse, and how long they live overall.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Institut Curie

Enrolment target

Start

06 Jun 2023

GATA3-mutant ER-positive HER2-negative advanced or metastatic breast cancer

What is this study about?

This study is called "DEMETER" and it's a Phase II clinical trial. Imagine clinical trials like steps – Phase II trials are a mid-stage step where researchers test if a new treatment is safe and effective for a specific group of patients. Here, they are testing a new drug called milademetan along with fulvestrant, which is already used to treat breast cancer.

The trial is specifically for people with advanced or metastatic breast cancer. This means the cancer has either spread from where it started to other parts of the body (metastatic) or is too advanced to be treated with surgery. The doctors are looking for a particular type of breast cancer, which has specific features: it's 'GATA3-mutant', 'ER-positive' (meaning it uses hormones to grow), and 'HER2-negative' (meaning it doesn't have too much of a protein called HER2).

The main thing researchers want to find out is how many patients respond to this combination treatment. They'll be looking carefully to see if tumours shrink, disappear completely, or if their growth is kept stable for at least 24 weeks (about six months). They'll also be tracking any side effects, how the treatment affects quality of life, and how long people live without their disease worsening or overall.

Key takeaways

This study is for advanced breast cancer with specific genetic markers (GATA3-mutant, ER-positive, HER2-negative).
It tests a new drug, milademetan, combined with an existing one, fulvestrant.
The main goal is to see if the treatment shrinks tumours or keeps them stable.
Participation involves regular clinic visits, tests, and closely tracking how you feel.
It's a Phase II trial, meaning it's still an early-stage investigation into the treatment.
You can discuss it with your doctor to see if it's right for you.

Who may be eligible?

To join this study, you would need to be an adult, aged 18 or older. The study is open to both men and women.

Crucially, your breast cancer must be advanced or metastatic, meaning it has spread beyond the original site or cannot be removed by surgery. It also needs to have specific characteristics: it must be 'GATA3-mutant', 'ER-positive' (meaning it's sensitive to hormones), and 'HER2-negative'. Doctors will do tests to confirm these specific features of your cancer.

There will be other medical checks and criteria that your doctor will review to make sure this study is safe and suitable 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 advanced or metastatic breast cancer?
Has your doctor told you your cancer is GATA3-mutant, ER-positive, and HER2-negative?
Are you able to attend regular hospital or clinic appointments?
Are you willing to have regular medical checks, including blood tests and scans?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive the study treatment, which involves milademetan (likely taken as a tablet or liquid) and fulvestrant, which is given as a liquid injection. You would have regular visits to the hospital or clinic to have various tests and assessments. These might include blood tests, scans (like CT or MRI) to check on your cancer, and check-ups with the doctor to see how you are feeling and if you are experiencing any side effects.

Throughout the study, you'd be closely monitored for any changes in your health or the cancer. You would also be asked to complete questionnaires about your quality of life using a tool called the EQ-5D-5L. Doctors would also collect samples, like blood or tumour tissue, at different times to understand more about your cancer and how the treatment is working. The total length of your participation would depend on how your cancer responds to the treatment.

Potential risks and benefits

Taking part in this trial could offer the potential benefit of accessing a new treatment combination that might help stop your cancer from growing or even shrink it, especially if other treatments haven't worked well. However, like all medications, the study drugs, milademetan and fulvestrant, could cause side effects. These will be carefully monitored by the study team, and they will explain all known or potential risks to you. You are free to withdraw from the study at any time, for any reason, without 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 'advanced or metastatic breast cancer' mean?

It means the cancer has spread beyond the breast to other parts of the body, or it's grown to a stage where surgery isn't the best option.

What does 'GATA3-mutant, ER-positive, HER2-negative' mean?

These are specific features of your breast cancer that doctors find through special tests. They help doctors understand what might cause your cancer to grow and which treatments might work best. This study is for a very specific type of breast cancer with these particular characteristics.

What is a 'Phase II' trial?

Phase II means this is a mid-stage study. Researchers are checking if the new treatment is safe and effective enough to be tested in a larger group of people later on.

Will I definitely get the new drug?

Yes, in this trial, all participants will receive the combination of milademetan and fulvestrant. It's not a study where some people get a placebo (dummy drug).

What kind of side effects might I experience?

The study team will give you a list of known or potential side effects for both milademetan and fulvestrant. You will be closely monitored for any reactions throughout your participation.