AuthorisedTherapeutic exploratory (Phase II)Interventional

Time restricted Eating And Metformin (TEAM) in invasive breast cancer (IBC) or ductal carcinoma in situ (DCIS). A randomized, phase IIb, window of opportunity presurgical trial.

This research study, called TEAM, is investigating a new way to treat certain breast cancers or pre-cancerous conditions (ductal carcinoma in situ) before surgery. It involves two parts: a specific eating pattern called 'time-restricted eating' and taking a medicine called metformin, which is widely used for diabetes. The main goal is to see if these treatments can reduce how quickly cancer cells grow. Researchers will look at changes in cell growth markers in tissue samples taken before and after the treatment period. This is an early-stage study, meaning we're still learning how safe and effective these approaches are when used together for breast cancer. It's an opportunity to see how these interventions might work before a main surgery.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Ente Ospedaliero Ospedali Galliera Di Genova

Enrolment target

Start

25 Nov 2024

Luminal (ER+ve and/or PgR+ve >=1%) invasive breast cancer or ductal carcinoma in situ

What is this study about?

This study, called TEAM, is looking into new ways to help women who have been diagnosed with certain types of breast cancer. Specifically, it's for women with 'luminal' invasive breast cancer (meaning their cancer cells have specific hormone receptors, like ER+ve or PgR+ve) or a pre-cancerous condition called ductal carcinoma in situ (DCIS). DCIS means abnormal cells are found in the milk ducts, but they haven't spread outside.

The study is designed to be a 'window of opportunity' trial. This means the treatments being tested are given for a short period of time *before* the main surgery someone would typically have for their breast cancer. It's a chance to see how the cancer responds to the new treatments in a real-world setting, without delaying the necessary surgical treatment.

The main aim is to understand if a special way of eating, called 'time-restricted eating' (where you eat only during certain hours of the day), combined with a medicine called metformin, can affect how breast cancer cells grow. Metformin is a well-known drug commonly used to treat diabetes, and researchers are interested in its potential effects on cancer. By looking at markers of cell growth in tissue samples before and after this short treatment period, scientists hope to learn if these interventions can help slow down the growth of cancer cells or pre-cancerous cells.

Key takeaways

This study combines a special eating plan (time-restricted eating) with metformin for certain breast cancers.
It's a 'window of opportunity' study, meaning treatment is given for a short time before surgery.
The goal is to see if these interventions can slow down cancer cell growth.
It's an early-stage study to understand effectiveness and safety.
Only women aged 18 or over with specific types of breast cancer or DCIS are eligible.

Who may be eligible?

This study is looking for women who are at least 18 years old. There's no upper age limit, so older women can also take part if they meet the other criteria.

To join, you must have been diagnosed with a specific type of breast cancer. This includes 'luminal' invasive breast cancer, which means the cancer cells have certain hormone receptors (ER+ve or PgR+ve at 1% or higher). You might also be eligible if you have ductal carcinoma in situ (DCIS), which is an early, non-invasive form of breast cancer.

There will be other detailed health checks to make sure the study is right for you and that taking part would be safe. These checks will be done by the study team and your doctor.

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 female?
Are you aged 18 years or older?
Do you have a diagnosis of Oestrogen Receptor (ER) or Progesterone Receptor (PgR) positive breast cancer (meaning 1% or more)?
Have you been diagnosed with ductal carcinoma in situ (DCIS)?
Are you able to commit to a specific eating schedule and take medication as prescribed before surgery?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll be assigned by chance (like flipping a coin) to one of two groups. One group will follow a time-restricted eating plan and take metformin before surgery. The other group will be the control group, and their treatment before surgery will be discussed with the study team. Both treatments will be given for a short period before your planned surgery.

You will have several appointments at the clinic. These will include check-ups, blood tests, and possibly extra tissue samples (biopsies) to see how your cells are changing. The study team will explain the eating plan and how to take the medicine. You will need to keep a diary or record of your eating times and any medicines you take. The total duration of active treatment before surgery will be relatively short, but there may be follow-up appointments after surgery to see how you are doing.

Potential risks and benefits

Taking part in this study might offer some potential benefits, as you'd be trying a new approach that could affect your cancer before surgery. However, this is a research study, so we don't yet know for sure if it will be beneficial for you personally. There are potential risks associated with any new treatment or medication. Metformin can have side effects like an upset stomach, and time-restricted eating might cause temporary hunger or changes in energy levels. All potential side effects and risks will be fully explained by the study team. 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.

—
Unverified
Italy

Common questions

What is 'time-restricted eating'?

It's an eating pattern where you only eat during specific hours of the day and fast for the remaining hours, for example, eating only between 10 AM and 6 PM.

What is metformin?

Metformin is a common medicine typically used to treat type 2 diabetes, helping to control blood sugar levels. In this study, we're looking at its effects on cancer.

What does 'before surgery' mean?

This study involves giving the treatments for a short period of time *before* your planned breast cancer surgery, to see how the cancer responds.

Is this a new type of treatment?

Yes, combining time-restricted eating with metformin for breast cancer treatment before surgery is being studied to see its effects and safety, so it's considered experimental in this context.

What is 'ductal carcinoma in situ (DCIS)'?

DCIS is a very early form of breast cancer where abnormal cells are found only inside the milk ducts and haven't spread into the surrounding breast tissue.