Istituto Europeo Di Oncologia S.r.l.
Responsive
Milan, Italy
Not yet recruiting
Study on Time-Restricted Eating and Metformin for Patients with Invasive Breast Cancer or Ductal Carcinoma In Situ
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What is this trial about?
A plain-language summary of the goals, design and what participants do
This clinical trial is focused on studying the effects of a treatment for certain types of breast cancer. The diseases being studied are invasive breast cancer and ductal carcinoma in situ. The treatment involves a combination of a medication called Metformin Hydrochloride, which is commonly used to manage blood sugar levels, and a practice known as time-restricted eating, where participants fast for at least 16 hours overnight.
The purpose of the study is to understand how this combination affects cancer cells. Participants will be randomly assigned to either the treatment group or a control group. The study will begin with a biopsy, which is a procedure to take a small sample of tissue from the breast cancer. After the treatment period, which lasts up to 42 days, participants will undergo surgery to remove the cancer. The researchers will compare the cancer tissue from before and after the treatment to see if there are any changes.
Throughout the study, the safety of the treatment will be closely monitored, especially in the first group of participants. The researchers are particularly interested in any side effects that might occur, such as low blood sugar levels or other significant reactions. This study aims to provide valuable insights into whether this combination of Metformin and time-restricted eating can be a safe and effective approach for treating certain types of breast cancer.
The research process
The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.
Who can join the trial?
10 criteria
- Women with a confirmed diagnosis of **ER+ve** (estrogen receptor positive) and/or **PgR+ve** (progesterone receptor positive) breast cancer that is operable and suitable for surgery. This includes certain types of breast cancer like **HER2+ve** (human epidermal growth factor receptor 2 positive) and **DCIS** (ductal carcinoma in situ).
- Must be **18 years or older**.
- Have an **ECOG performance status** of 0 or 1, which means the person is fully active or has some symptoms but can still carry out light work. This is similar to a **Karnofsky score** of 70% or higher, indicating the ability to care for oneself.
- Must have normal function of organs and bone marrow, which includes:
- **Leukocytes** (white blood cells) count of at least 3,000 per microliter.
- **Absolute neutrophil count** (a type of white blood cell) of at least 1,500 per microliter.
- **Platelets** (cells that help with blood clotting) count of at least 100,000 per microliter.
- **AST/ALT** (liver enzymes) levels no more than 1.5 times the normal upper limit.
- **Creatinine clearance** (a measure of kidney function) greater than 45 mL/min, estimated using the Cockcroft-Gault formula.
- Women who can have children must agree to use **contraception** (methods to prevent pregnancy) or practice abstinence during the study. If a participant becomes pregnant or thinks she might be pregnant, she must inform her study doctor immediately.
- Must be able to understand and willing to sign a written **informed consent document**, which means agreeing to participate in the study after being informed about it.
Who cannot join the trial?
5 criteria
- Patients who do not have **luminal invasive breast cancer** or **ductal carcinoma in situ**. These are specific types of breast cancer.
- Patients who are not female, as the study is only for women.
- Patients who are not within the specified age range for the study.
- Patients who are part of a vulnerable population, which means they might need special protection or care.
- Patients who have any medical condition or situation that the study team believes would make it unsafe for them to participate.
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Investigated drugs
Metformin
is a medication commonly used to manage blood sugar levels in people with type 2 diabetes. In this clinical trial, it is being used to study its effects on breast cancer tissue, specifically looking at changes in cancer cell growth markers before and after treatment. The trial aims to see if Metformin, when combined with a specific eating pattern, can influence cancer cell activity.
Time Restricted Eating
involves limiting the hours during which food is consumed each day. In this trial, participants are asked to fast for at least 16 hours overnight. This approach is being tested to see if it can enhance the effects of Metformin on breast cancer cells, potentially slowing down their growth or reducing their activity.
What is already known about the treatment
Metformin – Metformin is typically administered orally in tablet form. It is a well-established medication in the medical literature, primarily used for managing type 2 diabetes. In the context of this clinical trial, it is being investigated for its potential effects on invasive breast cancer or ductal carcinoma in situ. Metformin works by decreasing glucose production in the liver and improving insulin sensitivity, which may also influence cancer cell growth. It belongs to the pharmacological class of biguanides.
Investigated diseases
Invasive Breast Cancer
This type of breast cancer occurs when cancer cells spread beyond the ducts or lobules into the surrounding breast tissue. It can be classified based on hormone receptor status, such as estrogen receptor-positive (ER+) or progesterone receptor-positive (PgR+). The disease progresses as cancer cells invade nearby tissues and potentially spread to other parts of the body through the lymphatic system or bloodstream. Early stages may not cause noticeable symptoms, but as it advances, it can lead to changes in breast shape, size, or skin texture. Regular monitoring and medical evaluations are crucial for understanding its progression.
Ductal Carcinoma In Situ (DCIS)
This is a non-invasive form of breast cancer where abnormal cells are found in the lining of a breast duct but have not spread outside the duct. It is considered the earliest form of breast cancer and is sometimes referred to as stage 0. DCIS itself does not typically cause symptoms, but it can be detected through mammograms as microcalcifications. If left untreated, it may progress to invasive breast cancer, where cancer cells break through the duct walls and invade surrounding tissue. Monitoring and early detection are key to managing this condition effectively.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-518402-40-00Estimated enrolment120 patientsSponsorEnte Ospedaliero Ospedali Galliera Di Genova
sourced from the EU Clinical Trials Register and site verification
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