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Study on Triple Negative Breast Cancer Treatment with Chemotherapy, Fasting-Mimicking Diet, and Metformin for Preoperative Patients

Verified siteRegistered drugNo placebo
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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 triple negative breast cancer, a type of breast cancer that does not have the three common receptors known to fuel most breast cancer growths. The study is exploring a treatment approach that combines chemotherapy with a special diet that mimics fasting, with or without the addition of a medication called metformin. Metformin is commonly used to treat diabetes and is being investigated here for its potential benefits in cancer treatment.

The purpose of the study is to see if this combination of treatments can improve outcomes for patients with triple negative breast cancer. Participants will receive chemotherapy drugs known as anthracyclines and taxanes every three weeks, along with a diet that mimics fasting. Some participants will also take metformin daily. The study will compare these treatments to historical results from standard chemotherapy to see if they increase the rate of complete response, meaning no cancer cells are found in the breast tissue and lymph nodes after treatment.

Throughout the study, participants will undergo regular assessments, including blood tests to check metabolic markers like glucose and insulin levels. The study will also look at how the treatments affect survival rates and the time until any cancer recurrence. The trial will monitor the safety and any side effects of the treatments, as well as any changes in the dosage or timing of the drugs and diet. The study aims to provide valuable insights into the effectiveness of combining chemotherapy with dietary changes and metformin in treating triple negative breast cancer.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Enrollment

    Upon joining the study, the patient will provide informed consent, confirming understanding of the trial's procedures and requirements.

    Eligibility will be confirmed based on specific criteria, including age, medical history, and current health status.

  2. Step 2

    Initial Assessment

    The patient will undergo a series of baseline assessments, including blood tests and imaging, to evaluate current health and establish a starting point for the trial.

  3. Step 3

    Treatment Phase

    The patient will receive a combination of chemotherapy drugs, specifically anthracycline and taxane, administered every three weeks.

    In addition to chemotherapy, the patient will follow a diet that mimics fasting, known as a fasting-mimicking diet (FMD).

    Some patients will also take metformin hydrochloride, a medication in the form of an 850 mg film-coated tablet, taken orally once daily.

  4. Step 4

    Regular Monitoring

    Throughout the treatment phase, the patient will attend scheduled visits for monitoring, including laboratory tests and assessments of metabolic biomarkers such as plasma glucose and insulin levels.

    Adjustments to medication dosage or dietary regimen may occur based on the patient's response and any side effects experienced.

  5. Step 5

    Surgery

    Following the treatment phase, the patient will undergo surgery to remove any remaining cancerous tissue.

  6. Step 6

    Post-Surgery Follow-Up

    After surgery, the patient will continue to be monitored for any signs of cancer recurrence or metastasis.

    Regular follow-up visits will assess overall health and any long-term effects of the treatment.

  7. Step 7

    Completion

    The trial is expected to conclude by the end of 2027, with final assessments and data collection to evaluate the effectiveness of the treatment.

Who can join the trial?

12 criteria

  • Must be of female sex.
  • If of childbearing potential, must meet at least one of the following:
    • Had a hysterectomy (surgery to remove the uterus) or bilateral oophorectomy (surgery to remove both ovaries).
    • Has medically confirmed ovarian failure (ovaries no longer work).
    • Is post-menopausal, meaning no periods for 12 months or more, or has no ovaries, and has a specific hormone level (FSH) that confirms menopause.
    • Age must be between 18 and 75 years.
    • Must have signed a document showing they understand the study and agree to participate.
    • Must be willing and able to follow the study's diet, take the study medication, attend visits, and complete tests and procedures.
    • Must have a confirmed diagnosis of triple negative breast cancer (TNBC), which means the cancer does not have certain hormone receptors or a protein called HER2.
    • Cancer must be in an early stage (stage I-III), and if stage I, the tumor must be at least 10 mm in size.
    • Must have a good general health status, as measured by a specific scale (ECOG performance status 0 or 1).
    • Must have adequate bone marrow and organ function, as shown by specific blood test results.
    • If of childbearing potential, must agree to avoid pregnancy by using two effective birth control methods or abstaining from sex during the study and for six months after.

Who cannot join the trial?

4 criteria

  • Patients who do not have triple negative breast cancer cannot participate. This type of breast cancer does not have three common receptors known to fuel most breast cancer growth.
  • Only females are eligible for this study, so males cannot participate.
  • Participants must be within certain age ranges, typically adults, so those outside these age ranges cannot join.
  • Individuals considered part of a vulnerable population, such as those unable to give informed consent, are not eligible.
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Investigated drugs

  • Anthracycline-Taxane Chemotherapy

    is a combination of two types of chemotherapy drugs used to treat breast cancer. Anthracyclines work by interfering with the DNA inside cancer cells, preventing them from growing and dividing. Taxanes help stop cancer cells from dividing by stabilizing their internal structure. This combination is commonly used to treat various types of breast cancer, including triple-negative breast cancer.

  • Fasting Mimicking Diet (FMD)

    is a special diet designed to mimic the effects of fasting. It is used in this trial to see if it can enhance the effectiveness of chemotherapy. The diet is low in calories, sugars, and proteins but high in healthy fats. It aims to stress cancer cells, making them more vulnerable to chemotherapy while protecting normal cells.

  • Metformin

    is a medication commonly used to treat type 2 diabetes. In this trial, it is being tested for its potential to improve the effectiveness of chemotherapy in treating breast cancer. Metformin may help by affecting the metabolism of cancer cells, making them more sensitive to treatment.

What is already known about the treatment

  • Metformin

    Metformin is taken orally and is commonly used to manage blood sugar levels in people with type 2 diabetes. In medical literature, it is being explored for its potential benefits in cancer treatment, particularly in combination with other therapies. The main therapeutic indication in this trial is for triple negative breast cancer. Metformin works by decreasing glucose production in the liver and improving insulin sensitivity, which may also affect cancer cell metabolism. It is classified as a biguanide in pharmacology.

  • Anthracycline-Taxane Chemotherapy

    This chemotherapy regimen is administered intravenously and is a standard treatment for various types of cancer, including breast cancer. It is well-established in medical practice and literature for its effectiveness in treating aggressive cancers. The main therapeutic indication in this trial is for triple negative breast cancer. Anthracyclines work by interfering with DNA replication, while taxanes stabilize microtubules, preventing cell division. This combination is classified under antineoplastic agents.

Investigated diseases

Triple Negative Breast Cancer – This is a type of breast cancer that does not have any of the three common receptors known to fuel most breast cancer growth: estrogen, progesterone, and the HER-2/neu gene. It is considered more aggressive and difficult to treat than other types of breast cancer. The disease often grows and spreads more quickly than other forms of breast cancer. It is more likely to be diagnosed in younger women and is more common in African American and Hispanic women. The cancer cells in triple negative breast cancer do not respond to hormonal therapy medicines or medicines that target HER2 protein receptors. This type of cancer is typically treated with a combination of surgery, radiation, and chemotherapy.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-508920-37-00Protocol codeBREAKFASTEstimated enrolment32 patientsSponsorFondazione IRCCS Istituto Nazionale Dei Tumori

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