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Study on Metformin to Prevent High Blood Sugar in Advanced Breast Cancer Patients with Alpelisib and Endocrine Therapy

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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 medication called metformin in preventing high blood sugar levels, also known as hyperglycemia, in patients with a specific type of advanced breast cancer. This type of breast cancer is characterized by being HR-positive and HER2-negative with a PIK3CA mutation. Patients in this study are being treated with a combination of alpelisib and various endocrine therapies, which are treatments that target hormone receptors to slow down or stop the growth of cancer cells.

The purpose of the study is to evaluate how well metformin can prevent high blood sugar levels in these patients. The study involves different groups of patients who will receive alpelisib along with endocrine therapies such as fulvestrant, letrozole, exemestane, or tamoxifen. Some patients may also receive a placebo, which is a substance with no active medication, to compare the effects. The study will monitor patients over a period of time to see how their blood sugar levels respond to the treatment and whether they experience any side effects that might require them to stop taking alpelisib.

Throughout the study, patients will be closely observed to ensure their safety and to gather information on how effective the treatment is in managing their condition. The study aims to provide valuable insights into the potential benefits of using metformin alongside cancer treatments to manage blood sugar levels in patients with this specific type 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.

  1. Step 1

    Initiation of treatment

    Upon joining the study, treatment begins with the administration of alpelisib in combination with endocrine therapy. The specific endocrine therapy may include letrozole, fulvestrant, exemestane, or tamoxifen, depending on individual medical history and physician's criteria.

    The primary goal during the first 8 weeks is to monitor the occurrence of high blood sugar levels, which is a potential side effect of alpelisib.

  2. Step 2

    Metformin administration

    To help prevent high blood sugar, metformin is administered orally. The dosage and frequency are determined by the healthcare provider based on individual needs and response to treatment.

  3. Step 3

    Monitoring and assessment

    Regular monitoring of blood sugar levels is conducted to assess the effectiveness of metformin in preventing high blood sugar.

    Additional assessments include evaluating the response to the combination of alpelisib and endocrine therapy, as well as monitoring for any side effects.

  4. Step 4

    Adjustment of treatment

    Based on the results of the monitoring, adjustments to the treatment plan may be made. This could involve changes in medication dosage or the introduction of additional treatments to manage side effects.

  5. Step 5

    Continuation of treatment

    The treatment continues with regular follow-up visits to ensure the ongoing effectiveness and safety of the therapy.

    The study aims to evaluate the long-term impact of the treatment on disease progression and overall health.

Who can join the trial?

18 criteria

  • Sign a document called the Informed Consent Form before doing any activities related to the study.
  • Have evidence that the cancer got worse while on or after a treatment with aromatase inhibitors (a type of medication) for cancer that has spread, or within 12 months after finishing such treatment.
  • May have had previous treatment with fulvestrant (a type of medication) either before or as the first treatment for cancer that has spread.
  • Have received no more than one previous chemotherapy treatment for cancer that has spread.
  • For certain groups, have specific levels of fasting plasma glucose (sugar in the blood after not eating) and HbA1c (a measure of blood sugar over time).
  • For another group, have been diagnosed with Type 2 Diabetes Mellitus (a type of diabetes) at least 90 days before the study and have stable diabetes treatment.
  • If cancer has spread to the brain, it must be controlled without certain medications.
  • Have adequate function of the bone marrow (where blood cells are made) and organs, as shown by specific blood tests.
  • Be willing and able to follow the study schedule, treatment plan, and tests.
  • Have recovered from any side effects of previous cancer treatments to a mild level, except for hair loss or other non-risky effects.
  • Be a man or a woman who is either pre-menopausal or post-menopausal and at least 18 years old.
  • Men and pre-menopausal women should have been treated with a specific hormone treatment at least one week before starting the study.
  • Have a Performance Status of 0 or 1, which means being fully active or restricted in physically strenuous activity but able to carry out light work.
  • Have a confirmed diagnosis of advanced breast cancer that cannot be cured or has spread.
  • Have a confirmed diagnosis of breast cancer that is positive for estrogen receptor (ER) and/or progesterone receptor (PR) and negative for HER2 (a protein).
  • Have measurable or evaluable disease according to specific criteria. Patients with only bone metastases are eligible.
  • Have a specific mutation called PIK3CA in the most recent tumor tissue or blood sample.
  • Have had no more than two previous treatments with hormone therapy for advanced breast cancer.

Who cannot join the trial?

12 criteria

  • Patients who have a known allergy or sensitivity to the study drugs.
  • Patients who are currently participating in another clinical trial.
  • Patients with a history of severe heart problems.
  • Patients with uncontrolled high blood pressure.
  • Patients with severe liver or kidney disease.
  • Patients who are pregnant or breastfeeding.
  • Patients with a history of another type of cancer within the last 5 years, except for certain skin cancers.
  • Patients with a history of severe lung disease.
  • Patients with a history of severe mental health disorders.
  • Patients who have had major surgery within the last 4 weeks.
  • Patients with a history of drug or alcohol abuse.
  • Patients who are unable to follow the study procedures.
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Investigated drugs

  • Metformin

    is a medication commonly used to help control blood sugar levels in people with type 2 diabetes. In this study, it is being used to prevent high blood sugar levels in patients with a specific type of advanced breast cancer who are receiving other cancer treatments.

  • Alpelisib

    is a cancer treatment used for patients with a specific mutation in their breast cancer. It works by blocking certain signals in cancer cells that help them grow. In this study, it is being used alongside other therapies to treat advanced breast cancer.

  • Endocrine Therapy

    refers to treatments that add, block, or remove hormones. For breast cancer, this often involves medications that block the effects of estrogen, which can help slow or stop the growth of cancer cells that rely on this hormone. In this study, it is used in combination with other treatments to manage advanced breast cancer.

What is already known about the treatment

Metformin – Metformin is an oral medication commonly used to manage blood sugar levels in individuals with type 2 diabetes. It is currently being studied for its potential to prevent hyperglycemia in patients with advanced breast cancer who are treated with alpelisib and endocrine therapy. The main therapeutic indication for metformin is to lower blood glucose levels, and it works by decreasing glucose production in the liver and improving insulin sensitivity. Metformin is classified as a biguanide, a type of antidiabetic medication.

Investigated diseases

Hyperglycemia – Hyperglycemia is a condition characterized by elevated levels of glucose in the blood. It often occurs when the body has insufficient insulin or when the body cannot effectively use insulin. Over time, high blood sugar levels can lead to various complications affecting the eyes, kidneys, nerves, and heart. Symptoms may include frequent urination, increased thirst, and fatigue. It is commonly associated with diabetes but can also occur in other medical conditions or as a side effect of certain medications. Monitoring and managing blood sugar levels are crucial to prevent complications.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-511295-33-00Protocol codeMEDOPP240Estimated enrolment88 patientsSponsorMedica Scientia Innovation Research S.L.

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).