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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 study about?

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.

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 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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Hospital Universitario Hm Sanchinarro Madrid Spain

Other Sites

Site Name City Country Status
Hospital Universitario 12 De Octubre Madrid Spain
Fundacion Instituto Valenciano De Oncologia Valencia Spain
Hospital San Pedro De Alcantara Caceres Spain
Hospital Universitario Basurto Bilbao Spain
Consorcio Hospitalario Provincial De Castellon Castello De La Plana Spain
Complejo Hospitalario Universitario Insular Materno Infantil Las Palmas De Gran Canaria Spain
Fundacion Onkologikoa Fundazioa Donostia / San Sebastian Spain
Virgen del Rocío University Hospital Sevilla Spain
Hospital Universitario De Leon Leon Spain
University Clinical Hospital Virgen De La Arrixaca Murcia Spain
Universidade De Santiago De Compostela Santiago De Compostela Spain
Ihkugqhl Cmumeb Dgsljdpkqwicpzzct L'hospitalet De Llobregat Spain
Hewvbndt Vkso ddrbnmnk Barcelona Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Spain Spain
Not recruiting
13.08.2020

Trial locations

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.

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 ID:
2024-511295-33-00
Protocol code:
MEDOPP240
Trial Phase:
Therapeutic exploratory (Phase II)

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