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Study on Alpelisib and Fulvestrant for Patients with HR+, HER2- Metastatic Breast Cancer

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What is this study about?

This clinical trial is focused on studying the effects of a medication called alpelisib on patients with a specific type of breast cancer known as metastatic breast cancer that is hormone receptor-positive and HER2-negative. This type of cancer has spread to other parts of the body and does not have an excess of the HER2 protein. The study will also involve a medication called fulvestrant, which is often used in combination with other treatments for this type of breast cancer. The trial aims to understand how the timing of taking alpelisib, along with fasting and a low carbohydrate diet, affects the side effects and effectiveness of the treatment.

The purpose of the study is to evaluate if there are differences in the occurrence of high blood sugar levels, known as hyperglycemia, when alpelisib is taken at night with a fasting period and a low carbohydrate diet, compared to taking it as usually recommended. The study will observe participants over a period of three months or until 30 days after they stop the treatment. Participants will be men and postmenopausal women who have a mutation in the PIK3CA gene and have experienced progression of their cancer after previous hormone therapy.

During the study, participants will be randomly assigned to different groups to receive the treatment at different times and under different dietary conditions. The study will monitor the incidence of severe hyperglycemia and other related outcomes. The goal is to determine the best way to administer alpelisib to minimize side effects and improve its effectiveness in treating this type of breast cancer.

1 introduction to the trial

Upon joining the study, the patient will receive an overview of the trial’s purpose and procedures. The trial aims to assess the effects of the medication alpelisib on certain health outcomes in individuals with specific types of breast cancer.

2 medication administration

The patient will be instructed to take alpelisib in the form of film-coated tablets. The medication is available in 50 mg and 200 mg doses. The specific dosage and frequency will be determined by the study protocol.

The administration of alpelisib will occur in the evening at 22:00, accompanied by a fasting period of five hours. A low carbohydrate diet is suggested during the trial.

3 combination therapy

In addition to alpelisib, the patient will receive fulvestrant, another medication used in the treatment of breast cancer. The combination of these medications is part of the study’s evaluation.

4 monitoring and evaluation

Throughout the trial, the patient will undergo regular monitoring to assess the incidence of high blood sugar levels, known as hyperglycemia. The study will focus on the occurrence of severe cases, classified as grade 3 or 4.

The monitoring period will last for the first three months or 30 days after stopping the treatment, whichever comes first.

5 completion of the trial

The trial is expected to conclude by June 28, 2025. The patient will be informed of the study’s findings and any relevant health information at the end of their participation.

Who Can Join the Study?

  • The patient must be an adult, meaning they are 18 years or older, with advanced breast cancer that is hormone receptor-positive and HER2-negative. This means the cancer grows in response to hormones but does not have a protein called HER2.
  • The patient must have a specific change, called a mutation, in a gene known as PIK3CA. This must be confirmed by a test on their tumor or blood.
  • The patient must agree to participate by signing a document called informed consent, which explains the study and its risks.
  • If the patient is female, she must be postmenopausal. This means she has stopped having menstrual periods due to age or surgery. It can be confirmed by certain hormone levels if she is under 60 and has not had periods for at least 12 months.
  • The patient must have had their cancer return or get worse during or after treatment with certain hormone therapies, like letrozole, anastrozole, or exemestane, or after treatment with these therapies combined with other drugs like ribociclib, palbociclib, or abemaciclib.
  • The patient must have a confirmed diagnosis of breast cancer that is positive for estrogen receptors (ER+) or progesterone receptors (PgR+), which means the cancer cells have proteins that bind to these hormones.
  • The patient must have healthy bone marrow and organs, shown by specific blood test results, including:
    • A certain level of white blood cells called neutrophils.
    • A certain number of platelets, which help with blood clotting.
    • A certain level of hemoglobin, which carries oxygen in the blood.
    • Normal levels of minerals like potassium, magnesium, and calcium, or levels that are not concerning to the doctor.
    • A blood clotting measure called INR must be at a safe level.
    • Kidney function must be above a certain level, shown by a test called creatinine clearance.
    • Liver enzymes, called ALT and AST, must be within safe limits, even if there are cancer spots in the liver.
    • The total bilirubin, a substance made by the liver, must be within normal limits, with some allowances if there are liver issues or a condition called Gilbert’s syndrome.
    • Blood sugar levels, shown by fasting plasma glucose and HbA1c, must be below certain levels.
    • Levels of enzymes called amylase and lipase, which help digest food, must be within safe limits.

Who Cannot Join the Study?

  • Patients who have not been diagnosed with metastatic breast cancer that is hormone positive and HER2 negative cannot participate. Metastatic breast cancer means the cancer has spread to other parts of the body. Hormone positive means the cancer grows in response to hormones. HER2 negative means the cancer does not have a protein called HER2 on its surface.
  • Patients who do not have a specific genetic change called PIK3CA mutation in their cancer cannot participate. A PIK3CA mutation is a change in a gene that can affect how cancer cells grow.
  • Patients who have not progressed on previous hormone therapy cannot participate. Hormone therapy is a treatment that adds, blocks, or removes hormones to slow or stop cancer growth.
  • Patients who are not men or postmenopausal women cannot participate. Postmenopausal means a woman who has stopped having menstrual periods.
  • Patients who are not within the specified age range cannot participate. The age range includes adults and older adults.
  • Patients who are part of a vulnerable population cannot participate. A vulnerable population includes groups who may need special protection, like children or people with certain disabilities.

Where you can join this trial?

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Other Sites

Site Name City Country Status
Ccpvzvun Civmtrhfbzo Gfvur Fzs Chtkbbck Tgeuy Rmdkgftk Ih Ozginwis Split Croatia

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

Trial status

Country Status Recruitment Start
Croatia Croatia
Not yet recruiting
10.02.2025

Trial locations

Investigated drugs:

Alpelisib is a medication used in this trial to treat certain types of breast cancer. It works by blocking specific proteins that help cancer cells grow. The trial is exploring different ways of taking this medication, such as the time of day it is taken and whether it is taken with or without food, to see if these factors affect its effectiveness and side effects.

Fulvestrant is another medication used in the trial. It is a hormone therapy that helps to slow down the growth of cancer cells by blocking the effects of estrogen, a hormone that can promote the growth of breast cancer cells. This medication is used in combination with alpelisib to see if it improves treatment outcomes for patients with certain types of breast cancer.

Investigated diseases:

Metastatic Breast Cancer, Hormone Receptor Positive, HER2 Negative – This type of breast cancer is characterized by the spread of cancer cells beyond the breast to other parts of the body. It is hormone receptor positive, meaning the cancer cells grow in response to hormones like estrogen or progesterone. The HER2 negative status indicates that the cancer cells do not have an excess of the HER2 protein on their surface. This type of cancer often progresses by spreading to bones, liver, lungs, or brain. The progression can vary, with some patients experiencing slow growth while others may have more rapid advancement. Hormone therapies are typically used to manage the disease, focusing on blocking the hormones that fuel cancer growth.

Trial ID:
2025-521008-22-00
Protocol code:
CBYL719A0HR01T
Trial Phase:
Therapeutic exploratory (Phase II)

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