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Study on Alpelisib with Fulvestrant or Letrozole for Patients with Advanced Breast Cancer and PIK3CA Mutation After Previous Treatments

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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 a type of breast cancer known as advanced breast cancer that has specific characteristics: it is hormone receptor (HR)-positive, HER2-negative, and has a PIK3CA mutation. The study is investigating the effectiveness and safety of combining the medication alpelisib with either fulvestrant or letrozole. These medications are used to treat patients whose cancer has progressed after previous treatments. Alpelisib is taken as a film-coated tablet, while fulvestrant is given as an injection, and letrozole is taken as a tablet.

The purpose of the study is to see how well patients do without their disease getting worse over a period of six months. The study is divided into three groups, or cohorts. Two of these groups will receive alpelisib combined with fulvestrant, and the third group will receive alpelisib combined with letrozole. The study will monitor patients to see how they respond to the treatment and whether the cancer stops growing or spreading. The study will also look at how long patients live and any side effects they might experience.

Participants in the study will receive treatment for up to 93 days. The study will track the progress of the disease and any changes in the patients' health. The goal is to gather information that could help improve treatment options for people with this type of breast cancer in the future. The study will also include a group of patients who will receive a placebo to compare the effects of the actual medications with no active treatment. This research is important for understanding how these medications can help manage advanced breast cancer with specific genetic mutations.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, eligibility is confirmed based on specific criteria, including age, bone marrow function, and tumor characteristics.
The study involves patients with advanced breast cancer that is not suitable for curative therapy and has a specific genetic mutation (PIK3CA).
Step 2
Treatment assignment
Patients are assigned to one of three treatment groups based on prior therapy.
Group A and C receive alpelisib in combination with fulvestrant, while Group B receives alpelisib with letrozole.
Step 3
Medication administration
Alpelisib is taken orally. The dosage and frequency are determined by the study protocol.
Fulvestrant is administered through an intramuscular injection.
Letrozole is taken orally.
Additional medications such as leuprorelin acetate and goserelin may be administered via injection, depending on individual treatment plans.
Step 4
Monitoring and assessments
Regular assessments are conducted to monitor the patient's health and response to treatment.
The primary goal is to evaluate the proportion of patients who are alive without disease progression at 6 months.
Step 5
Follow-up and conclusion
The study is expected to conclude by July 2025.
Patients will continue to be monitored for overall survival and any adverse effects of the treatment.

Who can join the trial?

10 criteria

The patient must be an adult, male or female, who is 18 years old or older.
The patient must have enough healthy bone marrow, which is the soft tissue inside bones that makes blood cells.
The patient must have enough tumor tissue available for testing to check for a specific gene change called **PIK3CA mutation**. This test will be done by a special laboratory.
The patient must have advanced breast cancer that has come back or spread and cannot be cured with current treatments.
The patient must have a confirmed **PIK3CA mutation**, which is a specific change in the cancer cells, as determined by a certified laboratory.
The patient must have breast cancer that is confirmed to be **ER+** (estrogen receptor-positive) and/or **PgR+** (progesterone receptor-positive), which means the cancer grows in response to these hormones.
The patient must have breast cancer that is confirmed to be **HER2-negative**, meaning the cancer does not have high levels of a protein called HER2. This is determined by specific tests.
The patient must have advanced breast cancer with proof that the cancer has gotten worse after previous treatments. The patient can have had no more than one previous chemotherapy treatment for cancer that has spread. The total number of previous treatments for advanced breast cancer should not be more than two. The patient must have recovered from any side effects of previous treatments, except for hair loss, before joining the study.
The patient must have either measurable disease, which means at least one tumor that can be measured, or if not, at least one bone lesion that is mostly lytic, meaning it causes bone to break down.
The patient must have an **ECOG performance status** of 2 or less. This is a scale used to assess how well a patient can perform daily activities, with lower numbers indicating better ability.

Who cannot join the trial?

8 criteria

Patients who do not have a specific genetic change called a PIK3CA mutation in their cancer.
Patients whose cancer is not HR-positive, meaning it does not have receptors for hormones like estrogen or progesterone.
Patients whose cancer is HER2-positive, which means it has too much of a protein called HER2.
Patients who have not tried other treatments before.
Patients who are not adults.
Patients who are not part of the specified age range for the study.
Patients who are not part of the specified gender group for the study.
Patients who are considered part of a vulnerable population, which means they might need special protection or care.

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Verified sites

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Istituto Europeo Di Oncologia S.r.l.
Responsive
Milan, Italy
Sygehus Lillebaelt Vejle Sygehus
Verified
Vejle, Denmark

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Investigated drugs

Alpelisib
is a medication used in this trial to treat advanced breast cancer that has specific genetic characteristics. It works by targeting and inhibiting a protein that is involved in the growth and survival of cancer cells. This medication is used in combination with other treatments to help control the progression of the disease.
Fulvestrant
is a therapy used in combination with alpelisib for patients with advanced breast cancer. It works by blocking the effects of estrogen in the body, which can help slow or stop the growth of certain types of breast cancer cells that need estrogen to grow.
Letrozole
is another therapy used in combination with alpelisib for treating advanced breast cancer. It is an aromatase inhibitor, which means it lowers the amount of estrogen in the body. By reducing estrogen levels, letrozole can help slow the growth of breast cancer cells that rely on this hormone.

What is already known about the treatment

Alpelisib – This medication is administered orally and is currently being studied in clinical trials for its effectiveness in treating advanced breast cancer with specific genetic mutations. It is used in combination with other drugs like fulvestrant or letrozole for patients with PIK3CA mutant, hormone receptor-positive, HER2-negative advanced breast cancer. Alpelisib works by inhibiting a protein called PI3K, which is involved in cancer cell growth and survival. It is classified as a PI3K inhibitor and is being evaluated for its ability to slow disease progression in patients who have not responded to previous treatments.

Investigated diseases

Advanced Breast Cancer – Advanced breast cancer refers to cancer that has spread beyond the breast to other parts of the body. It is characterized by the presence of cancer cells in distant organs, which can include the bones, liver, lungs, or brain. In this context, the cancer is hormone receptor-positive (HR-positive) and human epidermal growth factor receptor 2-negative (HER2-negative), meaning it grows in response to hormones but does not overexpress the HER2 protein. The progression of this disease involves the growth and spread of cancer cells, which can lead to symptoms such as pain, fatigue, and other organ-specific issues depending on where the cancer has spread. The presence of a PIK3CA mutation in the cancer cells can influence the behavior and progression of the disease.