Not recruiting

Study on Alpelisib and Fulvestrant for Advanced Breast Cancer in Patients with PIK3CA Mutation and Hormone-Receptor Positive, HER2 Negative Tumors

Verified siteRegistered drugNo placebo

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying advanced breast cancer that is hormone-receptor positive and HER2 negative, with a specific mutation known as PIK3CA. The study involves a combination treatment using two medications: fulvestrant and alpelisib (also known by its code name, BYL719). The purpose of the study is to explore the effectiveness of this combination treatment in patients whose cancer has progressed after previous therapy with fulvestrant.

Participants in the study will receive the treatment orally in the form of film-coated tablets. The study will last for a period of up to 52 weeks. During this time, the effects of the treatment will be monitored to assess how well it works in controlling the cancer and to evaluate any side effects. The study will also look into how the treatment impacts the quality of life of the participants and will gather information on how the body processes the medication.

The trial aims to provide valuable insights into the potential benefits of combining fulvestrant and alpelisib for treating this specific type of breast cancer. It will also help in understanding the management of side effects, such as alpelisib-induced hyperglycemia, which is an increase in blood sugar levels. The study will contribute to the knowledge of how these medications can be used effectively in patients with the PIK3CA mutation.

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
Enrollment and initial assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes reviewing medical history and current health status.
Eligibility criteria include a confirmed diagnosis of advanced breast cancer with specific characteristics, such as hormone-receptor positive and HER2 negative status, and a PIK3CA mutation.
Step 2
Treatment initiation
The treatment involves a combination of two medications: fulvestrant and alpelisib.
Fulvestrant is administered as an injection, typically given once a month.
Alpelisib is taken orally in the form of film-coated tablets. The dosage may vary, with options including 150 mg, 200 mg, or a combination of 50 mg and 200 mg tablets.
Step 3
Ongoing treatment and monitoring
Regular monitoring is conducted to assess the effectiveness of the treatment and to manage any side effects.
Progression-free survival is a key measure, tracking the time from enrollment to disease progression or any cause of death.
Additional assessments include evaluating the objective response rate, clinical benefit rate, and duration of response.
Step 4
Safety and quality of life assessments
Safety and tolerability of the treatment are continuously evaluated.
Quality of life and patient-reported outcomes are assessed to understand the impact of the treatment on daily living.
Specific attention is given to managing and resolving any alpelisib-induced hyperglycemia.
Step 5
Completion of study participation
The study is estimated to conclude by March 2026.
Upon completion, final assessments are conducted to evaluate overall survival and other long-term outcomes.

Who can join the trial?

11 criteria

Adults, both women and men, aged 18 or older, with a confirmed diagnosis of breast cancer that has come back or spread to other parts of the body and cannot be treated with surgery or radiation to cure it. Women must be postmenopausal, have had their ovaries removed, or be receiving a medication called a luteinizing hormone-releasing hormone (LHRH) analogue. Men must also receive an LHRH-analogue.
Must be willing and able to attend scheduled visits, follow the treatment plan, and undergo necessary tests and procedures.
Must have signed a document showing they understand the study and agree to participate.
Must have a confirmed diagnosis of breast cancer with more than 10% of cells showing estrogen receptor (ER) or progesterone receptor (PR) expression. The cancer must not have a protein called HER2. If HER2 status is unknown, testing must be done.
Must have previously been treated with a drug called fulvestrant and shown disease progression. If fulvestrant was stopped, it should not have been more than 12 weeks ago. If fulvestrant was used with a CDK4/6 inhibitor as the last treatment, the patient must have progressed during or shortly after stopping another treatment called adjuvant treatment with an (NS)AI.
Must have been treated with a CDK4/6 inhibitor in the advanced stage of the disease.
Must have a specific change in the cancer called an activating PIK3CA mutation, preferably found in a metastasis. If a sample from a metastasis is not available, testing can be done on the original tumor or stored tumor material.
Must have evaluable disease, meaning the cancer can be measured or assessed according to specific guidelines. If the disease is only in the form of fluid buildup (ascites or pleural effusion), the patient is not considered evaluable. Bone-only disease is considered evaluable.
Must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2, which indicates how well the patient is able to carry out daily activities.
Must have adequate function of organs and bone marrow, which includes specific levels of blood cells and kidney and liver function.
Must have recovered from any immediate side effects of previous cancer treatments or surgeries, except for side effects that are not considered a safety risk by the study doctor.

Who cannot join the trial?

4 criteria

Patients who have not previously been treated with a CDK 4/6 inhibitor. A CDK 4/6 inhibitor is a type of medication used to treat certain types of breast cancer.
Patients who do not have a PIK3CA mutation in their tumor. A PIK3CA mutation is a change in a specific gene that can affect how cancer grows.
Patients who are not pre- or postmenopausal women or men. This means the study is only for women who have gone through menopause or have not yet reached it, and for men.
Patients who do not have HR+HER2- advanced breast cancer. This is a type of breast cancer that tests positive for hormone receptors (HR+) and negative for a protein called HER2.

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Amphia Hospital
Verified
Breda, The Netherlands
Amsterdam UMC
Responsive
Amsterdam, The Netherlands
Sint Franciscus Vlietland Groep Stichting
Responsive
Rotterdam, The Netherlands

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting

Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

Fulvestrant
is a medication used in the treatment of hormone-receptor positive advanced breast cancer. It works by blocking the effects of estrogen in the body, which can help slow down or stop the growth of certain types of breast cancer cells that need estrogen to grow.
Alpelisib
is a medication used in combination with other treatments for advanced breast cancer. It specifically targets and inhibits a protein called PI3K, which is involved in the growth and survival of cancer cells. This medication is particularly used for tumors that have a specific mutation known as PIK3CA, which can make the cancer more aggressive.

Alpelisib

What is already known about the treatment

Fulvestrant
Fulvestrant is administered as an injection into the muscle, typically in the buttocks. It is currently used in the treatment of hormone receptor-positive, HER2-negative advanced breast cancer, particularly in cases with a PIK3CA mutation. Fulvestrant works by binding to estrogen receptors on cancer cells, blocking the effects of estrogen, and promoting the degradation of these receptors, which slows the growth of the cancer. It is classified as an estrogen receptor antagonist.
Alpelisib
Alpelisib is taken orally in tablet form. It is used in combination with other medications for the treatment of advanced breast cancer that is hormone receptor-positive and HER2-negative, especially in patients with a PIK3CA mutation. Alpelisib inhibits the PI3K enzyme, which is involved in cell growth and survival, thereby reducing cancer cell proliferation. It belongs to the class of phosphatidylinositol-3-kinase (PI3K) inhibitors.

Investigated diseases

Breast Cancer – Breast cancer is a disease where cells in the breast grow uncontrollably, forming a tumor that can often be felt as a lump or seen on an X-ray. It typically begins in the ducts or lobules of the breast and can spread to other parts of the body if not managed. The progression of breast cancer can vary, with some tumors growing slowly and others rapidly. Hormone receptor-positive (HR+) and HER2-negative (HER2-) breast cancer is a subtype that relies on hormones to grow but does not overexpress the HER2 protein. This type of cancer may progress after initial treatments, necessitating further therapeutic strategies. Understanding the genetic mutations, such as PIK3CA, can influence the progression and treatment approach for this disease.