Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not recruiting

Study of Alpelisib, Trastuzumab, and Fulvestrant for Patients with PIK3CA Mutated HER2+ Advanced Breast Cancer Previously Treated with Trastuzumab

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 a type of breast cancer known as HER2-positive breast cancer, which has a specific mutation called PIK3CA. The study involves patients who have already received treatment for this advanced form of breast cancer. The trial will test a new combination of treatments to see if it can improve outcomes for these patients. The treatments being studied include a drug called alpelisib, which is taken as a tablet, and another drug called trastuzumab. Some patients will also receive a drug called fulvestrant, while others will receive standard chemotherapy drugs like vinorelbine, capecitabine, or eribulin.

The purpose of the study is to determine if the combination of alpelisib and trastuzumab, with or without fulvestrant, is more effective than trastuzumab with chemotherapy. The study will compare how long patients live without their cancer getting worse, which is known as progression-free survival. The trial will also look at overall survival, which is the time from starting the treatment until death from any cause, and the safety and side effects of the treatments.

Participants in the study will be randomly assigned to receive either the new combination of treatments or the standard chemotherapy. The study will last for a period of up to nine months, during which patients will take the medications and have regular check-ups to monitor their health and the progress of their cancer. The trial aims to provide valuable information that could lead to better treatment options for patients with this type of breast cancer.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, you will be asked to provide written informed consent. This means you agree to participate and understand the procedures involved.

    You will need to meet certain criteria, such as being at least 18 years old and having a specific type of breast cancer that has been previously treated.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to evaluate your health status. This includes checking your heart function and ensuring your organs are working properly.

    You will also need to have measurable disease or at least one bone lesion that can be assessed through imaging tests like CT or MRI.

  3. Step 3

    Randomization

    You will be randomly assigned to one of the treatment groups. This means you will either receive alpelisib with trastuzumab and possibly fulvestrant, or trastuzumab with chemotherapy chosen by your doctor.

    The chemotherapy options may include vinorelbine, capecitabine, or eribulin.

  4. Step 4

    Treatment phase

    During the treatment phase, you will take the medications as prescribed. Alpelisib is taken orally, meaning you swallow it in pill form.

    The frequency and dosage of the medications will be determined by your doctor based on your specific needs and the treatment group you are in.

  5. Step 5

    Regular monitoring

    You will have regular check-ups to monitor your progress and any side effects. This includes blood tests and imaging tests to see how the treatment is affecting your cancer.

    Your doctor will assess your response to the treatment and make any necessary adjustments.

  6. Step 6

    End of treatment

    The treatment will continue until the study ends or until your doctor decides it is best to stop.

    The study is expected to conclude by June 2026, but your participation may end earlier depending on your health and response to the treatment.

Who can join the trial?

14 criteria

  • Provide written informed consent to show willingness to follow all study procedures.
  • Be at least 18 years old.
  • Have an ECOG Performance Status of 0-1, which means you are fully active or have some symptoms but do not need bed rest during the day.
  • Be either male or female. If you are in the HR+ group and not post-menopausal, you must have been on a GnRH agonist (a type of hormone therapy) for at least 14 days before starting the study treatment.
  • Have locally recurrent inoperable or metastatic breast cancer with HER2+ status, confirmed by a laboratory test.
  • Have documented HR status (hormone receptor status) based on a laboratory test.
  • Have a PIK3CA tumor mutation confirmed by a central laboratory test.
  • Have received at least one prior line of anti-HER2 therapy for metastatic breast cancer.
  • Have received at least one prior line of trastuzumab in the metastatic setting or in the (neo)adjuvant setting, provided you relapsed while on therapy or within 6 months after completing adjuvant trastuzumab.
  • Have measurable disease or at least one bone lesion that can be assessed by CT or MRI scans.
  • Have a life expectancy of at least 12 weeks.
  • Have adequate organ and marrow function, which includes specific levels of blood cells, calcium, magnesium, creatinine, bilirubin, potassium, liver enzymes, amylase, lipase, and blood sugar.
  • Have resolved any acute toxic effects from previous cancer treatments to a mild level, except for hair loss or other non-risky side effects.
  • Have adequate heart function, with a left ventricular ejection fraction (LVEF) of at least 50% as measured by heart scans.

Who cannot join the trial?

7 criteria

  • Patients who have not been previously treated with trastuzumab cannot participate. Trastuzumab is a medication used to treat certain types of breast cancer.
  • Patients who do not have a PIK3CA mutation in their cancer cannot participate. A PIK3CA mutation is a change in a specific gene that can affect cancer growth.
  • Patients who do not have HER2-positive breast cancer cannot participate. HER2-positive means the cancer has higher levels of a protein called HER2, which can promote the growth of cancer cells.
  • Patients who have not experienced advanced or relapsed breast cancer cannot participate. Advanced or relapsed means the cancer has spread or returned after treatment.
  • Patients who are not within the specified age range cannot participate. The age range is typically defined by the study.
  • Patients who are not female or male as specified by the study cannot participate.
  • Patients who are considered part of a vulnerable population, as defined by the study, cannot participate. Vulnerable populations may include groups like children or pregnant women.
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

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

  • Trastuzumab

    is a medication used to treat certain types of breast cancer. It works by targeting and blocking a specific protein called HER2, which can promote the growth of cancer cells. By blocking this protein, trastuzumab helps to slow down or stop the growth of cancer cells.

  • Alpelisib

    is a medication that targets a specific pathway in cancer cells known as the PI3K pathway. This pathway can be overactive in some breast cancers, leading to tumor growth. Alpelisib helps to block this pathway, which may slow down or stop the growth of cancer cells.

  • Fulvestrant

    is a type of hormone therapy used to treat breast cancer. It works by blocking the effects of estrogen, a hormone that can promote the growth of breast cancer cells. By blocking estrogen, fulvestrant helps to slow down or stop the growth of cancer cells.

  • Vinorelbine

    is a chemotherapy drug used to treat breast cancer. It works by interfering with the ability of cancer cells to divide and grow. This helps to slow down or stop the growth of cancer cells.

  • Capecitabine

    is a chemotherapy medication that is used to treat breast cancer. It works by interfering with the DNA of cancer cells, which prevents them from growing and dividing. This helps to slow down or stop the growth of cancer cells.

  • Eribulin

    is a chemotherapy drug used to treat breast cancer. It works by stopping cancer cells from dividing and growing. This helps to slow down or stop the growth of cancer cells.

What is already known about the treatment

  • Trastuzumab

    Trastuzumab is administered as an injection, typically given intravenously, meaning it's delivered directly into a vein. It is a well-established medication in the treatment of HER2-positive breast cancer, often used in combination with other drugs. The main therapeutic indication for trastuzumab is to treat breast cancer that overexpresses the HER2 protein, which promotes cancer cell growth. At the molecular level, trastuzumab works by binding to the HER2 protein on cancer cells, blocking them from receiving growth signals. It is classified as a monoclonal antibody, a type of targeted cancer therapy.

  • Alpelisib

    Alpelisib is taken orally in the form of tablets. It is currently being studied for its effectiveness in treating breast cancer with specific genetic mutations, particularly PIK3CA mutations. The main therapeutic indication for alpelisib is to treat advanced breast cancer with these mutations, especially when other treatments have failed. Alpelisib works by inhibiting the PI3K enzyme, which is involved in cancer cell growth and survival. It is classified as a PI3K inhibitor, a type of targeted therapy that aims to block cancer cell growth pathways.

  • Fulvestrant

    Fulvestrant is administered as an injection, typically given intramuscularly, meaning it's injected into a muscle. It is used in the treatment of hormone receptor-positive breast cancer, often in combination with other therapies. The main therapeutic indication for fulvestrant is to treat advanced breast cancer that is hormone receptor-positive. Fulvestrant works by binding to estrogen receptors on cancer cells, blocking the effects of estrogen and leading to the degradation of these receptors. It is classified as an estrogen receptor antagonist, a type of hormone therapy.

Investigated diseases

PIK3CA Mutated HER2+ Advanced Breast Cancer – This type of breast cancer is characterized by mutations in the PIK3CA gene and overexpression of the HER2 protein. It typically occurs in advanced stages or after the cancer has relapsed. The disease progresses as cancer cells grow and spread, often becoming resistant to initial treatments. The presence of the PIK3CA mutation can lead to increased cell growth and survival, contributing to the cancer's aggressiveness. HER2+ breast cancer is known for its rapid growth and potential to spread to other parts of the body. The progression of this cancer is influenced by the interaction between genetic mutations and protein overexpression, which can affect the behavior of the cancer cells.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-514611-98-00Estimated enrolment27 patientsSponsorFundacion Grupo Espanol De Investigacion En Cancer De Mama

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

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.