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Study on Alpelisib and Fulvestrant for Men and Postmenopausal Women with Advanced HR-positive, HER2-negative Breast Cancer with PIK3CA Mutation

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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 hormone receptor-positive, HER2-negative advanced breast cancer. This type of cancer has specific characteristics that make it different from other breast cancers. The study is testing a treatment that combines two medications: alpelisib and fulvestrant. Alpelisib is a medication that targets a specific mutation in the cancer cells called the PIK3CA mutation, while fulvestrant is used to block the effects of estrogen, a hormone that can promote the growth of breast cancer cells.

The purpose of the study is to find out if the combination of alpelisib and fulvestrant can help patients live longer without their cancer getting worse, compared to using fulvestrant with a placebo. A placebo is a substance with no active medication, used to compare the effects of the actual treatment. Participants in the study will be randomly assigned to receive either the combination of alpelisib and fulvestrant or fulvestrant with a placebo. The study will be conducted in a way that neither the participants nor the researchers know who is receiving the actual treatment or the placebo, which is known as a double-blind study.

Throughout the study, participants will take the medications for a period of up to 60 days, and their health will be monitored regularly to assess the effects of the treatment. The study aims to provide valuable information on whether this combination of medications can offer a better treatment option for people with this specific type of breast cancer. Participants will be closely observed for any changes in their condition and any side effects they may experience during the study.

The research process

The trial runs in 4 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, the participant will be randomly assigned to receive either the combination of alpelisib and fulvestrant or a placebo with fulvestrant. This process is double-blind, meaning neither the participant nor the researchers will know which treatment is being administered.

  2. Step 2

    Medication administration

    Participants receiving alpelisib will take it orally. The specific dosage and frequency will be determined by the study protocol.

    Participants will also receive fulvestrant through an intramuscular injection. The dosage and schedule for these injections will be provided by the study team.

  3. Step 3

    Monitoring and assessments

    Throughout the study, participants will undergo regular assessments to monitor the progression of the disease. These assessments will include imaging tests and other evaluations as per the study protocol.

    The primary goal is to determine if the treatment prolongs the time before the disease progresses.

  4. Step 4

    Completion of the study

    The study is expected to continue until August 2026. Participants will be informed about the end of their participation and any follow-up procedures that may be necessary.

Who can join the trial?

8 criteria

  • The participant must be an adult who is 18 years or older and has signed a consent form before any trial activities begin.
  • The participant must have a confirmed diagnosis of breast cancer that is positive for estrogen receptors (ER+) or progesterone receptors (PgR+). This means the cancer grows in response to these hormones.
  • The participant must have breast cancer that is **HER2-negative**. This means the cancer does not have high levels of a protein called HER2.
  • The participant must have at least one measurable tumor or lesion that can be evaluated by the study doctor. If the lesion was previously treated with radiation, it must show signs of growth since the treatment.
  • The participant must have experienced a return or worsening of the disease during or after treatment with a combination of hormone therapy (like letrozole, anastrozole, exemestane) and a CDK4/6 inhibitor, which are types of cancer treatments.
  • The participant must have received no more than two previous treatments for cancer that has spread, and only one of these treatments can be chemotherapy (not counting chemotherapy given before or after surgery).
  • The participant must have a specific genetic change called a **PIK3CA mutation** in their tumor, confirmed by a special test.
  • If the participant is female, she must be in **postmenopausal status**, meaning she has stopped having menstrual periods.

Who cannot join the trial?

8 criteria

  • Patients who have a different type of cancer than the one being studied, which is **hormone receptor positive, HER2-negative advanced breast cancer**.
  • Patients who are not within the specified age range for the study.
  • Patients who are not able to follow the study procedures or take the study medications as required.
  • Patients who have other serious health conditions that might interfere with the study or make it unsafe for them to participate.
  • Patients who are pregnant or breastfeeding, as the study medications might affect the baby.
  • Patients who have participated in another clinical trial recently, as this might affect the results of the study.
  • Patients who have allergies or reactions to the study medications or similar drugs.
  • Patients who are unable to provide informed consent, which means they cannot understand the study and agree to participate.
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Investigated drugs

  • Alpelisib

    is a medication used in this trial to treat advanced breast cancer. It works by blocking a specific protein that helps cancer cells grow. This medication is being tested to see if it can help slow down the progression of the disease when used together with another treatment.

  • Fulvestrant

    is another medication used in this trial. It is a hormone therapy that 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. In this study, it is combined with alpelisib to see if the combination is more effective in treating advanced breast cancer.

What is already known about the treatment

  • Alpelisib

    This medication is taken orally and is currently being studied in clinical trials for its effectiveness in treating hormone receptor-positive, HER2-negative advanced breast cancer with a PIK3CA mutation. It is used in combination with fulvestrant, a hormone therapy, to potentially improve progression-free survival in patients who have not responded to previous treatments. Alpelisib works by inhibiting a specific enzyme in the PI3K pathway, which is involved in cancer cell growth and survival. It is classified as a PI3K inhibitor.

  • Fulvestrant

    Administered as an injection, fulvestrant is a well-established medication used in the treatment of hormone receptor-positive, HER2-negative advanced breast cancer. It is being evaluated in combination with alpelisib to assess its effectiveness in prolonging progression-free survival in patients with a PIK3CA mutation. Fulvestrant works by blocking and degrading estrogen receptors, which are necessary for the growth of certain types of breast cancer cells. It is classified as an estrogen receptor antagonist.

Investigated diseases

Hormone receptor positive, HER2-negative advanced breast cancer – This type of breast cancer is characterized by the presence of hormone receptors, meaning the cancer cells grow in response to hormones like estrogen or progesterone. It is classified as HER2-negative, indicating that the cancer cells do not have an excess of the HER2 protein on their surface. This form of breast cancer is considered advanced when it has spread beyond the breast to other parts of the body. The progression of the disease can vary, but it typically involves the growth and spread of cancer cells to other organs. The disease may initially respond to hormone therapies, but over time, resistance to treatment can develop, leading to further progression. Monitoring and managing the disease often involve regular assessments to track changes in tumor size and spread.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-509133-39-00Protocol codeCBYL719C2303Estimated enrolment249 patientsSponsorNovartis Pharma AG

sourced from the EU Clinical Trials Register and site verification

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