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Study on the Safety and Effectiveness of Capivasertib and Fulvestrant for Patients with Advanced HR+/HER2- Breast Cancer After Hormone Treatment

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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 HR-positive/HER2-negative advanced breast cancer. This type of cancer is characterized by the presence of hormone receptors (HR) and the absence of a protein called HER2. The study is investigating the effects of a treatment combination that includes a medication called capivasertib and another drug named fulvestrant. Capivasertib, also known by its code name AZD5363, is taken in the form of film-coated tablets. Fulvestrant is a medication used to treat certain types of breast cancer by blocking the effects of estrogen, a hormone that can promote the growth of cancer cells.

The purpose of this study is to evaluate the safety and effectiveness of the combination of capivasertib and fulvestrant in patients whose cancer has progressed despite previous hormone-based treatments. Participants in the study will receive these medications and will be monitored to assess how long they can continue the treatment before needing to switch to another therapy. The study will also look at how this treatment affects the quality of life of the participants.

Throughout the study, participants will take the medications orally and will be regularly assessed by healthcare professionals. The study aims to provide insights into how well this combination of treatments works in managing advanced breast cancer and improving the time patients can stay on treatment. The trial will also explore the impact of the treatment on patients' daily lives and overall well-being.

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

    Beginning of the trial

    Upon joining the study, the patient will start by taking the medication capivasertib in combination with fulvestrant. These medications are used to treat HR+/HER2- advanced breast cancer.

    The patient will take capivasertib orally in the form of film-coated tablets. The dosage will be either 200 mg or 160 mg, as determined by the study protocol. The frequency and duration of administration will be specified by the study team.

  2. Step 2

    Treatment administration

    The patient will receive fulvestrant as part of the treatment regimen. This medication is administered to help manage the progression of breast cancer.

    The patient will continue to take capivasertib and fulvestrant as directed by the study team, with regular monitoring to assess the effectiveness and safety of the treatment.

  3. Step 3

    Monitoring and evaluation

    Throughout the trial, the patient's health and response to the treatment will be closely monitored. This includes regular check-ups and assessments by the healthcare team.

    The study aims to evaluate the benefits of the treatment in terms of time to next treatment and quality of life improvements.

  4. Step 4

    End of the trial

    The trial is expected to continue until March 29, 2030. The patient will be informed about the end of their participation and any follow-up procedures that may be necessary.

    Upon completion of the trial, the patient will receive information about the results and any further steps regarding their treatment plan.

Who can join the trial?

11 criteria

  • Participants must be 18 years or older, both females and males.
  • Females can be pre-menopausal, peri-menopausal, or post-menopausal. Pre-menopausal women must be willing to receive treatment with an LHRH agonist (a medication that affects hormone levels).
  • Participants must have a diagnosis of HR+/HER2- advanced breast cancer. This means the cancer is hormone receptor-positive and does not have excess HER2 protein.
  • The cancer must be metastatic (spread to other parts of the body) or locally advanced and not treatable with surgery aimed at curing it.
  • Participants should have received previous treatment with endocrine therapy (hormone therapy) and have evidence of cancer progression during or after this treatment.
  • Participants must have one or more of the following biomarkers: PIK3CA, AKT1, or PTEN, preferably found in tumor tissue.
  • Participants must be starting treatment with capivasertib + fulvestrant.
  • Participants must provide informed consent before joining the study.
  • Female participants of childbearing potential must have a negative pregnancy test and use an acceptable method of contraception during the study and for a specified period after the last dose of study drugs.
  • Male participants must be surgically sterile or use an acceptable method of contraception during the study and for a specified period after the last dose of study drugs.
  • Participants must have an ECOG performance status of 0 or 1, which means they are fully active or have some restrictions but can carry out light work. They must also have a life expectancy of at least 12 weeks.

Who cannot join the trial?

8 criteria

  • Patients with any other type of cancer besides HR+/HER2- advanced breast cancer cannot participate.
  • Patients who are not within the specified age range cannot participate.
  • Patients who are not willing or able to follow the study procedures cannot participate.
  • Patients who have a medical condition that the study doctors believe would make it unsafe for them to participate cannot join the study.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients who have participated in another clinical trial recently may not be eligible.
  • Patients who have certain medical conditions that could interfere with the study results cannot participate.
  • Patients who are unable to give informed consent cannot participate.
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Investigated drugs

  • Capivasertib

    is a medication being studied for its potential to help treat advanced breast cancer. It works by targeting specific proteins in cancer cells that help them grow and spread. By blocking these proteins, capivasertib may slow down or stop the growth of cancer cells, potentially improving the patient's condition and delaying the need for further treatment.

  • Fulvestrant

    is a therapy used in the treatment of certain types of breast cancer. It works by blocking the effects of estrogen, a hormone that can promote the growth of cancer cells in some breast cancers. By interfering with estrogen's action, fulvestrant may help to slow down or stop the growth of cancer cells, providing a beneficial effect for patients with hormone receptor-positive breast cancer.

What is already known about the treatment

  • Capivasertib

    Capivasertib is administered orally in the form of tablets and is currently being studied in clinical trials for its effectiveness in treating HR+/HER2- advanced breast cancer, particularly in patients who have experienced progression after previous endocrine-based treatments. It works by targeting specific proteins in cancer cells, which helps to slow down or stop their growth. Capivasertib is classified as a targeted therapy, specifically an AKT inhibitor, which interferes with the signaling pathways that promote cancer cell survival and proliferation.

  • Fulvestrant

    Fulvestrant is given as an injection into the muscle, typically in the buttocks, and is an established treatment for HR+/HER2- advanced breast cancer. It is used in combination with other medications like capivasertib to enhance treatment effectiveness. Fulvestrant works by blocking and degrading estrogen receptors on cancer cells, which reduces the growth-promoting effects of estrogen on these cells. It is classified as an estrogen receptor antagonist and is widely recognized in medical literature for its role in hormone therapy for breast cancer.

Investigated diseases

Hormone Receptor-Positive/Human Epidermal Growth Factor Receptor 2-Negative Advanced Breast Cancer – This type of breast cancer is characterized by the presence of hormone receptors and the absence of excess HER2 protein. It typically progresses by growing in response to hormones like estrogen or progesterone. As the disease advances, it may spread beyond the breast to other parts of the body, such as bones, liver, or lungs. The progression can lead to symptoms like pain, fatigue, and changes in the affected breast or other areas. The disease often requires ongoing management to control its spread and alleviate symptoms.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-511392-15-00Protocol codeWSG-AM14Estimated enrolment250 patientsSponsorWSG Women's Cancer Study Group GmbH

sourced from the EU Clinical Trials Register and site verification

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