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Study of Capivasertib and Fulvestrant for Patients with Advanced or Metastatic HR+/HER2- Breast Cancer

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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 locally advanced (inoperable) or metastatic HR-positive/HER2-negative breast cancer. This type of cancer is characterized by its spread beyond the original site and its resistance to certain treatments. The study is testing a combination of two treatments: Capivasertib, which is taken as a film-coated tablet, and Fulvestrant, which is given as a solution for injection. The trial will compare the effects of this combination against a placebo combined with Fulvestrant. The purpose of the study is to evaluate how well the combination of Capivasertib and Fulvestrant works in slowing down the progression of the cancer.

Participants in the study will receive either the combination of Capivasertib and Fulvestrant or a placebo with Fulvestrant. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the actual treatment or the placebo. This helps ensure that the results are not biased. The trial will monitor the participants over time to assess the progression of the disease and any side effects that may occur. The study will also look at specific genetic changes, such as PIK3CA mutations, to see if they affect how well the treatment works.

The trial aims to provide valuable information on the safety and effectiveness of Capivasertib and Fulvestrant in treating this type of breast cancer. It will also gather data on overall survival rates, response to treatment, and quality of life for participants. The study is expected to continue until 2025, allowing researchers to collect comprehensive data on the long-term effects of the treatment. Participants will be closely monitored throughout the study to ensure their safety and well-being.

The research process

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

  1. Step 1

    Randomization

    Upon joining the study, you will be randomly assigned to one of two groups. One group will receive capivasertib and fulvestrant, while the other group will receive a placebo and fulvestrant. This process is called randomization and ensures that the study results are unbiased.

  2. Step 2

    Treatment initiation

    If you are in the group receiving fulvestrant, you will receive it as an injection into the muscle. The dosage is 250 mg, and it is administered according to the study schedule.

    If you are in the group receiving capivasertib, you will take it orally in the form of film-coated tablets. The specific dosage and frequency will be provided by the study team.

  3. Step 3

    Treatment duration

    The treatment will continue for the duration of the study, which is estimated to end by June 30, 2025. The exact duration of your participation will depend on your individual response to the treatment and the study's progress.

  4. Step 4

    Monitoring and assessments

    Throughout the study, regular assessments will be conducted to monitor your health and the effectiveness of the treatment. These assessments may include imaging tests, blood tests, and questionnaires about your quality of life.

    Your progression-free survival (PFS) will be evaluated, which is the time from the start of the treatment until the disease progresses or you experience any cause of death.

  5. Step 5

    Completion of study

    At the end of the study, your overall survival (OS) and other health outcomes will be assessed. This includes the objective response rate (ORR), duration of response (DoR), and clinical benefit rate (CBR).

    Safety and tolerability of the treatment will also be evaluated through various health parameters and questionnaires.

Who can join the trial?

7 criteria

  • Participants must be adult females, either before or after menopause, and adult males. Women who are premenopausal can join if they agree to treatment with a medication called an LHRH agonist, which helps manage hormone levels. They should start this treatment before or on the first day of the study and continue it throughout the study.
  • Participants must have a type of breast cancer called **HR+/HER2-**. This means the cancer has certain hormone receptors but not a protein called HER2. This should be confirmed by a test on the most recent tumor sample.
  • The cancer must be either **metastatic** (spread to other parts of the body) or **locally advanced** (grown too much to be removed by surgery). There should be evidence that the cancer has come back or gotten worse after previous treatment.
  • Participants should have a performance status of 0-1 according to the **ECOG/WHO** scale, which measures how well they can perform daily activities.
  • Participants must have been treated with a type of medication called an **aromatase inhibitor (AI)**. They should have evidence of cancer coming back or getting worse during or within 12 months after this treatment, or while on AI treatment for advanced cancer.
  • Participants must have cancer that can be measured by a scan, or at least one bone lesion that can be assessed by a CT or MRI scan. If the cancer is only in the bones and cannot be measured, they are not eligible.
  • A sample of the tumor from the primary or recurrent cancer must be available for testing.

Who cannot join the trial?

10 criteria

  • Patients with other types of cancer that are not the specific type being studied.
  • Patients who have had previous treatment with the same drugs being tested in the study.
  • Patients with serious medical conditions that could interfere with the study, such as severe heart disease.
  • Patients who are pregnant or breastfeeding.
  • Patients who are unable to follow the study procedures or attend the required visits.
  • Patients who have an active infection that requires treatment.
  • Patients who have a history of allergic reactions to the study drugs.
  • Patients who are currently participating in another clinical trial.
  • Patients with a history of drug or alcohol abuse that could affect their ability to participate in the study.
  • Patients who have had a major surgery within a certain time frame before the study starts.
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Investigated drugs

  • Capivasertib

    is a medication being studied for its potential to treat certain types of breast cancer. It works by targeting specific proteins in cancer cells, which may help to slow down or stop the growth of the cancer. In this trial, it is being tested in combination with another medication to see if it can improve outcomes for patients with advanced breast cancer.

  • Fulvestrant

    is a medication used in the treatment of hormone receptor-positive breast cancer. It works by blocking the effects of estrogen in the body, which can help to slow the growth of certain types of breast cancer cells that need estrogen to grow. In this trial, it is used in combination with capivasertib to evaluate the effectiveness of the treatment.

What is already known about the treatment

  • Capivasertib

    Capivasertib is administered orally and is currently being studied in clinical trials for its effectiveness in treating certain types of breast cancer. It is primarily used for patients with locally advanced or metastatic hormone receptor-positive, HER2-negative breast cancer. The medication works by inhibiting specific proteins involved in cancer cell growth, particularly targeting the AKT pathway, which is crucial for cell survival and proliferation. Capivasertib is classified as a protein kinase inhibitor, focusing on disrupting cancer cell signaling pathways.

  • Fulvestrant

    Fulvestrant is administered via intramuscular injection and is an established treatment in the medical field for hormone receptor-positive breast cancer. It is used for patients with advanced or metastatic breast cancer, particularly after other hormonal therapies have failed. Fulvestrant works by binding to estrogen receptors and degrading them, thereby blocking the effects of estrogen on cancer cells. It is classified as an estrogen receptor antagonist, effectively reducing the growth of hormone-dependent cancer cells.

Investigated diseases

Locally Advanced (Inoperable) or Metastatic HR+/HER2- Breast Cancer – This type of breast cancer is characterized by the presence of hormone receptors (HR+) and the absence of human epidermal growth factor receptor 2 (HER2-). It is considered locally advanced when it has spread beyond the breast to nearby tissues but cannot be surgically removed. When it becomes metastatic, the cancer cells have spread to distant parts of the body, such as bones, liver, or lungs. The disease progresses as cancer cells continue to grow and spread, often leading to symptoms like pain, fatigue, and swelling in affected areas. The progression can vary greatly among individuals, influenced by factors like the cancer's biology and the patient's overall health.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-505042-25-00Protocol codeD3615C00001Estimated enrolment700 patientsSponsorAstraZeneca AB

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