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Study on Capivasertib and Fulvestrant for Patients with Advanced HR+/HER2- Breast Cancer After Standard Treatment Progression

Verified siteRegistered drugNo placebo
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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 use 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 how effective the combination of capivasertib and fulvestrant is for patients whose cancer has returned or progressed after receiving standard treatments, including hormone therapy and a type of medication known as a CDK4/6 inhibitor. The study will observe how long it takes for patients to need another treatment after starting the study medication. Participants will take the study medications orally and will be monitored for any side effects or changes in their condition. The study aims to reflect real-world clinical practice in Spain, providing insights into how this treatment combination works in everyday healthcare settings.

Throughout the study, researchers will collect information on the frequency and severity of any side effects, as well as how long patients continue with the treatment before needing to switch to another therapy. The study will also look at how the treatment affects patients' overall survival and quality of life. By gathering this information, the study hopes to provide valuable data on the potential benefits and risks of using capivasertib and fulvestrant together for treating HR-positive/HER2-negative advanced 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

    Initiation of treatment

    Upon joining the study, the patient begins treatment with two medications: capivasertib and fulvestrant.

    Capivasertib is administered orally in the form of film-coated tablets. The patient will receive either 160 mg or 200 mg tablets, depending on the specific requirements of the study.

    Fulvestrant is administered as an injection. The dosage and frequency will be determined by the study protocol.

  2. Step 2

    Treatment monitoring

    Throughout the study, the patient's response to the treatment will be closely monitored.

    Regular assessments will be conducted to evaluate the effectiveness of the treatment and to identify any potential side effects.

    The primary goal is to measure the time to the next treatment, which is the period from the first dose until the need for another anti-cancer therapy or any cause of death.

  3. Step 3

    Adverse event management

    The study will track the frequency of adverse events, which may lead to changes in dosage, temporary interruptions, or permanent discontinuation of the treatment.

    Special attention will be given to serious adverse events and those of grade 3 or higher.

  4. Step 4

    Treatment duration and follow-up

    The median duration of treatment will be recorded, along with the reasons for any discontinuations at 6, 12, and 24 months after starting the treatment.

    The study will also measure the time to the first subsequent chemotherapy and progression-free survival, which is the time until disease progression or death.

  5. Step 5

    Quality of life assessments

    The patient's quality of life will be assessed using various questionnaires, including the EORTC QLQ-C30 and EORTC QLQ-BR23.

    Changes in symptom severity, treatment tolerability, and daily bowel habits will be monitored.

  6. Step 6

    Study conclusion

    The study is expected to conclude by November 15, 2026.

    Final assessments will be conducted to evaluate the overall survival and objective response rate to the treatment.

Who can join the trial?

9 criteria

  • Participants must be adults, meaning they are 18 years or older. This includes both females (pre- and post-menopausal) and males.
  • Participants must have a type of breast cancer called HR+ / HER2-. This means the cancer cells have certain hormone receptors (HR+) and do not have a protein called HER2 (HER2-). This should be confirmed by a test on a recent tumor sample.
  • The cancer must have specific genetic changes, known as PIK3CA/AKT1/PTEN alterations, which are detected through a special test called NGS (Next-Generation Sequencing).
  • The cancer must be either metastatic (spread to other parts of the body) or locally advanced (grown significantly in the original area) and must have shown signs of getting worse after previous treatment.
  • Participants should have previously received a treatment that includes ET (Endocrine Therapy) combined with CDK4/6 inhibitors, and the cancer should have shown signs of getting worse during or shortly after this treatment.
  • Participants must provide informed consent, which means they agree to participate in the study after understanding all the details. This includes agreeing to additional tests and research related to the study.
  • Participants must have a certain level of physical ability, measured by a scale called ECOG/WHO performance status, which should be 2 or less. This scale assesses how the disease affects daily living abilities.
  • Pre-menopausal female participants must agree to use two forms of effective birth control during the study and for a specified time after the study ends to prevent pregnancy.
  • Male participants must use barrier contraception, like condoms, during the study and for a specified time after the study ends. They should also consider sperm freezing if they wish to have children in the future.

Who cannot join the trial?

5 criteria

  • Patients who do not have HR+ / HER2- advanced breast cancer cannot participate. This type of breast cancer is defined by specific characteristics of the cancer cells.
  • Patients who do not have changes in certain genes, specifically PIK3CA, AKT1, or PTEN, are excluded. These genes can affect how cancer grows.
  • Patients who are not within the specified age range for the study cannot participate. The study is open to certain age groups only.
  • Both male and female patients can participate, but those who do not meet other criteria will be excluded.
  • Patients who are considered part of a vulnerable population, which means they might need special protection or care, are not included in this study.
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Investigated drugs

  • Capivasertib

    is a medication used in this study to treat advanced breast cancer. It works by targeting specific proteins in cancer cells, which can help slow down or stop the growth of the cancer. This medication is being tested in combination with another treatment to see how effective it is for patients whose cancer has progressed after other treatments.

  • Fulvestrant

    is another medication used in this study. It is a type of hormone therapy that works by blocking the effects of estrogen on breast cancer cells. This can help slow the growth of the cancer. In this study, fulvestrant is used together with capivasertib to see if the combination is more effective than previous treatments.

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 HR+ / HER2- advanced breast cancer. It is not yet widely used in standard medical practice but shows promise in ongoing research. The medication works by inhibiting the AKT pathway, which is involved in cell growth and survival, potentially slowing cancer progression. It is classified as a targeted therapy, specifically an AKT inhibitor.

  • Fulvestrant

    Fulvestrant is administered via intramuscular injection and is an established treatment for HR+ / HER2- advanced breast cancer, particularly in patients who have progressed on endocrine therapy and CDK4/6 inhibitors. It acts by binding to estrogen receptors and promoting their degradation, thereby blocking the effects of estrogen on cancer cells. Fulvestrant is classified as an estrogen receptor antagonist.

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, meaning the cancer cells grow in response to hormones like estrogen or progesterone. It is also negative for the HER2 protein, which means the cancer does not overexpress the HER2 protein that can promote the growth of cancer cells. 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 often involves the cancer spreading to bones, liver, lungs, or brain. The growth and spread of the cancer are influenced by hormonal changes, and it may progress slowly or rapidly depending on various factors.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-513952-13-00Protocol codeD3612L00005Estimated enrolment100 patientsSponsorAstrazeneca Farmaceutica Spain S.A.

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