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Study of Capivasertib with CDK4/6 Inhibitors and Fulvestrant for Patients with Advanced HR+/HER2- Breast Cancer

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 treatments for a type of breast cancer known as hormone receptor-positive and HER2-negative breast cancer. This type of cancer is characterized by the presence of hormone receptors and the absence of a protein called HER2. The study involves patients with advanced stages of this cancer, which means it has spread beyond the breast and is not suitable for surgery. The trial is testing a new treatment combination that includes a medication called Capivasertib, along with other drugs known as CDK4/6 inhibitors—specifically Palbociclib, Ribociclib, and Abemaciclib—and a drug called Fulvestrant. These medications are taken orally, except for Fulvestrant, which is given as an injection.

The purpose of the study is to evaluate the safety and effectiveness of this new combination of treatments. The trial is divided into two phases. In the first phase, the focus is on assessing how safe and tolerable the combination is for patients. This means checking for any side effects and determining the best dose to use in the next phase. The second phase aims to see if the new treatment combination is better than the current standard treatment in delaying the progression of the cancer. This is measured by how long patients live without the cancer getting worse, known as progression-free survival. The study also looks at specific genetic changes in the cancer, such as PIK3CA, AKT1, and PTEN mutations, to see if these affect how well the treatment works.

Participants in the study will receive either the new treatment combination or the standard treatment, which includes CDK4/6 inhibitors and Fulvestrant. The study will monitor patients over a period of time to collect data on their health, any side effects, and the effectiveness of the treatment. This information will help determine if the new combination offers a better option for treating this type of breast cancer.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, participants will be randomly assigned to one of two groups. One group will receive a combination of capivasertib, CDK4/6 inhibitors (such as palbociclib, ribociclib, or abemaciclib), and fulvestrant. The other group will receive CDK4/6 inhibitors and fulvestrant without capivasertib.
Step 2
Medication administration
Participants will take capivasertib orally in the form of film-coated tablets. The dosage and frequency will be determined by the study team based on the phase of the trial.
Participants will also take one of the CDK4/6 inhibitors orally. The options include palbociclib (available in 75 mg, 100 mg, or 125 mg doses), ribociclib (200 mg), or abemaciclib (50 mg, 100 mg, or 150 mg). The specific dosage and frequency will be provided by the study team.
Fulvestrant will be administered as a solution for injection. The study team will provide details on the dosage and schedule.
Step 3
Monitoring and assessments
Throughout the trial, participants will undergo regular monitoring to assess the safety and tolerability of the medications. This includes checking vital signs, blood tests, and other health assessments.
Participants will also have imaging tests, such as CT or MRI scans, to evaluate the response of the cancer to the treatment.
Step 4
Completion of the trial
The trial is expected to continue until April 2028. Participants will be informed about the duration of their involvement and any follow-up assessments required after completing the treatment phase.

Who can join the trial?

8 criteria

Participants must be adult females (both pre-menopausal and post-menopausal) or adult males.
Participants must have a confirmed diagnosis of HR+ (Hormone Receptor-Positive) / HER2- (Human Epidermal Growth Factor Receptor 2-Negative) breast cancer from the most recent tumor sample.
Participants must be eligible for treatment with fulvestrant and at least one of the following medications: palbociclib, ribociclib, or abemaciclib. These are specific cancer medications.
Participants must have adequate organ and bone marrow functions. This means their organs and bone marrow are working well enough to handle the treatment.
Participants must agree to provide a mandatory FFPE tumor sample. FFPE stands for Formalin-Fixed, Paraffin-Embedded, which is a way of preserving tissue samples for examination.
For Phase III only: Participants must have had previous treatment with an endocrine therapy (ET) such as tamoxifen, AI (Aromatase Inhibitors), or oral SERD (Selective Estrogen Receptor Degraders), and have evidence of cancer recurrence or progression during or shortly after this treatment.
For Phase III only: Participants must provide mandatory blood samples for testing specific gene alterations (PIK3CA, AKT1, PTEN) at the start of the study.
For Phase III only: Participants must have measurable lesions according to specific criteria (RECIST v1.1) or bone lesions that can be assessed by CT or MRI scans.

Who cannot join the trial?

10 criteria

Patients with other types of cancer that are not the focus of this study.
Patients who have had a heart attack or severe heart problems in the past 6 months.
Patients with uncontrolled high blood pressure.
Patients with severe liver or kidney disease.
Patients who are pregnant or breastfeeding.
Patients who have an active infection that requires treatment.
Patients who have a known allergy to any of the study medications.
Patients who have participated in another clinical trial within the last 4 weeks.
Patients who have a history of certain lung diseases.
Patients who have a history of bleeding disorders.

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Verified sites

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Responsive
Azienda Ospedaliero Universitaria Careggi
Florence, Italy
Responsive
Cliniques Universitaires Saint-Luc
Woluwe-Saint-Lambert, Belgium
Responsive
Istituto Oncologico Veneto
Padua, Italy

Trial locations

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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 survive. In this trial, researchers are testing whether adding Capivasertib to other cancer treatments can improve outcomes for patients with certain types of breast cancer.
Palbociclib
is a medication used to treat certain types of breast cancer. It works by blocking proteins that cancer cells need to divide and grow. In this study, Palbociclib is being used in combination with other treatments to see if it can help control cancer growth more effectively.
Ribociclib
is another medication used to treat breast cancer by inhibiting proteins that are important for cancer cell growth. This trial is exploring how well Ribociclib works when combined with other therapies to treat advanced breast cancer.
Abemaciclib
is a treatment for breast cancer that also targets proteins involved in cell division. The study is investigating whether using Abemaciclib alongside other treatments can improve the management of advanced breast cancer.
Fulvestrant
is a 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. In this trial, Fulvestrant is being used with other medications to see if it can help slow down or stop the progression of cancer.

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 a specific type of advanced breast cancer known as hormone receptor-positive and HER2-negative breast cancer. This medication is being tested in combination with other drugs like CDK4/6 inhibitors and fulvestrant to see if it can improve outcomes for patients. Capivasertib works by targeting and inhibiting certain proteins involved in cancer cell growth, specifically those in the AKT pathway, which is often overactive in cancer cells. It is classified as a targeted therapy, aiming to interfere with specific molecules involved in tumor growth and progression.

Investigated diseases

Hormone Receptor-Positive and Human Epidermal Growth Factor Receptor 2-Negative Locally Advanced, Unresectable or Metastatic Breast Cancer – This type of breast cancer is characterized by the presence of hormone receptors and the absence of excess HER2 protein. It is considered locally advanced when it has spread beyond the breast to nearby tissues but is not surgically removable. When it becomes metastatic, it has spread to distant parts of the body. The disease progresses as cancer cells grow and spread, often influenced by hormones like estrogen and progesterone. The growth of these cancer cells can be slower compared to other types of breast cancer. Over time, the cancer may become resistant to hormone therapy, leading to further progression.