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Study on Ribociclib, Alpelisib, and Letrozole for Adults with Advanced Hormone Receptor-Positive 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 treatments for advanced hormone receptor-positive (HR+) breast cancer, a type of breast cancer that grows in response to hormones. The study involves a combination of medications: Letrozole, Ribociclib (also known as LEE011), and Alpelisib (also known as BYL719). These medications are taken orally in the form of tablets or capsules. The purpose of the study is to explore the safety and effectiveness of these drug combinations in treating advanced HR+ breast cancer.

Participants in the study will receive different combinations of these medications. Some will take Letrozole with Ribociclib, others will take Letrozole with Alpelisib, and some will take all three medications together. The study will monitor how well these combinations are tolerated by patients and how they affect the cancer. The trial will also look at how the body processes these medications, which is known as pharmacokinetics.

The study is designed to help researchers understand the best doses of these medications and how they can be used together to treat advanced HR+ breast cancer. It will also provide information on any side effects that may occur. This research is important for developing new treatment options for patients with this type of breast cancer.

The research process

The trial runs in 5 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, the patient will be informed about the trial's purpose and procedures. The patient will be required to provide informed consent, acknowledging understanding of the study and agreeing to participate.
Step 2
Initial assessment
The patient will undergo an initial assessment to confirm eligibility. This includes verifying the diagnosis of advanced hormone-receptor positive breast cancer and ensuring the patient meets all inclusion criteria.
Step 3
Treatment phase
The treatment phase involves taking medications orally. The patient will receive a combination of letrozole, alpelisib, and ribociclib.
The specific regimen may vary: some patients will receive letrozole with ribociclib, others with alpelisib, and some with all three medications. The dosage and frequency will be determined based on the specific arm of the study the patient is assigned to.
The treatment is administered in cycles, with each cycle lasting 28 days. The patient will be monitored for any side effects or adverse reactions during this period.
Step 4
Monitoring and follow-up
Throughout the trial, the patient will have regular check-ups to monitor health status and response to treatment. This includes blood tests, imaging studies, and other necessary evaluations.
The patient will be observed for any dose-limiting toxicities and other adverse events. Adjustments to the treatment regimen may be made based on these observations.
Step 5
Completion of the trial
Upon completion of the trial, the patient will undergo a final assessment to evaluate the overall response to the treatment.
The patient will be informed about the results and any potential next steps in their treatment plan.

Who can join the trial?

8 criteria

Must be an adult woman, aged 18 years or older, with advanced breast cancer that cannot be cured by surgery or radiation.
Must have confirmation through tests that the breast cancer is **hormone-receptor positive**. This means the cancer grows in response to hormones like estrogen or progesterone.
Must be a **postmenopausal** woman, meaning she has stopped having menstrual periods.
For the **Dose Escalation** part of the study, any number of previous hormone treatments is allowed, but only one previous chemotherapy treatment in the advanced stage is permitted.
For the **Dose Expansion** part of the study (Arms 1, 2, and 3), no previous treatments for advanced breast cancer are allowed, except for a short treatment with letrozole or anastrozole for up to one month.
For certain parts of the study (Dose Expansion Arms 2 and 3 and Dose Escalation Arm 4), the patient must know their **PIK3CA status**, which is a specific gene mutation that can be present or absent.
For the **Dose Escalation** part, the patient must have either measurable or non-measurable disease, as defined by specific medical criteria (RECIST 1.1).
For the **Dose Expansion** part, the patient must have at least one measurable tumor or specific types of bone lesions if there are no measurable tumors, according to the same medical criteria (RECIST 1.1).

Who cannot join the trial?

3 criteria

Patients who do not have advanced HR+ breast cancer cannot participate. This type of breast cancer is hormone receptor-positive, meaning it grows in response to hormones.
Only female patients are eligible, so male patients cannot participate.
Patients who are part of a vulnerable population, such as those who cannot make decisions for themselves, are not eligible.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
Hospital General Universitario Gregorio Maranon
Madrid, Spain
Responsive
Hospital Universitario Hm Sanchinarro
Madrid, Spain
Verified
Institut Paoli-Calmettes Cancer Centre
Marseille, France

Trial locations

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Investigated drugs

LEE011
This medication is being studied for its potential to treat advanced breast cancer. It is used in combination with other drugs to see if it can help slow down or stop the growth of cancer cells. LEE011 is taken in cycles, with a period of taking the medication followed by a break.
BYL719
This is another medication being tested for its effectiveness in treating advanced breast cancer. It is used alongside other treatments to determine if it can improve outcomes for patients. BYL719 is taken daily, and the study is exploring different times of day for taking the medication to find the most effective regimen.
Letrozole
This is a standard treatment for certain types of breast cancer. It works by lowering estrogen levels in the body, which can help slow or stop the growth of cancer cells that need estrogen to grow. In this study, letrozole is used in combination with other investigational drugs to see if the combination is more effective than letrozole alone.

What is already known about the treatment

LEE011
This medication is administered orally and is currently being studied in clinical trials for its effectiveness in treating advanced hormone receptor-positive breast cancer. It is often used in combination with letrozole, a standard treatment for this type of cancer. LEE011 works by inhibiting certain proteins that are involved in cell division, thereby slowing down the growth of cancer cells. It is classified as a CDK4/6 inhibitor, which is a type of targeted cancer therapy.
BYL719
Administered orally, BYL719 is under investigation in clinical trials for its potential to treat advanced hormone receptor-positive breast cancer. It is typically combined with letrozole to enhance its therapeutic effects. BYL719 functions by inhibiting a specific enzyme involved in cancer cell growth, known as PI3K, which helps to reduce tumor progression. This medication is classified as a PI3K inhibitor, a category of drugs that target specific pathways in cancer cells.

Investigated diseases

Advanced Hormone Receptor-Positive Breast Cancer – This type of breast cancer is characterized by the presence of receptors for hormones like estrogen or progesterone on the surface of the cancer cells. These receptors allow the cancer to grow in response to these hormones. As the disease progresses, it may spread beyond the breast to other parts of the body, such as bones, liver, or lungs. The cancer is considered advanced when it has spread to these distant sites or is not responding to initial treatments. The progression can vary, with some patients experiencing slow growth and others facing more rapid changes. Hormone receptor-positive breast cancer often requires ongoing management to control its spread and impact.