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Study of Ribociclib and Letrozole for Patients with High-Risk Estrogen Receptor-Positive, HER2-Negative 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 estrogen receptor-positive and HER2-negative breast cancer. This type of cancer is characterized by the presence of estrogen receptors and the absence of a protein called HER2, which can influence the growth of cancer cells. The study is particularly interested in patients who have a high risk of the cancer returning after treatment. The treatment being tested involves a combination of two medications: Ribociclib, also known by its code name LEE011, and Letrozole. These medications are taken in the form of film-coated tablets.

The purpose of the study is to evaluate the long-term effectiveness of this treatment combination in patients with this specific type of breast cancer. Participants in the study will receive the treatment over a period of time, and their response to the treatment will be monitored. The study aims to determine if this combination can help reduce the risk of the cancer returning and improve overall outcomes for patients.

Throughout the study, participants will take the medications orally and will be regularly monitored by healthcare professionals. The study will assess various outcomes, including the time it takes for the cancer to return and the overall survival of the participants. The trial will also look at the safety of the treatment and any side effects that may occur. This research is important for understanding how to better treat this type of breast cancer and improve the quality of life for those affected by it.

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
Initial treatment phase
Begin taking ribociclib and letrozole orally. Ribociclib is administered as Kisqali 200 mg film-coated tablets, and letrozole as FEMARA 2.5 mg film-coated tablets.
The treatment involves taking these medications daily. The specific dosage and duration will be provided by the healthcare provider based on individual needs and response to treatment.
Step 2
Monitoring and assessment
Regular visits to the healthcare facility are required for monitoring the response to the treatment. This includes laboratory tests and other necessary procedures to ensure the treatment is effective and safe.
The healthcare team will assess the biological response to the treatment, focusing on the reduction of cancer markers and overall health status.
Step 3
Surgical evaluation
After the initial treatment phase, a surgical evaluation will be conducted to assess the response of the cancer to the treatment.
The evaluation aims to determine the presence or absence of cancer cells in the breast and axillary lymph nodes.
Step 4
Post-surgery treatment
Based on the surgical evaluation, further treatment may be necessary. This could involve continuing with ribociclib and letrozole or adjusting the treatment plan as needed.
The goal is to ensure long-term efficacy and prevent recurrence of the cancer.
Step 5
Long-term follow-up
Regular follow-up appointments will be scheduled to monitor health status and detect any signs of cancer recurrence.
These appointments will include physical examinations, imaging tests, and laboratory assessments as required.

Who can join the trial?

9 criteria

Sign an Informed Consent Form before any study-specific procedures. You must be willing and able to follow the study plan, including visits, treatment, lab tests, and other procedures. Note: In France, you must be part of a Social Security System or equivalent.
Be a male aged 18 or older, a pre-menopausal woman aged 40 or older, or a post-menopausal woman. Pre-menopausal men and women will receive LHRH agonists (a type of medication) 2 weeks before starting treatment and during the study. Post-menopausal status means you are 60 years or older, or under 60 with 12 months without periods and specific hormone levels, or have had both ovaries removed at least 7 days before starting treatment.
Have a confirmed invasive breast cancer by a local pathologist with these features: Clinical stage II, ER-positive (estrogen receptor-positive), HER2-negative (a protein not overexpressed in the cancer), tumor cells with more than 10% ER staining, and grade 2 or 3 breast cancer. The Ki-67 index (a measure of how fast cancer cells are growing) should be 20% or higher, or have a high genomic risk based on specific tests. Multifocal and multicentric tumors are allowed if they are stage II. Not all lesions need a biopsy.
Breast cancer must be suitable for primary surgery.
Have a pre-treatment biopsy sample available for specific testing, or be able to obtain one. The sample must meet certain size and quality requirements.
Have an ECOG performance status of 0 to 1, which means you are fully active or have some symptoms but can still do light work. This evaluation should be done within 14 days before joining the study.
Have adequate blood, kidney, and liver function, including specific levels of neutrophils, platelets, hemoglobin, and other markers.
If you are a male participant, agree to use contraception during the chemotherapy period and for at least 21 days after the last dose, plus an additional 120 days. Do not donate sperm during this time.
If you are a female participant, you must not be pregnant or breastfeeding. You must either not be of childbearing potential or agree to use contraception during the treatment period and for at least 21 days after the last dose, plus 30 days for treatments with a risk of affecting genes. Follow local guidelines for contraception after the study.

Who cannot join the trial?

10 criteria

Patients who have a different type of breast cancer than the one being studied.
Patients who have a stage of breast cancer that is not stage II.
Patients whose cancer is not grade 2 or 3. Grade refers to how much the cancer cells look like normal cells under a microscope.
Patients whose cancer has a Ki67 level higher than 20%. Ki67 is a marker that shows how fast cancer cells are growing.
Patients whose cancer is not HR+ or HER2-. HR+ means the cancer grows in response to hormones, and HER2- means the cancer does not have too much of a protein called HER2.
Patients who are not biologically responding to the treatment with ribociclib and letrozole before surgery. Biologically responding means the cancer is shrinking or not growing.
Patients who do not have a low ROR at surgery. ROR stands for Risk of Recurrence, which is a measure of how likely the cancer is to come back.
Patients who are not within the specified age range for the study.
Patients who are not female or male, as both genders are included in the study.
Patients who are considered part of a vulnerable population, which means they might need special protection or care.

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Verified sites

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

Verified
Besancon University Hospital Center
Besançon, France
Responsive
Hospital Universitario Hm Sanchinarro
Madrid, Spain
Responsive
Institut De Cancerologie De Lorraine
Vandoeuvre Les Nancy, France

Trial locations

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Investigated drugs

Ribociclib
is a medication used in this trial to treat breast cancer. It works by blocking certain proteins that help cancer cells grow, which may slow down or stop the progression of the disease. Ribociclib is used in combination with other therapies to enhance its effectiveness.
Endocrine Therapy
involves using medications that affect hormone levels in the body. For breast cancer, this therapy is used to block or lower the amount of estrogen, which can help slow or stop the growth of cancer cells that rely on this hormone to multiply.

What is already known about the treatment

Ribociclib – This medication is administered orally and is used in combination with other therapies for treating certain types of breast cancer. It is currently being studied in clinical trials to assess its safety and long-term effectiveness in patients with high-risk estrogen receptor-positive, HER2-negative breast cancer. Ribociclib works by inhibiting specific proteins called cyclin-dependent kinases, which are involved in cell division, thereby slowing down the growth of cancer cells. It is classified as a CDK4/6 inhibitor and is part of targeted cancer therapies.

Investigated diseases

Breast Cancer – Breast cancer is a disease where cells in the breast grow out of control. It can start in different parts of the breast, most commonly in the ducts or lobules. The disease is categorized into stages, with stage II indicating that the cancer is larger or has spread to nearby lymph nodes. The grade of the cancer, such as grade 2 or 3, describes how much the cancer cells look like normal cells, with higher grades being more abnormal. Breast cancer can be hormone receptor-positive (HR+) and human epidermal growth factor receptor 2-negative (HER2-), which influences how the cancer behaves and grows. The progression of breast cancer can involve local growth in the breast and potential spread to other parts of the body.