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Study on Ribociclib with Hormone Therapy and Radiotherapy for Elderly Patients with Newly Diagnosed Breast Cancer with Positive Hormone Receptors and Negative HER2 Status

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 cancer known as breast cancer. Specifically, it involves patients with breast cancer that has positive hormone receptors and negative HER2 status. The study is designed for elderly patients who have been newly diagnosed and are not immediately able to undergo surgery or prefer to avoid it. The treatment being tested in this study includes a medication called Ribociclib, also known by its code name LEE011. Ribociclib is a type of drug known as a CDK4 inhibitor, which is used in combination with hormone therapy and a specific type of radiation treatment called hypofractionated radiotherapy.

The purpose of this study is to determine how safe and effective Ribociclib is when used with hormone therapy and hypofractionated radiotherapy in treating breast cancer in the specified patient group. The study is divided into two phases. In the first phase, the focus is on finding the best dose of Ribociclib that can be safely given to patients. In the second phase, the study aims to evaluate how well the treatment works in controlling the cancer. Patients participating in the study will receive Ribociclib and hormone therapy alongside radiotherapy, and their health will be monitored over time to assess the treatment's effects.

Throughout the study, the overall health and quality of life of the patients will be regularly assessed. This includes checking how well patients tolerate the treatment and monitoring their progress over several months. The study will also look at how long patients live without the cancer getting worse and their overall survival rates. Additionally, the study will evaluate how well patients adhere to the treatment plan and their general health status using various health questionnaires and assessments.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial registration
Upon joining the study, the patient is registered in the screening phase. This involves confirming eligibility and understanding the study requirements.
Step 2
Medication administration
The patient receives Ribociclib, a medication in the form of 200 mg film-coated tablets. The patient must be able to swallow these tablets.
During the screening phase, the patient takes Ribociclib at a dose of 600 mg without any reduction in dosage.
Step 3
Treatment phase 1
In Phase 1, the main goal is to determine the safest and most effective dose of Ribociclib when combined with hormone therapy and a specific type of radiotherapy called hypofractionated radiotherapy.
The patient undergoes 8 weeks of radiotherapy while continuing to take Ribociclib and hormone therapy.
Step 4
Treatment phase 2
In Phase 2, the focus is on evaluating how effective the combination of Ribociclib, hormone therapy, and hypofractionated radiotherapy is in treating breast cancer.
The patient's progress is monitored to assess the treatment's success.
Step 5
Follow-up
After completing the treatment phases, the patient enters a follow-up period lasting 24 months.
During this time, the patient's health and any progression of the disease are closely monitored.
Step 6
Evaluation of outcomes
The primary outcome is to determine the rate of non-progression at 24 months, meaning the percentage of patients who are alive and have not experienced disease progression.
Secondary outcomes include overall survival rates at 24 and 60 months, progression-free survival, and quality of life assessments.

Who can join the trial?

16 criteria

Patient must be registered in the study-screening phase.
Patient must be receiving 3 cycles of Ribociclib at 600mg during the screening phase without any dose reduction. Ribociclib is a medication used in cancer treatment.
Patient must have a performance status of 0 to 2 on the ECOG Performance Scale. This scale measures how well a patient can perform daily activities.
Patient must not be immediately operable due to the stage of disease, other health conditions, or refusal of surgery, with the tumor still present.
Patient must have measurable disease based on RECIST 1.1. This is a set of guidelines to measure how well a cancer treatment is working.
Patient must demonstrate adequate organ functions, such as:
- Hemoglobin level greater than 9 g/dL. Hemoglobin is a protein in red blood cells that carries oxygen.
- Absolute neutrophil count greater than 1.5 G/L. Neutrophils are a type of white blood cell important for fighting infections.
- Platelet count greater than 100 G/L. Platelets help with blood clotting.
- Patient must have standard 12-lead ECG values, which include:
  - QTcF interval at screening less than 450 msec. This is a measure of the heart's electrical cycle.
  - Mean resting heart rate between 50-90 beats per minute, determined from the ECG. An ECG is a test that records the electrical activity of the heart.
  - Patient must be indicated for treatment with hormone therapy and hypofractionated radiotherapy. Hypofractionated radiotherapy is a type of radiation treatment given in larger doses over a shorter period of time.
  - Patient must have read the information sheet and signed the informed consent, agreeing to participate in the study.
  - Patient must be covered by medical insurance.
  - Patient must be able to swallow Ribociclib.
  - Patient must be able to communicate with the investigator and comply with the study procedures.
  - Patient must be willing to remain at the clinical site as required by the study protocol.

Who cannot join the trial?

3 criteria

Patients who are not diagnosed with breast cancer cannot participate.
Only elderly women are eligible, so men and younger women cannot participate.
Patients who are part of a vulnerable population are not eligible. This means people who might need special protection or care.

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Verified sites

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Verified
Institut de Cancérologie Hématologie Universitaire de Saint Etienne (iCHUSE)
Saint Priest En Jarez, France

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Investigated drugs

Ribociclib
is a medication used in this trial to help treat breast cancer. It works by blocking certain proteins in cancer cells that help them grow and divide. By stopping these proteins, Ribociclib can slow down or stop the growth of cancer cells. In this study, it is being tested to find the best dose that can be safely used with other treatments.
Hormone Therapy
is another treatment used in this trial. It involves using medications that either lower the levels of hormones in the body or block their effects. Since some breast cancers grow in response to hormones, this therapy can help slow down or stop the growth of these cancer cells.
Hypofractionated Radiotherapy
is a type of radiation treatment used in this study. It involves giving higher doses of radiation over a shorter period of time compared to traditional radiotherapy. This approach aims to effectively target and kill cancer cells while minimizing the number of treatment sessions needed.

Ribociclib

What is already known about the treatment

Ribociclib – Ribociclib is administered orally in the form of tablets and is currently being studied in clinical trials for its safety and effectiveness in treating breast cancer, particularly in elderly patients with hormone receptor-positive and HER2-negative status. It is used in combination with hormone therapy and hypofractionated radiotherapy. The medication works by inhibiting certain proteins in cancer cells, which helps to slow down or stop their growth. Ribociclib belongs to a class of drugs known as CDK4/6 inhibitors, which are designed to target specific pathways that cancer cells use to multiply.

Investigated diseases

Breast Cancer – Breast cancer is a disease where cells in the breast grow uncontrollably. It typically begins in the ducts or lobules of the breast. As the disease progresses, it can spread to nearby tissues and lymph nodes. The cancer cells can invade other parts of the body through the blood and lymph systems. The progression of breast cancer can vary, with some forms growing slowly and others more rapidly. The disease can manifest as a lump in the breast, changes in breast shape, or skin dimpling.