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Study Comparing Ribociclib and Endocrine Therapy to Chemotherapy for Patients with Intermediate-Risk HR+/HER2- Early 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 a type of breast cancer known as HR-positive/HER2-negative early breast cancer. The study is comparing two treatment options for patients with this type of cancer. One group will receive a combination of endocrine therapy and a medication called ribociclib (also known by its code name, LEE011), while the other group will receive standard chemotherapy. The purpose of the study is to determine if the combination of endocrine therapy and ribociclib is more effective than chemotherapy in preventing the cancer from returning.

Participants in the study will take part in a treatment period that can last up to 24 months. During this time, they will receive either the combination of endocrine therapy and ribociclib or chemotherapy. The study aims to observe the participants over a period of time to see how well the treatments work in preventing the cancer from coming back and to monitor the overall health and quality of life of the participants.

The study will also look at how well participants adhere to their treatment plans, which means how consistently they take their medication as prescribed. Additionally, researchers will collect information on the participants' response to treatment, including any changes in the size of the tumor and the rate of breast-conserving surgeries. The ultimate goal is to find the most effective treatment option for patients with HR-positive/HER2-negative early breast cancer, improving their chances of living without the disease returning.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    The trial begins with an initial assessment to confirm eligibility. This includes a review of medical history and a series of tests to ensure the patient meets the criteria for participation.

    Tests may include blood tests, imaging studies, and an electrocardiogram (ECG) to check heart function.

  2. Step 2

    Treatment assignment

    Patients are randomly assigned to one of two treatment groups: one receiving ribociclib with endocrine therapy, and the other receiving standard chemotherapy.

    Ribociclib is administered as Kisqali 200 mg film-coated tablets taken orally.

  3. Step 3

    Treatment phase

    Patients in the ribociclib group take the medication as prescribed, typically once daily, in combination with endocrine therapy. The specific dosage and duration depend on the treatment plan.

    Patients in the chemotherapy group receive standard chemotherapy according to the treatment plan.

  4. Step 4

    Monitoring and follow-up

    Regular monitoring is conducted to assess the effectiveness of the treatment and to check for any side effects. This includes routine blood tests and imaging studies.

    Patients are required to attend follow-up appointments to evaluate their response to the treatment and to adjust the treatment plan if necessary.

  5. Step 5

    Completion and evaluation

    Upon completion of the treatment phase, a final evaluation is conducted to assess the overall outcomes of the trial.

    This includes a review of the patient's health status, any changes in the condition, and the overall effectiveness of the treatment.

Who can join the trial?

21 criteria

  • Provide a signed agreement to participate in the study before any tests or procedures begin.
  • Be classified as having an intermediate risk of breast cancer according to specific criteria. Details are in the study protocol.
  • No medical reasons that prevent you from receiving hormone therapy or chemotherapy.
  • Have an ECOG performance status of 0 or 1, which means you are fully active or have some symptoms but can still do light work.
  • Have healthy bone marrow and organs, shown by specific blood test results, such as:
    • Enough white blood cells and platelets.
    • Hemoglobin level of at least 9.0 g/dL.
    • Kidney function with an eGFR of at least 30 mL/min.
    • Normal liver function tests, unless you have a condition called Gilbert’s Syndrome.
    • Have a normal heart rhythm and heart rate, as shown by an ECG test.
    • Be able to swallow the study medication tablets.
    • Be able to communicate with the study doctor and follow the study procedures.
    • Be willing to stay at the clinical site during therapy as required.
    • Be female.
    • Be 18 years of age or older.
    • Meet one of the following conditions:
      • Be postmenopausal, which means you have stopped having periods due to age or surgery.
      • If premenopausal, have a negative pregnancy test or have had a hysterectomy.
      • Have a confirmed diagnosis of early breast cancer that is positive for estrogen or progesterone receptors.
      • Have breast cancer that is HER2-negative, confirmed by specific tests.
      • Receive local treatment for breast cancer according to current guidelines, which may include radiotherapy.
      • No signs of cancer spreading to other parts of the body, confirmed by imaging tests.
      • Have available tumor tissue from the initial biopsy for testing.

Who cannot join the trial?

4 criteria

  • Patients who do not have **HR+/HER2- early breast cancer**. This is a specific type of breast cancer that has certain characteristics related to hormone receptors and a protein called HER2.
  • Patients who are not within the specified age range for the study. The study is looking for participants in certain age groups.
  • Patients who are male, as the study is only accepting female participants.
  • Patients who are considered part of a vulnerable population, which means they might need special protection or care.
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Investigated drugs

  • Ribociclib

    is a medication used in this trial to treat early breast cancer. It works by blocking certain proteins that help cancer cells grow, which may slow down or stop the progression of the disease. In this study, it is combined with endocrine therapy to see if it can improve survival rates compared to standard chemotherapy.

  • Endocrine Therapy

    is a treatment that involves using medications to block or lower the amount of hormones in the body. This is important in hormone receptor-positive breast cancer, where hormones like estrogen can promote the growth of cancer cells. The goal of endocrine therapy in this trial is to help prevent the cancer from returning after initial treatment.

What is already known about the treatment

Ribociclib – Ribociclib is administered orally in the form of tablets. It is currently being studied in clinical trials for its effectiveness in treating HR+/HER2- early breast cancer. The main therapeutic indication for ribociclib is to improve invasive disease-free survival when combined with endocrine therapy, compared to standard chemotherapy. At the molecular level, 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 targeted cancer therapy.

Investigated diseases

Hormone Receptor-Positive/Human Epidermal Growth Factor Receptor 2-Negative Early 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 grow due to the presence of this protein. In its early stages, the cancer is confined to the breast or nearby lymph nodes and has not spread to distant parts of the body. The progression of this cancer can vary, but it typically involves the growth of the tumor within the breast tissue and potentially spreading to nearby lymph nodes. The disease may progress slowly due to its hormone receptor-positive nature, which can influence the growth rate of the cancer cells. Monitoring and managing hormone levels can be crucial in understanding the progression of this type of breast cancer.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-515769-32-00Protocol codeWSG-AM08Estimated enrolment1 684 patientsSponsorWSG Women's Cancer Study Group GmbH

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