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Study on Optimizing CDK 4/6 Inhibitors and Endocrine Therapy for Older Patients with Advanced Breast Cancer Using Abemaciclib, Palbociclib, and Ribociclib

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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 Breast Cancer in older patients. The study involves several medications, including Verzenios (abemaciclib), Faslodex (fulvestrant), IBRANCE (palbociclib), Arimidex (anastrozole), Kisqali (ribociclib), Aromasin (exemestane), and Femara (letrozole). These medications are used to explore the effectiveness of different doses of CDK 4/6-inhibitors, which are a type of cancer treatment that helps to slow down the growth of cancer cells. The purpose of the study is to investigate how well these treatments work when given at a lower initial dose along with endocrine therapy, compared to the full recommended dose, in older patients who may be more vulnerable or frail.

Participants in the study will receive either the lower dose or the full dose of the CDK 4/6-inhibitors along with endocrine therapy. The study will monitor the time it takes for the treatment to stop being effective, known as "time to treatment failure." Other aspects being observed include overall survival, progression-free survival, and the time it takes before chemotherapy is needed. The study will also look at the side effects of the treatments, the quality of life of the participants, and the cost-effectiveness of the treatments.

The trial is expected to run until 2031, with recruitment starting in November 2023. This study aims to provide valuable insights into optimizing treatment for older patients with advanced breast cancer, ensuring they receive the most effective and safe care possible.

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

    Joining the study

    Upon joining the study, the patient will be informed about the trial's purpose and procedures. Consent is required before any study-specific activities begin.

  2. Step 2

    Initial assessment

    A comprehensive assessment will be conducted to evaluate the patient's health status. This includes a geriatric assessment to determine the appropriate dosage of medications.

  3. Step 3

    Medication administration

    The patient will receive a combination of CDK 4/6-inhibitors and endocrine therapy. The specific medications include abemaciclib, palbociclib, and ribociclib, administered orally in tablet form.

    The dosage and frequency will be adjusted based on the initial assessment. The treatment aims to manage advanced breast cancer in older patients.

  4. Step 4

    Ongoing monitoring

    Regular monitoring will be conducted to assess the patient's response to treatment. This includes evaluating the time to treatment failure and other health indicators.

    Adjustments to the treatment plan may be made based on the patient's progress and any side effects experienced.

  5. Step 5

    End of treatment

    The study will continue until the estimated end date in May 2031, or until the patient completes the treatment protocol.

    Final assessments will be conducted to evaluate the overall effectiveness and impact of the treatment on the patient's quality of life.

Who can join the trial?

10 criteria

  • Patients must be at least 70 years old. Male patients should use effective birth control methods during and for at least 14 weeks after therapy.
  • Patients must be able to understand and give consent in English or their native language.
  • Patients must have a confirmed diagnosis of HR-positive (estrogen-receptor 1% or more) and HER2-negative breast cancer, based on the most recent tumor test.
  • Patients must have advanced breast cancer that cannot be cured with current treatments.
  • Patients should not have had any previous systemic treatment for advanced breast cancer. However, if the cancer returned during previous hormone therapy, they can still participate. A short treatment with certain hormone therapies before starting the study treatment is allowed.
  • Patients who had previous treatment with CDK4/6-inhibitors can participate if they have been free of the disease for more than 12 months after stopping the treatment.
  • Patients must have either measurable disease or bone-only disease that can be evaluated according to specific criteria.
  • Patients must provide written consent before any study-related procedures begin.
  • Patients must have adequate organ function, which includes specific blood counts and liver and kidney function levels. An ECG test is required to check heart function before starting treatment with ribociclib.
  • Patients must be able to swallow capsules.

Who cannot join the trial?

5 criteria

  • Patients who do not have advanced breast cancer. Advanced breast cancer means the cancer has spread beyond the breast to other parts of the body.
  • Patients who are not considered older. This study is focused on older patients.
  • Patients who are not vulnerable or frail. Vulnerable or frail means patients who may have additional health challenges or are weaker.
  • Patients who cannot take CDK 4/6-inhibitors. These are medications used to treat certain types of breast cancer.
  • Patients who cannot undergo endocrine therapy. Endocrine therapy is a treatment that blocks or removes hormones that fuel some cancers.
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Investigated drugs

  • CDK 4/6-inhibitors

    are a type of medication used to treat certain types of breast cancer. They work by blocking specific proteins in cancer cells, which helps to stop the cells from growing and dividing. In this trial, these inhibitors are being tested to see if starting with a lower dose is effective for older patients who are more vulnerable or frail.

  • Endocrine therapy

    is a treatment that adds, blocks, or removes hormones. For certain types of breast cancer that are sensitive to hormones, this therapy can help slow or stop the growth of cancer by interfering with the body's hormone production or action. In this trial, endocrine therapy is used in combination with CDK 4/6-inhibitors to see how well they work together in treating older breast cancer patients.

What is already known about the treatment

CDK 4/6 Inhibitors – These medications are typically administered orally in the form of tablets. They are currently being studied in clinical trials for their effectiveness in treating advanced breast cancer, particularly in older patients. The main therapeutic use of CDK 4/6 inhibitors is to slow down the progression of certain types of breast cancer by interfering with specific proteins involved in cell division. At the molecular level, they work by inhibiting the activity of cyclin-dependent kinases 4 and 6, which are crucial for the transition of cells from the G1 phase to the S phase of the cell cycle. CDK 4/6 inhibitors are classified as targeted cancer therapies, focusing on specific molecular targets associated with cancer.

Investigated diseases

Advanced Breast Cancer – This is a stage of breast cancer where the disease has spread beyond the breast and nearby lymph nodes to other parts of the body. It is often referred to as metastatic breast cancer. The progression of the disease can vary, with cancer cells potentially affecting organs such as the bones, liver, lungs, or brain. Symptoms may include persistent pain, fatigue, and changes in appetite or weight. The disease can progress at different rates, and its impact on daily life can vary significantly among individuals. Management focuses on controlling the spread and alleviating symptoms to improve quality of life.
Trial detailsLast updated 2 Oct 2026
Age65+ yearsPhasePhase ITrial ID2023-506620-87-00Protocol codeIMPORTANT TRIALEstimated enrolment495 patientsSponsorRegion Oerebro Laen

sourced from the EU Clinical Trials Register and site verification

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