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Study on Abemaciclib with Endocrine Therapy for Patients with HR+/HER2- Early Breast Cancer at Intermediate to High Risk

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 investigating a treatment that combines a medication called abemaciclib with standard hormone therapy, which is commonly used after initial cancer treatment to help prevent the cancer from returning. Abemaciclib is a type of drug known as a CDK4/6 inhibitor, which works by interfering with cancer cell growth. The purpose of the study is to see if adding abemaciclib to the standard hormone therapy is more effective than using the hormone therapy alone.

Participants in the study will be randomly assigned to one of two groups. One group will receive the combination of abemaciclib and standard hormone therapy, while the other group will receive only the standard hormone therapy. The study will be conducted in an open-label manner, meaning that both the participants and the researchers will know which treatment each participant is receiving. The treatment period will last up to 24 months, during which participants will take the medication orally in the form of film-coated tablets. Throughout the study, participants will be monitored regularly to assess their health and the effectiveness of the treatment.

The main goal of the study is to determine if the combination of abemaciclib and standard hormone therapy can improve the time participants remain free from invasive breast cancer compared to those receiving only the standard hormone therapy. Additionally, the study will look at other outcomes, such as overall survival and quality of life, to provide a comprehensive understanding of the treatment's impact. Participants will be followed for several years to gather long-term data on the effectiveness and safety of the treatment.

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

    Randomization

    Upon joining the study, the patient is randomly assigned to one of two groups. One group receives abemaciclib combined with standard endocrine therapy, while the other group receives only standard endocrine therapy.

    Randomization ensures that each patient has an equal chance of being assigned to either group, which helps in comparing the effectiveness of the treatments.

  2. Step 2

    Treatment initiation

    Patients in the abemaciclib group begin taking the medication orally. The dosage and frequency are determined by the study protocol and are monitored by the healthcare team.

    Standard endocrine therapy is administered according to the current medical guidelines, which may include medications such as tamoxifen or aromatase inhibitors.

  3. Step 3

    Treatment duration

    The treatment with abemaciclib and standard endocrine therapy continues for a specified period, as outlined in the study protocol. This period is designed to assess the long-term effects of the treatment on disease-free survival.

    Regular follow-up appointments are scheduled to monitor the patient's health and response to the treatment.

  4. Step 4

    Monitoring and follow-up

    Throughout the trial, patients undergo regular health assessments, which may include physical exams, blood tests, and imaging studies to monitor for any signs of disease progression or side effects.

    Patient-reported outcomes and quality of life are also evaluated using standardized questionnaires.

  5. Step 5

    Completion of trial

    At the end of the trial period, the patient's health status is thoroughly evaluated to determine the effectiveness of the treatment.

    The data collected during the trial is analyzed to compare the outcomes between the two groups, focusing on disease-free survival and overall survival.

Who can join the trial?

17 criteria

  • Provide written informed consent before any study procedures begin.
  • No signs of cancer spreading to distant parts of the body. This should be confirmed by tests like CT scans, X-rays, ultrasounds, bone scans, or PET-CT scans.
  • Have tumor tissue available from the initial biopsy when the cancer was first diagnosed.
  • No medical reasons preventing the use of additional hormone therapy (ET).
  • Have a good general health status, as measured by the Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. This is a scale that helps doctors assess how a disease affects a patient's daily living abilities.
  • Have healthy bone marrow and organ function, shown by specific blood test results.
  • Be able to swallow the study medication tablets.
  • Be able to communicate with the study doctor and follow the study procedures.
  • Willing to receive treatment at the clinical site as required by the study plan.
  • Must be female.
  • Must be 18 years of age or older.
  • Meet specific menopausal status requirements, such as being postmenopausal or having a negative pregnancy test if premenopausal.
  • Have a confirmed diagnosis of early breast cancer that is positive for estrogen or progesterone receptors, which are proteins that can affect cancer growth.
  • Have breast cancer that is HER2-negative, meaning it does not have high levels of a protein that can promote cancer growth.
  • Be eligible if they have completed, planned, or ongoing hormone therapy without signs of cancer returning or new cancer, and if the initial diagnosis was made 6 years or less before joining the study.
  • Meet certain risk criteria for cancer returning, based on clinical or genetic factors, or have had a specific type of cancer recurrence that has been surgically treated.
  • Have completed the main treatment for breast cancer, including surgery and possibly chemotherapy and radiotherapy, according to current medical guidelines.

Who cannot join the trial?

3 criteria

  • Patients who do not have **HR+/HER2- early breast cancer** cannot participate. This type of breast cancer is hormone receptor-positive and does not have an excess of the HER2 protein.
  • Only **female** patients are eligible for this study. Male patients cannot participate.
  • Patients who are considered part of a **vulnerable population** are not eligible. This term refers to groups of people who may be at a higher risk of harm or exploitation, such as children, pregnant women, or those with certain disabilities.
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Investigated drugs

  • Abemaciclib

    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 standard endocrine therapy to see if it improves outcomes for patients with intermediate to high risk, hormone receptor-positive, HER2-negative early breast cancer.

  • Standard Endocrine Therapy

    is a common treatment for hormone receptor-positive breast cancer. It involves medications that either lower the levels of hormones in the body or block their effects on cancer cells. This therapy is used to help prevent the cancer from returning after initial treatment. In this trial, it is used alone or in combination with abemaciclib to compare the effectiveness of the treatments.

What is already known about the treatment

Abemaciclib – Abemaciclib is administered orally in tablet form and is currently being studied in clinical trials for its effectiveness in treating HR+/HER2- early breast cancer. It is being evaluated for its potential to improve invasive disease-free survival when combined with standard adjuvant endocrine therapy. Abemaciclib works by inhibiting certain 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 in pharmacology.

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 and the absence of excess HER2 protein. It typically grows in response to hormones like estrogen or progesterone. The disease often begins in the milk ducts or lobules of the breast and can spread to nearby tissues. In its early stages, it may not cause noticeable symptoms, but as it progresses, it can lead to changes in breast shape, size, or texture. The progression of this cancer can vary, with some cases remaining localized while others may spread to lymph nodes or other parts of the body. Understanding the hormone receptor status is crucial for determining the appropriate treatment approach.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-509242-35-00Protocol codeWSG-AM11Estimated enrolment1 624 patientsSponsorWSG Women's Cancer Study Group GmbH

sourced from the EU Clinical Trials Register and site verification

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