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Study Comparing Standard Chemotherapy with Letrozole and Abemaciclib for High/Intermediate Risk HR-Positive, HER2-Negative Breast Cancer Patients

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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 hormone receptor (HR) positive and human epidermal growth factor receptor 2 (HER2) negative breast cancer. This type of cancer is considered to be at high or intermediate risk and requires treatment before surgery, known as neoadjuvant therapy. The study aims to compare the effectiveness and safety of two different treatment approaches. One group of patients will receive standard chemotherapy, while the other group will receive a combination of two medications: letrozole and abemaciclib (also known by its code name LY2835219), which is provided in the form of Verzenios 50 mg film-coated tablets.

The purpose of the study is to evaluate how well these treatments work in reducing the amount of cancer left after treatment, known as the Residual Cancer Burden (RCB). Patients will be randomly assigned to one of the two treatment groups. The study will involve taking the assigned medication for a period of time before undergoing surgery to remove the breast cancer. Throughout the study, patients will have regular check-ups and tests to monitor their health and the effectiveness of the treatment. The study will also look at other factors, such as changes in a protein called Ki67, which is related to how quickly cancer cells are growing.

This trial is designed to help doctors understand which treatment option is more effective and safer for patients with this specific type of breast cancer. The study will continue for several years to gather enough information to make a clear comparison between the two treatment methods. Participants will be closely monitored by healthcare professionals throughout the study to ensure their safety and well-being.

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, you will be randomly assigned to one of two treatment groups. This means you will either receive the standard chemotherapy or a combination of letrozole and abemaciclib.

    You will be informed about the specific treatment you will receive and any potential side effects.

  2. Step 2

    Treatment phase

    If you are in the group receiving letrozole and abemaciclib, you will take Verzenios 50 mg film-coated tablets orally. The dosage and frequency will be explained to you by the medical team.

    The treatment will be administered as a neoadjuvant therapy, which means it is given before surgery to help shrink the tumor.

  3. Step 3

    Monitoring and assessments

    Throughout the treatment, regular monitoring will be conducted to assess your response to the therapy. This includes blood tests, imaging studies, and other necessary evaluations.

    The main goal is to evaluate the Residual Cancer Burden (RCB), which measures the amount of cancer remaining after treatment.

  4. Step 4

    Surgery preparation

    After completing the neoadjuvant therapy, you will be prepared for surgery. The type of surgery will depend on the response to the treatment and the surgeon's assessment.

    A sentinel lymph node biopsy (SLNB) may be performed to check for cancer spread to the lymph nodes.

  5. Step 5

    Post-treatment follow-up

    Following surgery, you will have follow-up visits to monitor your recovery and any long-term effects of the treatment.

    Additional tests may be conducted to ensure there is no recurrence of cancer and to evaluate your overall health.

Who can join the trial?

20 criteria

  • Provide written informed consent before any study procedures begin.
  • Be a woman aged 18 years or older.
  • Have a confirmed diagnosis of primary invasive adenocarcinoma of the breast. This is a type of breast cancer that starts in the glandular tissue.
  • Have a sample of the primary tumor available for testing before treatment.
  • Have breast cancer that is hormone receptor (HR) positive and HER2 negative. This means the cancer grows in response to hormones but does not have too much of the HER2 protein.
  • Be considered at intermediate or high risk based on a test called the Ki67 index, which measures how quickly cancer cells are growing.
  • Be in certain stages of breast cancer as defined by the TNM Classification, which describes the size and spread of the cancer.
  • If diagnosed with multiple areas of breast cancer, at least two tumor areas should be biopsied, and all must meet the HR positive and HER2 negative criteria.
  • Have an indication for neoadjuvant treatment, which is therapy given before the main treatment, usually surgery.
  • Be a candidate for surgery that aims to cure the cancer, as assessed by a surgeon.
  • If a sentinel lymph node biopsy (SLNB) was done before treatment, it must show no cancer spread (negative result).
  • Be either premenopausal or postmenopausal. Postmenopausal status is defined by certain criteria, such as age or surgical removal of ovaries.
  • Have an ECOG performance status of 0 or 1, which means being fully active or restricted in physically strenuous activity but able to carry out light work.
  • Be able to swallow oral medications.
  • Have adequate function of organs and bone marrow, as shown by specific blood test results.
  • Have a left ventricular ejection fraction (LVEF) of 50% or higher, which measures how well the heart pumps blood.
  • For premenopausal women, agree to use effective non-hormonal birth control methods during the study and for a short period after.
  • Have a negative pregnancy test before starting treatment if premenopausal or recently menopausal.
  • Agree to provide biological samples for research purposes.
  • Be willing and able to attend scheduled visits, follow the treatment plan, and undergo necessary tests and procedures.

Who cannot join the trial?

4 criteria

  • Patients who do not have **high/intermediate risk hormone receptor (HR) positive/human epidermal growth factor receptor 2 (HER2) negative breast cancer**.
  • Patients who are not indicated for **neoadjuvant therapy** (treatment given before the main treatment to shrink a tumor).
  • Patients who are not female.
  • Patients who are considered part of a vulnerable population, which may include those who are unable to give informed consent or are at higher risk of harm.
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Investigated drugs

  • Letrozole

    is a medication used in the treatment of breast cancer. It works by lowering the levels of estrogen in the body, which can help slow or stop the growth of certain types of breast cancer cells that need estrogen to grow. In this trial, letrozole is being used as part of a combination therapy to see if it can help reduce the size of the cancer before surgery.

  • Abemaciclib

    is a medication that helps treat breast cancer by blocking certain proteins in cancer cells, which can slow down or stop their growth. It is used in combination with other treatments to see if it can improve the effectiveness of the therapy in reducing the cancer before surgery.

What is already known about the treatment

  • Letrozole

    Letrozole is taken orally in the form of a tablet and is currently being studied in clinical trials for its effectiveness in treating certain types of breast cancer. It is primarily used for patients with high or intermediate risk hormone receptor-positive and HER2-negative breast cancer who need neoadjuvant therapy, which is treatment given before the main treatment. Letrozole works by blocking an enzyme called aromatase, which is involved in estrogen production, thereby reducing the growth of cancer cells that rely on estrogen. It is classified as an aromatase inhibitor, a type of hormone therapy.

  • Abemaciclib

    Abemaciclib is administered orally as a tablet and is being evaluated in clinical trials for its role in treating specific breast cancer types. It is indicated for patients with high or intermediate risk hormone receptor-positive and HER2-negative breast cancer requiring neoadjuvant therapy. Abemaciclib functions by inhibiting proteins known as cyclin-dependent kinases 4 and 6 (CDK4/6), which are crucial for cell division, thus slowing down the growth of cancer cells. It belongs to the class of drugs known as CDK4/6 inhibitors.

Investigated diseases

Hormone Receptor Positive/Human Epidermal Growth Factor Receptor 2 Negative Breast Cancer – This type of breast cancer is characterized by the presence of hormone receptors for estrogen or progesterone and the absence of excess HER2 protein. It typically grows in response to hormones and progresses at a variable rate depending on the hormonal environment. The cancer may initially be confined to the breast tissue but can spread to nearby lymph nodes and other parts of the body over time. The progression is often monitored by changes in tumor size and the presence of cancer cells in lymph nodes. The disease can be classified into different stages based on the size of the tumor and the extent of spread. The response to treatment is often evaluated by measuring the reduction in tumor size and the presence of residual cancer cells after therapy.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-514395-40-00Protocol codeGEICAM/2019-01Estimated enrolment200 patientsSponsorFundacion Grupo Espanol De Investigacion En Cancer De Mama

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