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Study of Abemaciclib and Giredestrant for Patients with Early Stage ER-Positive, HER2-Negative Breast Cancer

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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 ER-positive, HER2-negative early breast cancer. The study will explore the effects of two medications, abemaciclib and giredestrant, which are being tested for their ability to stop cancer cells from growing before surgery. Abemaciclib is a type of medicine called a kinase inhibitor, which helps to block certain proteins that cancer cells need to grow. Giredestrant is an ER antagonist, which means it works against the estrogen receptor, a protein that can help some breast cancers grow.

The purpose of the study is to evaluate how effective and safe these medications are when used together. Participants will take these medications orally, in the form of tablets and capsules, over a period of several weeks. The study will monitor how well the medications work in stopping the cancer cells from growing, as well as any side effects that may occur. The trial will also involve regular check-ups and tests, including imaging tests like MRI, to assess the response of the cancer to the treatment.

Throughout the study, researchers will collect information on how the medications affect the cancer and the body, including changes in specific markers like Ki67, which is a protein associated with cell growth. The study aims to provide valuable insights into the potential benefits of using abemaciclib and giredestrant together for treating this type of breast cancer before surgery.

The research process

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

  1. Step 1

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history and a physical examination.

    Blood tests and imaging studies, such as an ultrasound, are performed to evaluate the breast cancer status.

  2. Step 2

    Medication administration

    The treatment involves taking two medications: abemaciclib and giredestrant. Both are administered orally in the form of hard capsules.

    The dosage and frequency of these medications are determined by the study protocol and are monitored by the healthcare team.

  3. Step 3

    Treatment period

    The treatment period lasts until the surgery. During this time, regular monitoring is conducted to assess the response to the medications.

    Patients are required to attend scheduled visits for blood tests, imaging studies, and other assessments to track progress and ensure safety.

  4. Step 4

    Week 2 assessment

    At Week 2, a key assessment is performed to evaluate the effect of the medications on the cancer cells. This involves a biopsy to measure the Ki67 score, which indicates cell growth activity.

    The goal is to achieve a complete cell cycle arrest, which is a significant reduction in cancer cell activity.

  5. Step 5

    Pre-surgery evaluation

    Before surgery, a comprehensive evaluation is conducted to determine the effectiveness of the treatment. This includes clinical and radiologic assessments, such as MRI scans.

    The results help in planning the surgical procedure and any additional treatments that may be necessary.

  6. Step 6

    Surgery

    Surgery is performed to remove the breast cancer. The type of surgery depends on the size and location of the tumor, as well as the response to the medications.

    Post-surgery, further assessments are conducted to evaluate the success of the treatment and to plan any additional care.

Who can join the trial?

14 criteria

  • Female patients who are willing and able to provide written consent to participate.
  • A Ki67 score of 10% or higher, which is a measure of how fast cancer cells are growing. This score will be checked both locally and centrally.
  • Patients with breast cancer who are eligible for primary surgery.
  • An ECOG performance status of 0 or 1, which means the patient is fully active or has some symptoms but can still carry out light work.
  • Patients must have adequate bone marrow, blood clotting, and organ function, as determined by specific blood tests.
  • Patients must be able to swallow pills.
  • Women who are 18 years of age or older.
  • Postmenopausal women, which means they have not had a menstrual period for at least 12 months or have had both ovaries removed.
  • Patients with a breast tumor that is at least 1.0 cm in size, as measured by ultrasound.
  • The breast cancer must be ER-positive, meaning the cancer cells grow in response to the hormone estrogen, confirmed by local testing.
  • The breast cancer must be HER2-negative, meaning the cancer does not have high levels of the HER2 protein, confirmed by local testing.
  • Patients with multiple breast tumors are eligible if at least one tumor is 1.0 cm or larger and meets the criteria for ER positivity and HER2 negativity.
  • No previous treatment for the breast cancer, such as chemotherapy, hormone therapy, surgery, or radiotherapy.
  • Patients must be considered suitable for hormone therapy by their doctor.

Who cannot join the trial?

3 criteria

  • Participants must not have any other type of breast cancer besides ER-positive, HER2-negative early breast cancer. This means the cancer must have specific characteristics related to certain proteins.
  • Participants must not be male, as the study is only for females.
  • Participants must not be part of a vulnerable population, which means they should not be in a group that needs special protection or care.
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Investigated drugs

  • Abemaciclib

    is a medication used in this trial to help stop the growth of cancer cells. It works by blocking certain proteins that are involved in cell division, which may slow down or stop the progression of breast cancer. This medication is being tested to see how effective it is when given before surgery to patients with early-stage, estrogen receptor-positive, HER2-negative breast cancer.

  • Giredestrant

    is another medication being tested in this trial. It is designed to target and block the activity of estrogen receptors on cancer cells. By doing so, it may help to prevent the cancer cells from growing and dividing. This medication is also being evaluated for its effectiveness and safety when used before surgery in patients with early-stage, estrogen receptor-positive, HER2-negative breast cancer.

What is already known about the treatment

  • Abemaciclib

    Abemaciclib is administered orally in tablet form. It is currently being studied in clinical trials for its effectiveness in treating early-stage, estrogen receptor-positive, HER2-negative breast cancer. The medication 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.

  • Giredestrant

    Giredestrant is taken orally as a tablet. It is under investigation in clinical trials for its potential to treat early-stage, estrogen receptor-positive, HER2-negative breast cancer. The drug functions by blocking estrogen receptors, which are proteins that can promote the growth of breast cancer cells, thus helping to slow or stop the progression of the disease. It belongs to the class of selective estrogen receptor degraders (SERDs).

Investigated diseases

ER-positive, HER2-negative Early Breast Cancer – This type of breast cancer is characterized by the presence of estrogen receptors (ER-positive) and the absence of human epidermal growth factor receptor 2 (HER2-negative) on the cancer cells. It typically grows in response to the hormone estrogen. This form of breast cancer is considered early stage when it 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 often involves the growth and multiplication of cancer cells within the breast tissue. Over time, if untreated, it may spread to other areas, but in its early stages, it is often localized.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-510153-42-00Protocol codeGIM31-Neo-AGILEEstimated enrolment51 patientsSponsorFondazione Oncotech Impresa Sociale

sourced from the EU Clinical Trials Register and site verification

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