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Study of Fulvestrant and Abemaciclib for Women with Hormone Receptor Positive, HER2 Negative Advanced 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 hormone receptor positive (HR+), HER2 negative breast cancer. This type of cancer is characterized by the presence of hormone receptors and the absence of a protein called HER2. The study involves women with this specific type of breast cancer that is either locally advanced, meaning it has spread to nearby tissues, or metastatic, meaning it has spread to other parts of the body.

The treatment being studied includes two medications: fulvestrant and abemaciclib. Fulvestrant is a type of endocrine therapy that works by blocking the effects of estrogen, a hormone that can promote the growth of breast cancer cells. Abemaciclib, also known by its code name LY2835219, is a targeted therapy that inhibits certain proteins called CDK4 and CDK6, which are involved in cell division and cancer growth. The study will compare the effects of using fulvestrant alone versus using fulvestrant combined with abemaciclib. Some participants will receive a placebo instead of abemaciclib to help determine the effectiveness of the combination treatment.

The purpose of the study is to evaluate how well the combination of fulvestrant and abemaciclib works in extending the time patients live without their cancer getting worse, known as progression-free survival. Participants will receive treatment over a period of time, and their health will be monitored regularly to assess the effects of the treatment. The study aims to provide valuable information on whether the combination of these medications can offer better outcomes for women with this type of breast cancer.

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, eligibility is confirmed based on specific criteria, including a diagnosis of hormone receptor positive, HER2 negative breast cancer.

    Participants must have either locally advanced disease not suitable for surgery or metastatic disease.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to evaluate the current health status and confirm postmenopausal status, either through natural or surgical menopause or ovarian suppression.

    A negative serum pregnancy test is required within 14 days prior to randomization.

  3. Step 3

    Treatment phase

    Participants receive fulvestrant as a solution for injection and abemaciclib for oral use.

    Fulvestrant is administered as an injection, while abemaciclib is taken orally.

    The treatment aims to compare the effectiveness of fulvestrant with abemaciclib versus fulvestrant with a placebo.

  4. Step 4

    Monitoring and follow-up

    Regular monitoring is conducted to assess the progression-free survival (PFS), which is the primary endpoint of the study.

    Participants are observed for any side effects or changes in health status throughout the study duration.

  5. Step 5

    Completion of study

    The study is estimated to conclude by December 30, 2024.

    Upon completion, participants may undergo final assessments to evaluate the overall outcomes of the treatment.

Who can join the trial?

14 criteria

  • Must have a diagnosis of HR+, HER2- breast cancer. HR+ means hormone receptor-positive, and HER2- means human epidermal growth factor receptor 2-negative.
  • Must have locally advanced disease that cannot be treated with surgery or have metastatic disease, which means the cancer has spread to other parts of the body.
  • Must meet one of the following conditions regarding disease progression and previous treatments:
  • Relapsed with evidence of cancer progression while on hormone therapy before surgery or after surgery, without receiving further hormone therapy after progression.
  • Relapsed with evidence of cancer progression within one year after finishing hormone therapy after surgery, without receiving further hormone therapy after progression.
  • Relapsed with evidence of cancer progression more than one year after finishing hormone therapy after surgery and then relapsed again after receiving treatment with either an antiestrogen or an aromatase inhibitor as the first hormone therapy for metastatic disease. Must not have received more than one type of hormone therapy or any chemotherapy for metastatic disease.
  • Initially presented with metastatic disease and then relapsed with evidence of cancer progression after receiving treatment with either an antiestrogen or an aromatase inhibitor as the first hormone therapy for metastatic disease. Must not have received more than one type of hormone therapy or any chemotherapy for metastatic disease.
  • Must be postmenopausal, which means no longer having menstrual periods, due to surgery, natural menopause, or ovarian suppression (started at least 28 days before the first day of the study) with a medication like goserelin.
  • Must have a negative pregnancy test at the start of the study and agree to use medically approved methods to prevent pregnancy during the study and for 12 weeks after the last dose of the study drug if postmenopausal status is due to ovarian suppression.
  • Must have either measurable disease, which means the cancer can be measured, or nonmeasurable bone-only disease.
  • Must have a performance status of 0 or 1 on the ECOG scale, which is a way to measure how well a person can perform daily activities.
  • Must have stopped previous cancer treatments, including hormone therapies, chemotherapy, radiotherapy, and immunotherapy, for at least 21 days for treatments that affect blood cells or 14 days for those that do not, before starting the study drug. Must have recovered from any immediate side effects of previous treatments, except for hair loss or nerve damage.
  • Must be female.
  • Must be within the age range of 18 to 65 years or older.

Who cannot join the trial?

5 criteria

  • Patients who are not women cannot participate.
  • Patients who do not have **HR+** (hormone receptor-positive) and **HER2-** (human epidermal growth factor receptor 2-negative) breast cancer cannot participate.
  • Patients who do not have locally advanced or metastatic breast cancer cannot participate. **Locally advanced** means the cancer has spread to nearby tissues or lymph nodes, and **metastatic** means it has spread to other parts of the body.
  • Patients who are not within the specified age range cannot participate. The age range is typically defined by the study.
  • Patients who are considered part of a vulnerable population may not be eligible. **Vulnerable population** refers to groups who may have limited ability to give informed consent or are at higher risk of harm.
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Investigated drugs

  • Fulvestrant

    is a medication used in the treatment of hormone receptor-positive breast cancer. It works by blocking the effects of estrogen in the body, which can help slow down or stop the growth of certain types of breast cancer cells that need estrogen to grow.

  • Abemaciclib

    is a type of medication known as a CDK4/6 inhibitor. It is used in combination with other treatments for breast cancer. Abemaciclib works by interfering with the growth and division of cancer cells, which can help slow the progression of the disease. In this trial, it is being studied in combination with fulvestrant to see if it improves outcomes for women with hormone receptor-positive, HER2-negative breast cancer.

What is already known about the treatment

  • Abemaciclib

    This medication is administered orally and is used in combination with fulvestrant for treating hormone receptor-positive, HER2-negative advanced or metastatic breast cancer. It is currently being studied in clinical trials and is recognized in medical literature as a CDK4/6 inhibitor. Abemaciclib works by blocking proteins called cyclin-dependent kinases 4 and 6, which are involved in cell division, thereby slowing down the growth of cancer cells. It is classified as a targeted cancer therapy.

  • Fulvestrant

    This medication is administered via intramuscular injection and is used for treating hormone receptor-positive, HER2-negative advanced or metastatic breast cancer, often in combination with other drugs like abemaciclib. It is well-established in medical practice and literature as an estrogen receptor antagonist. Fulvestrant works by binding to estrogen receptors and degrading them, which reduces the growth of cancer cells that rely on estrogen. It is classified as a hormonal therapy for breast cancer.

Investigated diseases

Breast Cancer – Breast cancer is a disease where cells in the breast grow uncontrollably. It can begin in different parts of the breast, most commonly in the ducts or lobules. The disease may spread to nearby lymph nodes or other parts of the body. It is classified by the presence or absence of hormone receptors and the HER2 protein, which can influence its growth. Locally advanced breast cancer refers to cancer that has spread beyond the breast to nearby tissues but not to distant organs. Metastatic breast cancer indicates that the cancer has spread to other parts of the body, such as bones, liver, or lungs.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-506781-30-00Protocol codeI3Y-MC-JPBLEstimated enrolment70 patientsSponsorEli Lilly & Co.

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