Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not recruiting

Study Comparing Abemaciclib and Fulvestrant with Placebo and Fulvestrant for Patients with Advanced or Metastatic Breast Cancer After Previous Treatment

Verified siteRegistered drug
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

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 advanced or metastatic breast cancer. This type of cancer is characterized by the presence of hormone receptors (HR) and the absence of a protein called HER2. The study is designed to evaluate the effectiveness of a treatment combination involving two medications: abemaciclib and fulvestrant. Abemaciclib is a medication that works by inhibiting certain proteins involved in cancer cell growth, while fulvestrant is a hormone therapy that blocks the effects of estrogen on cancer cells. The trial will compare the effects of using both abemaciclib and fulvestrant together against using a placebo with fulvestrant.

The purpose of the study is to determine how well the combination of abemaciclib and fulvestrant works in treating patients who have already been treated with a type of medication called a CDK4/6 inhibitor and hormone therapy. Participants in the study will be randomly assigned to receive either the combination of abemaciclib and fulvestrant or a placebo with fulvestrant. The study will be conducted in a way that neither the participants nor the researchers know who is receiving the actual medication or the placebo, which is known as a double-blind study.

Throughout the study, participants will receive regular check-ups and monitoring to assess the progression of their cancer and any side effects from the treatment. The study aims to provide valuable information on whether the combination of abemaciclib and fulvestrant can help improve outcomes for patients with this specific type of breast cancer. The trial is expected to continue for a period of time to gather sufficient data on the treatment's effectiveness and safety.

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, such as having a diagnosis of HR+, HER2- advanced or metastatic breast cancer and evidence of disease progression.

    Participants must be able to swallow tablets and have adequate organ function.

  2. Step 2

    Treatment initiation

    The treatment involves the administration of two medications: abemaciclib and fulvestrant.

    Abemaciclib is provided in the form of 50 mg film-coated tablets and is taken orally.

    Fulvestrant is administered through an intramuscular injection.

  3. Step 3

    Treatment schedule

    The treatment is conducted in cycles, with specific dosages and frequencies determined by the study protocol.

    Participants receive fulvestrant injections on a regular schedule, while abemaciclib tablets are taken daily.

  4. Step 4

    Monitoring and assessments

    Throughout the study, regular monitoring and assessments are conducted to evaluate the response to treatment.

    Progression-Free Survival (PFS) is the primary endpoint, meaning the time during which the disease does not worsen is measured.

  5. Step 5

    Completion of the study

    The study is estimated to conclude by February 16, 2026.

    Upon completion, final assessments are conducted to determine the overall efficacy of the treatment.

Who can join the trial?

8 criteria

  • Have a diagnosis of **HR+** (hormone receptor-positive), **HER2-** (human epidermal growth factor receptor 2-negative) locally advanced or metastatic breast cancer.
  • Have radiologic evidence (imaging tests) showing that the disease has gotten worse or come back. This should be either while on treatment with a **CDK4/6 inhibitor** (a type of cancer treatment) with an **aromatase inhibitor** (AI) as the first treatment for advanced disease, or on/after treatment with a CDK4/6 inhibitor plus **endocrine therapy** (ET) given as additional treatment for early-stage breast cancer.
  • Must be considered suitable for treatment with **endocrine therapy** (ET), which is a treatment that blocks or removes hormones that fuel certain cancers.
  • If female, must be in a **postmenopausal status**, which means having gone through menopause naturally, through surgery, or by using medication to stop the ovaries from working.
  • Have **Response Evaluable Criteria in Solid Tumors (RECIST)** evaluable disease, meaning the disease can be measured or assessed through medical imaging.
  • Have a performance status of 0 or 1 on the **Eastern Cooperative Oncology Group scale**, which is a way to measure how well a person can perform daily activities. A score of 0 means fully active, and 1 means restricted in physically strenuous activity but able to do light work.
  • Have adequate **renal** (kidney), **hematologic** (blood), and **hepatic** (liver) organ function, meaning these organs are working well enough.
  • Must be able to swallow capsules or tablets.

Who cannot join the trial?

10 criteria

  • Patients who have a different type of cancer than the one being studied.
  • Patients who have not reached the required age range for the study.
  • Patients who are not able to follow the study procedures or instructions.
  • Patients who have a medical condition that could interfere with the study treatment.
  • Patients who are pregnant or breastfeeding.
  • Patients who are participating in another clinical trial at the same time.
  • Patients who have had a recent surgery or medical procedure that could affect the study.
  • Patients who have a history of allergic reactions to the study medications.
  • Patients who have a serious infection or illness that could affect their participation.
  • Patients who have a history of drug or alcohol abuse.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

  • Abemaciclib

    is a medication used in this trial to treat advanced or metastatic breast cancer. It works by blocking certain proteins called CDK4 and CDK6, which are involved in the growth and division of cancer cells. By inhibiting these proteins, abemaciclib can help slow down or stop the progression of cancer.

  • Fulvestrant

    is another medication used in this trial for treating advanced or metastatic breast cancer. It is a type of hormone therapy that works by blocking and degrading estrogen receptors on cancer cells. Since some breast cancers need estrogen to grow, fulvestrant can help slow down or stop the growth of these cancer cells.

What is already known about the treatment

  • Abemaciclib

    Abemaciclib is administered orally in the form of tablets. It is currently being studied in clinical trials for its effectiveness in treating advanced or metastatic breast cancer, particularly in patients who have progressed after previous treatments. The medication works by inhibiting certain proteins known as CDK4 and CDK6, which are involved in cell division, thereby slowing down the growth of cancer cells. It is classified as a CDK4/6 inhibitor, a type of targeted cancer therapy.

  • Fulvestrant

    Fulvestrant is administered through an injection into the muscle. It is an established treatment for hormone receptor-positive, HER2-negative advanced or metastatic breast cancer, often used when the disease progresses after other hormonal therapies. Fulvestrant works by binding to estrogen receptors and degrading them, which reduces the growth-promoting effects of estrogen on cancer cells. It is classified as an estrogen receptor antagonist.

Investigated diseases

  • Breast Neoplasm

    This is a condition where abnormal cells in the breast grow uncontrollably, forming a mass or lump known as a tumor. It can start in different parts of the breast, such as the ducts or lobules. As the disease progresses, the tumor may grow larger and can potentially spread to nearby tissues or lymph nodes. The growth rate and behavior of the tumor can vary, with some being slow-growing and others more aggressive. Over time, if not managed, it may lead to changes in the shape or size of the breast and can cause symptoms like lumps, pain, or discharge.

  • Neoplasm Metastasis

    This refers to the process by which cancer cells spread from the original tumor site to other parts of the body. It occurs when cancer cells break away from the primary tumor and travel through the bloodstream or lymphatic system. These cells can form new tumors in other organs or tissues, which are known as metastatic tumors. The progression of metastasis can vary, with some cancers spreading quickly and others more slowly. This process can lead to the involvement of multiple organs, affecting their function and potentially leading to a range of symptoms depending on the organs affected.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-506771-10-00Protocol codeI3Y-MC-JPEFEstimated enrolment347 patientsSponsorEli Lilly & Co.

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.