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Study Comparing Chemotherapy and Abemaciclib with Hormone Therapy for Patients with ER+ HER2- Metastatic Breast Cancer with Visceral Involvement

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 treatments for patients with a specific type of breast cancer known as Estrogen Receptor positive (ER+) and Human Epidermal Growth Factor Receptor-2 negative (HER2-) breast cancer. This type of cancer has spread to other parts of the body, such as the liver or lungs, which is referred to as metastatic breast cancer. The study aims to compare two different treatment approaches for this condition. One approach involves using a combination of hormone therapy with a medication called abemaciclib, which is also known by its code name LY2835219. The other approach uses standard chemotherapy treatments, which may include medications like paclitaxel or capecitabine.

The purpose of the study is to determine which treatment is more effective in delaying the progression of the cancer. Participants in the study will be randomly assigned to receive either the hormone therapy with abemaciclib or the chemotherapy. The study will monitor the participants over a period to see how long the cancer can be controlled without worsening. The study will also assess the quality of life of the participants during the treatment period using questionnaires.

Throughout the study, participants will receive regular assessments to track the progress of their treatment. These assessments will include medical tests and evaluations to ensure the safety and effectiveness of the treatments. The study will continue until the estimated end date in 2028, with the goal of providing valuable information on the best treatment options for patients with this type of breast cancer.

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

    Joining the study

    Upon joining the study, the patient will be randomly assigned to one of two treatment groups: standard chemotherapy or a combination of hormone therapy with abemaciclib.

    The patient must have signed a written informed consent form before any study-specific procedures begin.

  2. Step 2

    Treatment group assignment

    If assigned to the chemotherapy group, the patient may receive either paclitaxel or capecitabine as determined by their physician.

    If assigned to the hormone therapy group, the patient will receive a combination of hormone therapy with abemaciclib.

  3. Step 3

    Chemotherapy treatment

    For patients receiving paclitaxel, the medication is administered intravenously.

    For patients receiving capecitabine, the medication is taken orally.

  4. Step 4

    Hormone therapy treatment

    Patients in the hormone therapy group will take abemaciclib orally, in combination with other hormone therapies such as anastrozole or letrozole.

    Non-menopausal women will receive LH-RH agonists before starting the hormone therapy and every 28 days thereafter.

  5. Step 5

    Treatment duration and monitoring

    The treatment will continue until disease progression or unacceptable side effects occur.

    Progression-free survival will be monitored, and the patient's quality of life will be assessed using specific questionnaires every 6 weeks for 24 weeks.

  6. Step 6

    Follow-up and assessments

    Regular follow-up visits will be scheduled to monitor the patient's response to treatment and overall health.

    Radiological assessments will be conducted to evaluate the response to treatment.

Who can join the trial?

14 criteria

  • The patient must have signed a written informed consent form before any study-specific procedures.
  • The cancer must be **Estrogen Receptor positive (ER-positive)**, meaning the cancer cells grow in response to the hormone estrogen.
  • The cancer must be **HER2-negative**, which means the cancer does not have high levels of the protein HER2.
  • Non-menopausal women will receive **LH-RH agonists**, which are medications that help control hormone levels, before starting the hormone therapy and every 28 days after that.
  • The patient must have adequate kidney, liver, and blood functions, as defined by specific medical tests.
  • Women who can have children must agree to use highly effective birth control during treatment and for a certain period after the last dose of the study drugs.
  • The patient must be a female aged 18 years or older.
  • Women who can have children must have a negative pregnancy test before starting any study treatment.
  • The patient must be willing and able to attend scheduled visits, follow the treatment plan, and undergo laboratory tests and other trial procedures.
  • The patient must have health insurance coverage.
  • The patient must have a **performance status of ECOG 0-2**, which is a scale used to assess how a patient's disease is progressing and how the disease affects their daily living abilities.
  • The patient must have a confirmed diagnosis of **adenocarcinoma of the breast**, a type of breast cancer.
  • The patient must have **metastatic breast cancer**, meaning the cancer has spread to other parts of the body, such as the liver, lungs, or other areas, with a high tumor burden.
  • The patient must be considered a candidate for first-line chemotherapy in a metastatic setting by their physician and may receive first-line hormone therapy combined with **abemaciclib**, a cancer treatment drug.

Who cannot join the trial?

7 criteria

  • Patients who have not received treatment for their breast cancer that has spread to other parts of the body.
  • Patients with breast cancer that is positive for the Estrogen Receptor (ER+), which means the cancer grows in response to the hormone estrogen.
  • Patients with breast cancer that is negative for the Human Epidermal Growth Factor Receptor-2 (HER2-), meaning the cancer does not have high levels of the HER2 protein.
  • Patients with cancer that has spread to organs inside the body, known as visceral involvement.
  • Patients who are not within the specified age range for the study.
  • Patients who are male, as the study is only for female participants.
  • Patients who are considered part of a vulnerable population, which may include those who are unable to give informed consent or have other special considerations.
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Investigated drugs

  • Abemaciclib

    is a medication used in this trial as part of a combination therapy for breast cancer. It works by inhibiting certain proteins that are involved in the growth and division of cancer cells, helping to slow down or stop the progression of the disease.

  • Endocrine Therapy

    is a treatment that involves using medications to block or lower the amount of hormones in the body, particularly estrogen, which can fuel the growth of certain types of breast cancer. This therapy is used in combination with Abemaciclib in the trial to treat patients with breast cancer.

  • Chemotherapy

    is a standard cancer treatment that uses drugs to kill cancer cells or stop them from growing. In this trial, chemotherapy is used as a comparison to the combination of endocrine therapy and Abemaciclib to evaluate which treatment is more effective in managing breast cancer with visceral metastases.

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 metastatic breast cancer that is estrogen receptor-positive (ER+) and human epidermal growth factor receptor-2 negative (HER2-), particularly in patients with visceral metastases. The medication works by inhibiting certain proteins called cyclin-dependent kinases (CDK4 and CDK6), which are involved in cell division, thereby slowing down the growth of cancer cells. Abemaciclib is classified as a CDK4/6 inhibitor and is being compared to standard chemotherapy in ongoing research to determine its efficacy in improving progression-free survival in affected patients.

Investigated diseases

Metastatic Estrogen Receptor Positive (ER+), Human Epidermal Growth Factor Receptor-2 Negative (HER2-) Breast Cancer – This type of breast cancer is characterized by the presence of estrogen receptors on the surface of the cancer cells, which means the cancer cells may receive signals from estrogen that could promote their growth. It is also negative for the HER2 protein, which is another factor that can influence cancer growth. In its metastatic form, the cancer has spread beyond the breast to other parts of the body, often involving organs such as the liver or lungs, referred to as visceral involvement. The progression of this disease can vary, but it typically involves the growth and spread of cancer cells to distant organs, which can lead to various symptoms depending on the organs affected. The disease is often managed by targeting the hormone receptors to slow down or stop the growth of cancer cells.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-513005-31-00Protocol codeUC-0140/1901Estimated enrolment180 patientsSponsorUnicancer

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