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Study on Abemaciclib and Endocrine Therapy for Patients with Advanced Hormone Receptor 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 the treatment of hormone receptor-positive HER2-negative breast cancer that is either locally advanced or has spread to other parts of the body, known as metastatic breast cancer. The study will use a combination of medications, including Abemaciclib (also known by its code name LY2835219), which is taken orally as a film-coated tablet, and various types of endocrine therapy. Endocrine therapy involves medications that block or lower the amount of hormones in the body to slow down or stop the growth of cancer. The specific endocrine therapies being studied include Exemestane, Anastrozole, Letrozole, and Fulvestrant. These medications are used to manage the cancer by targeting the hormones that help the cancer grow.

The purpose of this study is to evaluate how well the combination of Abemaciclib and endocrine therapy works in managing the cancer and to focus on managing side effects using digital tools. Participants will be divided into two groups based on their previous treatment history. The study will monitor the time it takes for the cancer to progress or for the patient to pass away, which is known as progression-free survival. This will help researchers understand the effectiveness of the treatment. The study will also look at overall survival, which is the length of time patients live after starting the treatment, and the objective response rate, which measures how much the cancer shrinks or disappears after treatment.

Participants in the study will take the medications for a period of up to 36 months. The study will involve regular check-ups and assessments to monitor the cancer's response to the treatment and any side effects experienced. The use of a digital health application is encouraged to help report side effects and other outcomes during the study. This trial aims to provide valuable information on the effectiveness and safety of combining Abemaciclib with endocrine therapy in treating hormone receptor-positive HER2-negative breast cancer.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the trial
Upon joining the trial, the patient will be registered and provided with detailed information about the study. This includes understanding the trial's purpose, procedures, and potential risks and benefits.
The patient must provide written informed consent before any trial-specific procedures begin.
Step 2
Initial assessment
An initial assessment will be conducted to confirm eligibility. This includes verifying the diagnosis of hormone receptor positive, HER2 negative breast cancer, and ensuring the patient meets all inclusion criteria.
The patient must have adequate bone marrow and organ function, and be able to swallow oral medications.
Step 3
Treatment initiation
The treatment involves a combination of abemaciclib and endocrine therapy. Abemaciclib is administered as 150 mg film-coated tablets taken orally.
Endocrine therapy may include medications such as exemestane, anastrozole, fulvestrant, or letrozole, depending on the specific treatment plan.
Step 4
Medication schedule
Abemaciclib is taken twice daily, with or without food, as directed by the healthcare provider.
Endocrine therapy medications are taken according to the prescribed schedule, which may vary based on the specific drug and patient needs.
Step 5
Monitoring and assessments
Regular monitoring and assessments will be conducted to evaluate the patient's response to treatment and manage any side effects.
The use of a digital health application, such as CANKADO, is recommended for reporting side effects and patient-reported outcomes, although it is not mandatory.
Step 6
Progression-free survival evaluation
The primary goal is to measure progression-free survival, which is the time from trial registration until disease progression or death from any cause.
Regular radiographic assessments will be performed to monitor disease status.
Step 7
Completion of trial participation
The trial is estimated to end by May 31, 2029. Participation may conclude earlier if the patient experiences disease progression or other specified conditions.
Upon completion, the patient will receive a final assessment and any necessary follow-up care.

Who can join the trial?

19 criteria

Must have given written informed consent before any trial-specific procedures.
If cancer has spread to the brain (known as CNS metastases), it must be stable. This means any radiation treatment must have been completed more than 14 days ago, and no steroid medication over 4 mg of Dexamethasone per day is needed.
Both premenopausal and postmenopausal patients can participate. Postmenopausal means no menstrual periods for 12 months without another medical reason.
Women who can have children must use highly effective birth control methods during the trial and for at least 3 weeks after the last dose of trial drugs. If taking fulvestrant, birth control must continue for two years after the last dose.
No previous treatment for cancer that has spread (metastatic disease), except for up to 3 months of first-line hormone therapy if there was no disease progression before joining the study.
Previous hormone therapy and chemotherapy given after surgery (adjuvant) or before surgery (neoadjuvant) are allowed.
If chemotherapy was received, the patient must have recovered from its immediate effects, except for hair loss or mild nerve damage. A break of at least 21 days is needed between the last chemotherapy dose and joining the trial.
If radiation therapy was received, it must be completed, and the patient must have recovered from its immediate effects. A break of at least 14 days is needed between the end of radiation therapy and joining the trial.
Must have either measurable disease or non-measurable bone-only disease, as defined by specific medical guidelines (RECIST v1.1).
Must have adequate bone marrow and organ function, as shown by tests done within 14 days before joining the trial.
Must be able to swallow oral medications.
Should be willing to use a digital health application called CANKADO to report side effects and outcomes, although it is not mandatory.
Must be reliable, willing to be available for the trial's duration, and willing to follow trial procedures.
Women who can have children must have a negative pregnancy test before joining the trial and use highly effective birth control if there is a risk of becoming pregnant.
Must be female and at least 18 years old.
Must have a diagnosis of hormone receptor-positive (HR+) and HER2-negative (HER2-) breast cancer.
Must have locally advanced disease that cannot be removed by surgery or treated with radiation to cure, or have metastatic disease.
Must need hormone-based therapy for cancer that has spread.
Must have a performance status of 2 or less on the ECOG scale, which measures the ability to perform daily activities.

Who cannot join the trial?

5 criteria

Patients who do not have **hormone receptor positive HER2 negative** breast cancer. This means the cancer does not respond to hormones and does not have a protein called HER2.
Patients who have not been diagnosed with **locally advanced or metastatic** breast cancer. This means the cancer has not spread beyond the breast or nearby areas.
Patients who are male, as the study is only for female patients.
Patients who are not in the specified age range for the study.
Patients who are part of a vulnerable population that the study does not include.

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Verified sites

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

Verified
Gynaekologisches Zentrum Bonn
Bonn, Germany
Verified
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH
Ulm, Germany
Verified
Klinikum Nuernberg
Nürnberg, Germany

Trial locations

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Investigated drugs

Abemaciclib
is a medication used in this trial to treat patients with hormone receptor-positive, HER2-negative advanced or metastatic 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 another treatment used in this trial for patients with hormone receptor-positive breast cancer. This therapy involves medications that either lower the levels of hormones in the body or block their effects on cancer cells, which can help to slow or stop the growth of the cancer.

What is already known about the treatment

Abemaciclib – Abemaciclib is administered orally in tablet form and is currently being studied in clinical trials for its effectiveness in treating hormone receptor-positive, HER2-negative locally advanced or metastatic breast cancer. It is a well-documented medication in medical literature, primarily used in combination with endocrine therapy. The main therapeutic indication for Abemaciclib is to inhibit cancer cell growth in specific types of breast cancer. At the molecular level, it works by inhibiting cyclin-dependent kinases 4 and 6, which are proteins that help control cell division. Abemaciclib is classified as a targeted cancer therapy, specifically a CDK4/6 inhibitor.

Investigated diseases

Hormone Receptor Positive HER2 Negative Breast Cancer – This type of breast cancer is characterized by the presence of hormone receptors, meaning the cancer cells grow in response to hormones like estrogen or progesterone, but lack excess HER2 protein. It can be locally advanced, where the cancer has spread beyond the breast to nearby tissues, or metastatic, where it has spread to distant parts of the body. The progression of this cancer can vary; it may grow slowly and respond well to hormone therapies initially. However, over time, the cancer may become resistant to these treatments, leading to further progression. The disease is often monitored through imaging and clinical assessments to track changes in tumor size and spread.