Not recruiting

Study of Abemaciclib and Tamoxifen in Women with Metastatic 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 treatments for metastatic breast cancer, which is a type of breast cancer that has spread to other parts of the body. The study involves two treatments: abemaciclib, also known by its code name LY2835219, and tamoxifen. Abemaciclib is a medication that helps to slow down the growth of cancer cells, while tamoxifen is used to block the effects of estrogen, a hormone that can promote the growth of breast cancer cells.

The purpose of the study is to evaluate the safety and effectiveness of using abemaciclib in combination with tamoxifen, or using abemaciclib alone, in women who have previously been treated for hormone receptor-positive and HER2-negative metastatic breast cancer. Hormone receptor-positive means that the cancer cells grow in response to hormones, and HER2-negative indicates that the cancer does not have high levels of the protein HER2, which can promote the growth of cancer cells.

Participants in the study will receive either the combination of abemaciclib and tamoxifen or abemaciclib alone. The study will monitor the participants over a period to assess how the cancer responds to the treatment and to observe any side effects. The goal is to determine how long the treatment can prevent the cancer from progressing and to measure the overall response to the treatment. The study aims to provide valuable information that could help improve treatment options 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.

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 metastatic breast cancer.
Previous treatments must have included at least two chemotherapy regimens, with specific conditions regarding the timing and type of prior therapies.
Step 2
Initial assessment
An initial assessment is conducted to evaluate the current health status and ensure all inclusion criteria are met.
This includes a performance status check and confirmation of adequate organ function.
Step 3
Treatment phase
The treatment involves taking abemaciclib and tamoxifen orally. Abemaciclib is administered as Verzenios 50 mg film-coated tablets.
The dosage and frequency of administration are determined by the study protocol, focusing on safety and efficacy.
Step 4
Monitoring and follow-up
Regular monitoring is conducted to assess the response to treatment and any side effects.
Progression-free survival is a primary endpoint, with evaluations continuing until disease progression or up to 21 months.
Step 5
Completion of study
The study is estimated to conclude by December 30, 2024, with final assessments conducted to evaluate the overall response and outcomes.
Participants are required to follow specific precautions to prevent pregnancy during the study and for three weeks after the last dose.

Who can join the trial?

10 criteria

Must have a diagnosis of **hormone receptor-positive (HR+)**, **human epidermal growth factor receptor 2 negative (HER2-)** breast cancer. This means the cancer grows in response to hormones but does not have a certain protein called HER2.
The cancer must have come back or gotten worse after treatment with hormone therapy.
Must have had at least 2 chemotherapy treatments, with at least 1 but no more than 2 given after the cancer spread to other parts of the body.
Must have cancer that can be measured using specific medical guidelines called **Response Evaluation Criteria in Solid Tumors (RECIST 1.1)**.
Must have a **performance status** of 0 or 1 on the **Eastern Cooperative Oncology Group (ECOG) scale**, which means being fully active or restricted in physically strenuous activity but able to carry out light work.
Must have stopped previous cancer treatments like hormone therapy, chemotherapy, or radiation for a certain period before starting the study drug and must have recovered from any immediate side effects of those treatments, except for hair loss or nerve damage.
Must have organs that are working well enough to handle the study treatment.
If able to become pregnant, must have a negative pregnancy test before starting the study and agree to use effective birth control during the study and for 3 weeks after the last dose.
Must be able to swallow pills.
Must be female.

Who cannot join the trial?

4 criteria

Patients who have not been previously treated for their **hormone receptor-positive** (**HR+**) breast cancer. **Hormone receptor-positive** means the cancer cells grow in response to hormones like estrogen or progesterone.
Patients with **human epidermal growth factor receptor 2 positive** (**HER2+**) breast cancer. **HER2** is a protein that can promote the growth of cancer cells.
Patients who are male, as the study is only for female participants.
Patients who are not considered part of a **vulnerable population**. This term refers to groups who may need special protection, such as children, pregnant women, or those with certain disabilities.

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Verified sites

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Azienda Ospedaliera Universitaria Federico II Di Napoli
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Naples, Italy

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Investigated drugs

Abemaciclib
is a medication used in this trial to treat women with hormone receptor-positive, HER2-negative, 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.
Tamoxifen
is another medication used in combination with abemaciclib in this trial. It is a type of hormone therapy that blocks estrogen receptors on breast cancer cells, which can help prevent the cancer from growing. This combination aims to enhance the effectiveness of the treatment in managing breast cancer.

What is already known about the treatment

Abemaciclib
This medication is administered orally in the form of tablets. It is currently being studied in clinical trials for its effectiveness in treating hormone receptor-positive, HER2-negative metastatic breast cancer. Abemaciclib 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 targeted cancer therapy.
Tamoxifen
This medication is also taken orally, typically as a tablet. It is well-established in medical literature as a treatment for hormone receptor-positive breast cancer. Tamoxifen functions by blocking estrogen receptors on cancer cells, preventing estrogen from promoting the growth of these cells. It is classified as a selective estrogen receptor modulator (SERM).

Investigated diseases

Metastatic Breast Cancer – This is a type of breast cancer that has spread beyond the breast to other parts of the body, such as the bones, liver, lungs, or brain. It is also known as stage IV breast cancer. The cancer cells in metastatic breast cancer are the same as the original breast cancer cells, but they have traveled to other areas. The progression of the disease can vary, with some patients experiencing rapid spread while others may have slower progression. Symptoms can include pain, fatigue, and other issues depending on where the cancer has spread. The disease is considered chronic, meaning it requires ongoing management.