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Study on Everolimus and Exemestane for Patients with Metastatic Breast Cancer

Registered 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 the effects of a medication called everolimus in patients with metastatic breast cancer. Metastatic breast cancer is a type of breast cancer that has spread beyond the breast to other parts of the body. The study will use two forms of everolimus tablets, Verimmus and Everolimus Onkogen, which are taken orally. Another medication, exemestane, may also be used in the study. The purpose of the study is to explore how these treatments can affect the quality of life for patients with this condition.

Participants in the study will be divided into two groups, or "arms," to receive different treatment plans. The study will last for about four months, during which the quality of life of the participants will be assessed using a specific test called the FACT-B quality of life test. This test helps to measure how the treatment impacts the daily life and well-being of the participants. The study will also look at other factors, such as the response rate to the treatment, the safety and side effects of the medications, and how the body processes the medication over time.

The trial aims to determine if there is a significant improvement in the quality of life for patients taking everolimus, and whether it is possible to safely increase the dose for some patients. The study will also monitor the occurrence and severity of any side effects experienced by participants. By the end of the study, researchers hope to gather valuable information that could help improve treatment options for people with metastatic breast cancer.

The research process

The trial runs in 8 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, you will be informed about the trial's purpose, which is to evaluate the change in quality of life for patients with metastatic breast cancer using the FACT-B quality of life test.
Step 2
Medication administration
You will be assigned to one of two study groups. Each group will receive different dosages of the medication everolimus, which is taken orally in tablet form.
The dosages may include Verimmus 5 mg or 10 mg tablets, or Everolimus Onkogen 5 mg or 10 mg tablets. The exact dosage and frequency will be determined by the study protocol.
Additionally, you may receive exemestane, also taken orally in tablet form.
Step 3
Treatment duration
The treatment will last for a period of four months. During this time, your quality of life will be assessed regularly using the FACT-B quality of life test.
Step 4
Quality of life assessment
Throughout the study, your quality of life will be evaluated using various tools, including the EORTC C30 and EORTC BR23 questionnaires, which assess global health, physical functionality, fatigue, and side effects of systemic treatment.
Step 5
Response evaluation
Your clinical response to the treatment will be monitored. This includes assessing whether there is a complete or partial remission of the cancer, as defined by specific criteria.
Step 6
Safety monitoring
The occurrence and severity of any side effects will be closely monitored throughout the study. This is to ensure your safety and to evaluate the treatment's safety profile.
Step 7
Dose adjustment
Based on your response and tolerance to the medication, there may be an opportunity to adjust the dose. This will be determined by specific pharmacological parameters.
Step 8
End of study
At the end of the four-month treatment period, a final assessment of your quality of life and clinical response will be conducted. The study aims to determine if there is a significant improvement in quality of life and treatment response.

Who can join the trial?

13 criteria

Patient must be over 18 years of age.
Must have a breast tumor that is estrogen receptor positive (tumor grows in response to estrogen) and HER2 receptor negative (tumor does not have excess HER2 protein).
Must have cancer that cannot be removed by surgery (irresectable) or has spread to other parts of the body (metastatic).
Must have a satisfactory overall health status, measured by a scale called ECOG (Eastern Cooperative Oncology Group) with a score of 0-1, where 0 means fully active and 1 means restricted in physically strenuous activity but able to carry out light work.
Must have adequate organ function, which includes:
- Neutrophil count (a type of white blood cell) of at least 1.5 G/l.
- Platelet count (cells that help with blood clotting) of at least 100 G/l.
- Hemoglobin (protein in red blood cells) of at least 10 g/dl.
- GOT/GPT (liver enzymes) less than 2.5 times the upper limit of normal, or 5 times if there is liver metastasis.
- Bilirubin (a substance made during the breakdown of red blood cells) less than 1.5 times the upper limit of normal, except in Gilbert's disease where it should be less than 3 times.
- Creatinine (a waste product from muscle metabolism) less than 1.5 times the upper limit of normal or an eGFR (a test of kidney function) higher than 60 ml/min.
- Must have had at least one previous treatment with hormone-based therapy that included a CDK4/6 inhibitor (a type of drug that blocks certain proteins to stop cancer cells from growing).
- Previous treatment with chemotherapy for symptom relief (palliative chemotherapy) is allowed.
- Must be a postmenopausal female, or if premenopausal female or male, must use a GNRH analogue (a drug that affects hormone levels).

Who cannot join the trial?

4 criteria

Patients with **metastatic breast cancer** cannot participate. This means the cancer has spread to other parts of the body.
Only patients within certain age ranges can participate. If you are not in the specified age range, you cannot join.
Both **female** and **male** patients are considered for the study, but specific criteria may apply.
Patients who are part of a **vulnerable population** are not eligible. This refers to groups who may need special protection or care.

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Investigated drugs

Everolimus is a medication used in this clinical trial to treat metastatic breast cancer. It works by slowing down the growth of cancer cells. Everolimus is a type of targeted therapy, which means it specifically targets certain pathways that cancer cells use to grow and spread. By blocking these pathways, everolimus can help control the progression of the disease and improve the quality of life for patients.

What is already known about the treatment

Everolimus – Everolimus is administered orally in the form of tablets. It is currently being studied in clinical trials for its effectiveness in treating metastatic breast cancer, a type of cancer that has spread beyond the breast to other parts of the body. The main therapeutic use of everolimus in this context is to improve the quality of life for patients, as measured by a specific quality of life test. At the molecular level, everolimus works by inhibiting a protein called mTOR, which plays a role in cell growth and survival, thereby potentially slowing down the growth of cancer cells. It is classified as an mTOR inhibitor in pharmacology.

Investigated diseases

Metastatic Breast Cancer – Metastatic breast cancer is a stage of breast cancer where the cancer cells have spread beyond the breast to other parts of the body, such as the bones, liver, lungs, or brain. This spread occurs when cancer cells break away from the original tumor and travel through the bloodstream or lymphatic system. The progression of metastatic breast cancer can vary, with some patients experiencing rapid spread while others may have a slower progression. Symptoms depend on the location of the metastasis and can include bone pain, difficulty breathing, or neurological symptoms. The disease is considered chronic, and its progression is monitored through regular medical evaluations. Management focuses on controlling the spread and alleviating symptoms to maintain quality of life.