Not recruiting

Study on Atorvastatin for Patients with Early Breast Cancer

Verified siteRegistered drug

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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 atorvastatin in patients with breast cancer. Atorvastatin is a type of medication known as a statin, which is commonly used to lower cholesterol levels. In this study, it is being tested to see if it can help improve outcomes for patients with early-stage breast cancer. The trial involves comparing the standard treatment for breast cancer, which may include surgery, chemotherapy, or hormone therapy, with the same standard treatment plus atorvastatin. Some participants will receive atorvastatin, while others will receive a placebo, which looks like the medication but does not contain the active ingredient.

The purpose of the study is to determine if adding atorvastatin to the standard treatment can improve the time patients remain free from invasive breast cancer. This is known as invasive disease-free survival. The study will also look at other outcomes, such as overall survival and safety, to ensure that atorvastatin is safe and effective for use in this context. Participants in the study will take atorvastatin or a placebo daily for up to two years, and their health will be monitored regularly to track the progress of their breast cancer and any side effects they may experience.

This trial is designed for women with early-stage breast cancer who are receiving or have recently received standard treatments. The study aims to provide valuable information on whether atorvastatin can be a beneficial addition to the current treatment options for breast cancer, potentially leading to better outcomes for patients in the future.

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, the patient must provide written informed consent. This is a formal agreement to participate, ensuring understanding of the study's purpose and procedures.
Step 2
Randomization
The patient is randomly assigned to one of two groups: one receiving standard therapy plus a placebo, and the other receiving standard therapy plus atorvastatin.
Step 3
Medication administration
If assigned to the atorvastatin group, the patient will take 80 mg of atorvastatin daily. This medication is taken orally in the form of a film-coated tablet.
The duration of atorvastatin administration is two years.
Step 4
Monitoring and follow-up
Throughout the study, the patient's health and response to treatment are monitored. This includes regular check-ups to assess the effectiveness and safety of the treatment.
The primary focus is on invasive disease-free survival, which measures the time until the first occurrence of specific cancer-related events.
Step 5
Study completion
The study is estimated to end by January 1, 2045. At this point, the final analysis of the collected data will be conducted to evaluate the outcomes of the treatment.

Who can join the trial?

5 criteria

Must be a woman with **breast cancer** that is sensitive to a hormone called estrogen.
Should be a candidate for **(neo)adjuvant systemic therapy**, which is treatment given before or after the main treatment to help improve outcomes, or have received no more than 3 years of **adjuvant endocrine therapy**, which is hormone therapy given after the main treatment to lower the risk of cancer returning.
Must be older than 18 years.
Should have a **performance status of ECOG ≤ 2**, which means the patient is able to carry out all self-care but is unable to carry out any work activities; up and about more than 50% of waking hours.
Must provide written informed consent before joining the study, following international and local guidelines.

Who cannot join the trial?

3 criteria

Patients who are not diagnosed with breast cancer cannot participate.
Only female patients are eligible; male patients cannot participate.
Patients who are part of a vulnerable population, meaning those who might need special protection or care, are not eligible.

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Verified sites

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

Aalborg University Hospital
Verified
Aalborg, Denmark
Herlev Hospital
Verified
Herlev, Denmark
Region Midtjylland
Responsive
Aarhus, Denmark

Trial locations

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Investigated drugs

Atorvastatin is a medication used in this clinical trial to see if it can help improve the survival of patients with early breast cancer. It is being tested to find out if it can prevent the cancer from coming back when used alongside standard cancer treatments.

Atorvastatin

What is already known about the treatment

Atorvastatin – Atorvastatin is administered orally in tablet form. It is currently being studied in clinical trials for its potential benefits in treating early breast cancer, specifically in improving invasive disease-free survival when used alongside standard (neo)adjuvant therapy. The main therapeutic indication for atorvastatin is its use as a cholesterol-lowering agent, but it is being explored for its potential anti-cancer properties. At the molecular level, atorvastatin works by inhibiting the enzyme HMG-CoA reductase, which plays a crucial role in cholesterol synthesis. It is classified pharmacologically as a statin, a type of medication primarily used to lower cholesterol levels in the blood.

Investigated diseases

Breast Cancer – Breast cancer is a disease where cells in the breast grow uncontrollably, forming a tumor that can often be felt as a lump. It typically begins in the ducts or lobules of the breast and can spread to other parts of the body if not treated. The progression of breast cancer can vary, with some tumors growing slowly and others rapidly. It may remain localized to the breast or spread to nearby lymph nodes and other organs. The disease is categorized into stages based on the size of the tumor and the extent of spread. Early detection and understanding of its progression are crucial for managing the disease effectively.