RecruitingPhase 3NCT04601116

The MASTER Study (MAmmary Cancer STatin ER Positive Study)

A Randomized, Multicenter, Double-blind, Placebo-controlled Comparison of Standard (Neo)Adjuvant Therapy Plus Placebo Versus Standard (Neo)Adjuvant Therapy Plus Atorvastatin in Patients With Early Breast Cancer

Sponsor

Aarhus University Hospital

Enrollment

3,360 participants

Start Date

Jan 4, 2021

Study Type

INTERVENTIONAL

Conditions

Breast Cancer Female Estrogen Receptor Positive Tumor

Summary

Given the compelling evidence supporting a protective effect of statins on breast cancer recurrence, calls for prospective clinical trials have been expressed. In this trial - the MASTER trial - we hypothesize that the addition of statin treatment to the current breast cancer treatment will improve the prognosis of women with early breast cancer. This trial is designed as follows: a randomized, multicenter, double-blind, placebo-controlled comparison of standard (neo)adjuvant therapy plus placebo versus standard (neo)adjuvant therapy plus atorvastatin in patients with early breast cancer.

Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial studies whether adding a statin (cholesterol-lowering drug) to standard hormone therapy improves outcomes for women with estrogen receptor-positive breast cancer. You may be eligible if... - You are a woman over 18 with estrogen receptor-positive breast cancer - You are a candidate for hormone therapy or have been on it for 3 years or less - You have a performance status of ECOG 2 or better You may NOT be eligible if... - You have a history of prior invasive breast cancer in either breast - You are already taking cholesterol-lowering medications (statins, fibrates, ezetimibe, or PCSK9 inhibitors) - You have significant liver or kidney problems - You are pregnant or breastfeeding - You have risk factors for serious muscle breakdown (rhabdomyolysis) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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