A Phase 3 Study Comparing Standard Breast Cancer Therapy With or Without Daily Atorvastatin for Women With Early Estrogen Receptor Positive Breast Cancer

What this Trial Is About

Researchers are evaluating the addition of atorvastatin, a cholesterol-lowering drug, to standard breast cancer treatments in women with early estrogen receptor positive breast cancer. This Phase 3 trial, called the MASTER trial, is designed as a randomized, multicenter, double-blind, placebo-controlled study to see if atorvastatin can improve invasive disease-free survival. The trial involves women who are candidates for systemic cancer therapy before or after breast surgery. Participants are randomly assigned to receive either atorvastatin 80 mg daily or a placebo, alongside their usual neoadjuvant treatment, for two years. The randomization is in a 11 ratio and is blinded. Standard breast cancer treatment continues as planned regardless of study group. The study is conducted across Denmark and aims to include 3,360 women. During the trial, participants will follow their regular clinical follow-up routines and complete questionnaires about side effects or new health events for up to ten years. The primary outcome is invasive disease-free survival measured over 10 years. Researchers will also assess other outcomes such as recurrence-free intervals, overall survival, adverse events, cardiac death-free interval, and co-morbidity. Follow-up of at least six and a half years is required to evaluate differences between the groups.

The MASTER Study (MAmmary Cancer STatin ER Positive Study)