Adding atorvastatin to breast cancer treatment for better outcomes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The MASTER trial investigates the effect of atorvastatin, a cholesterol-lowering medication, on the prognosis of women with early-stage estrogen receptor positive breast cancer. This phase 3, randomized, multicenter, double-blind, placebo-controlled trial will compare standard (neo)adjuvant therapy combined with atorvastatin versus standard therapy with a placebo. The primary objective is to assess the clinical efficacy of atorvastatin by measuring invasive disease-free survival among participants. A total of 3,360 women across Denmark will be enrolled in the trial, with eligibility criteria focusing on those who are candidates for systemic cancer therapy.

Why it matters

Who can join: the full rules

Patients must meet ALL of the following criteria to be eligible for randomization:

Inclusion Criteria:

1. Women with estrogen receptor positive breast cancer who are candidates for (neo)adjuvant systemic therapy OR have received ≤3 years of adjuvant endocrine therapy.
2. Age \> 18 years.
3. Performance status of ECOG ≤ 2.
4. Prior to patient registration, written informed consent must be given according to ICH/GCP, and national/local regulations.

Patients meeting ANY one of the following criteria are not eligible:

Exclusion Criteria:

1. History of any prior (ipsi- and/or contralateral) invasive breast carcinoma.
2. Ongoing (prevalent) cholesterol-lowering therapy (statins, fibrates, ezetimibe, PCSK9 inhibitors). If so, the patient can be enrolled in the observational arm.
3. Evidence of hepatic dysfunction (alanine aminotransferase level more than three times the upper limit of the normal range) or renal dysfunction (creatinine level more than three times the upper limit of the normal range).
4. Predisposing factors for rhabdomyolysis, including hypothyroidism, reduced renal function, any muscle - or liver disease, or excessive alcohol consumption AND creatine kinase (CK) measured to less than five times the upper limit (CK only measured in case of predisposing factors).
5. No current medication with potent CYP3A4-inhibitors (e.g. ketokonazole, erythromycin) or gemfibrozile, cyclosporin or danazol.
6. Pregnancy or breast-feeding.
7. Psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; these conditions will be discussed with the patient before registration in the trial.
8. History of allergic reactions attributed to compounds of similar chemical or biological composition to atorvastatin.

Where it's running

• Aarhus University Hospitak
  Aarhus, Denmark Recruiting

Study contacts

• Principal investigator: Signe SB Borgquist, MD, PhD — Aarhus University Hospital
• Study coordinator: Signe SB Borgquist, MD, PhD
• Email: signe.borgquist@auh.rm.dk
• Phone: 004522624525

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.