Adding atorvastatin to breast cancer treatment for better outcomes

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

This study is testing if adding atorvastatin, a cholesterol-lowering drug, to standard breast cancer treatment can help women with early-stage estrogen receptor positive breast cancer live longer without the disease coming back.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 3360 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: Aarhus University Hospital (Academic / other)
• Locations: 1 site (Aarhus)
• Trial ID: NCT04601116 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are women over 18 years old with estrogen receptor positive breast cancer who are eligible for (neo)adjuvant systemic therapy.

Not a fit: Patients with a history of invasive breast carcinoma or those currently on cholesterol-lowering therapies may not benefit from this study.

Why it matters

Potential benefit: If successful, this trial could improve disease-free survival rates for women with early breast cancer.

How similar studies have performed: Previous studies have shown promising results regarding the protective effects of statins on breast cancer outcomes, supporting the rationale for this trial.

Eligibility criteria

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 this trial is running

Aarhus

• 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

Conditions Breast Cancer Female; Estrogen Receptor Positive Tumor; Breast Cancer; Atorvastatin; Estrogen Receptor Positiv Tumor; Adjuvant therapy; Neoadjuvant; Statin