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Statin Therapy in Early Breast Cancer : The MASTER Trial; A Randomized Phase III, Placebo-Controlled Comparison of Standard (Neo)Adjuvant Therapy Plus Atorvastatin versus Standard (Neo)Adjuvant Therapy Plus Placebo

Borgquist, Signe LU ; Jensen, Maj Britt ; Bendorff, Cecilie Linea ; Christiansen, Peer ; Offersen, Birgitte Vrou ; Kodahl, Annette Raskov ; Ewertz, Marianne ; Jensen, Anders Bonde ; Ahern, Thomas P. and Cronin-Fenton, Deirdre , et al. (2025) In Clinical Epidemiology 17. p.409-419
Abstract

Purpose: Statin use has been consistently associated with improved clinical outcomes (especially recurrence) in breast cancer in multiple observational studies backed by compelling preclinical evidence. The strength of this evidence warrants a clinical trial to test the efficacy of statin exposure on breast cancer recurrence. Patients and Methods: The double-blind, phase III, randomized, placebo-controlled MASTER (MAmmary cancer STatins in ER positive breast cancer) trial includes women diagnosed with early-stage, estrogen receptor-positive (ER+) breast cancer who are candidates for systemic (neo)adjuvant therapy. Enrolled patients are given standard (neo)adjuvant therapy and additionally randomized to either atorvastatin (80 mg/day) or... (More)

Purpose: Statin use has been consistently associated with improved clinical outcomes (especially recurrence) in breast cancer in multiple observational studies backed by compelling preclinical evidence. The strength of this evidence warrants a clinical trial to test the efficacy of statin exposure on breast cancer recurrence. Patients and Methods: The double-blind, phase III, randomized, placebo-controlled MASTER (MAmmary cancer STatins in ER positive breast cancer) trial includes women diagnosed with early-stage, estrogen receptor-positive (ER+) breast cancer who are candidates for systemic (neo)adjuvant therapy. Enrolled patients are given standard (neo)adjuvant therapy and additionally randomized to either atorvastatin (80 mg/day) or placebo for two years. The trial’s primary outcome is invasive disease-free survival (IDFS), with a target accrual of 3360 patients in total to achieve 80% power (two-sided alpha=0.05) to detect a 25% reduction in the risk of an IDFS event comparing the statin and placebo arms. At 3-, 6-, 12-, and 24-month follow-up time points, patients will have blood drawn for biomarker studies, answer patient-reported outcome (PRO) questionnaires, and control for adverse events. Subsequently, patients will receive annual PRO-criteria for Adverse Events (CTCAE) questionnaires until the completion of their 10 years of follow-up. Secondary endpoints include additional clinical endpoints; pathological response (neo-adjuvant treated patients), recurrence-free survival, distant-recurrence-free interval, overall survival and cardiac death-free interval, co-morbidity, and health-related quality-of-life measured by PRO-CTCAE questionnaires during and beyond study medication. Translational endpoints are evaluated in collected blood-and tumor samples. Discussion: If a protective effect of statins on breast cancer recurrence is supported by evidence from the MASTER trial, then the indications for a safe, well-tolerated, and inexpensive treatment can be expanded towards improved clinical outcomes for breast cancer patients.

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organization
publishing date
type
Contribution to journal
publication status
published
subject
keywords
breast cancer, cholesterol, endocrine therapy, randomized trial, recurrence, statin
in
Clinical Epidemiology
volume
17
pages
11 pages
publisher
Dove Medical Press Ltd.
external identifiers
  • scopus:105003946998
  • pmid:40260427
ISSN
1179-1349
DOI
10.2147/CLEP.S509873
language
English
LU publication?
yes
id
6cda834d-ca3e-4cf3-93f9-cd58918de81b
date added to LUP
2025-09-19 15:01:22
date last changed
2025-10-17 18:53:20
@article{6cda834d-ca3e-4cf3-93f9-cd58918de81b,
  abstract     = {{<p>Purpose: Statin use has been consistently associated with improved clinical outcomes (especially recurrence) in breast cancer in multiple observational studies backed by compelling preclinical evidence. The strength of this evidence warrants a clinical trial to test the efficacy of statin exposure on breast cancer recurrence. Patients and Methods: The double-blind, phase III, randomized, placebo-controlled MASTER (MAmmary cancer STatins in ER positive breast cancer) trial includes women diagnosed with early-stage, estrogen receptor-positive (ER+) breast cancer who are candidates for systemic (neo)adjuvant therapy. Enrolled patients are given standard (neo)adjuvant therapy and additionally randomized to either atorvastatin (80 mg/day) or placebo for two years. The trial’s primary outcome is invasive disease-free survival (IDFS), with a target accrual of 3360 patients in total to achieve 80% power (two-sided alpha=0.05) to detect a 25% reduction in the risk of an IDFS event comparing the statin and placebo arms. At 3-, 6-, 12-, and 24-month follow-up time points, patients will have blood drawn for biomarker studies, answer patient-reported outcome (PRO) questionnaires, and control for adverse events. Subsequently, patients will receive annual PRO-criteria for Adverse Events (CTCAE) questionnaires until the completion of their 10 years of follow-up. Secondary endpoints include additional clinical endpoints; pathological response (neo-adjuvant treated patients), recurrence-free survival, distant-recurrence-free interval, overall survival and cardiac death-free interval, co-morbidity, and health-related quality-of-life measured by PRO-CTCAE questionnaires during and beyond study medication. Translational endpoints are evaluated in collected blood-and tumor samples. Discussion: If a protective effect of statins on breast cancer recurrence is supported by evidence from the MASTER trial, then the indications for a safe, well-tolerated, and inexpensive treatment can be expanded towards improved clinical outcomes for breast cancer patients.</p>}},
  author       = {{Borgquist, Signe and Jensen, Maj Britt and Bendorff, Cecilie Linea and Christiansen, Peer and Offersen, Birgitte Vrou and Kodahl, Annette Raskov and Ewertz, Marianne and Jensen, Anders Bonde and Ahern, Thomas P. and Cronin-Fenton, Deirdre and Ejlertsen, Bent}},
  issn         = {{1179-1349}},
  keywords     = {{breast cancer; cholesterol; endocrine therapy; randomized trial; recurrence; statin}},
  language     = {{eng}},
  pages        = {{409--419}},
  publisher    = {{Dove Medical Press Ltd.}},
  series       = {{Clinical Epidemiology}},
  title        = {{Statin Therapy in Early Breast Cancer : The MASTER Trial; A Randomized Phase III, Placebo-Controlled Comparison of Standard (Neo)Adjuvant Therapy Plus Atorvastatin versus Standard (Neo)Adjuvant Therapy Plus Placebo}},
  url          = {{http://dx.doi.org/10.2147/CLEP.S509873}},
  doi          = {{10.2147/CLEP.S509873}},
  volume       = {{17}},
  year         = {{2025}},
}