| 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 |
| Authors: |
Borgquist, Signe; Jensen, Maj Britt; Bendorff, Cecilie Linea; Christiansen, Peer; Offersen, Birgitte Vrou; Kodahl, Annette Raskov; Ewertz, Marianne; Jensen, Anders Bonde; Ahern, Thomas P.; Cronin-Fenton, Deirdre; Ejlertsen, Bent |
| Source: |
Borgquist, S, Jensen, M B, Bendorff, C L, Christiansen, P, Offersen, B V, Kodahl, A R, Ewertz, M, Jensen, A B, Ahern, T P, Cronin-Fenton, D & Ejlertsen, B 2025, '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', Clinical epidemiology, vol. 17, pp. 409-419. https://doi.org/10.2147/CLEP.S509873 |
| Publication Year: |
2025 |
| Collection: |
Aarhus University: Research |
| Subject Terms: |
breast cancer; cholesterol; endocrine therapy; randomized trial; recurrence; statin |
| Description: |
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 ... |
| Document Type: |
article in journal/newspaper |
| Language: |
English |
| ISSN: |
1179-1349 |
| Relation: |
info:eu-repo/semantics/altIdentifier/pmid/40260427; info:eu-repo/semantics/altIdentifier/pissn/1179-1349; info:eu-repo/semantics/altIdentifier/eissn/1179-1349 |
| DOI: |
10.2147/CLEP.S509873 |
| Availability: |
https://pure.au.dk/portal/en/publications/c62f0cde-3581-4643-a533-33f698731f20; https://doi.org/10.2147/CLEP.S509873; https://www.scopus.com/pages/publications/105003946998 |
| Rights: |
info:eu-repo/semantics/openAccess ; http://creativecommons.org/licenses/by-nc/4.0/ |
| Accession Number: |
edsbas.AFE73FB2 |
| Database: |
BASE |