NCT04601116

The MASTER Study (MAmmary Cancer STatin ER Positive Study)

Recruiting now Phase 3 Last updated 14 January 2021

What this trial tests

Phase 3 trial testing Atorvastatin 80 Mg Oral Tablet in Breast Cancer Female in 3,360 participants. Currently enrolling.

Timeline

4 January 2021

Primary endpoint
1 January 2025

1 January 2035

Quick facts

Lead sponsor	Aarhus University Hospital
Phase	Phase 3
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	3,360
Start date	4 January 2021
Primary completion	1 January 2025
Estimated completion	1 January 2035
Sites	1 location across Denmark

Drugs / interventions tested

• Atorvastatin 80 Mg Oral Tablet
• Placebo oral tablet — full drug profile →

Conditions studied

• Breast Cancer Female — all drugs for Breast Cancer Female →
• Estrogen Receptor Positive Tumor — all drugs for Estrogen Receptor Positive Tumor →

Sponsor

Aarhus University Hospital

Who can join

18 and older, female only, with Breast Cancer Female or Estrogen Receptor Positive Tumor. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Given the compelling evidence supporting a protective effect of statins on breast cancer recurrence, calls for prospective clinical trials have been expressed. In this trial - the MASTER trial - we hypothesize that the addition of statin treatment to the current breast cancer treatment will improve the prognosis of women with early breast cancer. This trial is designed as follows: 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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Lactate dehydrogenase B regulates macrophage metabolism in the tumor microenvironment.
   Frank AC, Raue R, Fuhrmann DC, Sirait-Fischer E, et al · · 2021 · cited 44× · PMID 34158867 · DOI 10.7150/thno.58380
2. Statins as anti-tumor agents: A paradigm for repurposed drugs.
   Tripathi S, Gupta E, Galande S. · · 2024 · cited 34× · PMID 38711272 · DOI 10.1002/cnr2.2078
3. Crown-Like Structures in Breast Adipose Tissue: Early Evidence and Current Issues in Breast Cancer.
   Maliniak ML, Miller-Kleinhenz J, Cronin-Fenton DP, Lash TL, et al · · 2021 · cited 30× · PMID 34066392 · DOI 10.3390/cancers13092222
4. Concomitant medication, comorbidity and survival in patients with breast cancer.
   Dumas E, Grandal Rejo B, Gougis P, Houzard S, et al · · 2024 · cited 17× · PMID 38580683 · DOI 10.1038/s41467-024-47002-3
5. Mutant p53, the Mevalonate Pathway and the Tumor Microenvironment Regulate Tumor Response to Statin Therapy.
   Pereira M, Matuszewska K, Glogova A, Petrik J. · · 2022 · cited 17× · PMID 35884561 · DOI 10.3390/cancers14143500
6. The Impact of Statin Use and Breast Cancer Recurrence - A Retrospective Study in Singapore.
   Sim Y, Lim C, Phyu N, Tan KTB, et al · · 2022 · cited 16× · PMID 35433431 · DOI 10.3389/fonc.2022.835320
7. The Present and Future of Clinical Management in Metastatic Breast Cancer.
   Lin PH, Laliotis G. · · 2022 · cited 14× · PMID 36233758 · DOI 10.3390/jcm11195891
8. Estrogen Receptor Bio-Activities Determine Clinical Endocrine Treatment Options in Estrogen Receptor-Positive Breast Cancer.
   Xia S, Lin Q. · · 2022 · cited 13× · PMID 35450488 · DOI 10.1177/15330338221090351