The MASTER Study (MAmmary Cancer STatin ER Positive Study)
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18+
SponsorAarhus University Hospital
About this trial
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.
Eligibility criteria
Qualifiers
Women with estrogen receptor positive breast cancer who are candidates for (neo)adjuvant systemic therapy OR have received ≤3 years of adjuvant endocrine therapy.
Age > 18 years.
Performance status of ECOG ≤ 2.
Prior to patient registration, written informed consent must be given according to ICH/GCP, and national/local regulations.
Disqualifiers
History of any prior (ipsi- and/or contralateral) invasive breast carcinoma.
Ongoing (prevalent) cholesterol-lowering therapy (statins, fibrates, ezetimibe, PCSK9 inhibitors). If so, the patient can be enrolled in the observational arm.
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).
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).
Trial design
Treatments tested in this trial
- Atorvastatin 80 Mg Oral Tablet
- Placebo oral tablet
Treatment groups
3,360 Participants
are divided into 2 treatment groupsSponsors and collaborators
Aarhus University Hospital
Lead sponsor
Rigshospitalet, Denmark
Collaborator
Hospital of Southern Jutland
Collaborator
University of Copenhagen
Collaborator
Bornholms Hospital
Collaborator
Naestved Hospital
Collaborator
Vejle Hospital
Collaborator
Odense University Hospital
Collaborator
Nordsjaellands Hospital
Collaborator
Aalborg University Hospital
Collaborator
Herning Hospital
Collaborator
Source ClinicalTrials.gov