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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Atorvastatin 80 Mg Oral Tablet
DrugAtorvastatin 80 mg per day for 2 years
Placebo oral tablet
DrugPlacebo 1 tablet per day for 2 years
Treatment groups
3,360 Participants
are divided into 2 treatment groupsGroup A: Atorvastatin 80 Mg Oral TabletActive comparator 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Invasive disease-free survival
Invasive disease-free survival (IDFS), defined as the time from randomization until the date of the first occurrence of one of the following events: * Ipsilateral invasive breast tumor recurrence: invasive breast cancer involving the same breast parenchyma as the original primary. * Regional invasive breast cancer recurrence: Invasive breast cancer in the axilla, regional lymph nodes, chest wall, and skin of the ipsilateral breast. * Distant recurrence: Metastatic disease-breast cancer that has either been biopsy confirmed or clinically diagnosed as recurrent invasive breast cancer. * Death attributable to any cause, including breast cancer, non-breast cancer, or unknown cause. * Contralateral invasive breast cancer. * Second primary non-breast invasive cancer.
Time frame
10 yearsSecondary outcomes
1
Distant-recurrence free interval
Distant-recurrence free interval defined as time from inclusion to first distant recurrence including associations with first site of recurrence.
Time frame
10 years2
Recurrence-free interval
Recurrence-free interval including associations with first site of recurrence
Time frame
10 years3
Overall survival.
Overall survival.
Time frame
10 years4
Incidence of Treatment-Emergent Adverse Events as assessed by CTC-AE, 5.0
Incidence of Treatment-Emergent Adverse Events as assessed by CTC-AE, 5.0
Time frame
10 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
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