Actively Recruiting
The MASTER Study (MAmmary Cancer STatin ER Positive Study)
Led by Aarhus University Hospital · Updated on 2021-01-14
3360
Participants Needed
1
Research Sites
730 weeks
Total Duration
On this page
Sponsors
A
Aarhus University Hospital
Lead Sponsor
R
Rigshospitalet, Denmark
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
The MASTER Study (MAmmary Cancer STatin ER Positive Study)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women with estrogen receptor positive breast cancer who are candidates for (neo)adjuvant systemic therapy or have received 3 years or less of adjuvant endocrine therapy
- Age over 18 years
- Performance status of ECOG 2 or less
- Provided written informed consent according to ICH/GCP and local regulations
You will not qualify if you...
- History of any prior invasive breast cancer in either breast
- Currently using cholesterol-lowering therapy such as statins, fibrates, ezetimibe, or PCSK9 inhibitors (may join observational arm)
- Evidence of liver dysfunction (alanine aminotransferase over three times normal) or kidney dysfunction (creatinine over three times normal)
- Risk factors for rhabdomyolysis including hypothyroidism, reduced kidney function, muscle or liver disease, or excessive alcohol use and creatine kinase above five times normal (measured only if risk factors present)
- Current use of strong CYP3A4 inhibitors or certain other specified medications
- Pregnancy or breastfeeding
- Psychological, family, social, or geographic issues that may affect study compliance
- History of allergic reactions to compounds similar to atorvastatin
AI-Screening
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Trial Site Locations
Total: 1 location
1
Aarhus University Hospitak
Aarhus, Denmark
Actively Recruiting
Research Team
S
Signe SB Borgquist, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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