Actively Recruiting
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
Led by Aarhus University Hospital · Updated on 2021-01-14
3360
Participants Needed
1
Research Sites
521 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
Researchers are evaluating the addition of atorvastatin, a cholesterol-lowering drug, to standard breast cancer treatments in women with early estrogen receptor positive breast cancer. This Phase 3 trial, called the MASTER trial, is designed as a randomized, multicenter, double-blind, placebo-controlled study to see if atorvastatin can improve invasive disease-free survival. The trial involves women who are candidates for systemic cancer therapy before or after breast surgery. Participants are randomly assigned to receive either atorvastatin 80 mg daily or a placebo, alongside their usual (neo)adjuvant treatment, for two years. The randomization is in a 1:1 ratio and is blinded. Standard breast cancer treatment continues as planned regardless of study group. The study is conducted across Denmark and aims to include 3,360 women. During the trial, participants will follow their regular clinical follow-up routines and complete questionnaires about side effects or new health events for up to ten years. The primary outcome is invasive disease-free survival measured over 10 years. Researchers will also assess other outcomes such as recurrence-free intervals, overall survival, adverse events, cardiac death-free interval, and co-morbidity. Follow-up of at least six and a half years is required to evaluate differences between the groups.
CONDITIONS
Brief 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 greater than 18 years
- Performance status of ECOG 2 or less
- Written informed consent provided according to regulations
You will not qualify if you...
- History of any prior invasive breast carcinoma in either breast
- Current use of cholesterol-lowering therapy such as statins, fibrates, ezetimibe, or PCSK9 inhibitors
- Evidence of liver dysfunction (alanine aminotransferase more than three times normal) or kidney dysfunction (creatinine more than three times normal)
- Predisposing factors for rhabdomyolysis including hypothyroidism, muscle or liver disease, or excessive alcohol use, with creatine kinase levels considered
- Use of medications that strongly interact with atorvastatin such as ketoconazole, erythromycin, gemfibrozil, cyclosporin, or danazol
- Pregnancy or breastfeeding
- Psychological, family, social, or geographic conditions that may prevent following the study protocol
- History of allergic reactions to drugs similar to atorvastatin
AI-Screening
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Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
screening and enrollment visit
Duration - 2 years
Participants receive standard (neo)adjuvant therapy plus either atorvastatin 80 mg daily or a placebo for 2 years unless side effects require stopping the study drug earlier.
Visits occur as part of standard cancer treatment routines; additional questionnaires are completed periodically to report side effects or new events.
Duration - Up to 10 years
After treatment, participants are followed for up to 10 years to monitor breast cancer recurrence, survival, and long-term side effects through clinical assessments and questionnaires.
Periodic follow-up visits and questionnaires up to 10 years
Trial Site Locations
Total: 1 location
1
Aarhus University Hospitak
Aarhus, Denmark
Actively Recruiting
Research Team
S
Signe SB Borgquist, MD, PhD
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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