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Recruiting Phase 3

The MASTER Study (MAmmary Cancer STatin ER Positive Study)

NCT04601116 · tracked via the Priya Life Science Denmark tracker
Phase
Phase 3
Started
2021-01-04
Last updated
2021-01-14

Condition(s) studied

Breast Cancer FemaleEstrogen Receptor Positive Tumor

Investigational drug(s) / intervention(s)

Atorvastatin 80 Mg Oral Tablet →Placebo oral tablet

Atorvastatin 80 Mg Oral Tablet: Atorvastatin 80 mg per day for 2 years

Placebo oral tablet: Placebo 1 tablet per day for 2 years

Study summary

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

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
Patients must meet ALL of the following criteria to be eligible for randomization: Inclusion Criteria: 1. Women with estrogen receptor positive breast cancer who are candidates for (neo)adjuvant systemic therapy OR have received ≤3 years of adjuvant endocrine therapy. 2. Age \> 18 years. 3. Performance status of ECOG ≤ 2. 4. Prior to patient registration, written informed consent must be given according to ICH/GCP, and national/local regulations. Patients meeting ANY one of the following criteria are not eligible: Exclusion Criteria: 1. History of any prior (ipsi- and/or contralateral) invasive breast carcinoma. 2. Ongoing (prevalent) cholesterol-lowering therapy (statins, fibrates, ezetimibe, PCSK9 inhibitors). If so, the patient can be enrolled in the observational arm. 3. 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). 4. 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). 5. No current medication with potent CYP3A4-inhibitors (e.g. ketokonazole, erythromycin) or gemfibrozile, cyclosporin or danazol. 6. Pregnancy or breast-feeding. 7. Psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; these conditions will be discussed with the patient before registration in the trial. 8. History of allergic reactions attributed to compounds of similar chemical or biological composition to atorvastatin.

Primary outcome measure(s)

  • Invasive disease-free survival — 10 years
    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.

Trial sites (1)

FacilityCityRegionStatus
Aarhus University Hospitak Aarhus Denmark Recruiting

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04601116 on ClinicalTrials.gov ↗ ← All trials in Denmark