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OncoMatch/Clinical Trials/NCT04601116

The MASTER Study (MAmmary Cancer STatin ER Positive Study)

Is NCT04601116 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies Atorvastatin 80 Mg Oral Tablet for breast cancer female.

Phase 3RecruitingAarhus University HospitalNCT04601116Data as of May 2026

Treatment: Atorvastatin 80 Mg Oral TabletGiven 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.

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Extracted eligibility criteria

Cancer type

Breast Carcinoma

Biomarker criteria

Required: ESR1 positive

estrogen receptor positive breast cancer

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

Cannot have received: cholesterol-lowering therapy (statins, fibrates, ezetimibe, PCSK9 inhibitors)

Exception: If so, the patient can be enrolled in the observational arm.

Ongoing (prevalent) cholesterol-lowering therapy (statins, fibrates, ezetimibe, PCSK9 inhibitors). If so, the patient can be enrolled in the observational arm.

Lab requirements

Kidney function

creatinine level more than three times the upper limit of the normal range [excluded]

Liver function

alanine aminotransferase level more than three times the upper limit of the normal range [excluded]

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)

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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