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The MASTER Study (MAmmary Cancer STatin ER Positive Study)

NCT04601116 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 3360

Last updated 2021-01-14

No results posted yet for this 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.

Conditions

  • Breast Cancer Female
  • Estrogen Receptor Positive Tumor

Interventions

DRUG

Atorvastatin 80 Mg Oral Tablet

Atorvastatin 80 mg per day for 2 years

DRUG

Placebo oral tablet

Placebo 1 tablet per day for 2 years

Sponsors & Collaborators

  • Rigshospitalet, Denmark

    collaborator OTHER

  • Hospital of Southern Jutland

    collaborator OTHER

  • University of Copenhagen

    collaborator OTHER

  • Bornholms Hospital

    collaborator UNKNOWN

  • Naestved Hospital

    collaborator OTHER

  • Vejle Hospital

    collaborator OTHER

  • Odense University Hospital

    collaborator OTHER

  • Nordsjaellands Hospital

    collaborator OTHER

  • Aalborg University Hospital

    collaborator OTHER

  • Herning Hospital

    collaborator OTHER

  • Aarhus University Hospital

    lead OTHER

Principal Investigators

  • Signe SB Borgquist, MD, PhD · Aarhus University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-04
Primary Completion
2025-01-01
Completion
2035-01-01
FDA Drug
Yes

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04601116 on ClinicalTrials.gov