The MASTER Study (MAmmary Cancer STatin ER Positive Study)

NCT04601116 | Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: SBMASTER2019-002508-42
• Study Type: interventional
• Target: 3,360
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Breast Cancer; Atorvastatin; Estrogen Receptor Positiv Tumor; Adjuvant therapy; Neoadjuvant; Statin

Outcome Measures

Primary Outcomes (1)

• Invasive disease-free survival

  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.

  10 years

Secondary Outcomes (6)

• Distant-recurrence free interval

  10 years

• Recurrence-free interval

  10 years

• Overall survival.

  10 years

• Incidence of Treatment-Emergent Adverse Events as assessed by CTC-AE, 5.0

  10 years

• Cardiac death-free interval

  10 years

Study Arms (2)

Atorvastatin 80 Mg Oral Tablet

ACTIVE COMPARATOR

Atorvastatin 80 mg tablets per day for 2 years

Drug: Atorvastatin 80 Mg Oral Tablet

Placebo

PLACEBO COMPARATOR

Placebo tablets 1 per day for 2 years.

Drug: Placebo oral tablet

Interventions

Atorvastatin 80 Mg Oral Tablet DRUG

Atorvastatin 80 mg per day for 2 years

Atorvastatin 80 Mg Oral Tablet

Placebo oral tablet DRUG

Placebo 1 tablet per day for 2 years

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women with estrogen receptor positive breast cancer who are candidates for (neo)adjuvant systemic therapy OR have received ≤3 years of adjuvant endocrine therapy.
• Age \> 18 years.
• Performance status of ECOG ≤ 2.
• 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:

You may not qualify if:

• History of any prior (ipsi- and/or contralateral) invasive breast carcinoma.
• Ongoing (prevalent) cholesterol-lowering therapy (statins, fibrates, ezetimibe, PCSK9 inhibitors). If so, the patient can be enrolled in the observational arm.
• 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).
• 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).
• No current medication with potent CYP3A4-inhibitors (e.g. ketokonazole, erythromycin) or gemfibrozile, cyclosporin or danazol.
• Pregnancy or breast-feeding.
• 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.
• History of allergic reactions attributed to compounds of similar chemical or biological composition to atorvastatin.

Sponsors & Collaborators

• Aarhus University Hospital: lead
• Rigshospitalet, Denmark: collaborator
• Hospital of Southern Jutland: collaborator
• University of Copenhagen: collaborator
• Bornholms Hospital: collaborator
• Naestved Hospital: collaborator
• Vejle Hospital: collaborator
• Odense University Hospital: collaborator
• Nordsjaellands Hospital: collaborator
• Aalborg University Hospital: collaborator
• Herning Hospital: collaborator

Study Sites (1)

Aarhus University Hospitak

Aarhus, Denmark

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Atorvastatin; Tablets

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Signe SB Borgquist, MD, PhD

  Aarhus University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Signe SB Borgquist, MD, PhD

CONTACT

004522624525; signe.borgquist@auh.rm.dk

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Chair Professor

Model Details: A prospective, two-armed, randomized (1:1), multicenter, national, double-blind, placebo-controlled study in early breast cancer patients.

Study Record Dates

• First Submitted: July 25, 2019
• First Posted: October 23, 2020
• Study Start: January 4, 2021
• Primary Completion: January 1, 2025
• Study Completion (Estimated): January 1, 2035
• Last Updated: January 14, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)