The MASTER Study (MAmmary Cancer STatin ER Positive Study)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

3360 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-04

Study Completion Date

2035-01-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Atorvastatin in Treating Patients With Stage IIb-III Triple Negative Breast Cancer Who Did Not Achieve a Pathologic Complete Response After Receiving Neoadjuvant Chemotherapy

NCT03872388

Anatomic Stage IIB Breast Cancer AJCC v8 Anatomic Stage III Breast Cancer AJCC v8 Anatomic Stage IIIA Breast Cancer AJCC v8 +17 more

TERMINATED PHASE2

Comparing Anastrozole-Placebo to the Combination Anastrozole-ZD1839 in Postmenopausal Patients With Estrogen Receptor and/or Progesterone Receptor Metastatic Breast Cancer

NCT00077025

Breast Cancer

COMPLETED PHASE2

Study of Statin as Neo-Adjuvant Therapy in Postmenopausal Breast Cancer

NCT00816244

Breast Cancer Postmenopausal

COMPLETED PHASE2

A Study of Elacestrant Versus Standard Endocrine Therapy in Women and Men With ER+,HER2-, Early Breast Cancer With High Risk of Recurrence

NCT06492616

Breast Cancer

RECRUITING PHASE3

A Phase I Prevention Study of Atorvastatin in Women at Increased Risk for Breast Cancer

NCT00637481

Atypical Ductal Breast Hyperplasia Breast Cancer Ductal Breast Carcinoma in Situ +1 more

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Cholesterol-lowering drugs such as statins are currently used to lower cholesterol levels and prevent cardiovascular events. Statins have, however, received substantial scientific attention as cancer-inhibiting drugs. Previous findings were recently supported in a large-scaled study again demonstrating the beneficial effects of statins on breast cancer outcome this time nested within a large, international, randomized clinical trial of modern adjuvant cancer therapy. 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. Thus, the primary objective of the MASTER trial is to determine the clinical efficacy of the statin - atorvastatin - as measured by invasive disease-free survival among patients with primary breast cancer.

The trial is nationwide throughout Denmark and a total of 3,360 women are to be included in the trial. Women eligible for the trial have been diagnosed with an estrogen receptor positive breast cancer and are candidates for systemic cancer therapy, either prior to or following breast surgery. Upon eligibility and signed informed consent, trial participants will be randomized in a 1:1 manner to either standard treatment and atorvastatin 80 mg/day or standard treatment and placebo. The randomization is blinded. The treatment with atorvastatin or placebo will continue for two years unless side effects are experienced and further treatment with atorvastatin or the placebo is deemed inadequate. The standard treatment will of course continue as planned. The trial participants will follow the standard clinical routines in terms of follow-up and in addition they are asked to fill in questionnaires, i.e. regarding potential side effects or new events or diagnoses, up to ten years following inclusion. Potential breast cancer recurrences are hereby identified and a follow-up of at least 61/2 years will be required for the trial the demonstrate the estimated clinical difference between the randomized groups of patients.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Breast Cancer Female Estrogen Receptor Positive Tumor

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Atorvastatin 80 Mg Oral Tablet

Atorvastatin 80 mg tablets per day for 2 years

Group Type ACTIVE_COMPARATOR

Atorvastatin 80 Mg Oral Tablet

Intervention Type DRUG

Atorvastatin 80 mg per day for 2 years

Placebo

Placebo tablets 1 per day for 2 years.

Group Type PLACEBO_COMPARATOR

Placebo oral tablet

Intervention Type DRUG

Placebo 1 tablet per day for 2 years

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Atorvastatin 80 Mg Oral Tablet

Atorvastatin 80 mg per day for 2 years

Intervention Type DRUG

Placebo oral tablet

Placebo 1 tablet per day for 2 years

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No