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

Who is this study for? Patients with Breast Cancer
What treatments are being studied? Atorvastatin
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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:

Locations
Other Locations
Denmark
Aarhus University Hospitak
RECRUITING
Aarhus
Contact Information
Primary
Signe SB Borgquist, MD, PhD
signe.borgquist@auh.rm.dk
004522624525
Time Frame
Start Date: 2021-01-04
Estimated Completion Date: 2035-01-01
Participants
Target number of participants: 3360
Treatments
Active_comparator: Atorvastatin 80 Mg Oral Tablet
Atorvastatin 80 mg tablets per day for 2 years
Placebo_comparator: Placebo
Placebo tablets 1 per day for 2 years.
Related Therapeutic Areas
Sponsors
Collaborators: Bornholms Hospital, University of Copenhagen, Herning Hospital, Nordsjaellands Hospital, Odense University Hospital, Naestved Hospital, Hospital of Southern Jutland, Aalborg University Hospital, Vejle Hospital, Rigshospitalet, Denmark
Leads: Aarhus University Hospital

This content was sourced from clinicaltrials.gov