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A Randomized, placebo-controlled, Phase III Study of (Neo)Adjuvant Atorvastatin Therapy in Patients with Early Breast Cancer

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-515404-39-00
Enrollment
3360
Registered
2024-09-15
Start date
2021-01-14
Completion date
Unknown
Last updated
2025-06-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast cancer

Brief summary

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, Regional invasive breast cancer recurrence, Distant recurrence, Death attributable to any cause, including breast cancer, non-breast cancer, or unknown cause, Contralateral invasive breast cancer or Second primary non-breast invasive cancer.

Detailed description

Pathological response (only neo-adjuvant treated patients), Distant-recurrence free interval defined as time from inclusion to first distant recurrence including associations with first site of recurrence., Recurrence-free interval including associations with first site of recurrence, Overall survival., Overall safety., Cardiac death-free interval. Cardiac death is defined as: Definitive cardiac death due to heart failure, myocardial infarction or documented primary arrhythmia.

Interventions

DRUGPlacebo til Atorvastatin TEVA tablet 80 mg
DRUGAtorvastatin Teva

Sponsors

Region Midtjylland
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
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, Regional invasive breast cancer recurrence, Distant recurrence, Death attributable to any cause, including breast cancer, non-breast cancer, or unknown cause, Contralateral invasive breast cancer or Second primary non-breast invasive cancer.

Secondary

MeasureTime frame
Pathological response (only neo-adjuvant treated patients), Distant-recurrence free interval defined as time from inclusion to first distant recurrence including associations with first site of recurrence., Recurrence-free interval including associations with first site of recurrence, Overall survival., Overall safety., Cardiac death-free interval. Cardiac death is defined as: Definitive cardiac death due to heart failure, myocardial infarction or documented primary arrhythmia.

Countries

Denmark

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026