ATORVASTATIN for Breast cancer|Early breast cancer

Inclusion criteria

• {"criterion_text":"- Women with estrogen receptor positive breast cancer who are candidates for (neo)adjuvant systemic therapy OR have received ≤3 years of adjuvant endocrine therapy.\n- Age > 18 years.\n- Performance status of ECOG ≤ 2.\n- Prior to patient registration, written informed consent must be given according to ICH/GCP, and national/local regulations."}

Exclusion criteria

• {"criterion_text":"- History of any prior (ipsi- and/or contralateral) invasive breast carcinoma.\n- Ongoing (prevalent) cholesterol-lowering therapy (statins, fibrates, ezetimibe, PCSK9 inhibitors). If so, the patient can be enrolled in the observational arm given fulfillment of other in- and exclusion criteria.\n- 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).\n- Predisposing factors for rhabdomyolysis, including hypothyroidism, reduced renal function, any muscle – or liver disease, or excessive alcohol consumption (above 14 drinks/week) AND creatine kinase (CK) measured to less more than five times the upper limit (CK only measured in case of predisposing factors).\n- Current medication with potent CYP3A4-inhibitors (e.g. ketokonazole, erythromycin) or gemfibrozile, cyclosporin or danazol.\n- Pregnancy or breast-feeding (contraception according to clinical routines for premenopausal, fertile breast cancer patients, that includes non-hormonal contraception such as condom, vaginal diaphragm, or intrauterine device).\n- 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.\n- History of allergic reactions attributed to compounds of similar chemical or biological composition to atorvastatin."}

Primary endpoints

• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Defined as the time from randomization until the date of the first occurrence of one of the listed 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; Second primary non-breast invasive cancer)."}

Secondary endpoints

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

Denmark

Earliest CTIS Part Ii Submission Date

28-08-2024

Latest Decision Or Authorization Date

03-06-2025

Processing Time Days

279

Number Of Sites

11

Number Of Participants

3360

Primary sponsor

Full Name

Region Midtjylland

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Denmark

Third parties

• {"country":"Denmark","full_name":"Aarhus Universitet","duties_or_roles":"sponsorDuties code: 1","organisation_type":"Educational Institution"}