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

A Phase II Study of Neo-Adjuvant Statin Therapy in Postmenopausal Primary Breast Cancer: A Window-of-Opportunity Study

The purpose of this study is to monitor:

• Tumor biological alterations following two weeks of neo-adjuvant statin therapy.
• Effects of statins on tumor proliferation.
• Functional studies on the mevalonate pathway.

Blood samples and three core biopsies are taken after diagnosis. Treatment with atorvastatin at a daily dosis of 80 mg is initiated 14 days before planned surgery. Translational research will be performed from the core biopsy and blood samples taken before surgery and from the specimen from surgery.

Inclusion Criteria:

• Women with primary breast cancer who are candidates for radical surgery.
• Breast tumours clinically ≥ 15 mm, Nx, M0.
• Breast tumours identified on mammography and verified on fine needle aspiration.
• Age > 18 years.
• Performance status of ECOG ≤ 1.
• Laboratory requirements at the day of diagnosis (t1-):Prior to inclusion a normal renal (serum creatinine) and hepatic (transaminases) function (within normal limits) estimated in blood samples is required.
• Prior to patient registration, written informed consent must be given according to ICH/GCP, and national/local regulations.
• Negative pregnancy test for pre menopausal women before inclusion in the trial

Exclusion Criteria:

• Ongoing cholesterol lowering therapy (statins, fibrates, ezetimibe).
• Prior breast cancer treatment.
• Current HRT.
• Known liver disease.
• History of hemorrhagic stroke.
• 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.