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

• Status: Completed
• Trial end date: 2012-03-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Lund University Hospital
• Treatments: Atorvastatin; Atorvastatin Calcium

Criteria

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.