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

Lund University Hospital

Status and phase

Completed

Phase 2

Conditions

Breast Cancer

Postmenopausal

Treatments

Drug: Atorvastatin

Study type

Interventional

Funder types

Other

Identifiers

NCT00816244

EudraCT number: 2008-005863-32

MAST1

Details and patient eligibility

About

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.

Full description

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.

Enrollment

50 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.