Status:
COMPLETED
Study of Statin as Neo-Adjuvant Therapy in Postmenopausal Breast Cancer
Lead Sponsor:
Lund University Hospital
Conditions:
Breast Cancer
Postmenopausal
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief 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 me...
Detailed 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 perfo...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2012
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00816244
Start Date
January 1 2009
End Date
March 1 2012
Last Update
April 13 2012
Active Locations (1)
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1
University Hospital, Department of Oncology
Lund, Sweden, 221 85