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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Breast Cancer, Postmenopausal

Intervention / Treatment
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* Drug: Atorvastatin


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Atorvastatin<br> | Drug: Atorvastatin<br>* Atorvastatin 80 mg daily for two weeks, ending at the day of operation for breast cancer.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumor biological alterations following two weeks of neo-adjuvant statin therapy in postmenopausal breast cancer patients; to evaluate the tumor proliferation using Ki67 as proliferation marker. |  | After two weeks of treatment with statin therapy. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessments of apoptosis using immunohistochemistry. |  | After two weeks of treatment with statin therapy. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast cancer, Postmenopausal, Neo-adjuvant, Tumor proliferation, Statin, Atorvastatin, Ki67, Translational research, Cell cycle regulators, Gene expression, Genomic profiling, Apoptosis, Window-of-opportunity