Breast Cancer, Postmenopausal
Conditions
Keywords
Breast cancer, Postmenopausal, Neo-adjuvant, Tumor proliferation, Statin, Atorvastatin, Ki67, Translational research, Cell cycle regulators, Gene expression, Genomic profiling, Apoptosis, Window-of-opportunity
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 mevalonate pathway.
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 performed from the core biopsy and blood samples taken before surgery and from the specimen from surgery.
Interventions
DRUGAtorvastatin
Atorvastatin 80 mg daily for two weeks, ending at the day of operation for breast cancer.
Sponsors
Lund University Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| Assessments of apoptosis using immunohistochemistry. | After two weeks of treatment with statin therapy. |
Countries
Sweden
Outcome results
None listed