A Phase II Study of Neo-Adjuvant Statin Therapy in Postmenopausal Primary Breast Cancer: A Window-of-Opportunity Study
18 Years
N/A
Female
Breast Cancer, Postmenopausal
Trial Information
A Phase II Study of Neo-Adjuvant Statin Therapy in Postmenopausal Primary Breast Cancer: A Window-of-Opportunity Study
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.
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.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
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.
Outcome Time Frame:
After two weeks of treatment with statin therapy.
Safety Issue:
Yes
Principal Investigator
Carsten Rose, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
University Hospital Lund
Authority:
Sweden: Medical Products Agency
Study ID:
MAST1
NCT ID:
NCT00816244
Start Date:
January 2009
Completion Date:
March 2012
Related Keywords:
- Breast Cancer
- Postmenopausal
- Breast cancer
- Postmenopausal
- Neo-adjuvant
- Tumor proliferation
- Statin
- Atorvastatin
- Ki67
- Translational research
- Cell cycle regulators
- Gene expression
- Genomic profiling
- Apoptosis
- Window-of-opportunity
- Breast Neoplasms
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