Postmenopausal women with primary invasive breast cancer. MedDRA version: 9.1 Level: LLT Classification code 10006187 Term: Breast cancer
Conditions
Interventions
Trade Name: Lipitor
Pharmaceutical Form: Tablet
INN or Proposed INN: ATORVASTATIN
CAS Number: 134523005
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 80-
Sponsors
Department of Oncology
Eligibility
Sex/Gender
All
Inclusion criteria
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. • Postmenopausal women. Postmenopausal status defined as = 1 year since last menstruation in women with no medical history of hysterectomy or women with a medical history of oophofectomy. • 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 |
|---|---|
| Main Objective: The primary objective of the current study is to evaluate statin induced effects on tumour proliferation response.;Secondary Objective: The secondary objectives are: - To evaluate the treatment predictive role of HMG-CoA reductase expression. - To evaluate the relation between blood lipid profile and statin induced tumour inhibition. - To evaluate the the relation between statin induced tumour effects and other proteins synthesized in the mevalonate pathway.;Primary end point(s): Tumour proliferation will be determined by immunohistochemical expression of Ki67 (monoclonal antibody, 1:200 MIB-1, Dako, Denmark) in the core biopsy (t1) and in breast cancer tissue obtained from the operated lump (t2). Ki67 will be assessed as the percentage of positively stained cells among a minimum of 1000 malignant cells (fraction as a continuous variable). A relative change of 35% between t1 and t2 will be regarded as clinically significant result. Prior to statistical analyses and final decision on the clinically relevant reduction in proliferation rate (Ki67), the expected normal variability of the investigated biological markers between biopsy specimens and surgical specimens with approximately two weeks interval in untreated patients, should be estimated in a retrospectively collected cohort of postmenopausal breast cancer cases. | — |
Countries
Sweden
Outcome results
None listed