Early breast cancer MedDRA version: 20.0 Level: LLT Classification code 10006175 Term: Breast adenocarcinoma stage I System Organ Class: 100000004864 MedDRA version: 20.0 Level: LLT Classification code 10006176 Term: Breast adenocarcinoma stage II System Organ Class: 100000004864
Conditions
Interventions
Trade Name: ATORVASTATINA PFIZER - 80 MG COMPRESSE RIVESTITE CON FILM 98 COMPRESSE IN BLISTER PA/AL/PVC-CARTA/PET/AL
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: ATORVASTATINA
CAS Numb
Sponsors
ISTITUTI FISIOTERAPICI OSPITALIERI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Signed written informed consent Female aged >18 years and 10% in diagnostic core biopsies Adequate baseline organ function Negative pregnancy test Patients of childbearing potential must agree to use a double effective method of contraception throughout the study and for 3 months after the last dose of assigned treatment. 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 60 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 18
Exclusion criteria
Exclusion criteria: Previous systemic therapy including chemotherapy, hormone therapy and targeted agents Administration of an investigational drug prior to enrolment History of another malignancy. Except for a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma. Subjects who have current active hepatic or biliary disease (with exception of patients with Gilbert's syndrome and asymptomatic gallstones) Serious cardiac illness or medical conditions including but not confined to: history of documented congestive heart failure (CHF) or systolic dysfunction (LVEF 180mm Hg or diastolic >100mm Hg) Have a concurrent disease or condition that may interfere with study participation, or any serious medical disorder that would interfere with the subject's safety (for example, active or uncontrolled infection or any psychiatric condition prohibiting understanding or rendering of informed consent) Current or recent therapy with statins for hypercholesterolemia or other lipid-lowering drugs Current or recent therapy with glucose-lowering drugs for diabetes History of hypothyroidism personal or family history of hereditary muscular disorders Previous myotoxicity due to statins and/or fibrates
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Ki-67 reduction;Secondary Objective: the rate of decreased TAZ expression and its correlation with Ki-67 reduction, the predictive value of HMG-CoA reductase expression, and downgrading;Primary end point(s): the rate of Ki-67 reduction below the 15% ;Timepoint(s) of evaluation of this end point: 3 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): the rate of decreased TAZ expression; KI67 and TAZ correlation; predictive value of HMG-CoA reductase expression;Timepoint(s) of evaluation of this end point: 3 weeks; 3 weeks; 3 weeks | — |
Countries
Italy
Contacts
Public ContactRESPONSABILE SCIENTIFICO
ISTITUTO REGINA ELENA
Outcome results
None listed