A phase II, randomized, non-comparative, pre-surgical study of atorvastatin or observation in early breast cancer patients
- Conditions
- Early breast cancerMedDRA version: 20.0Level: LLTClassification code 10006175Term: Breast adenocarcinoma stage ISystem Organ Class: 100000004864MedDRA version: 20.0Level: LLTClassification code 10006176Term: Breast adenocarcinoma stage IISystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2014-005508-62-IT
- Lead Sponsor
- ISTITUTI FISIOTERAPICI OSPITALIERI
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Female
- Target Recruitment
- 78
Signed written informed consent
Female aged >18 years and <75 years at the time of the enrolment
Histologically confirmed BC independently on the intrinsic subtype
Stage I-IIa BC patients candidate for elective surgery
BC expressing Ki-67 = 15% and TAZ > 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
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 <50%); high-risk uncontrolled arrhythmias (ventricular tachycardia, high-grade AV-block, supraventricular arrhythmias which are not adequately controlled); angina pectoris requiring antianginal medication; clinically significant valvular heart disease; evidence of transmural infarction on ECG; poorly controlled hypertension (e.g. systolic >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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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