Study of the Therapeutic Effect of Atorvastatin on the Clinical Outcomes in HER2 Negative Breast Cancer Patients"
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- Beni-Suef University
- Enrollment
- 60
- Locations
- 2
- Primary Endpoint
- TAZ (WWTR1) TAZ expression
Study Overview
Brief Summary
Statins, a major class of drugs for treatment of hypercholesterolemia, are widely used due to a notable prevention of cardiovascular disease, and accumulating evidence proposes a promising role of statins in breast cancer
Detailed Description
Statin has lipid independent effects include inhibition of inflammatory responses, immunomodulatory actions, apoptotic and antiproliferative effects, which might contribute to the suggested anti-tumoral effects of these agents. The epidemiological evidence projecting statins as anticancer agents is variable, depending on the particular type of cancer in question as well as the class of statin used
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Participant)
Masking Description
single blind
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Confirmed breast cancer any stage confirmed by radiological and pathological or by clinical evaluation undergo surgery or receiving neo/adjuvant chemotherapy treatment
- •Age above 18 years
- •HER2 negative core biopsy
- •Adequate renal function: the calculated creatinine clearance should be ≥50 mL/min
- •Patients must be accessible for treatment and follow-up
- •Performance status of Eastern Cooperative Oncology Group (ECOG) ≤ 2
Exclusion Criteria
- •Known hypersensitivity reaction to the investigational compounds or incorporated substances
- •patients who are unlikely to comply with trial requirements (eg, confusion, psychological or mood disturbances ,alcoholism, cardiac arrhythmia)
Arms & Interventions
study
breast cancer patient received Atorvastatin 80 mg
Intervention: Atorvastatin 80mg (Drug)
control group
breast cancer patient received placebo
Intervention: placebo (Other)
Outcomes
Primary Outcomes
TAZ (WWTR1) TAZ expression
Time Frame: 3 months
cell proliferative ability via TAZ (WWTR1) TAZ expression
cardiac markers
Time Frame: 3 months
protective effect of atorvastatin for Anthracycline induced cardiotoxicity
Ki-67 molecular
Time Frame: 3 month
antiproliferative effect Ki-67 molecular gene expression
Secondary Outcomes
- Overall survival OS(time frame 6 month)
- Overall response rate(6 months)
Investigators
ALshaimaa Ibrahim Rabie
clinical pharmacist Msc, Pharm D
Beni-Suef University