Breast Cancer
Conditions
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
Interventions
DRUGAtorvastatin 80mg
patients received statin experimental group
OTHERplacebo
patients received placebo control group
Sponsors
Beni-Suef University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Masking description
single blind
Intervention model description
study group control group
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Confirmed breast cancer any stage confirmed by radiological and pathological or by clinical evaluation undergo surgery or receiving neo/adjuvant chemotherapy treatment 2. Age above 18 years 3. HER2 negative core biopsy 4. Adequate renal function: the calculated creatinine clearance should be ≥50 mL/min 5. Patients must be accessible for treatment and follow-up 6. Performance status of Eastern Cooperative Oncology Group (ECOG) ≤ 2
Exclusion criteria
1. Known hypersensitivity reaction to the investigational compounds or incorporated substances 2. patients who are unlikely to comply with trial requirements (eg, confusion, psychological or mood disturbances ,alcoholism, cardiac arrhythmia)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ki-67 molecular | 3 month | antiproliferative effect Ki-67 molecular gene expression |
| TAZ (WWTR1) TAZ expression | 3 months | cell proliferative ability via TAZ (WWTR1) TAZ expression |
| cardiac markers | 3 months | protective effect of atorvastatin for Anthracycline induced cardiotoxicity |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival OS | time frame 6 month | The length of time from r the start of treatment for a disease and are still alive |
| Overall response rate | 6 months | the proportion of patients who have a partial or complete response to therapy |
Countries
Egypt
Contacts
Primary ContactALshaimaa Ibrahim Rabie, Msc
Backup ContactRaghda RS Hussein, PHD
Outcome results
None listed