Study of the Therapeutic Effect of Atorvastatin on the Clinical Outcomes in HER2 Negative Breast Cancer Patients

Study Overview
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Brief Summary
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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
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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

Official Title
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Study of the Therapeutic Effect of Atorvastatin on the Clinical Outcomes in HER2 Negative Breast Cancer Patients

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: Atorvastatin 80mg
* Other: placebo


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: study group control group
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: study<br>breast cancer patient received Atorvastatin 80 mg | Drug: Atorvastatin 80mg<br>* patients received statin experimental group<br>* Other names: ATOR;|
| Placebo Comparator: control group<br>breast cancer patient received placebo | Other: placebo<br>* patients received placebo control group<br>* Other names: placebo single blind;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ki-67 molecular | antiproliferative effect Ki-67 molecular gene expression | 3 month | 
| TAZ (WWTR1) TAZ expression | cell proliferative ability via TAZ (WWTR1) TAZ expression | 3 months | 
| cardiac markers | protective effect of atorvastatin for Anthracycline induced cardiotoxicity | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival OS | The length of time from r the start of treatment for a disease and are still alive | time frame 6 month | 
| Overall response rate | the proportion of patients who have a partial or complete response to therapy | 6 months |