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

Phase 2

Recruiting

• Conditions: Breast Cancer
• Interventions: Drug: Atorvastatin 80mg; Other: placebo

• Registration Number: NCT05103644
• Lead Sponsor: Beni-Suef University

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 Timeline

• Study First Submitted: 2021-10-21
• Study First Submitted QC: 2021-10-21
• Study Start: 2021-10-30
• Study First Posted: 2021-11-02
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-31
• Last Update Posted: 2022-11-02
• Primary Completion: 2023-12-30
• Study Completion: 2024-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 60

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
study	Atorvastatin 80mg	breast cancer patient received Atorvastatin 80 mg
control group	placebo	breast cancer patient received placebo

Primary Outcome Measures

Name	Time	Method
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
Ki-67 molecular	3 month	antiproliferative effect Ki-67 molecular gene expression

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Fayoum Oncology Center; 🇪🇬 Fayoum, Egypt

Beni-Suef university hospital; 🇪🇬 Banī Suwayf, Egypt