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

Beni-Suef University

Status and phase: Enrolling; Phase 3; Phase 2

Conditions: Breast Cancer

Treatments: Other: placebo; Drug: Atorvastatin 80mg

Study type: Interventional

Funder types: Other

Identifiers

NCT05103644

FMBSUREC/10102021/Rabie

Details and patient eligibility

About

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

Full 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

Enrollment: 60 estimated patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups, including a placebo group

study

Experimental group

Description:

breast cancer patient received Atorvastatin 80 mg

Treatment:

Drug: Atorvastatin 80mg

control group

Placebo Comparator group

Description:

breast cancer patient received placebo

Treatment:

Other: placebo