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

NCT ID: NCT05103644

Last Updated: 2022-11-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-30
• Study Completion Date: 2024-12-30

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

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

study

breast cancer patient received Atorvastatin 80 mg

Group Type: EXPERIMENTAL

Atorvastatin 80mg

Intervention Type: DRUG

patients received statin experimental group

control group

breast cancer patient received placebo

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: OTHER

patients received placebo control group

Interventions

Atorvastatin 80mg

patients received statin experimental group

Intervention Type: DRUG

placebo

patients received placebo control group

Intervention Type: OTHER

Other Intervention Names

ATOR; placebo single blind

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Beni-Suef University

OTHER

Sponsor Role: lead

Responsible Party

ALshaimaa Ibrahim Rabie

clinical pharmacist Msc, Pharm D

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ahmed Hassan shaaban, MD

Role: STUDY_DIRECTOR

Beni-Suef University

Raghda RS Hussein, PHD

Role: STUDY_DIRECTOR

Beni-Suef University

Reham shehab El-Nemr, MD

Role: STUDY_DIRECTOR

Fayoum University

Locations

Fayoum Oncology Center

Al Fayyum, , Egypt

Site Status: NOT_YET_RECRUITING

Beni-Suef university hospital

Banī Suwayf, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

ALshaimaa Ibrahim Rabie, Msc

Role: CONTACT

alshaimaa.ph@o6u.edu.eg

01061263030

Raghda RS Hussein, PHD

Role: CONTACT

Raghda.hussien@phram.bsu.edu.eg

Facility Contacts

Alshaimaa Ibrahim, Rabie

Role: primary

alshaimaa.ph@o6u.edu.eg

Ahmed Hasssan Shaaban, MD

Role: primary

Other Identifiers

FMBSUREC/10102021/Rabie

Identifier Type: -

Identifier Source: org_study_id