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

NCT05103644 | Unknown Phase 2

• 1 other identifier: FMBSUREC/10102021/Rabie
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Overall survival OS

  time frame 6 month

• Overall response rate

  6 months

Study Arms (2)

study

EXPERIMENTAL

breast cancer patient received Atorvastatin 80 mg

Drug: Atorvastatin 80mg

control group

PLACEBO COMPARATOR

breast cancer patient received placebo

Other: placebo

Interventions

Atorvastatin 80mg DRUG

patients received statin experimental group

Also known as: ATOR

study

placebo OTHER

patients received placebo control group

Also known as: placebo single blind

control group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Gender Eligibility Details: Femal breast cancer
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Beni-Suef University: lead

Study Sites (2)

Fayoum Oncology Center

Al Fayyum, Egypt

NOT YET RECRUITING

Beni-Suef university hospital

Banī Suwayf, Egypt

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Atorvastatin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids

Study Officials

• Ahmed Hassan shaaban, MD

  Beni-Suef University

  STUDY DIRECTOR

• Raghda RS Hussein, PHD

  Beni-Suef University

  STUDY DIRECTOR

• Reham shehab El-Nemr, MD

  Fayoum University

  STUDY DIRECTOR

Central Study Contacts

ALshaimaa Ibrahim Rabie, Msc

CONTACT

01061263030; alshaimaa.ph@o6u.edu.eg

Raghda RS Hussein, PHD

CONTACT

Raghda.hussien@phram.bsu.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: single blind
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: clinical pharmacist Msc, Pharm D

Model Details: study group control group

Study Record Dates

• First Submitted: October 21, 2021
• First Posted: November 2, 2021
• Study Start: October 30, 2021
• Primary Completion: December 30, 2023
• Study Completion: December 30, 2024
• Last Updated: November 2, 2022

Record last verified: 2022-10

Locations

EG (2)