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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05103644
• Other study ID #: FMBSUREC/10102021/Rabie
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: October 30, 2021
• Est. completion date: December 30, 2024

Study information

• Verified date: October 2022
• Source: Beni-Suef University
• Contact: ALshaimaa Ibrahim Rabie, Msc
• Phone: 01061263030
• Email: alshaimaa.ph[@]o6u.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 30, 2024
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Atorvastatin 80mg
patients received statin experimental group

Other:
• placebo
patients received placebo control group

Locations

Country	Name	City	State
Egypt	Beni-Suef university hospital	Bani Suwayf
Egypt	Fayoum Oncology Center	Fayoum

Sponsors (1)

Lead Sponsor	Collaborator
Beni-Suef University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ki-67 molecular	antiproliferative effect Ki-67 molecular gene expression	3 month
Primary	TAZ (WWTR1) TAZ expression	cell proliferative ability via TAZ (WWTR1) TAZ expression	3 months
Primary	cardiac markers	protective effect of atorvastatin for Anthracycline induced cardiotoxicity	3 months
Secondary	Overall survival OS	The length of time from r the start of treatment for a disease and are still alive	time frame 6 month
Secondary	Overall response rate	the proportion of patients who have a partial or complete response to therapy	6 months