The Anti-tumor Effect of Metformin And Atorvastatin in Breast Cancer

Breast Cancer Female Clinical Trial

Official title:

Comparative Clinical Study Evaluating the Anti-tumor Effect of Metformin Versus Atorvastatin as an Adjuvant Therapy With Chemotherapy in Patients With Non-metastatic Breast Cancer

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05507398
• Other study ID #: Breast cancer treatment
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: October 2022
• Est. completion date: September 2023

Study information

• Verified date: October 2022
• Source: Tanta University
• Contact: ahmed elabd, doctor
• Phone: 01004862455
• Email: drahmedh.elabd12[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aims at evaluating and comparing the anti-tumor effects of metformin and statins (hydroxyl-methyl-glutaryl-CoA reductase inhibitors) in patients with non-metastatic breast cancer (stage I, II, & III).

Description:

Worldwide, BC is the most frequently diagnosed life-threatening cancer in women. In EGYPT, breast cancer is the foremost oncologic problem, contributing to 20% of all cancers and 43% of female cancers. Metformin and atorvastatin have anti-tumor effects. To date, there are limited data to investigate and compare the anti-tumor effect between metformin and statins in patients with breast cancer.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: September 2023
• Est. primary completion date: July 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with radiologically and histologically (biopsy) confirmed diagnosis of breast cancer and with stage I, II, and stage III breast cancer according to the American Joint Committee on Cancer (TNM staging system of breast cancer).

• Patients with no contraindication for chemotherapy, metformin, or statins

• Females aged = 18 years old

• Performance status < 2 according to the Eastern Cooperative Oncology Group (ECOG) score

Exclusion Criteria:

• Patients with metastatic breast cancer (stage IV)

• Pregnant or lactating women.

• Patients with hepatic or renal impairment.

• Patients with myopathy.

• Patients with any condition predispose to acidosis (COPD, heart failure, ….)

• Patients who had dementia, mental retarded, and any psychiatric condition that would prohibit the understanding or signing of informed consent.

Related Conditions & MeSH terms

• Breast Cancer Female
• Breast Neoplasms

Intervention

Drug:
• Placebo, metformin and atorvastatin
comparing the anti-tumor effects of metformin and atorvastatin

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in the overall response rate	The improvement in the overall response rate (ORR) will be assessed in 3 arms at the end of the study using the RECIST criteria and Miller-Payne grading system respectively	6 months
Primary	Improvement in the pathological response	The improvement in the pathological response will be assessed in 3 arms at the end of the study using the RECIST criteria and Miller-Payne grading system respectively	6 monthes