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NCT05507398 Clinical Trial

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
Secondary ID
Status Not yet recruiting
Phase Phase 4
First received
Last updated
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
Health authority
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.

Study Design

Related Conditions & MeSH terms

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
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