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

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

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Breast Cancer Female
• Intervention / Treatment: Drug: Placebo, metformin and atorvastatin

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: ahmed elabd, doctor; Phone Number: 01004862455; Email: drahmedh.elabd12@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: control group; 30 patients who will serve as a control group and will receive placebo tablets	Drug: Placebo, metformin and atorvastatin; comparing the anti-tumor effects of metformin and atorvastatin; Other Names: Cidophage 1000 mg; Ator 20 mg
Active Comparator: metformin group; 30 patients who will receive metformin 1000 mg/day.	Drug: Placebo, metformin and atorvastatin; comparing the anti-tumor effects of metformin and atorvastatin; Other Names: Cidophage 1000 mg; Ator 20 mg
Active Comparator: atorvastatin group; 30 patients who will receive atorvastatin 20 mg/day.	Drug: Placebo, metformin and atorvastatin; comparing the anti-tumor effects of metformin and atorvastatin; Other Names: Cidophage 1000 mg; Ator 20 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Tanta University
• Investigators: Principal Investigator: ahmed elabd, doctor, Tanta university, faculty of pharmacy

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2022
• Primary Completion (Anticipated): July 1, 2023
• Study Completion (Anticipated): September 1, 2023

Study Registration Dates

• First Submitted: August 14, 2022
• First Submitted That Met QC Criteria: August 17, 2022
• First Posted (Actual): August 19, 2022

Study Record Updates

• Last Update Posted (Actual): October 31, 2022
• Last Update Submitted That Met QC Criteria: October 28, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Atorvastatin; Metformin
• Other Study ID Numbers: Breast cancer treatment

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No