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

Phase 4

Not yet recruiting

• Conditions: Breast Cancer Female
• Interventions: Drug: Placebo, metformin and atorvastatin

• Registration Number: NCT05507398
• Lead Sponsor: Tanta University

Brief 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).

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.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2022-08-14
• Study First Submitted QC: 2022-08-17
• Study First Posted: 2022-08-19
• Status Verified: 2022-10
• Study Start: 2022-10
• Last Update Submitted: 2022-10-28
• Last Update Posted: 2022-10-31
• Primary Completion: 2023-07
• Study Completion: 2023-09

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 100

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
metformin group	Placebo, metformin and atorvastatin	30 patients who will receive metformin 1000 mg/day.
atorvastatin group	Placebo, metformin and atorvastatin	30 patients who will receive atorvastatin 20 mg/day.
control group	Placebo, metformin and atorvastatin	30 patients who will serve as a control group and will receive placebo tablets

Primary Outcome Measures

Name	Time	Method
Improvement in the overall response rate	6 months	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
Improvement in the pathological response	6 monthes	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