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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Breast Cancer Female

Intervention / Treatment
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* Drug: Placebo, metformin and atorvastatin


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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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 |