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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| control group | Placebo Comparator | 30 patients who will serve as a control group and will receive placebo tablets |
|
| metformin group | Active Comparator | 30 patients who will receive metformin 1000 mg/day. |
|
| atorvastatin group | Active Comparator | 30 patients who will receive atorvastatin 20 mg/day. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo, metformin and atorvastatin | Drug | comparing the anti-tumor effects of metformin and atorvastatin |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| ahmed elabd, doctor | Contact | 01004862455 | drahmedh.elabd12@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| ahmed elabd, doctor | Tanta university, faculty of pharmacy | Principal Investigator |
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| ID | Term |
|---|---|
| D008687 | Metformin |
| D000069059 | Atorvastatin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| D011758 |
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|
| Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006538 | Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |