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This study aims to determine the effect of metformin along with standard cancer treatment, and its effect on the prognosis of the metastatic breast in non-diabetic patients.
the role of metformin when combined with traditional metastatic breast cancer treatment in non-diabetic patients compared to diabetic patients who are not using metformin. In this randomized control study, there will be a demonstration either it is effective to suppress tumor burden or not through normal screening for tumor.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Metformin group | Experimental | Non Diabetic metastatic breast cancer Patients will take metformin 1 gm. twice daily (Nathan 2009) along with standard chemotherapy |
|
| control group | Other | Non Diabetic metastatic breast cancer Patients will take standard chemotherapy only |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metformin plus chemotherapy | Drug | determine the effect of metformin along with standard chemotherapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| The radiologic response rate | The Response Evaluation Criteria in Solid Tumors (RECIST 1.1) was used to evaluate the response to chemotherapy alone in case of control arm and chemotherapy plus metformin in case of drug arm for breast cancer with distant metastasis | 3 months |
| Overall survival (OS) | the time period from the start of trial till death or end of follow-up | 6 months |
| Progression-free survival | from the time between start of the trial and recurrence or disease progression, or end of follow-up | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Insulin Growth like Factor -1 (IGF-1) at base line and after 3 cycle. | measure blood Insulin Growth like Factor -1 (IGF-1) at the begining of trial then after 3 months at the end of 3 cycles (each cycle arround 28 days ) | 3 months |
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Inclusion Criteria:
The non-diabetic patients will be included in the study if they meet the following criteria:
Exclusion Criteria:
The patients will be excluded from the study if they have the following criteria:
Bad prognosis disease: Criteria defined as the following
Hypersensitivity for metformin: if happened patient will be treated as following
• Pheniramine Maleate 3 times daily for 7 days and Tablet Dexamethasone 1mg daily in 2 divided doses for 5 days [16].
Any condition associated with increased risk of metformin-associated lactic acidosis (e.g., congestive heart failure defined as New York Heart Association {NYHA} Class III or IV functional status; the history of acidosis of any type, severe infections, kidney or liver disease, respiratory disease, seizures .
Diabetic patients.
metastatic breast cancer female
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| Name | Affiliation | Role |
|---|---|---|
| ahmed a berry, PhD | Faculty of Medicine, Beni Suef University | Study Director |
| ahmed h shaaban, MD | Faculty of Medicine, Beni Suef University | Study Director |
| hoda m rabea, PhD | Faculty of pharmacy, Beni Suef University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beni-Seuf University Hospital | Banī Suwayf | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40579605 | Derived | Salah H, Rabea H, Sheemy MS, Rabie AI, Moustafa HAM, Elberry AA, Hassan A. Targeting insulin-like growth factor-1 (IGF-1) by using metformin in non-diabetic metastatic breast cancer female patients: a randomized controlled trial. Cancer Chemother Pharmacol. 2025 Jun 28;95(1):64. doi: 10.1007/s00280-025-04791-8. |
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upon request
3 MONTHS
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D008687 | Metformin |
| D004358 | Drug Therapy |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| D013812 |
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| Chemotherapy | Drug | standard chemotherapy |
|
| D017437 |
| Skin and Connective Tissue Diseases |
| Therapeutics |