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The purpose of this study is to examine the impact of metformin as an adjuvant to chemotherapy on IGF levels in both progressing and non progressing cases of metastatic breast cancer in female patients.
One hundred and seven women with metastatic breast cancer (MBC) are randomly assigned to either a metformin (500 mg twice daily) or placebo (placebo) group during chemotherapy. All patients followed the standard chemotherapy protocol developed by the South Egypt Cancer Institute (SECI). Blood IGF-1 levels were measured at the start of treatment (baseline) and again six months later.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Metformin and Chemotherapy | Experimental | Metformin (500 mg twice daily) plus chemotherapy is administered to Group A (n=57) |
|
| Chemotherapy alone | Other | Chemotherapy is administered alone to Group B (n=50). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MetFORMIN 500 Mg Oral Tablet | Drug | MetFORMIN 500 Mg Oral Tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| IGF-1 levels | IGF-1 levels were measured before and after treatment. | 6 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival (PFS) | The measurement values of IGF were divided into two groups, high and low, based on the cut off value. After a year of observation, researchers in both groups compared their progression-free survival (PFS). | 1 Year |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Marian S. Boshra | Banī Suwayf | 62514 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26293146 | Background | Ko KP, Ma SH, Yang JJ, Hwang Y, Ahn C, Cho YM, Noh DY, Park BJ, Han W, Park SK. Metformin intervention in obese non-diabetic patients with breast cancer: phase II randomized, double-blind, placebo-controlled trial. Breast Cancer Res Treat. 2015 Sep;153(2):361-70. doi: 10.1007/s10549-015-3519-8. Epub 2015 Aug 21. | |
| 36233373 | Background |
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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 |
| D013607 | Tablets |
| D004358 | Drug Therapy |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| D004304 |
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| Chemotherapy | Drug | The standard chemotherapy protocol developed by the South Egypt Cancer Institute (SECI). |
|
|
| Essa NM, Salem HF, Elgendy MO, Gabr A, Omran MM, Hassan NA, Tashkandi HM, Harakeh S, Boshra MS. Efficacy of Metformin as Adjuvant Therapy in Metastatic Breast Cancer Treatment. J Clin Med. 2022 Sep 20;11(19):5505. doi: 10.3390/jcm11195505. |
| 19029956 | Result | Pollak M. Insulin and insulin-like growth factor signalling in neoplasia. Nat Rev Cancer. 2008 Dec;8(12):915-28. doi: 10.1038/nrc2536. |
| D017437 |
| Skin and Connective Tissue Diseases |
| Dosage Forms |
| D004364 | Pharmaceutical Preparations |
| D013812 | Therapeutics |