Evaluation of the Effect of Metformin on Metastatic Breast Cancer as Adjuvant Treatment

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Evaluation of the Effect of Metformin on Metastatic Breast Cancer as Adjuvant Treatment

Conditions
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Metastatic Breast Cancer

Intervention / Treatment
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* Drug: Metformin plus chemotherapy
* Drug: Chemotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The non-diabetic patients will be included in the study if they meet the following criteria: Confirmed metastatic breast cancer (IV stage) radiologically or by clinical evaluation receiving chemotherapy Age between 18- 70 years. Life expectancy at least 6 months Exclusion Criteria: The patients will be excluded from the study if they have the following criteria: Bad prognosis disease: Criteria defined as the following If patient >70 years If patient has bad site metastasis (brain) 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Metformin group<br>Non Diabetic metastatic breast cancer Patients will take metformin 1 gm. twice daily (Nathan 2009) along with standard chemotherapy | Drug: Metformin plus chemotherapy<br>* determine the effect of metformin along with standard chemotherapy<br>|
| Other: control group<br>Non Diabetic metastatic breast cancer Patients will take standard chemotherapy only | Drug: Chemotherapy<br>* standard chemotherapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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metformin, non metastatic breast cancer, non-diabetic