Metastatic Breast Cancer
Conditions
Keywords
metformin, non metastatic breast cancer, non-diabetic
Brief summary
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
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.
Interventions
DRUGMetformin plus chemotherapy
determine the effect of metformin along with standard chemotherapy
DRUGChemotherapy
standard chemotherapy
Sponsors
Hager salah el din
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* The non-diabetic patients will be included in the study if they meet the following criteria: 1. Confirmed metastatic breast cancer (IV stage) radiologically or by clinical evaluation receiving chemotherapy 2. Age between 18- 70 years. 3. Life expectancy at least 6 months
Exclusion criteria
* The patients will be excluded from the study if they have the following criteria: 1. Bad prognosis disease: Criteria defined as the following * If patient \>70 years * If patient has bad site metastasis (brain) 2. 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 \[16\]. 3. 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 . 4. Diabetic patients.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The radiologic response rate | 3 months | 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 |
| Overall survival (OS) | 6 months | the time period from the start of trial till death or end of follow-up |
| Progression-free survival | 6 months | from the time between start of the trial and recurrence or disease progression, or end of follow-up |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Insulin Growth like Factor -1 (IGF-1) at base line and after 3 cycle. | 3 months | 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 ) |
Countries
Egypt
Outcome results
None listed