Breast Cancer Female
Conditions
Brief summary
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).
Detailed description
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.
Interventions
DRUGPlacebo, metformin and atorvastatin
comparing the anti-tumor effects of metformin and atorvastatin
Sponsors
Tanta University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with radiologically and histologically (biopsy) confirmed diagnosis of breast cancer and with stage I, II, and stage III breast cancer according to the American Joint Committee on Cancer (TNM staging system of breast cancer). * Patients with no contraindication for chemotherapy, metformin, or statins * Females aged ≥ 18 years old * Performance status \< 2 according to the Eastern Cooperative Oncology Group (ECOG) score
Exclusion criteria
* Patients with metastatic breast cancer (stage IV) * Pregnant or lactating women. * Patients with hepatic or renal impairment. * Patients with myopathy. * Patients with any condition predispose to acidosis (COPD, heart failure, ….) * Patients who had dementia, mental retarded, and any psychiatric condition that would prohibit the understanding or signing of informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in the overall response rate | 6 months | 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 |
| Improvement in the pathological response | 6 monthes | 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 |
Contacts
Primary Contactahmed elabd, doctor
Outcome results
None listed