Comparative Clinical Study Evaluating the Anti-tumor Effect of Metformin Versus Atorvastatin as an Adjuvant Therapy With Chemotherapy in Patients With Non-metastatic Breast Cancer
Trial Snapshot
- Phase
- Phase 4
- Status
- Not yet recruiting
- Sponsor
- Tanta University
- Enrollment
- 100
- Primary Endpoint
- Improvement in the overall response rate
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts 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.
Arms & Interventions
control group
30 patients who will serve as a control group and will receive placebo tablets
Intervention: Placebo, metformin and atorvastatin (Drug)
metformin group
30 patients who will receive metformin 1000 mg/day.
Intervention: Placebo, metformin and atorvastatin (Drug)
atorvastatin group
30 patients who will receive atorvastatin 20 mg/day.
Intervention: Placebo, metformin and atorvastatin (Drug)
Outcomes
Primary Outcomes
Improvement in the overall response rate
Time Frame: 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
Time Frame: 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
Secondary Outcomes
No secondary outcomes reported
Investigators
Ahmed Hassan Mohammed El-Abd
Principal Investigator
Tanta University