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Trial Title:
The Anti-tumor Effect of Metformin And Atorvastatin in Breast Cancer
NCT ID:
NCT05507398
Condition:
Breast Cancer Female
Conditions: Official terms:
Breast Neoplasms
Metformin
Atorvastatin
Study type:
Interventional
Study phase:
Phase 4
Overall status:
Unknown status
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Single (Participant)
Intervention:
Intervention type:
Drug
Intervention name:
Placebo, metformin and atorvastatin
Description:
comparing the anti-tumor effects of metformin and atorvastatin
Arm group label:
atorvastatin group
Arm group label:
control group
Arm group label:
metformin group
Other name:
Cidophage 1000 mg
Other name:
Ator 20 mg
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.
Criteria for eligibility:
Criteria:
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.
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
October 2022
Completion date:
September 2023
Lead sponsor:
Agency:
Tanta University
Agency class:
Other
Source:
Tanta University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05507398
