Back to resultsThe Anti-tumor Effect of Metformin And Atorvastatin in Breast Cancer
Primary Purpose
Breast Cancer Female
Status
Not yet recruiting
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Placebo, metformin and atorvastatin
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer Female
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Active Comparator
Active Comparator
Arm Label
control group
metformin group
atorvastatin group
Arm Description
30 patients who will serve as a control group and will receive placebo tablets
30 patients who will receive metformin 1000 mg/day.
30 patients who will receive atorvastatin 20 mg/day.
Outcomes
Primary Outcome Measures
Improvement in the overall response rate
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
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 Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05507398
Brief Title
The Anti-tumor Effect of Metformin And Atorvastatin in Breast Cancer
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2022 (Anticipated)
Primary Completion Date
July 2023 (Anticipated)
Study Completion Date
September 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tanta University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer Female
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
control group
Arm Type
Placebo Comparator
Arm Description
30 patients who will serve as a control group and will receive placebo tablets
Arm Title
metformin group
Arm Type
Active Comparator
Arm Description
30 patients who will receive metformin 1000 mg/day.
Arm Title
atorvastatin group
Arm Type
Active Comparator
Arm Description
30 patients who will receive atorvastatin 20 mg/day.
Intervention Type
Drug
Intervention Name(s)
Placebo, metformin and atorvastatin
Other Intervention Name(s)
Cidophage 1000 mg, Ator 20 mg
Intervention Description
comparing the anti-tumor effects of metformin and atorvastatin
Primary Outcome Measure Information:
Title
Improvement in the overall response rate
Description
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
Time Frame
6 months
Title
Improvement in the pathological response
Description
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
Time Frame
6 monthes
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ahmed elabd, doctor
Phone
01004862455
Email
drahmedh.elabd12@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ahmed elabd, doctor
Organizational Affiliation
Tanta university, faculty of pharmacy
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
The Anti-tumor Effect of Metformin And Atorvastatin in Breast Cancer
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