The Anti-tumor Effect of Metformin And Atorvastatin in Breast Cancer

NCT05507398 | Unknown Phase 4

• 1 other identifier: Breast cancer treatment
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Breast Cancer Female

Outcome Measures

Primary Outcomes (2)

• 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

  6 months

• 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

  6 monthes

Study Arms (3)

control group

PLACEBO COMPARATOR

30 patients who will serve as a control group and will receive placebo tablets

Drug: Placebo, metformin and atorvastatin

metformin group

ACTIVE COMPARATOR

30 patients who will receive metformin 1000 mg/day.

Drug: Placebo, metformin and atorvastatin

atorvastatin group

ACTIVE COMPARATOR

30 patients who will receive atorvastatin 20 mg/day.

Drug: Placebo, metformin and atorvastatin

Interventions

Placebo, metformin and atorvastatin DRUG

comparing the anti-tumor effects of metformin and atorvastatin

Also known as: Cidophage 1000 mg, Ator 20 mg

atorvastatin group; control group; metformin group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanta University: lead

MeSH Terms

Interventions

Metformin; Atorvastatin

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids

Study Officials

• ahmed elabd, doctor

  Tanta university, faculty of pharmacy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

ahmed elabd, doctor

CONTACT

01004862455; drahmedh.elabd12@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 14, 2022
• First Posted: August 19, 2022
• Study Start: October 1, 2022
• Primary Completion: July 1, 2023
• Study Completion: September 1, 2023
• Last Updated: October 31, 2022

Record last verified: 2022-10