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

Sponsor
Tanta University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05507398
Collaborator
(none)
100
Enrollment
3
Arms
12
Anticipated Duration (Months)

Study Details

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).

Condition or Disease Intervention/Treatment Phase
  • Drug: neoadjuvant chemotherapy (AC-T protocol)
 Phase 4

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
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
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
Anticipated Study Start Date :
Sep 1, 2022
Anticipated Primary Completion Date :
Jul 1, 2023
Anticipated Study Completion Date :
Sep 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: control group

30 patients who will serve as a control group and will receive neoadjuvant chemotherapy (AC-T protocol) plus placebo tablets

Drug: neoadjuvant chemotherapy (AC-T protocol)
comparing the anti-tumor effects of metformin and atorvastatin
Other Names:
  • Metformin
  • Atorvastatin
  • placebo

    		•
    Active Comparator: metformin group

    30 patients who will receive neoadjuvant chemotherapy (AC-T protocol) + metformin 1000 mg/day.

    Drug: neoadjuvant chemotherapy (AC-T protocol)
    comparing the anti-tumor effects of metformin and atorvastatin
    Other Names:
  • Metformin
  • Atorvastatin
  • placebo

    		•
    Active Comparator: atorvastatin group

    30 patients who will receive neoadjuvant chemotherapy (AC-T protocol) + atorvastatin 20 mg/day.

    Drug: neoadjuvant chemotherapy (AC-T protocol)
    comparing the anti-tumor effects of metformin and atorvastatin
    Other Names:
  • Metformin
  • Atorvastatin
  • placebo

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    2. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Tanta University

    Investigators

    • Principal Investigator: ahmed elabd, doctor, Tanta university, faculty of pharmacy

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ahmed Hassan Mohammed El-Abd, Principal Investigator, Tanta University
    ClinicalTrials.gov Identifier:
    NCT05507398
    Other Study ID Numbers:
    • Breast cancer treatment
    First Posted:
    Aug 19, 2022
    Last Update Posted:
    Aug 19, 2022
    Last Verified:
    Aug 1, 2022
    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
    Additional relevant MeSH terms:
    Breast Neoplasms
    Metformin
    Atorvastatin

    Study Results

    No Results Posted as of Aug 19, 2022