Role of Adding Metformin to Neoadjuvant Chemotherapy in Patients With Breast Cancer (METNEO)

Summary

Metformin, the widely prescribed oral hypoglycemic drug, is well known for its established efficacy, favorable safety profile, and low cost. Metformin has recently received increasing attention because of its potential antitumorigenic effects that are thought to be independent of its hypoglycemic effects. It has been extensively studied in preclinical models, which have implicated several molecular pathways in its antitumor activity.

Metformin was proved to have anti-proliferative and apoptotic effects on tumor cells.Moreover, metformin enhances the T-cell mediated immune response to tumor tissue and fights metastases. Also, epidemiological studies have shown that metformin, but not other antidiabetic drugs, reduces cancer incidence and improves survivability in diabetic cancer patients.

The proposed research in this application will investigate two prime questions with regards to the combined use of metformin together with traditional neoadjuvant chemotherapy in breast cancer patients. First, the hypothesis that the simultaneous use of metformin along with doxorubicin/cyclophosphamide/paclitaxel neoadjuvant protocol produces better antitumor outcomes will be tested. Second, the study will examine if the improved apoptotic effect of such regimen is paralleled by exaggerated stimulatory influences on apoptosis biomarkers.

Conditions

• Breast Cancer Female

Interventions

DRUG

Metformin Hydrochloride 850 mg Tablets

Oral administration of Metformin hydrochloride 850 mg tablets (1700 mg/day) daily until the completion of neoadjuvant chemotherapy cycles

DRUG

AC-T chemotherapy regimen

AC: (Doxorubicin 60 mg/m2 IV + cyclophosphamide 600 mg/m2 IV) for 4 cycles every 3 weeks followed by Taxol cycles (Paclitaxel 80 mg/m2 IV) once weekly for 12 weeks.

Sponsors & Collaborators

• Alexandria University

  collaborator OTHER

• Damanhour University

  lead OTHER

Principal Investigators

• Mahmoud M El-Mas, PhD · Professor in Pharmacology, Faculty of Pharmacy, Alexandria University

• Yasser M El-Kerm, PhD · Professor in Clinical Oncology, Medical Research Institute,Alexandria University

• Maged W Helmy, PhD · Professor in Pharmacology, Faculty of pharmacy, Damanhour University

• Amira B Kassem, PhD · Lecturer in Clinical Pharmacy, Faculty of Pharmacy, Damanhour University

• Noha A El-Bassiouny, PhD · Lecturer in Clinical Pharmacy, Faculty of Pharmacy, Damanhour University

• Manar A Serageldin, Bachelor · Teaching assistant in Pharmacology, Faculty of Pharmacy, Alexandria University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-10-29

Primary Completion

2022-04-02

Completion

2022-06-28

Countries

• Egypt