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

Summary

Participation Requirements

Description

Ethical committee approval will be obtained from Ethics committee of Faculty of Pharmacy, Damanhour University. All participants should agree to take part in this clinical study and will provide informed consent. Sixty female breast cancer patients, who are candidates for neoadjuvant chemotherapy, w...

Ethical committee approval will be obtained from Ethics committee of Faculty of Pharmacy, Damanhour University. All participants should agree to take part in this clinical study and will provide informed consent. Sixty female breast cancer patients, who are candidates for neoadjuvant chemotherapy, will be recruited from the Medical Research Institute, Oncology department, Alexandria University, Alexandria. The 60 participants will be randomly assigned into 2 arms: Control arm (n=30): will be treated with AC-Taxol regimen (AC: Doxorubicin 60 mg/m2 IV + cyclophosphamide 600 mg/m2 IV) for 4 cycles every 3 weeks. Subsequent Taxol cycles (Paclitaxel 80mg/m2 IV) once weekly for 12 weeks. Metformin arm (n=30): will be treated with the AC-Taxol regimen mentioned above together with Metformin 850 mg tablets orally twice per day (1700 mg/day). All patients will be submitted to: Full patient history and clinical examination. Routine follow up before each chemotherapy cycle (complete blood picture, liver function tests, renal function tests). Routine Echocardiography before each chemotherapy cycle. All patients will be monitored for the incidence of chemotherapy toxicities during neoadjuvant therapy. After completion of the neoadjuvant therapy, participants will undergo surgical tumor removal. The excised tumor will be collected, and the following biomarkers will be measured: i. Ki-67 ii. Caspase-3 iii. TNF-? Also, pathologic complete response (pCR) will be assessed. Patients demographic data will be recorded with respect to age, weight and disease history. Statistical tests appropriate to the study design will be conducted to evaluate the significance of the results. Results, conclusion, discussion and recommendations will be given.

Tracking Information