Neoadjuvant Chemotherapy With or Without Metformin in Early Breast Cancer.

• Status: Recruiting
• Trial end date: 2023-05-01
• Target enrollment: 0
• Participant gender: Female

Summary

Metformin is a widely used anti-diabetic drug. Several studies have pointed out a potentially beneficial effect of metformin therapy in diabetic cancer patients. Several studies are investigating the anti-tumor effect of metformin in early breast cancer. However, the enhancing effect of metformin on anti-tumor immunity has only been demonstrated in animal models. This study examines the immune effect of metformin in breast cancer patients treated with preoperative chemotherapy.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mansoura University
• Treatments: Metformin

Criteria

Inclusion Criteria:

• Histologically proven breast carcinoma.

• American Society of Anesthesiology (ASA) score I-II.

• Candidate for neoadjuvant chemotherapy as per hospital's protocol.

• Clinically measurable tumor.

• No evidence of distant metastasis.

• Normal renal and liver functions.

• Non-diabetics.

Exclusion Criteria:

• Pregnant or lactating women.

• Metastatic breast cancer patients.

• Patients with hepatic impairment.

• Patients with renal impairment.

• Diabetics.

• Patients unwilling to participate or withdrawing from the trial.

• Psychological/ mental impairment.