Neoadjuvant Chemotherapy With or Without Metformin in Early Breast Cancer.
Overview
- Phase
- Phase 2
- Intervention
- Metformin
- Conditions
- Breast Cancer
- Sponsor
- Mansoura University
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Clinical Response rate
- Last Updated
- 5 years ago
Overview
Brief 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.
Investigators
Osama Hussein
Professor of Surgery
Mansoura University
Eligibility 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.
Arms & Interventions
metformin group
metformin 850 mg once daily increased within 3 weeks to a maximum dose of 2550 mg on three divided daily doses. Neoadjuvant cytotoxic chemotherapy as per MDT (multi-disciplinary team) decision. Patients scheduled for AC-T (adriamycin, Cyclophosphamide, paclitaxel) or AC (adriamycin, cyclophosphamide) will be eligible to randomization.
Intervention: Metformin
Placebo group
placebo. Neoadjuvant cytotoxic chemotherapy as per MDT(multi-disciplinary team) decision. Patients scheduled for AC-T (adriamycin, Cyclophosphamide, paclitaxel) or AC (adriamycin, cyclophosphamide) will be eligible to randomization.
Intervention: Placebo oral tablet
Outcomes
Primary Outcomes
Clinical Response rate
Time Frame: at three months from starting therapy.
Response to preoperative therapy as per ultrasonographic tumor size assessment. A responder will have \> 50% decrease in the size of the primary tumor without appearance of new lesions.