Neoadjuvant Chemotherapy With or Without Metformin in Early Breast Cancer.
Breast Cancer
About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring breast cancer, metformin, anti-tumor immunity
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.
Sites / Locations
- Mansoura University Cancer centerRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
metformin group
Placebo 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.
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.