Neoadjuvant Chemotherapy With or Without Metformin in Early Breast Cancer.
试验速览
- 阶段
- 2 期
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Clinical Response rate
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Metformin (Drug)
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.
干预措施: Placebo oral tablet (Drug)
结局指标
主要结局
Clinical Response rate
时间窗: 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.
次要结局
未报告次要终点
研究者
Osama Hussein
Professor of Surgery
Mansoura University