Randomized Phase II Trial of Anastrozole in Combination With/Without Metronomic Tegafur-uracil as Neo-adjuvant Therapy in Postmenopausal Primary Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 57
- 试验地点
- 1
- 主要终点
- Response Rate (confirmed by calipers CT or MRI)
研究概览
简要总结
The Aim of this study is to validate a treatment of anastrozole in combination with tegafur-uracil as pre-operative therapy for postmenopausal primary breast cancer. Although pre-operative hormone therapy is a novel therapeutic approach, only hormone therapy has limitation in terms of efficacy. Metronomic chemotherapy, which is the frequent administration of low-dose cytotoxic agents, is not only target tumor cells but also inhibiting angiogenesis. Because there was a report that efficacy of hormone therapy add to metronomic chemotherapy as pre-operative therapy, a randomized phase II trial of anastrozole (ANA) in combination with/without metronomic tegafur-uracil (UFT) as neo-adjuvant for postmenopausal breast cancer will be conducted.
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
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Histologically-confirmed diagnosis of invasive breast cancer
- •Clinical stage T2, N0 or N1, M0 (TNM Classification)
- •Patients must be postmenopausal
- •Tumors are estrogen receptor (ER) positive and human epidermal growth factor receptor (HER2) negative
- •ECOG Performance status (PS) 0 or 1
- •Patients must be able to swallow tablets and capsules
- •Candidates for mastectomy or breast-conserving surgery
- •Adequate bone marrow, liver and renal function
- •Written informed consent was obtained from all patients before randomization.
排除标准
- •Inoperable, bilateral or inflammatory breast cancer
- •multiple carcinoma
- •Personal history of invasive carcinoma
- •Patients receive systemic therapy of corticosteroid
- •Patients receive estrogen preparation or raloxifene
- •Patients with other concurrent severe and/or uncontrolled medical disease
- •Patients whom doctors judged inadequate to the enrollment of this study by other reasons.
研究组 & 干预措施
ANA
干预措施: Anastrozole (Drug)
ANA+UFT
干预措施: Anastrozole plus tegafur-uracil (Drug)
结局指标
主要结局
Response Rate (confirmed by calipers CT or MRI)
时间窗: six months
次要结局
- Reduction Rate, Pathological response, Breast-conserving surgery rate, Adverse event rate, Predictive factor(seven months)