NCT03507465Unknown2 期
Letrozole Plus Low-Dose Metronomic Capecitabine Versus EC-T (Epirubicin/Cyclophosphamide Followed by Docetaxel) as Neoadjuvant Therapy for ER+/HER2-negative Breast Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 290
- 试验地点
- 1
- 主要终点
- objective response rate
研究概览
简要总结
Patients with ER+/HER2- breast cancer (presumably the luminal A subtype) could potentially avoid the standard chemotherapy use. Letrozole Plus Low-Dose Metronomic Capecitabine may offer similar efficacy and less toxicity to standard chemotherapy in ER+/HER2- breast cancer patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •women (age 18-70 years) with clinical T2-3 N0-1 M0 ER-positive (ER) allred score 4-8，and progesterone receptor-positive (PgR) ，HER2-negative adequate bone marrow reserve (WBC count, 3.5 *109/L; platelets, 100*109/L; hemoglobin, 10g/dL), hepatic function (AST/ALT bilirubin and alkaline phosphatase levels 1.25 the upper limit of normal value), and renal function (serum creatinine 1.25 the upper limit of normal value).
- •Luminal A/ lymph node positive breast cancer or Luminal B breast cancer patients
排除标准
- •(a) male patients; (b) patients with inflammatory breast cancer or distant metastasis; (c) patients who were previously treated with chemotherapy, radiation therapy or prior treatment with AIs or antiestrogens for breast cancer; (d) patients with a second concomitant neoplasm; and (e) patients who could not meet the eligibility criteria.
研究组 & 干预措施
Letrozole Plus Low-Dose Metronomic Capecitabine
Experimental
干预措施: Letrozole Plus Low-Dose Metronomic Capecitabine (Drug)
EC-T
Active Comparator
干预措施: EC-T (Drug)
结局指标
主要结局
objective response rate
时间窗: 6 month
objective response rate (ORR) measured by breast ultrasound monthly
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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