Comparative Analysis of the Efficacies of AT and AC-T Regimens in Neoadjuvant Chemotherapy of Breast Cancer
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 104
- 试验地点
- 5
- 主要终点
- pathological complete response rate
研究概览
简要总结
The purpose of this study is to compare the short-term and long-term efficacies and the safeties of pirarubicin plus docetaxel(AT group) and pirarubicin plus cyclophosphamide followed by docetaxel(AC-T group) in neoadjuvant chemotherapy of breast cancer.
详细描述
Based on the results of NSABP(National Surgical Adjuvant Breast and Bowel Project) B27 trial, anthracyclines(A) and Taxanes(T) are most commonly recommended in neoadjuvant chemotherapy of breast cancer.
Pirarubicin is one of anthracyclines and by embedding the DNA double stranded, which inhibits DNA replication and RNA synthesis, thereby impedes the rapid growth of cancer cells.
Docetaxel in one of taxanes and by strengthening the tubulin polymerization, inhibiting of microtubule depolymerization and leading to the formation of stable non functional microtubule bundles, which destroys mitosis of tumor cells.
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 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •histopathologically diagnosed with stage I-III breast cancers;
- •clearly confirmed ER, PR and HER2 statuses;
- •the state of axillary lymph nodes was determined through the relevant examination steps (puncture or sentinel lymph node biopsy);
- •the patients were not treated with neoadjuvant therapy and surgery.
排除标准
- •the patients whose breasts or axillary lumps had received excision biopsy;
- •the patients who had severely abnormal organ functions or who could not tolerate chemotherapy,
- •the patients with severe concomitant diseases;
- •the patients with heart disease or left ventricular ejection fraction (LVEF) <50%.
研究组 & 干预措施
Combined therapy group
pirarubicin 50mg/m2, iv, d1; docetaxel 75mg/m2, div, d1. 21 days were a cycle of treatment, with a total of 4-8 cycles.
干预措施: Pirarubicin (Drug)
Combined therapy group
pirarubicin 50mg/m2, iv, d1; docetaxel 75mg/m2, div, d1. 21 days were a cycle of treatment, with a total of 4-8 cycles.
干预措施: Docetaxel (Drug)
Sequential therapy group
cyclophosphamide 600mg/m2, iv, d1; Pirarubicin 60mg/m2, iv, d1, 21 days were a cycle of treatment, with a total of 4 cycles. Then followed by Docetaxel 75- 100mg/m2, div, d1, 21 days were a cycle of treatment, with a total of 4 cycles.
干预措施: Pirarubicin (Drug)
Sequential therapy group
cyclophosphamide 600mg/m2, iv, d1; Pirarubicin 60mg/m2, iv, d1, 21 days were a cycle of treatment, with a total of 4 cycles. Then followed by Docetaxel 75- 100mg/m2, div, d1, 21 days were a cycle of treatment, with a total of 4 cycles.
干预措施: Docetaxel (Drug)
Sequential therapy group
cyclophosphamide 600mg/m2, iv, d1; Pirarubicin 60mg/m2, iv, d1, 21 days were a cycle of treatment, with a total of 4 cycles. Then followed by Docetaxel 75- 100mg/m2, div, d1, 21 days were a cycle of treatment, with a total of 4 cycles.
干预措施: Cyclophosphamide (Drug)
结局指标
主要结局
pathological complete response rate
时间窗: one year
次要结局
- clinical response rate(one year)
- Percentage of changes in hormone receptors status after treatment(one year)
- Number of relative prognostic factors which influence pCR(three years)
研究者
Shikai Wu
Chief Physician,Department of Radiotherapy
307 Hospital of PLA