NCT05914753尚未招募不适用
A Prospective Clinical Study Evaluating Xihuang Pill to Improve the Efficacy of Neoadjuvant Chemotherapy for Breast Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 200
- 主要终点
- Pathological complete response (pCR)
研究概览
简要总结
Evaluate the effectiveness of Xihuang Pill in improving the efficacy of neoadjuvant chemotherapy for breast cancer
详细描述
- To evaluate the safety and effectiveness of Xihuang Pill in improving the efficacy of neoadjuvant chemotherapy for breast cancer under the condition of widespread use.
- To provide data support for improving the efficacy of neoadjuvant chemotherapy for clinical 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
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Biopsy of breast mass was performed under ultrasound-guided treatment before neoadjuvant chemotherapy, and the diagnosis of breast cancer was confirmed pathologically, followed by immunohistochemical examination. Pathological sections before and after neoadjuvant chemotherapy were jointly diagnosed by 3 or more senior pathologists, and there were consistent definite conclusions.
- •Have detailed and complete clinicopathological data;
- •Diagnosis data of TCM syndrome type;
- •No biopsy-confirmed lymph node metastasis;
- •No serious systemic disease, able to tolerate neoadjuvant chemotherapy and surgical treatment;
- •At least 4 cycles of neoadjuvant chemotherapy were completed, and the efficacy of chemotherapy was evaluated at the end of chemotherapy and after surgery;
- •Under the guidance of doctors, take Xihuang pills in a standardized way throughout the whole process and review regularly;
- •The patient did not receive any antitumor therapy drugs associated with the tumor prior to neoadjuvant chemotherapy;
- •All patients were newly diagnosed
排除标准
- •Concurrent malignant tumors of other sites;
- •Patients with distant metastasis
- •Male breast cancer
- •Patients who did not receive full-course standardized neoadjuvant chemotherapy;
- •Lost contact or dropped out of the study, unable to follow up;
- •Inability to tolerate chemotherapy responses;
- •Intolerant to Xihuang Wan and unable to take it;
- •The patient has strong side effects of chemotherapy and cannot tolerate chemotherapy drugs;
- •Inflammatory breast cancer, bilateral breast cancer, paget's disease and other special types of breast cancer;
- •Various other possible influences.
研究组 & 干预措施
Experimental group
Experimental
Experimental group: Epirubicin :90 mg/m2, D1, q3W; Cyclophosphamide :600 mg/m2, D1, q3W; Xihuang Pill：3g po bid，4 cycles, Follow Docetaxel :100 mg/m2, D1, q3W；Xihuang Pill：3g po bid，4 cycles
干预措施: Epirubicin, Cyclophosphamide, Xihuang Pill, Docetaxel (Drug)
Control group
Placebo Comparator
Control group: Epirubicin :90 mg/m2, D1, q3W; Cyclophosphamide :600 mg/m2, D1, q3W，4 cycles, Follow Docetaxel :100 mg/m2, D1, q3W，4 cycles
干预措施: Epirubicin, Cyclophosphamide, Docetaxel (Drug)
结局指标
主要结局
Pathological complete response (pCR)
时间窗: six months
Pathological complete response
次要结局
未报告次要终点
研究者
Xuli Meng
Chief physician
Zhejiang Provincial People's Hospital
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