Huaier Granule in Treating Women With Triple Negative Breast Cancer
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Disease free survival (DFS)
研究概览
简要总结
RATIONALE:
Huaier (Trametes robiniophila Murr) is a traditional Chinese medicine, which has been widely used in China for many years. The investigators previous study has reported that Huaier could exert great inhibitory effects on breast cancer cells both in vitro and in vivo.
PURPOSE:
To evaluate the efficacy and safety of Huaier Granule in treating women who have triple negative breast cancer that has been surgically removed.
详细描述
OBJECTIVES:
Compare the disease-free survival (DFS) and overall survival (OS) of patients with triple negative breast cancer who are randomized to adjuvant Huaier Granule group vs. those randomized to Blank-control group.
OUTLINE:
Patients are randomized to the following one of two treatment groups and are followed annually.
Arm I: Patients taking Huaier Granule for adjuvant treatment after the triple negative breast cancer has been surgically removed.
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 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age: ≥ 18 and ≤ 75 years, female;
- •Triple negative breast cancer has been surgically removed;
- •The triple negative breast cancer has been confirmed by pathological examination and Immunohistochemistry (IHC);
- •Not receiving any preoperative anticancer drugs;
- •The liver and kidney function satisfies the following conditions within 3 days after surgery (excluding day 3): aspartate aminotransferase (AST), glutamic-oxalacetic transaminase (ALT) < 2 upper limit of normal (ULN), total bilirubin ≤ 1.5 ULN, serum creatinine < 1.5 ULN;
- •Other laboratory tests meet the following requirements within 3 days after surgery (excluding day 3): Hb ≥ 90g/l, platelet count ≥ 100×109/L, absolute neutrophil count > 1.5×109/L;
- •The expected survival time ≥ 6 months;
- •The subjects volunteer to sign the informed consent.
排除标准
- •Patients with stage IV breast cancer;
- •Triple negative breast cancer was not surgically removed;
- •Non-triple negative breast cancer patients confirmed by pathological examination and Immunohistochemistry (IHC);
- •Pregnant or lactating women;
- •Those with active bleeding due to various reasons;
- •Those with HIV infection or AIDS-associated diseases;
- •Those with severe acute and chronic diseases;
- •Those with severe diabetes;
- •Those with serious infectious diseases;
- •Those who can not take drugs by oral route;
- •Drug abusers or those with psychological or mental diseases that may interfere with study compliance;
- •Conditions that are considered not suitable for this study investigators
研究组 & 干预措施
Arm I
Patients taking Huaier Granule for adjuvant treatment after the triple negative breast cancer has been surgically removed. The Huaier Granule (Qidong Gaitianli Medicines Co., Ltd.) should be given orally from the 3rd day after surgery up to 5 years after surgery or until study termination.
干预措施: Huaier Granule (Drug)
结局指标
主要结局
Disease free survival (DFS)
时间窗: Up to 10 years
Time from randomization to recurrence, metastasis, appearance of a second primary tumor, or death from any cause, whichever occurs first, assessed up to 10 years.
次要结局
- Overall survival (OS)(Up to 10 years)
研究者
Qifeng Yang
Professor
Shandong University