Neoadjuvant Chemotherapy With or Without Huaier Granule in Treating Women With Locally Advanced Breast Cancer That Can Be Removed By Surgery
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Pathologic complete response (pCR)
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 have found that Huaier could exert synergistic effects with Epirubicin, Cyclophosphamide, and Paclitaxel on breast cancer cells. It is not yet known whether combination chemotherapy is more effective when given together with Huaier in the neoadjuvant setting .
PURPOSE:
To evaluate the effects of treatment with Huaier Granule in managing locally advanced breast cancers with synergistic action of the neoadjuvant chemotherapy.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age: ≥ 18, female;
- •Breast cancer (TNM II, III, IV) larger than 2cm in maximal diameter able to benefit from neoadjuvant chemotherapy;
- •Ductal or lobular histological type of the breast tumor;
- •The diagnosis and breast cancer has been confirmed by pathological examination;
- •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 ≥ 8 months;
- •The subjects volunteer to sign the informed consent.
排除标准
- •Breast cancers of rare histological type (other than ductal and lobular);
- •Noninvasive cancer;
- •Presence of organ, bone, or skin metastases;
- •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
Docetaxel, Epirubicin and Cyclophosphamide (TEC)
Six cycles of docetaxel (75 mg/m²), epirubicin (70 mg/m²) and cyclophosphamide (600 mg/m²). Patients will be treated with chemotherapy every 3 weeks (+/- 2 days ) in total. Huaier Granule will be not be administrated.
干预措施: Epirubicin (Drug)
Docetaxel, Epirubicin and Cyclophosphamide (TEC)
Six cycles of docetaxel (75 mg/m²), epirubicin (70 mg/m²) and cyclophosphamide (600 mg/m²). Patients will be treated with chemotherapy every 3 weeks (+/- 2 days ) in total. Huaier Granule will be not be administrated.
干预措施: Docetaxel (Drug)
Docetaxel, Epirubicin and Cyclophosphamide (TEC)
Six cycles of docetaxel (75 mg/m²), epirubicin (70 mg/m²) and cyclophosphamide (600 mg/m²). Patients will be treated with chemotherapy every 3 weeks (+/- 2 days ) in total. Huaier Granule will be not be administrated.
干预措施: Cyclophosphamide (Drug)
Docetaxel, Epirubicin and Cyclophosphamide + Huaier (TEC+HE)
Six cycles of docetaxel (75 mg/m²), epirubicin (70 mg/m²) and cyclophosphamide (600 mg/m²). Patients will be treated with chemotherapy every 3 weeks (+/- 2 days ) in total. Huaier Granule will be administrated from the first cycle of chemotherapy until time of definitive surgery.
干预措施: Huaier Granule (Drug)
Docetaxel, Epirubicin and Cyclophosphamide + Huaier (TEC+HE)
Six cycles of docetaxel (75 mg/m²), epirubicin (70 mg/m²) and cyclophosphamide (600 mg/m²). Patients will be treated with chemotherapy every 3 weeks (+/- 2 days ) in total. Huaier Granule will be administrated from the first cycle of chemotherapy until time of definitive surgery.
干预措施: Epirubicin (Drug)
Docetaxel, Epirubicin and Cyclophosphamide + Huaier (TEC+HE)
Six cycles of docetaxel (75 mg/m²), epirubicin (70 mg/m²) and cyclophosphamide (600 mg/m²). Patients will be treated with chemotherapy every 3 weeks (+/- 2 days ) in total. Huaier Granule will be administrated from the first cycle of chemotherapy until time of definitive surgery.
干预措施: Docetaxel (Drug)
Docetaxel, Epirubicin and Cyclophosphamide + Huaier (TEC+HE)
Six cycles of docetaxel (75 mg/m²), epirubicin (70 mg/m²) and cyclophosphamide (600 mg/m²). Patients will be treated with chemotherapy every 3 weeks (+/- 2 days ) in total. Huaier Granule will be administrated from the first cycle of chemotherapy until time of definitive surgery.
干预措施: Cyclophosphamide (Drug)
Epirubicin and Docetaxel (ET)
Six cycles of epirubicin (70 mg/m²) and docetaxel (75 mg/m²). Patients will be treated with chemotherapy every 3 weeks (+/- 2 days ) in total. Huaier Granule will be not be administrated.
干预措施: Epirubicin (Drug)
Epirubicin and Docetaxel (ET)
Six cycles of epirubicin (70 mg/m²) and docetaxel (75 mg/m²). Patients will be treated with chemotherapy every 3 weeks (+/- 2 days ) in total. Huaier Granule will be not be administrated.
干预措施: Docetaxel (Drug)
Epirubicin and Docetaxel+Huaier (ET+HE)
Six cycles of epirubicin (70 mg/m²) and docetaxel (75 mg/m²). Patients will be treated with chemotherapy every 3 weeks (+/- 2 days ) in total. Huaier Granule will be administrated from the first cycle of chemotherapy until time of definitive surgery.
干预措施: Huaier Granule (Drug)
Epirubicin and Docetaxel+Huaier (ET+HE)
Six cycles of epirubicin (70 mg/m²) and docetaxel (75 mg/m²). Patients will be treated with chemotherapy every 3 weeks (+/- 2 days ) in total. Huaier Granule will be administrated from the first cycle of chemotherapy until time of definitive surgery.
干预措施: Epirubicin (Drug)
Epirubicin and Docetaxel+Huaier (ET+HE)
Six cycles of epirubicin (70 mg/m²) and docetaxel (75 mg/m²). Patients will be treated with chemotherapy every 3 weeks (+/- 2 days ) in total. Huaier Granule will be administrated from the first cycle of chemotherapy until time of definitive surgery.
干预措施: Docetaxel (Drug)
结局指标
主要结局
Pathologic complete response (pCR)
时间窗: one month after operation
A pCR in the breast was defined as no pathologic evidence of invasive disease (residual ductal carcinoma in situ (DCIS) or lobular carcinoma in situ (LCIS) was allowed).
次要结局
- Clinical Complete Response (cCR)(one month after the neoadjuvant chemotherapy)
- Disease-free survival (DFS)(up to 10 years)
- Overall survival (OS)(up to 10 years)
研究者
Qifeng Yang
Professor
Shandong University