Phase 3 Study of Weekly Paclitaxel in Combination With Cisplatin as Adjuvant Chemotherapy for Early Stage Human Epidermal Growth Factor Receptor-2 (HER2) Negative Breast Cancer in High-risk Women
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 762
- 试验地点
- 1
- 主要终点
- Number of Participants With Disease-Free Survival (DFS) Events
研究概览
简要总结
The investigators hypotheses that paclitaxel combined with cisplatin in a weekly-based regimen as adjuvant chemotherapy is more effective for high risk, HER2 negative breast cancer .
详细描述
In this trial, patients will be randomly assigned in a 2:1 ratio to receive cisplatin-based adjuvant chemotherapy and to standard adjuvant 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 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged ≥18 years and ≤70 years
- •Have accepted surgical treatment, histologically confirmed early breast cancer, the pathological types of invasive carcinoma
- •Not received treatment for breast cancer before operation
- •Triple-negative breast cancer confirmed by pathology, or pathology confirmed as the HR positive breast cancer at the same time meet the following conditions: axillary lymph node positive breast cancer, tumor size≥2 cm and Ki - 67 >20% or tumor size ≥2 cm and grade III or tumor size ≥2cm and aged <35 years
- •HER2 negative: immunohistochemistry HER2 (1 +) or HER2 (0), or fluorescence in situ hybridization (FISH): not amplified
- •Performance status (PS) 0-1
- •Adequate bone marrow function:WBC≥4.0×109/L, Absolute neutrophil count（ANC）≥1.5×109/L, Platelets（PLT）≥100×109/L, Hemoglobin（Hb）≥90g/L;aspartate aminotransferase(AST),Alanine aminotransferase (ALT)≤1.5 upper normal limit , creatinine≤1.5 upper normal limit, bilirubin≤1.5 upper normal limit
- •No obvious main organs dysfunction
排除标准
- •metastatic breast cancer
- •Patient is pregnant or breast feeding
- •Any evidence of sense or motor nerve disorders
- •Bilateral Primary Breast Cancer (DCIS in one side not included)
- •Patients with medical conditions taht indicate intolerant to adjuvant chemotherapy, including uncontrolled cardiovascular disease, severe infection
- •Have received chemotherapy because of any malignancy other than breast cancer
- •Known severe hypersensitivity to any drugs in this study
研究组 & 干预措施
paclitaxel and cisplatin
Drug: paclitaxel, cisplatin, epirubicin and cyclophosphamide Patients will be administered paclitaxel (80 mg/m² i.v. given weekly on day 1 q day 8 for 12 weeks) and cisplatin (25 mg/m² weekly on day 1 ,8,and 15 q day 28 for 3 cycles) followed by epirubicin and cyclophosphamide (EC) (epirubicin 90mg/m² i.v.d1, cyclophosphamide 600mg/m² i.v.d1) for 4 cycles.
干预措施: Paclitaxel, Cisplatin (Drug)
epirubicin and cyclophosphamide
Drug：epirubicin, cyclophosphamide, paclitaxel and docetaxel
Investigators will declare one of the following regimens:
Patients with hormone receptor (HR) positive breast cancer wil be administered epirubicin (90mg/m² i.v.d1 q21d) and cyclophosphamide (600mg/m² i.v.d1 q21d) for 4 cycles followed by docetaxel (75mg/m² i.v.d1 q21d) for 4 cycles.
Patients with triple-negative breast cancer will be administered epirubicin (90mg/m² i.v.d1 q21d) and cyclophosphamide (600mg/m² i.v.d1 q21d) for 4 cycles followed by weekly paclitaxel (80 mg/m² i.v.d1) for 12 weeks or docetaxel (75mg/m² i.v.d1 q21d) for 4 cycles.
干预措施: EC to docetaxel or paclitaxel (Drug)
结局指标
主要结局
Number of Participants With Disease-Free Survival (DFS) Events
时间窗: up to 5 year follow up
DFS is defined as the time period between registration and first event
次要结局
- Number of participants with treatment-related adverse events as assessed by CTCAE v3.0.(5 months during adjuvant therapy)
- Number of Participants With Overall Survival (OS) Events(up to 5 year follow up)