Phase 2 Study of Weekly Paclitaxel in Combination With Cisplatin as Neoadjuvant Therapy for Locally Advanced Breast Cancer Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 132
- 试验地点
- 2
- 主要终点
- Pathological complete response of breast and lymph nodes
研究概览
简要总结
The investigators hypotheses that paclitaxel combined with cisplatin in a weekly-based regimen as neoadjuvant chemotherapy is effective and tolerable for locally advanced breast cancer.
详细描述
In this trial, all the patients will have weekly paclitaxel and cisplatin as neoadjuvant chemotherapy for 4 cycles. Patients with Her2 positive tumor will also receive the trastuzumab.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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 ≥18years and ≤70 years
- •At least on measurable disease according to the Response Evaluation Criteria in Solid Tumors (RECIST). Histologically confirmed invasive breast cancer, tumor size ≥2 cm, T2-4 N0-2M0
- •ER/PR/HER-2 and Ki-67 status detected on core biopsy. ER/PR positive is defined as >1% stained cells and HER2-positive is defined as immuno-histochemistry (IHC) 3+ or FISH ratio ≥ 2.0
- •No prior systemic or loco-regional treatment of breast cancer
- •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 （UNL）, creatinine≤1.5 UNL, bilirubin≤1.5UNL
- •No obvious main organs dysfunction
排除标准
- •Unwilling or unable to use an acceptable method of contraception in 8 weeks (including 8 weeks) after final dose of test drug
- •Patient is pregnant or breast feeding
- •Inflammatory breast cancer and metastatic breast cancer
- •Any evidence of sense or motor nerve disorders
- •Patients with medical conditions taht indicate intolerant to neoadjuvant therapy, including uncontrolled cardiovascular disease, severe infection
- •Any concurrent malignancy other than breast cancer
- •Know severe hypersensitivity to any drugs in this study
研究组 & 干预措施
Paclitaxel and Cisplatin
Paclitaxel: 80 mg/m² i.v. given weekly on day 1 q day 8 for 16 weeks. Cisplatin: 25 mg/m² weekly on day 1 ,8,and 15 q day 28 for 4 cycles.
Trastuzumab (only for human epidermal growth factor receptor-2(HER2)-positive patients): Loading dose: 4 mg/kg, Maintenance dose: 2 mg/kg, day 1 q day 8 for 16 weeks. Post-surgery: up to a total duration of 1 year
干预措施: Paclitaxel (Drug)
Paclitaxel and Cisplatin
Paclitaxel: 80 mg/m² i.v. given weekly on day 1 q day 8 for 16 weeks. Cisplatin: 25 mg/m² weekly on day 1 ,8,and 15 q day 28 for 4 cycles.
Trastuzumab (only for human epidermal growth factor receptor-2(HER2)-positive patients): Loading dose: 4 mg/kg, Maintenance dose: 2 mg/kg, day 1 q day 8 for 16 weeks. Post-surgery: up to a total duration of 1 year
干预措施: Cisplatin (Drug)
结局指标
主要结局
Pathological complete response of breast and lymph nodes
时间窗: after 4 months preoperative treatment
次要结局
- local recurrence free survival (LRFS)(5 years)
- regional recurrence free survival (RRFS)(5 years)
- overall survival (OS)(5 years)
- Tolerability and Safety(4 months during neoadjuvant therapy)
- Clinical and imaging response(4 months during treatment)
- distant-disease- free survival (DDFS)(5 years)
研究者
Jinsong Lu
Director of Breast Surgery
RenJi Hospital