Phase II Study of Primary Chemotherapy With Anthracycline-based Regimen Followed by Nab-paclitaxel and Trastuzumab in Patients With HER2 Positive Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- To evaluate the pathological complete response rate
研究概览
简要总结
The purpose of this study is to evaluate the efficacy in terms of the pathological complete response (pCR) rate and the efficacy to preoperative administration of Anthracycline-based regimen followed by Nab-paclitaxel and Trastuzumab in patients with HER2 positive operable breast cancer.
详细描述
Four cycles of anthracycline-based regimen followed by four cycles of Nab-paclitaxel and Trastuzumab are administrated.
Anthracycline-based regimen (d1, q3w):
EC (Epirubicin 90mg/m2 and Cyclophosphamide 600mg/m2) AC (Doxorubicin 60mg/m2 and Cyclophosphamide 600mg/m2) FEC (Fluorouracil 500mg/m2, Epirubicin 100mg/m2 and Cyclophosphamide 500mg/m2)
Nab-paclitaxel 260mg/m2 (d1, q3w)
Trastuzumab (d1, q3w) is given at a dose of 8 mg/kg IV on day 1 of the first treatment cycle over 90 min, and subsequently given at a dose of 6 mg/kg over 30 min.
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
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed invasive breast cancer
- •T1c-3 N0-2a
- •Confirmed of hormonal receptor status
- •HER2 positive confirmed by IHC 3+ or FISH+
- •LVEF > 50% by echocardiogram or MUGA
- •Adequate EKG
- •No prior treatment for breast cancer
- •Required baseline laboratory data WBC > 4,000/mm3 and Neut > 2,000/mm3 PLT > 100,000/mm3 Hb > 9.0g/dl AST and ALT < ULNx2.5 T-Bil < 1.5mg/dl Serum creatinin < 1.5mg/dl
- •Written informed consent
排除标准
- •With history of hypersensitivity reaction for important drug in this study
- •With history of invasive breast cancer
- •Bilateral invasive breast cancer
- •Patients with medical conditions that renders them intolerant to primary chemotherapy and related treatment, including infection, diarrhea, intestinal paralysis, severe Diabetes Mellitus
- •Positive for HBs antigen and with history of HVB
- •With history of congestive heart failure, uncontrolled or symptomatic angina pectoris, arrhythmia or myocardial infarction, poorly controlled hypertension
- •With severe edema
- •With severe peripheral neuropathy
- •With severe psychiatric disorder
- •Pregnant or nursing women
- •Cases who physician judged improper to entry this trial
研究组 & 干预措施
Nab-paclitaxel
Nab-paclitaxel q3w 260mg/m2
干预措施: Nab-paclitaxel (Drug)
结局指标
主要结局
To evaluate the pathological complete response rate
时间窗: 1 year from last patient enrolled
次要结局
- Overall response rate(After the protocol therapy)
- Disease free survival(5 years from the last patient enrolled)
- Breast-conserving surgery rate(After the protocol therapy)
- Safety(Within the protocol thepapy)
- Pathological response rate(After the protocol therapy)
研究者
Satoru Tanaka
MD, PhD
Osaka Medical College