Phase II Study of Neoadjuvant Nab-paclitaxel (PTX) and Trastuzumab for ER Negative and HER2 Positive Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Pathological complete response rate
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of nab-PTX and trastuzumab for ER negative and HER2 positive operable (tumor size of 3cm or less and N0) breast cancer.
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
- •Tumor size of 3cm or less and N0
- •Hormone receptors have been identified as negative
- •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 or HCV antibody
- •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
- •The case that is judged to be unsuitable for this study by physician
研究组 & 干预措施
nab-paclitaxel plus trastuzumab
Four cycles of nab-PTX 260 mg/m2 with trastuzumab 6 mg/kg (8 mg/kg as the loading dose). One year of adjuvant trastuzumab will be administrated. Anthracycline regimens may be administered by physician's choice for the case expected to have a high risk of recurrence based on the pathological findings of surgical specimen. Adjuvant endocrine therapy may be administrated for the case with weakly hormone-sensitive (1-9% of positive cells) tumor.
干预措施: nab-paclitaxel (Drug)
nab-paclitaxel plus trastuzumab
Four cycles of nab-PTX 260 mg/m2 with trastuzumab 6 mg/kg (8 mg/kg as the loading dose). One year of adjuvant trastuzumab will be administrated. Anthracycline regimens may be administered by physician's choice for the case expected to have a high risk of recurrence based on the pathological findings of surgical specimen. Adjuvant endocrine therapy may be administrated for the case with weakly hormone-sensitive (1-9% of positive cells) tumor.
干预措施: Trastuzumab (Drug)
结局指标
主要结局
Pathological complete response rate
时间窗: Up to 12 weeks after the protocol therapy
次要结局
- Objective response rate(Up to 6 weeks after the protocol therapy)
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0(Up to 6 weeks after the protocol therapy)
- Disease free survival(Five years after the last patient enrolled)
- Pathological response rate(Up to 12 weeks after the protocol therapy)
- Breast-conserving surgery rate(Up to 6 weeks after the protocol therapy)
研究者
Satoru Tanaka
MD, PhD
Osaka Medical College