BrUOG-BR-211B q3week Carboplatin With Weekly Abraxane and Trastuzumab As Neoadjuvant Therapy in Resectable and Unresectable HER2+ (Stage IIa-IIIb) Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 5
- 主要终点
- Number of Patients With Complete Pathologic Response Rate, Observed Following Treatment With q3week Carboplatin, Weekly Abraxane and Weekly Trastuzumab in Resectable and Unresectable LABC;
研究概览
简要总结
Q3week carboplatin with weekly abraxane and trastuzumab as neoadjuvant therapy in resectable and unresectable HER2+ (stage IIa-IIIb) breast cancer
详细描述
Our goal is to develop an induction chemotherapy regimen that will have a pCR rate above 50% in HER2+ patients without exposing patients to the toxicity of an anthracycline-based regimen. A minimum of 60 evaluable patients will be accrued to the study. We are assuming an observed pCR (or near pCR) rate of 70%. Assuming no more than 10% of patients will be inevaluable for the primary endpoint (pCR), we will have at least 54 evaluable patients. With this number, we will have 90% power, with a 1-sided alpha error of 0.05, to demonstrate a pCR rate exceeding 50% for our novel regimen.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •Histologically documented adenocarcinoma of the breast
- •ANC > 1000 cells
- •Female; age > 18; Zubrod PS 0-1
- •Platelets > 100,000
- •Stage IIA-IIIB disease
- •Total bilirubin < or = ULN
- •No evidence of metastatic disease Not pregnant or lactating
- •No prior systemic therapy for this breast cancer
- •Serum Creatinine < 1.5 mg/dl or Creat Cl > 30 ml/min
- •Serum ALT < 2.5 x ULN
- •ER, PR and HER2 status required
- •LVEF (MUGA/echo)WNL
- •No baseline > 2 neuropathy
- •Hemoglobin > 9.0 gm/dl
- •HER2+, defined by IHC 3+ or FISH ratio > 2.0
排除标准
- 未提供
研究组 & 干预措施
Neo-adjuvant cohort 1
干预措施: Cohort 1 neo-adjuvant (Drug)
Neo-adjuvant cohort 2
干预措施: Cohort 2 neo-adjuvant (Drug)
Adjuvant cohort 1
干预措施: Cohort 1 adjuvant (Drug)
Adjuvant cohort 2
干预措施: Cohort 2 adjuvant (Drug)
结局指标
主要结局
Number of Patients With Complete Pathologic Response Rate, Observed Following Treatment With q3week Carboplatin, Weekly Abraxane and Weekly Trastuzumab in Resectable and Unresectable LABC;
时间窗: 1 year
These numbers represent patients with a RCB score of zero (0). RCB stands for residual cancer burden.
次要结局
- Patients Affected by Toxicities of Regimen During Treatment, Including Grade >2 Neurotoxicity the Incidence of Subclinical and Clinical Cardiac Toxicity(1 year)
研究者
William Sikov MD
Principle Investigator
Brown University