A Phase II Study to Evaluate the Efficacy, Safety, and Pharmacodynamics of Lapatinib in Combination With Paclitaxel as Neoadjuvant Therapy in Patients With Newly Diagnosed Inflammatory Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- Percentage of participants with pathologic complete response rate (pCR)
研究概览
简要总结
This Study was designed to determine how effective and safe a new investigational drug, lapatinib, is in combination with paclitaxel in treating patients with newly diagnosed inflammatory breast cancer. Tumor tissue collected pre-treatment, following 14 days of treatment and at the time of surgical resection will be examined for pathologic response and biologic activity by IHC (immunohistochemistry) within the tumor. Treatment will consist of 14 days of lapatinib monotherapy followed by 12 weeks of combination therapy with lapatinib and paclitaxel. Blood samples for hematology and chemistry panels, MUGA/ECHO exams and physical exams will be performed throughout the study to monitor safety.
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
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Overall study
A Single arm study with 2 cohorts of participants. Cohort A consists of participants with tumors overexpressing HER2 and/or EGFR. Cohort B consists of participants with tumors expressing EGFR without overexpressing HER2.
干预措施: Lapatinib (Drug)
Overall study
A Single arm study with 2 cohorts of participants. Cohort A consists of participants with tumors overexpressing HER2 and/or EGFR. Cohort B consists of participants with tumors expressing EGFR without overexpressing HER2.
干预措施: Paclitaxel (Drug)
结局指标
主要结局
Percentage of participants with pathologic complete response rate (pCR)
时间窗: Week 12
pCR was defined as the percentage of participants who achieved an assessment of complete response (CR) following pathologic review of resected tissue. CR was the disappearance of all target lesions. Participants in each cohort with unknown or missing response (i.e., those that did not undergo surgery) were included in the denominator when calculating the percentage. From an efficacy standpoint, the HER2+ population response was considered to be of special interest.
次要结局
- Percentage of participants with pCR that underwent surgical resection(Week 12)
- Percentage of participants with objective response rate (ORR) at the end of study (Response evaluation criteria in solid tumor [RECIST])(Week 14)
- Percentage of participants with ORR at the end of study (Clinically Evaluable Skin Disease Criteria)(Week 14)
- Percentage of participants with ORR at the end of study ('Best' of RECIST and Clinically Evaluable Skin Disease Criteria)(Week 14)
- Percentage of participants with investigator-Assessed Best Response at the end of monotherapy phase (Day 14) (Clinically Evaluable Skin Disease Criteria)(Day 14)
- Number of participants with adverse events (AEs) and serious adverse events (SAEs)(Up to Week 14, surgical resection and post treatment)
- Number of participants with shift from Baseline in hematological toxicity grade(Day 14 and up to Week 23, surg resection and post treatment)
- Number of participants with shift from Baseline in clinical chemistry toxicity grade(Day 14, Week 4, 8, 12, 16, 20, Surg resection and post treatment)
- Change from Baseline in vital signs- Systolic blood pressure (SBP) and Diastolic blood pressure (DBP)(Day 14, Week 1 and up to Week 24, surg resection and post treatment)
- Change from Baseline in vital signs- Heart Rate (HR)(Day 14, Week 1 and up to Week 24, surg resection and post treatment)
- Change from Baseline in vital signs- Body temperature(Day 14, Week 1 and up to Week 24, surg resection and post treatment)
- Number of participants with abnormal electrocardiogram (ECG) findings(Screening and unscheduled)
- Number of participants with change from Baseline in echocardiogram (ECHO) or Multi-gated angiogram (MUGA) results at any post Baseline visit(Screening, Week 8, 16, 24, post treatment)