A Randomized, Open-label Study of the Effect of Herceptin Plus Arimidex Compared With Arimidex Alone on Progression-free Survival in Patients With HER2-positive and Hormone-receptor Positive Metastatic Breast Cancer
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 208
- 主要终点
- Progression Free Survival (PFS)
研究概览
简要总结
This 2 arm study assessed the safety and efficacy of adding intravenous trastuzumab (Herceptin®) to daily oral anastrozole (Arimidex®) tablets as first- and second-line treatment in postmenopausal patients with human epidermal growth factor receptor-2 (HER2) overexpressing metastatic breast cancer (ER+ve and/or PR+ve). Patients were randomized to receive either anastrazole 1 mg per os (po) daily, or anastrazole 1 mg po daily + a loading dose of Herceptin® 4 mg/kg intravenous (iv) followed by weekly doses of Herceptin® 2 mg/kg iv. The anticipated time on study treatment was until disease progression, and the target sample size was 100-500 individuals.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- •postmenopausal women;
- •metastatic breast cancer suitable for endocrine therapy;
- •positive hormone receptor status;
- •Human epidermal growth factor receptor 2 (HER2) overexpression.
排除标准
- •patients on hormone replacement therapy;
- •previous chemotherapy for metastatic disease;
- •uncontrolled cardiac disease and history of cardiac failure.
研究组 & 干预措施
trastuzumab + anastrozole
Trastuzumab 4 mg/kg loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes plus 1 mg oral dose of anastrozole every day for 24 Months in the Main phase and in the Extension Phase.
干预措施: trastuzumab (Herceptin®) (Drug)
trastuzumab + anastrozole
Trastuzumab 4 mg/kg loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes plus 1 mg oral dose of anastrozole every day for 24 Months in the Main phase and in the Extension Phase.
干预措施: anastrazole (Arimidex®) (Drug)
anastrozole
1 mg oral dose of anastrozole every day for 24 Months in the Main phase. In the Extension Phase participants could cross-over to also receive trastuzumab 4 mg/kg initial loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes.
干预措施: anastrazole (Arimidex®) (Drug)
结局指标
主要结局
Progression Free Survival (PFS)
时间窗: 24 Months, End of Study (Up to 5 years)
PFS was assessed by the investigator based on World Health Organization (WHO) criteria using radiographic tumor evaluations. Disease progression was defined as the appearance of any new lesion not previously identified or an estimated increase of 25% or more in existent bidimensionally or unidimensionally measurable lesions or progression of an existing non-measurable lesion. For bidimensionally measurable malignant lesions with an area of at least 2.0 centimeters squared (cm\^2) an increase of 1.0 cm\^2 was required and for unidimensionally measurable lesions of 1.0 cm or less an increase of 0.5 cm was required. PFS was defined as the number of days between date of randomization and date of documented disease progression or date of death. Kaplan Meier estimates of PFS are presented.
次要结局
- Percentage of Participants With Clinical Benefit(24 Months, End of Study (Up to 5 years))
- Duration of Response at 24 Months(24 Months)
- Time to Response at 24 Months(24 Months)
- Overall Survival at 24 Months(24 Months)
- Percentage of Participants With Two-Year Survival(24 Months)
- Percentage of Participants With Overall Tumor Response at 24 Months(24 Months)
- Percentage of Participants With Best Tumor Response at 24 Months(24 Months)
- Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status at Final Visit Compared to Baseline(Baseline, Final Visit (Up to 24 Months))
- Duration of Response at End of Study(End of Study (Up to 5 years))
- Time to Response at End of Study(End of Study (Up to 5 years))
- Percentage of Participants With Overall Tumor Response at End of Study(End of Study (Up to 5 years))
- Percentage of Participants With Best Tumor Response at End of Study(End of Study (Up to 5 years))
- Number of Participants With Adverse Events(Throughout the Study (Up to 5 years))