A Randomized, Open-Label, Phase III Study of Taxane Based Chemotherapy With Lapatinib or Trastuzumab as First-Line Therapy for Women With HER2/Neu Positive Metastatic Breast Cancer
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 652
- 试验地点
- 1
- 主要终点
- Progression Free Survival (PFS) at the Time of Primary Results
研究概览
简要总结
This was a multi-center, multinational, randomized, open-label, Phase III study comparing combination taxane-based chemotherapy plus lapatinib to combination taxane-based chemotherapy plus trastuzumab in women with documented evidence of human epidermal growth factor receptor 2 (HER2) positive metastatic breast cancer (MBC) (by local or central laboratory testing) who had received no prior chemotherapy or HER2 targeted therapy in the metastatic setting.
详细描述
Subjects were stratified by
- Prior (neo) adjuvant HER2/neu targeted therapy (yes, no)
- Prior (neo) adjuvant taxane chemotherapy (yes, no)
- Planned taxane treatment (once weekly paclitaxel versus docetaxel once every 3 weeks)
- Liver metastasis (yes, no)
Subjects were randomized 1:1 to the following treatments to a planned sample size of approximately 600 subjects (to achieve 536 centrally confirmed HER2 positive subjects):
- Taxane based chemotherapy plus lapatinib for 24 weeks followed by single agent lapatinib
- Taxane based chemotherapy plus trastuzumab for 24 weeks followed by single agent trastuzumab
The choice of taxane (once weekly paclitaxel versus docetaxel once every 3 weeks) was at the discretion of the treating physician and was specified at the time of subject randomization.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Lapatinib
Plus taxane based chemotherapy
干预措施: docetaxel (Drug)
Lapatinib
Plus taxane based chemotherapy
干预措施: lapatinib ditosylate (Drug)
Lapatinib
Plus taxane based chemotherapy
干预措施: paclitaxel (Drug)
Trastuzumab
Plus taxane based chemotherapy.
干预措施: trastuzumab (Biological)
Trastuzumab
Plus taxane based chemotherapy.
干预措施: docetaxel (Drug)
Trastuzumab
Plus taxane based chemotherapy.
干预措施: paclitaxel (Drug)
结局指标
主要结局
Progression Free Survival (PFS) at the Time of Primary Results
时间窗: From date of randomization until date of progression or date of death from any cause, whichever comes first, assessed up to approximately 39 months
Progression-free survival (PFS) is the time from randomization to the earliest date of RECIST 1.0 assessment of disease progression (with radiological evidence), death from any cause, or censoring. Disease progression was assessed by the Investigator and defined by RECIST v1.0 as a 20% increase in the sum of the longest diameter of target lesions, a measurable increase in a non-target lesion, or the appearance of new lesions.
次要结局
- Progression Free Survival (PFS) at the Time of Final Analysis(From date of randomization until date of progression or date of death from any cause, whichever comes first, assessed up to approximately 45 months)
- Overall Survival (OS) (IIT Population)(From date of randomization until date of death from any cause, assessed up approximately 165 months)
- Overall Survival (OS) (Central HER2+ Population)(From date of randomization until date of death from any cause, assessed up approximately 165 months)
- Incidence of Central Nervous System (CNS) Metastasis at First Progression (IIT Population)(From date of randomization to CNS metastases at time of first progression, assessed up approximately 45 months)
- Incidence of Central Nervous System (CNS) Metastasis at First Progression (Central HER2+ Population)(From date of randomization to CNS metastases at time of first progression, assessed up approximately 45 months)
- Time to Central Nervous System (CNS) Metastasis (IIT Population)(From date of randomization to CNS metastases at time of first progression, assessed up approximately 45 months)
- Time to Central Nervous System (CNS) Metastasis (Central HER2+ Population)(From date of randomization to CNS metastases at time of first progression, assessed up approximately 45 months)
- Overall Response Rate (ORR) (IIT Population)(From date of randomization until date of progression or date of death from any cause, whichever comes first, assessed up approximately 45 months)
- Overall Response Rate (ORR) (Central HER2+ Population)(From date of randomization until date of progression or date of death from any cause, whichever comes first, assessed up approximately 45 months)
- Clinical Benefit Response (CBR) (IIT Population)(From date of randomization until date of progression or date of death from any cause, whichever comes first, assessed up approximately 45 months)
- Clinical Benefit Response (CBR) (Central HER2+ Population)(From date of randomization until date of progression or date of death from any cause, whichever comes first, assessed up approximately 45 months)
- Time to Response (TTR) (IIT Population)(From date of randomization until date of first response, assessed up approximately 45 months)
- Time to Response (TTR) (Central HER2+ Population)(From date of randomization until date of progression or date of death from any cause, whichever comes first, assessed up approximately 45 months)
- Duration of Response (DoR) (IIT Population)(From first documented evidence of CR or PR (the response prior to confirmation) until time of documented disease progression or death due to any cause, whichever comes first, assessed up approximately 165 months)
- Duration of Response (DoR) (Central HER2+ Population)(From first documented evidence of CR or PR (the response prior to confirmation) until time of documented disease progression or death due to any cause, whichever comes first, assessed up approximately 165 months)
- EORTC QLQ-C30 Global Score at 12 Weeks(Week 12)
- Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only)(Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96, Week 120, Week 144)
- Change From Baseline in the EQ-VAS Score (Canadian and Australian Centers Only)(Baseline, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96, Week 120, Week 144)
- Number of Participants With Healthcare Utilization (Canadian and Australian Centers Only)(From date of randomization till 28 days safety follow-up, assessed up to 40 months)
- Number of Participant Hospitalized (Canadian and Australian Centers Only)(From date of randomization till 28 days safety follow-up, assessed up to 40 months)
- Total and Average Duration of Hospitalization (Canadian and Australian Centers Only)(From date of randomization till 28 days safety follow-up, assessed up to 40 months)
- Reasons for Hospitalization (Canadian and Australian Centers Only)(From date of randomization till 28 days safety follow-up, assessed up to 40 months)
- Type of Ward (Hospital Unit) (Canadian and Australian Centers Only)(From date of randomization till 28 days safety follow-up, assessed up to 40 months)
- Discharge Destinations (Canadian and Australian Centers Only)(From date of randomization till 28 days safety follow-up, assessed up to 40 months)
- Estrogen Receptor (ER) and Progesterone Receptor (PgR) Status(Up to approximately 39 months)