A Phase III Randomized, Multicenter, Two Arm, Open-label Trial to Evaluate the Efficacy of Trastuzumab Emtansine Compared With Treatment of Physician's Choice in Patients With HER2-positive Metastatic Breast Cancer Who Have Received at Least Two Prior Regimens of HER2 Directed Therapy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 602
- 主要终点
- Progression-free Survival
研究概览
简要总结
This randomized, multicenter, 2-arm, open-label study (TH3RESA) will evaluate the efficacy and safety of trastuzumab emtansine (T-DM1) in comparison with treatment of the physician's choice in participants with metastatic or unresectable locally advanced/recurrent human epidermal growth factor receptor 2 (HER2)-positive breast cancer. Eligible participants will be randomized to receive either trastuzumab emtansine 3.6 mg/kg intravenously every 21 days or treatment of the physician's choice. Participants continue to receive study treatment until disease progression or unacceptable toxicity occurs. This study is also known under Roche study protocol number BO25734.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Adult participants ≥ 18 years of age.
- •Histologically or cytologically documented breast cancer.
- •Metastatic or unresectable locally advanced/recurrent breast cancer.
- •HER2-positive disease by prospective laboratory confirmation.
- •Disease progression on the last regimen received as defined by the investigator.
- •Prior treatment with an trastuzumab, a taxane, and lapatinib.
- •Disease progression after at least two regimens of HER2-directed therapy in the metastatic or unresectable locally advanced/recurrent setting.
- •Adequate organ function, as evidenced by laboratory results.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or
- •Left ventricular ejection fraction (LVEF) ≥ 50% by echocardiogram or multi gated acquisition scan.
排除标准
- •Chemotherapy ≤ 21 days before first study treatment.
- •Trastuzumab ≤ 21 days before first study treatment.
- •Lapatinib ≤ 14 days before first study treatment.
- •Prior enrollment in a trastuzumab emtansine containing study, regardless whether the patient received prior trastuzumab emtansine.
- •Brain metastases that are untreated or symptomatic, or require any radiation, surgery or corticosteroid therapy to control symptoms within 1 month of randomization.
研究组 & 干预措施
Trastuzumab emtansine
Trastuzumab emtansine 3.6 mg/kg intravenously every 3 weeks until disease progression (as assessed by the investigator) or unmanageable toxicity.
干预措施: Trastuzumab emtansine (Drug)
Treatment of physician's choice
Treatment of physician's choice until disease progression (as assessed by the investigator) or unmanageable toxicity. The treatments included single-agent chemotherapy, single-agent or dual-agent hormonal therapy for hormone receptor positive-disease, and HER2-directed therapy.
干预措施: Treatment of physician's choice (Drug)
结局指标
主要结局
Progression-free Survival
时间窗: Baseline to the clinical cut-off date of 11 Feb 2013 (up to 2 years)
Progression-free survival was defined as the time from randomization to the first documented disease progression by investigator assessment using Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 or death from any cause, whichever occurred first. Progression-free survival was a co-primary endpoint.
Overall Survival
时间窗: Baseline to the clinical cut-off date of 11 Feb 2013 (up to 2 years)
Overall survival (OS) was defined as the time from randomization to death from any cause. Overall survival was a co-primary endpoint.
次要结局
- Time to Pain Symptom Progression(Baseline to the clinical cut-off date of 11 Feb 2013 (up to 2 years))
- Percentage of Participants With an Objective Response(Baseline to the clinical cut-off date of 11 Feb 2013 (up to 2 years))
- Duration of the Objective Response(Baseline to the clinical cut-off date of 11 Feb 2013 (up to 2 years))
- 6-month and 1-year Survival(Baseline to the clinical cut-off date of 11 Feb 2013 (up to 2 years))
- Change From Baseline in the EORTC QLQ-BM22 Pain Score on Day 1 of Each Cycle(Baseline to the clinical cut-off date of 11 Feb 2013 (up to 2 years))
- Overall Survival (Final Analysis)(Baseline to the clinical cut-off date of 13 Feb 2015 (up to 4 years))
- 6-month and 1-year Survival (Final Analysis)(Baseline to the clinical cut-off date of 13 Feb 2015 (up to 4 years))