EUCTR2011-000509-29-SK进行中（未招募）不适用
A Phase III randomized, multicenter, two-arm, open-label trial to evaluate the efficacy of T-DM1 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
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 795
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Age = 18 years
- •Histologically or cytologically documented breast cancer
- •Metastatic or unresectable locally advanced/recurrent breast cancer
- •HER2-positive disease by prospective central laboratory confirmation
- •Disease progression on the last regimen received as defined by the investigator
- •Prior treatment with an anthracycline, trastuzumab, a taxane,lapatinib, and capecitabine
- •Disease progression after at least regimens of HER2 directed therapy in the metastatic or unresectable locally advanced/recurrent breast cancer
- •A minimum of 6 weeks of prior trastuzumab
- •Patients must have prior exposure to lapatinib and capecitabine.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 795
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 79
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 T-DM1-containing study, regardless of whether the patient received prior T-DM1
- •Brain metastases that are untreated or symptomatic, or require any radiation, surgery, or steroid therapy to control symptoms within 2 months of randomization.
研究者
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