JPRN-jRCT2080223113未知2 期
AN OPEN-LABEL, MULTICENTER EXTENSION STUDY OF TRASTUZUMAB EMTANSINE ADMINISTERED AS A SINGLE AGENT OR IN COMBINATION WITH OTHER ANTI-CANCER THERAPIES IN PATIENTS PREVIOUSLY ENROLLED IN A GENENTECH AND/OR F. HOFFMANN-LA ROCHE LTD-SPONSORED TRASTUZUMAB EMTANSINE STUDY
试验速览
- 阶段
- 2 期
- 入组人数
- 720
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 ot applicable(—)
- 性别
- All
入选标准
- •Completed single-agent trastuzumab emtansine or combination trastuzumab emtansine treatment in the parent study or who continue to receive single-agent trastuzumab emtansine or combination trastuzumab emtansine treatment at the time of the parent study closure and received the last study drug dose within the 6 weeks (42 days) prior to the first dose of study therapy on the extension study
- •-Expectation by the investigator that the patient may continue to benefit from additional single-agent trastuzumab emtansine or combination trastuzumab emtansine treatment
排除标准
- •-AE(s) leading to single-agent trastuzumab emtansine or combination trastuzumab emtansine treatment discontinuation in the parent study
- •- Ongoing SAE(s) from the parent study
- •- PD (except for isolated brain metastases under certain conditions) on single-agent trastuzumab emtansine or a trastuzumab emtansine-containing regimen during the parent study or before starting the extension study, with the exception of patients from Study TDM4688g with early PD who went on to receive pertuzumab + trastuzumab emtansine treatment and have not experienced further disease progression on the combination regimen
研究者
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