JPRN-jRCT2051200152进行中（未招募）2 期
A phase 2 open-label, single arm study of MK-7119 in combination with trastuzumab and capecitabine in participants with previously treated locally advanced unresectable or metastatic HER2+ breast carcinoma
akamura Sosuke0 个研究点目标入组 55 人开始时间: 2021年3月12日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 55
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
- •Has histologically confirmed HER2+ breast carcinoma
- •- Has received previous treatment with trastuzumab, pertuzumab, and T-DM1
- •- Has radiographically and/or histologically confirmed disease progression on last systemic anticancer treatment for unresectable locally advanced or metastatic HER2+ breast carcinoma
- •- Has adequate organ function
- •- Female participant is not pregnant or breastfeeding and is not a woman of childbearing potential (WOCBP) or is a WOCBP and using contraception or abstinent from heterosexual intercourse during the intervention period and for at least 30 days after receiving the last dose of tucatinib, 7 months after receiving the last dose of trastuzumab, or 180 days after receiving the last dose of capecitabine, whichever occurs last and agrees to not donate eggs during this period
- •- Male participants refrain from donating sperm and are either abstinent from heterosexual intercourse or agree to use contraception during the intervention period and for at least 7 days after receiving the last dose of tucatinib and 90 days after receiving the last dose of capecitabine, whichever occurs last
- •- Previously treated brain metastasis is stable or progressed, provided there is no clinical indication for immediate re-treatment
排除标准
- •- Has been previously treated with lapatinib within 12 months of starting study treatment
- •- Has been previously treated with neratinib, afatinib, tucatinib or capecitabine for metastatic disease
- •- Has a history of exposure to doxorubicin, epirubicin, mitoxantrone, idarubicin, liposomal doxorubicin
- •- Has had treatment with any systemic anti-cancer therapy including hormonal therapy, non-central nervous system (CNS) radiation or experimental agent =<3 weeks before first dose of study treatment
- •- Has any toxicity related to prior cancer therapies that has not resolved with the exception of alopecia, congestive heart failure, anemia
- •- Has clinically significant cardiopulmonary disease
- •- Has known myocardial infarction or unstable angina within 6 months prior to the first dose of study treatment
- •- Has any uncontrolled viral, bacterial or fungal infection within 14 days prior to the first dose of study treatment
- •- Is positive for Hepatitis B, Hepatitis C or has known chronic liver disease
- •- Is known to be positive for human immunodeficiency virus (HIV)
- •- Has evidence within 2 years of the start of study treatment of another malignancy that required systemic treatment
- •- Has ongoing use of systemic corticosteroids for control of symptoms of brain metastases
- •- Has any brain lesion thought to require immediate local therapy
- •- Has known or suspected leptomeningeal disease (LMD)
- •- Has poorly controlled generalized or complex partial seizures or manifest neurologic progression due to brain metastases
研究者
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