JPRN-jRCT2031210130进行中（未招募）3 期
Phase III Study of Trastuzumab Deruxtecan (T-DXd) with or without Pertuzumab versus Taxane, Trastuzumab and Pertuzumab in HER2-positive, First-line Metastatic Breast Cancer - DESTINY-Breast09
Inoguchi Akihiro0 个研究点目标入组 1,134 人开始时间: 2021年6月4日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,134
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 <= 130age old（—）
- 性别
- All
入选标准
- •Patients must be >=18 years of age(>=20 years of age - applicable for Japan only)
- •- Pathologically documented breast cancer that:
- •1.is advanced or metastatic
- •2.is locally assessed and prospectively centrally confirmed as HER2-positive (IHC3+ or ISH+)
- •3.is documented by local testing as hormone receptor (HR)-positive or HR-negative disease in the metastatic setting
- •- No prior chemotherapy or HER2-targeted therapy for advanced or metastatic breast cancer or only 1 previous line of endocrine therapy in the metastatic setting. Participants who have received chemotherapy or HER2-targeted therapy in the neo-adjuvant or adjuvant setting are eligible if > 6 months from treatment to metastatic diagnosis.
- •- Has protocol-defined adequate organ and bone marrow function
排除标准
- •- Ineligible for any of the agents on the study.
- •- Any substance abuse or other medical conditions that, in the investigator's opinion, may interfere with subject's participation or study results
- •- Patients with spinal cord compression or clinically active central nervous system metastases. Participants with clinically inactive brain metastases or treated brain metastases that are no longer symptomatic may be included in the study.
- •- Active or prior documented interstitial lung disease (ILD)/pneumonitis or suspected ILD/pneumonitis that cannot be ruled out by imaging at screening
- •- Prior randomization or treatment in a previous trastuzumab deruxtecan study regardless of treatment arm assignment
研究者
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