NL-OMON52270招募中3 期
A Phase 3, Open-label, Randomized Study of Dato-DXd Versus Investigator*s Choice of Chemotherapy in Participants With Inoperable or Metastatic Hormone Receptor-Positive, HER2-Negative Breast Cancer Who Have Been Treated With One or Two Prior Lines of Systemic Chemotherapy (TROPION-Breast01) - TROPION-Breast01
Astra Zeneca0 个研究点目标入组 18 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 18
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
- 18 至 99（—）
入选标准
- •- Inoperable or metastatic HR-positive / HER2*negative breast cancer.
- •- Progressed on and not suitable for endocrine therapy per investigator
- •assessment, and previously treated with 1 or 2 lines of chemotherapy in the
- •inoperable / metastatic setting. Participant must have documented progression
- •on most recent line of chemotherapy. Targeted agents (such as mTOR inhibitors,
- •PD-1/PDL1 inhibitors), endocrine therapies, and CDK4/6 inhibitors on their own
- •do not contribute to the count of prior lines of chemotherapy; however,
- •regimens with such agents in combination with metastatic chemotherapy should be
- •classified as one line of chemotherapy.
- •- At least 1 measurable lesion not previously irradiated. Participants with
- •bone-only metastases are not permitted. Participants with clinically inactive
- •brain metastases may be included
- •- Adequate organ and bone marrow function; LVEF >= 50% by echocardiogram or MUGA
- •- All participants must have available a FFPE tumor sample
排除标准
- •- Uncontrolled medical conditions E.g. Cardiac Disease, leptomeningeal
- •carcinomatosis, systemic infections
- •- History of ILD, severe Pulmonary compromise
- •- Prior anticancer therapy with another ADC, TROP2-targeted therapy (e.g.,
- •Trodelvy), same ICC chemotherapy
- •- Concurrent anticancer treatment or hormonal therapy for non-cancer related
- •- Receipt of live, attenuated vaccine within 30 days before C1D1.
- •- Prior participation in any Enhertu (T-Dxd) study (regardless if received
- •T-DXd or not)
- •- Known hypersensitivity to Dato-DXd or any of the excipients of the product
- •(including, but not limited to, polysorbate 80), or any other monoclonal
研究者
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