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这是一项关于乳腺癌的III 期研究，登记的药物或干预包括Dato-DXd，当前状态为招募中。登记地点显示中国北京、长沙、广州、临沂等城市有研究中心记录。是否仍有名额以及是否值得进一步询问，需要向研究中心确认。
药物或干预
Dato-DXd · III 期
登记条件中文摘要
年龄范围：18岁及以上
登记的基本范围为不限性别，年龄18岁及以上；以下仅摘录8项专业入选条件，需结合英文原文并由研究团队确认。
登记记录列出8项主要排除条件，具体医学含义需结合英文原文并由研究团队确认。
中国哪些地方有记录
以下地点来自登记信息，不代表此刻仍有名额；请向研究中心确认最新情况。
- Research Site · 北京
- Research Site · 长沙
- Research Site · 广州
- Research Site · 临沂
- Research Site · 山东省
- Research Site · 武汉
- Research Site · 郑州
入选条件原文摘录
以下为摘录，请打开原始登记查看完整入排标准。
- 1. Participant must be ≥ 18 years (and above legal age) at the time of screening.
- 2. Inoperable or metastatic HR-positive, HER2 IHC 0 breast cancer (per ASCO/CAP guidelines, on local laboratory results); ie, is documented as HR-positive (either ER and/or PgR positive \[ER or PgR ≥ 1%\]) and HER2 IHC 0 (defined as including HER2 null with no staining or incomplete and faint/barely perceptible membrane staining in ≤ 10% of tumour cells) based on a fresh, or recent tissue sample. Tumour status must be confirmed using the most recent tumour biopsy (preferably fresh biopsy).
- A fresh biopsy may only be omitted if not medically feasible due to documented clinical reasons, such as anatomical inaccessibility, unacceptable procedural risk, or patient refusal after appropriate discussion. In such cases, the most recent available tumour sample may be used. The specific reason for not obtaining a fresh biopsy must be prospectively documented and may be subject to sponsor review.
- 3. Progressed on and not suitable for further endocrine therapy per investigator assessment.
- 4. ECOG performance status of 0 or 1, with no deterioration over the previous 2 weeks prior to the first dose of study intervention.
- 5. Minimum life expectancy of 12 weeks at screening.
- 6. Provision of acceptable tumour sample (newly acquired tumour biopsy at baseline or the latest archival biopsy available if a fresh biopsy is not feasible) as defined in the Laboratory Manual
- 7. Participants must have measurable disease as per RECIST 1.1 or evaluable disease. Lesions that will be subject to mandatory biopsy before, during, and after the dosing cannot be considered as TLs as per RECIST requirements.
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请继续确认中心是否启动、疾病分型、既往治疗、检查费用和知情同意安排。
查看登记信息
登记号：NCT07205822；登记信息更新于 2026-10-02；本站同步于 2026-10-08，中国中心当前名额未经人工确认。