Evaluating the Efficacy and Safety of PD-L1 Monoclonal Antibody Combined With VEX Metronomic Chemotherapy and Concurrent or Delayed Radiotherapy in Patients With Advanced HER2-Negative Breast Cancer With Brain Metastasis
报名条件（概要）
- 年龄：18 Years – 不限
- 性别：不限
- 健康志愿者：不接受
完整入排标准请以官方页面为准。
开展国家/地区
China
药品与企业信息
1. Adebrelimab: 1200 mg on Day 1, every 3 weeks (q3w). 2. VEX Metronomic Chemotherapy: Vinorelbine: 20 mg orally, every other day, every 3 weeks (q3w). Cyclophosphamide: 50 mg orally, once daily, every 3 weeks (q3w). Capecitabine: 500 mg orally, three times daily, every 3 weeks (q3w). 3. Radiotherapy: The interval between radiotherapy and immunotherapy should be within 3 weeks, with no specific order required. Different radiotherapy techniques will be selected based on the size and location of the metastatic lesions: Stereotactic Body Radiation Therapy (SBRT), Spatially Fractionated Radiation Therapy (SFRT), Low-dose Radiotherapy (LDRT).
1. Adebrelimab: 1200 mg on Day 1, every 3 weeks (q3w). 2. VEX Metronomic Chemotherapy: Vinorelbine: 20 mg orally, every other day, every 3 weeks (q3w). Cyclophosphamide: 50 mg orally, once daily, every 3 weeks (q3w). Capecitabine: 500 mg orally, three times daily, every 3 weeks (q3w). 3. Radiotherapy: If there is intracranial disease progression but extracranial disease remains stable, the systemic treatment regimen of Adelumab + VEX metronomic chemotherapy will be continued, with the addition of intracranial radiotherapy. If there is intracranial disease progression and extracranial disease progression, the systemic treatment regimen will be modified, with the addition of intracranial radiotherapy. The radiotherapy positioning and techniques will be the same as those used in the experimental group.
研发企业
试验官方登记的主要申办方；研究机构申办时会显示相应机构名称。
生产企业
公开药品批准资料或正式说明书暂未提供明确的生产企业信息。
研发企业与生产企业可能不是同一家。研究阶段药品可能尚未公布生产企业；生产企业仅取自美国上市原研药说明书所列企业（不含仿制药），不作推测；仅在其他国家上市的药品暂无法显示。
研究简介（原文）
A Prospective, multicenter, randomized controlled phase II study to evaluate the efficacy and safety of PD-L1 monoclonal antibody combined with vinorelbine + cyclophosphamide + capecitabine (VEX) metronomic chemotherapy and concurrent or delayed radiotherapy in patients with advanced HER2-negative breast cancer with brain metastasis
适应症
主动联系研究团队
总联系人（申办方／研究总部）
中国／港澳台研究中心
- Cancer Hospital, Chinese Academy of Medical Sciences, Beijing, Beijing 100021Beijing，Beijing Municipality，China
问自己是否符合条件、如何预筛
我的病情档案
档案只保存在您自己的浏览器里，不会上传，任何人（包括本站）都看不到。
英文版（发给研究团队）
Dear Study Team, I am a patient in China and I am interested in participating in your clinical trial: Study Title: Evaluating the Efficacy and Safety of PD-L1 Monoclonal Antibody Combined With VEX Metronomic Chemotherapy and Concurrent or Delayed Radiotherapy in Patients With Advanced HER2-Negative Breast Cancer With Brain Metastasis ClinicalTrials.gov Identifier: NCT06839560 Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences Investigational product: Adebrelimab+VEX Metronomic Chemotherapy+Concurrent Radiotherapy, Adebrelimab+VEX Metronomic Chemotherapy+Delayed Radiotherapy About me: - Age: (please fill in) - Sex: (please fill in) - Confirmed diagnosis and stage: (please fill in) - Biomarkers / genetic testing: not available - Prior and current treatments: (please fill in) - Performance status (ECOG): not assessed - Current location: China - Travel ability: (please fill in) Could you please let me know: 1. Whether I might be eligible for this study; 2. Which site would be closest and most practical for me, and whether remote pre-screening is possible; 3. What documents (medical records, pathology or imaging reports, recent labs) I should prepare for pre-screening. I can provide English translations of my medical records. Thank you very much for your time and help. Kind regards, (your name) (your email / phone with country code)
中文对照（供您核对）
尊敬的研究团队： 我是一位来自中国的患者，希望咨询参加以下临床试验的可能： 研究名称：Evaluating the Efficacy and Safety of PD-L1 Monoclonal Antibody Combined With VEX Metronomic Chemotherapy and Concurrent or Delayed Radiotherapy in Patients With Advanced HER2-Negative Breast Cancer With Brain Metastasis 试验编号：NCT06839560 申办方：Cancer Institute and Hospital, Chinese Academy of Medical Sciences 研究药物：Adebrelimab+VEX Metronomic Chemotherapy+Concurrent Radiotherapy、Adebrelimab+VEX Metronomic Chemotherapy+Delayed Radiotherapy 我的基本情况： - 年龄：（请填写） - 性别：（请填写） - 确诊疾病与分期：（请填写） - 基因／标志物检测：暂无 - 既往及当前治疗：（请填写） - 体能状态（ECOG）：未评估 - 目前所在城市：中国 - 可前往范围：（请填写） 想请教三个问题： 1. 我是否可能符合本研究的入组标准？ 2. 哪个中心对我最方便可行？能否远程预筛？ 3. 预筛需要准备哪些资料（病历、病理、影像、近期化验）？ 我可以提供英文翻译版病历。感谢您的时间与帮助。 顺祝安康 （您的姓名） （您的邮箱／带国际区号的电话）
提示：请与主治医生一起发信——由医生署名的申请，回复率远高于患者单独发信。首封邮件不要附身份证号等敏感信息。研究团队通常在 3–10 个工作日内回复，两周无回音可礼貌追问一次。
下一步怎么做？
- 把本页信息带给您的主治医生，评估是否适合参加。
- 点击下方按钮打开官方注册页，查看研究中心联系方式。
- 直接联系研究团队咨询报名事宜（通常有中文同声翻译服务可协助沟通）。