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正在招募III 期编号 NCT07060807

A Clinical Study of Patritumab Deruxtecan to Treat Breast Cancer (MK-1022-016)

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

United States、Argentina、Australia、Brazil、Canada、Chile、China、Colombia、France、Germany、Greece、Hong Kong

药品与企业信息

其他名称:MK-1022、HER3-DXd、U3-1402

Administered via intravenous (IV) infusion

其他名称:TAXOL®、ONXAL®

Administered via IV infusion

其他名称:Abraxane®

Administered via IV infusion

其他名称:XELODA®

Administered via oral tablets

Pegylated liposomal doxorubicin药物

其他名称:Doxil®

Administered via IV infusion

其他名称:T-DXd、Enhertu®

Administered via IV infusion

Rescue Medication药物

Participants receive rescue medications according to each approved drug's product label. Recommended rescue medications include: 5-HT3 receptor antagonist, NK-1 receptor antagonist, and corticosteroids.

研发企业

Merck Sharp & Dohme LLC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

Paclitaxel

Teva Pharmaceuticals, Inc.

合作机构

  • Daiichi Sankyo企业

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)

Researchers are looking for other ways to treat breast cancer (BC) that is hormone receptor-positive and human epidermal growth factor receptor 2-negative (HR+/HER2-) and either unresectable locally advanced or metastatic. * HR positive (HR+) means the cancer cells have proteins that attach to estrogen or progesterone (hormones) which help the cancer to grow and spread * HER2 negative (HER2-) means the cancer cells have a low amount of a protein called HER2 * Unresectable locally advanced means the cancer cannot be completely removed by surgery and has spread into nearby tissue or muscles * Metastatic means the cancer has spread to other parts of the body Treatment for this type of breast cancer usually includes endocrine therapy (ET) and sometimes a second treatment. The main goal of this study is to learn if people who receive patritumab deruxtecan (also known as HER3-DXd and MK-1022) live longer overall or without the cancer growing/spreading, compared to people who receive chemotherapy or a different drug called trastuzumab deruxtecan.

适应症

Breast Neoplasms

主动联系研究团队

总联系人(申办方/研究总部)

研究中心联系方式

  • Southern Cancer Center (SCC) ( Site 8000)Daphne,Alabama,United States
  • The University of Arizona Cancer Center - North Campus ( Site 0055)Tucson,Arizona,United States
  • Los Angeles Hematology Oncology Medical Group ( Site 0026)Los Angeles,California,United States
  • Hoag Memorial Hospital Presbyterian ( Site 0025)Newport Beach,California,United States
  • St. Marys Hospital and Regional Medical Center-SCL Health Cancer Centers of Colorado ( Site 0021)Grand Junction,Colorado,United States
  • Medical Oncology Hematology Consultants (MOHC) ( Site 8002)Newark,Delaware,United States

问自己是否符合条件、如何预筛

我的病情档案

管理档案

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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: A Clinical Study of Patritumab Deruxtecan to Treat Breast Cancer (MK-1022-016)
ClinicalTrials.gov Identifier: NCT07060807
Sponsor: Merck Sharp & Dohme LLC
Investigational product: Patritumab deruxtecan, Paclitaxel, Nab-paclitaxel, Capecitabine, Pegylated liposomal doxorubicin

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:A Clinical Study of Patritumab Deruxtecan to Treat Breast Cancer (MK-1022-016)
试验编号:NCT07060807
申办方:Merck Sharp & Dohme LLC
研究药物:Patritumab deruxtecan、Paclitaxel、Nab-paclitaxel、Capecitabine、Pegylated liposomal doxorubicin

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)
用邮件客户端发送给 Trialsites@msd.com

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?

  1. 把本页信息带给您的主治医生,评估是否适合参加。
  2. 点击下方按钮打开官方注册页,查看研究中心联系方式。
  3. 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)。
在 ClinicalTrials.gov 查看官方页面