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GIM27-THERapy: a Study to Describe the Effectiveness of Tucatinib in Combination With Capecitabine and Trastuzumab in the Treatment of Metastatic HER-2 Positive Breast Cancer Patients in Real World Setting (THERapy)

2026年5月6日 更新者：Fondazione Oncotech

Non-interventional, Multicentric, Prospective, Observational Study to Describe the Effectiveness of Tucatinib in Combination With Capecitabine and Trastuzumab in the Treatment of Metastatic HER-2 Positive Breast Cancer Patients in Real World Setting

Non-interventional, multicenter, prospective observational study of tucatinib-trastuzumab capecitabine administered according to the standard local clinical practice following approved SmPC indication and dose.

About 300 Her2 positive metastatic breast cancer patients who are candidate to tucatinib treatment in real world setting including patients previously treated with trastuzumab, pertuzumab, T-DM1, T-DXd as per authorized therapy setting and NPP/EAP ongoing program.

Primary Objective:

To assess the treatment safety and effectiveness as measured by investigator criteria in metastatic breast cancer patients within the real-world setting treated with tucatinib in combination with trastuzumab and capecitabine according to standard local clinical practice following approved Summary of Product Characteristics (SmPC) indication and dose.

The primary purpose of this study is to evaluate the real word effectiveness of the combination therapy "tucatinib/trastuzumab/capecitabine" in mBC patients according to the approved SmPC indication and dose in the real-world setting. Patients with human epidermal growth factor receptor 2 (HER2)- positive metastatic breast cancer who have disease progression after therapy with multiple HER2-targeted agents have limited treatment options. HER2 is a transmembrane tyrosine kinase receptor that mediates cell growth, differentiation, and survival. HER2 is overexpressed in approximately 20% of breast cancers. Both antibody and small-molecule drugs that target HER2 and block its tyrosine kinase activity has been demonstrated to be effective in treating HER2-driven cancers. Tucatinib is an investigational, oral, highly selective inhibitor of the HER2 tyrosine kinase. On April 17, 2020, the Food and Drug Administration approved tucatinib in combination with trastuzumab and capecitabine, for adult patients with advanced unresectable or metastatic HER2- positive breast cancer, including patients with brain metastases, who have received one or more prior anti-HER2-based regimens in the metastatic setting. On 10 December 2020, the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorization for Tukysa (tucatinib) in combination with trastuzumab and capecitabine for the treatment of adult patients with human epidermal growth factor receptor 2 (HER2)-positive locally advanced or metastatic breast cancer (BC) who have received at least two prior anti-HER2 treatment regimens. Tucatinib received a marketing authorization valid throughout the EU on February 2021. The approvals were based on the results of the phase II HER2CLIMB trial in which HER2-positive breast cancer patients, previously treated with trastuzumab, pertuzumab (Perjeta) and trastuzumab emtansine (T-DM1; Kadcyla), have been randomized to receive trastuzumab and capecitabine with either tucatinib or placebo (randomization 2:1).Among the 511 patients with measurable disease at baseline, an objective response was confirmed in 40.6% of patients in the tucatinib-combination group and 22.8% of patients in the placebo-combination group. The primary endpoint of the trial was PFS and the secondary end points comprised overall survival (OS), as well as confirmed objective response rate (ORR). Tucatinib demonstrated efficacy compared with placebo in PFS (7.8 months versus 5.6months) and OS (21.9 months versus 17.4 months). The most common adverse events in the tucatinib arm were diarrhea, palmar-plantar erythrodysesthesia syndrome, fatigue, nausea, and vomiting and transaminitis, even though typically low-grade, transient, and reversible. In addition, out of the ∼600 patients enrolled, 291 patients had brain metastases at baseline. Brain mets including those with active brain mets. Among patients with brain mets PFS at 1 y was 24,9% in the tucatinib combination group vs 0% in the placebo combination group, HR: 0.48;95% CI to 69%;p<0.0001 and median PFS was 7.6 and 5.4 respectively. This represents for many patients the availability of a new valuable therapeutic option especially where the occurrence of brain metastases is frequent. Based on the reported data and considering the clinical benefit of the therapy such as prolongation of PFS/OS, a prospective study on the efficacy and safety profile of the tucatinib in the real-world population can be very useful to follow the evolution of HER2- positive metastatic breast cancer with this promising treatment.

研究概览

地位

招聘中

条件

详细说明

study procedures:

Patients will be managed by their treating clinician without any additional instructions. The study will require no additional treatment procedures during patient visits. Patients meeting the selection criteria will be invited to participate in the study. Before any study-specific data are recorded, patients will be provided with all the study details prior to their decision to participate and will be requested to sign an informed consent form (ICF) prior to their participation in the study. Patient's baseline data, safety, and PS (evaluation according to the Eastern Cooperative Oncology Group [ECOG] score) will be

collected during the observation period (treatment with tucatinib- trastuzumab-capecitabine). Response and survival assessments will

be collected during the study and include symptomatic response and best response by the treating clinician's assessment, according to investigator criteria and the local clinical practice procedures. Safety, response, and survival will be assessed during the follow-up period (18 months post tucatinib treatment). Previous and subsequent non-tucatinib treatments that the patient will receive since the follow-up period will also be described.

研究类型

观察性的

注册 (估计的)

300

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 意大利
      • Ancona、意大利
        • 主动，不招人
        • AOU delle Marche
      • Aviano、意大利
        • 招聘中
        • Irccs Centro Di Riferimento Oncologico (CRO)
        • 接触：
      • Bari、意大利
        • 招聘中
        • IRCCS Istituto Tumori "Giovanni Paolo II"
        • 接触：
      • Barletta、意大利
        • 尚未招聘
        • Mons. Dimiccoli P.O. Barletta
        • 接触：
      • Bergamo、意大利
        • 招聘中
        • Asst Papa Giovanni Xxiii
        • 接触：
      • Caserta、意大利
      • Genova、意大利
        • 主动，不招人
        • IRCCS Ospedale Policlinico San Martino
      • Milan、意大利
        • 招聘中
        • IRCCS Ospedale San Raffaele
        • 接触：
      • Milan、意大利
        • 招聘中
        • Istituto Europeo di Oncologia
        • 接触：
      • Misterbianco、意大利
        • 招聘中
        • Humanitas Istituto Clinico Catanese
        • 接触：
      • Naples、意大利
      • Naples、意大利
        • 主动，不招人
        • AOU Federico II
      • Naples、意大利
      • Padova、意大利
        • 招聘中
        • Istituto Oncologico Veneto I.R.C.C.S.
        • 接触：
      • Pagani、意大利
        • 尚未招聘
        • P.O. "Andrea Tortora"
        • 接触：
      • Palermo、意大利
        • 主动，不招人
        • A.O.U.P. "P. Giaccone"
      • Palermo、意大利
        • 尚未招聘
        • ARNAS Civico - Palermo
        • 接触：
      • Palermo、意大利
      • Piacenza、意大利
        • 招聘中
        • Ospedale "Guglielmo Da Saliceto"
        • 接触：
      • Pollena Trocchia、意大利
        • 尚未招聘
        • A.S.L. Napoli 3 SUD - P.O. Apicella
        • 接触：
      • Rimini、意大利
      • Roma、意大利
      • Roma、意大利
      • Roma、意大利
        • 尚未招聘
        • Ospedale "Sandro Pertini" - A.S.L. Roma 2
        • 接触：
      • Rozzano、意大利
      • Salerno、意大利
      • San Giovanni Rotondo、意大利
      • Torino、意大利
        • 尚未招聘
        • A.O.U. "Città della Salute e della Scienza di Torino" - P.O. Sant'Anna
        • 接触：
      • Trento、意大利
        • 尚未招聘
        • Azienda Provinciale Servizi Sanitari di Trento - Ospedale Santa Chiara
        • 接触：
    • AV
      • Avellino、AV、意大利

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

取样方法

非概率样本

研究人群

Her2 positive metastatic breast cancer patients who are candidate to tucatinib treatment in real world setting including patients previously treated with trastuzumab, pertuzumab, T-DM1, T-DXd as per authorized therapy setting and NPP/EAP ongoing program.

描述

Inclusion Criteria:

  • Women aged 18 years or older;
  • Metastatic breast cancer her2 positive;
  • Treatment and treated indication according to local label SmPC and reimbursement for tucatinib-trastuzumab capecitabine treatment;
  • At least 2 prior anti her2 treatment in any setting;
  • Written informed consent indicating that patients understand the purpose and procedures and are willing to participate in the study.

Exclusion Criteria:

  • Patients with diseases or significant clinical condition, according to the findings of the investigator, may interfere with the study evaluations;
  • Absence of any radiological assessment;
  • No data on tucatinib efficacy and safety.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

队列和干预

团体/队列
Her2 positive metastatic breast cancer patients
Her2 positive metastatic breast cancer patients who are candidate to tucatinib treatment in real world setting including patients previously treated with trastuzumab, pertuzumab, T-DM1, T-DXd as per authorized therapy setting and NPP/EAP ongoing program.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
To assess the treatment safety and effectiveness as measured by investigator criteria in metastatic breast cancer patients
大体时间：From enrollment to the end of follow-up (18 months after tucatinib treatment)

Primary endpoint:

  • Real world Effectiveness of tucatinib/trastuzumab/capecitabine treatments will be collected according to SmPC indication and will include the evaluation in routine clinical practice of:
  • TTNT (time to next systemic treatment) defined as time from first administration of any study treatment ( i.e. tucatinib/trastuzumab/ capecitabine) to start of a subsequent systemic antineoplastic therapy or death whichever comes first
From enrollment to the end of follow-up (18 months after tucatinib treatment)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Fondazione Oncotech

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2024年7月1日

初级完成 (估计的)

2029年7月1日

研究完成 (估计的)

2029年7月1日

研究注册日期

首次提交

2026年4月28日

首先提交符合 QC 标准的

2026年5月6日

首次发布 (实际的)

2026年5月13日

研究记录更新

最后更新发布 (实际的)

2026年5月13日

上次提交的符合 QC 标准的更新

2026年5月6日

最后验证

2026年5月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • GIM27-THERapy
  • 701 (注册表标识符：RSO)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

未定

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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