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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)

6 de mayo de 2026 actualizado por: 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.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Descripción detallada

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.

Tipo de estudio

De observación

Inscripción (Estimado)

300

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Ubicaciones de estudio

  • Italia
      • Ancona, Italia
        • Activo, no reclutando
        • AOU delle Marche
      • Aviano, Italia
        • Reclutamiento
        • Irccs Centro Di Riferimento Oncologico (CRO)
        • Contacto:
      • Bari, Italia
        • Reclutamiento
        • IRCCS Istituto Tumori "Giovanni Paolo II"
        • Contacto:
      • Barletta, Italia
        • Aún no reclutando
        • Mons. Dimiccoli P.O. Barletta
        • Contacto:
      • Bergamo, Italia
        • Reclutamiento
        • Asst Papa Giovanni Xxiii
        • Contacto:
      • Caserta, Italia
        • Reclutamiento
        • AORN "Sant'Anna e San Sebastiano" Caserta
        • Contacto:
      • Genova, Italia
        • Activo, no reclutando
        • IRCCS Ospedale Policlinico San Martino
      • Milan, Italia
        • Reclutamiento
        • IRCCS Ospedale San Raffaele
        • Contacto:
      • Milan, Italia
        • Reclutamiento
        • Istituto Europeo di Oncologia
        • Contacto:
      • Misterbianco, Italia
        • Reclutamiento
        • Humanitas Istituto Clinico Catanese
        • Contacto:
      • Naples, Italia
      • Naples, Italia
        • Activo, no reclutando
        • AOU Federico II
      • Naples, Italia
        • Reclutamiento
        • Istituto Nazionale Tumori "Fondazione G. Pascale"
        • Contacto:
      • Padova, Italia
        • Reclutamiento
        • Istituto Oncologico Veneto I.R.C.C.S.
        • Contacto:
      • Pagani, Italia
        • Aún no reclutando
        • P.O. "Andrea Tortora"
        • Contacto:
      • Palermo, Italia
        • Activo, no reclutando
        • A.O.U.P. "P. Giaccone"
      • Palermo, Italia
        • Aún no reclutando
        • ARNAS Civico - Palermo
        • Contacto:
      • Palermo, Italia
      • Piacenza, Italia
        • Reclutamiento
        • Ospedale "Guglielmo Da Saliceto"
        • Contacto:
      • Pollena Trocchia, Italia
        • Aún no reclutando
        • A.S.L. Napoli 3 SUD - P.O. Apicella
        • Contacto:
      • Rimini, Italia
      • Roma, Italia
        • Aún no reclutando
        • A.O.U. Policlinico "Umberto I"
        • Contacto:
      • Roma, Italia
        • Aún no reclutando
        • Fondazione Universitaria Policlinico Gemelli IRCCS
        • Contacto:
      • Roma, Italia
        • Aún no reclutando
        • Ospedale "Sandro Pertini" - A.S.L. Roma 2
        • Contacto:
      • Rozzano, Italia
      • Salerno, Italia
        • Aún no reclutando
        • A.O.U. "San Giovanni di Dio e Ruggi d'Aragona"
        • Contacto:
      • San Giovanni Rotondo, Italia
      • Torino, Italia
        • Aún no reclutando
        • A.O.U. "Città della Salute e della Scienza di Torino" - P.O. Sant'Anna
        • Contacto:
      • Trento, Italia
        • Aún no reclutando
        • Azienda Provinciale Servizi Sanitari di Trento - Ospedale Santa Chiara
        • Contacto:
    • AV
      • Avellino, AV, Italia
        • Reclutamiento
        • AORN S.G. Moscati
        • Contacto:

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Método de muestreo

Muestra no probabilística

Población de estudio

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.

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

Cohortes e Intervenciones

Grupo / Cohorte
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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
To assess the treatment safety and effectiveness as measured by investigator criteria in metastatic breast cancer patients
Periodo de tiempo: 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)

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Fondazione Oncotech

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

1 de julio de 2024

Finalización primaria (Estimado)

1 de julio de 2029

Finalización del estudio (Estimado)

1 de julio de 2029

Fechas de registro del estudio

Enviado por primera vez

28 de abril de 2026

Primero enviado que cumplió con los criterios de control de calidad

6 de mayo de 2026

Publicado por primera vez (Actual)

13 de mayo de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

13 de mayo de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

6 de mayo de 2026

Última verificación

1 de mayo de 2026

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • GIM27-THERapy
  • 701 (Identificador de registro: RSO)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

INDECISO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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