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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. Mai 2026 aktualisiert von: 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.

Studienübersicht

Status

Rekrutierung

Bedingungen

Detaillierte Beschreibung

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.

Studientyp

Beobachtungs

Einschreibung (Geschätzt)

300

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

  • Italien
      • Ancona, Italien
        • Aktiv, nicht rekrutierend
        • Aou Delle Marche
      • Aviano, Italien
        • Rekrutierung
        • Irccs Centro Di Riferimento Oncologico (CRO)
        • Kontakt:
      • Bari, Italien
        • Rekrutierung
        • IRCCS Istituto Tumori "Giovanni Paolo II"
        • Kontakt:
      • Barletta, Italien
        • Noch keine Rekrutierung
        • Mons. Dimiccoli P.O. Barletta
        • Kontakt:
      • Bergamo, Italien
        • Rekrutierung
        • ASST Papa Giovanni XXIII
        • Kontakt:
      • Caserta, Italien
      • Genova, Italien
        • Aktiv, nicht rekrutierend
        • IRCCS Ospedale Policlinico San Martino
      • Milan, Italien
        • Rekrutierung
        • IRCCS Ospedale San Raffaele
        • Kontakt:
      • Milan, Italien
        • Rekrutierung
        • Istituto Europeo di Oncologia
        • Kontakt:
      • Misterbianco, Italien
        • Rekrutierung
        • Humanitas Istituto Clinico Catanese
        • Kontakt:
      • Naples, Italien
      • Naples, Italien
        • Aktiv, nicht rekrutierend
        • AOU Federico II
      • Naples, Italien
      • Padova, Italien
        • Rekrutierung
        • Istituto Oncologico Veneto I.R.C.C.S.
        • Kontakt:
      • Pagani, Italien
        • Noch keine Rekrutierung
        • P.O. "Andrea Tortora"
        • Kontakt:
      • Palermo, Italien
        • Aktiv, nicht rekrutierend
        • A.O.U.P. "P. Giaccone"
      • Palermo, Italien
        • Noch keine Rekrutierung
        • ARNAS Civico - Palermo
        • Kontakt:
      • Palermo, Italien
      • Piacenza, Italien
        • Rekrutierung
        • Ospedale "Guglielmo Da Saliceto"
        • Kontakt:
      • Pollena Trocchia, Italien
        • Noch keine Rekrutierung
        • A.S.L. Napoli 3 SUD - P.O. Apicella
        • Kontakt:
      • Rimini, Italien
      • Roma, Italien
        • Noch keine Rekrutierung
        • A.O.U. Policlinico "Umberto I"
        • Kontakt:
      • Roma, Italien
      • Roma, Italien
        • Noch keine Rekrutierung
        • Ospedale "Sandro Pertini" - A.S.L. Roma 2
        • Kontakt:
      • Rozzano, Italien
      • Salerno, Italien
      • San Giovanni Rotondo, Italien
      • Torino, Italien
        • Noch keine Rekrutierung
        • A.O.U. "Città della Salute e della Scienza di Torino" - P.O. Sant'Anna
        • Kontakt:
      • Trento, Italien
        • Noch keine Rekrutierung
        • Azienda Provinciale Servizi Sanitari di Trento - Ospedale Santa Chiara
        • Kontakt:
    • AV
      • Avellino, AV, Italien

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

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.

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Kohorten und Interventionen

Gruppe / Kohorte
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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
To assess the treatment safety and effectiveness as measured by investigator criteria in metastatic breast cancer patients
Zeitfenster: 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)

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Fondazione Oncotech

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

1. Juli 2024

Primärer Abschluss (Geschätzt)

1. Juli 2029

Studienabschluss (Geschätzt)

1. Juli 2029

Studienanmeldedaten

Zuerst eingereicht

28. April 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

6. Mai 2026

Zuerst gepostet (Tatsächlich)

13. Mai 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

13. Mai 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

6. Mai 2026

Zuletzt verifiziert

1. Mai 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • GIM27-THERapy
  • 701 (Registrierungskennung: RSO)

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

UNENTSCHIEDEN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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