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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 maj 2026 uppdaterad av: 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.

Studieöversikt

Status

Rekrytering

Betingelser

Detaljerad beskrivning

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.

Studietyp

Observationell

Inskrivning (Beräknad)

300

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Testmetod

Icke-sannolikhetsprov

Studera befolkning

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.

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Kohorter och interventioner

Grupp / Kohort
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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
To assess the treatment safety and effectiveness as measured by investigator criteria in metastatic breast cancer patients
Tidsram: 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)

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Fondazione Oncotech

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

1 juli 2024

Primärt slutförande (Beräknad)

1 juli 2029

Avslutad studie (Beräknad)

1 juli 2029

Studieregistreringsdatum

Först inskickad

28 april 2026

Först inskickad som uppfyllde QC-kriterierna

6 maj 2026

Första postat (Faktisk)

13 maj 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

13 maj 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

6 maj 2026

Senast verifierad

1 maj 2026

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • GIM27-THERapy
  • 701 (Registeridentifierare: RSO)

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

OBESLUTSAM

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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