Observational Study of Effectiveness and Safety of Trastuzumab Emtansine (T-DM1) in HER2-positive Breast Cancer Patients With Residual Invasive Disease Following Neoadjuvant Chemotherapy and Anti-HER2 Target Therapy

Last updated: March 2, 2023
Sponsor: Consorzio Oncotech
Overall Status: Active - Recruiting

Phase

N/A

Condition

Breast Cancer

Cancer

Treatment

N/A

Clinical Study ID

NCT05754502
GIM26-TRASTHER
  • Ages > 18
  • All Genders

Study Summary

This is an observational, multi-centre study analysing data from patients treated with T-DM1 within the compassionate use program AL41711. During the compassionate use program AL41711, subjects received T-DM1 treatment for a total of 14 cycles or less, in case of disease recurrence or unmanageable toxicity. After the completion of the treatment, and 90 days of wash-out period, they can be enrolled in the study. After the signature of the Informed Consent Form, all their data reported in the medical charts up to then (as detailed in section 12 of the protocol) will be extracted retrospectively and inserted in the study database. From the end of the washout period following the last treatment with T-DM1, each subject will enter in an observation phase for a maximum of 3 years, or until death whichever happens first. This phase will be prospective after the signature of the Informed Consent Form.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Signed written informed consent
  • Patients who have received T-DM1 treatment within the compassionate use programAL41711 and have completed the entire treatment for at least 90 days or haveinterrupted it prematurely, due to disease recurrence or unmanageable toxicity, for atleast 90 days, corresponding to the wash out period;

Exclusion

Exclusion Criteria:

  • NA

Study Design

Total Participants: 300
Study Start date:
July 27, 2021
Estimated Completion Date:
May 02, 2025

Connect with a study center

  • Nuovo ospedale di Prato - S. Stefano

    Prato, Firenze 59100
    Italy

    Active - Recruiting

  • A.O.U. Ospedali Riuniti Umberto I

    Ancona, 60020
    Italy

    Active - Recruiting

  • IRCCS Istituto Tumori "Giovanni Paolo II"

    Bari,
    Italy

    Active - Recruiting

  • Humanitas Centro Catanese di Oncologia U.O. Oncologia Medica

    Catania, 95126
    Italy

    Active - Recruiting

  • Azienda Ospedaliera Istituti Ospitalieri di Cremona

    Cremona, 26100
    Italy

    Active - Recruiting

  • I.R.C.C.S. A.O.U San Martino - IST

    Genova,
    Italy

    Active - Recruiting

  • ASST Lecco - P.O. "A. Manzoni"

    Lecco,
    Italy

    Active - Recruiting

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Milano,
    Italy

    Active - Recruiting

  • Istituto Europeo di Oncologia

    Milano, 20141
    Italy

    Active - Recruiting

  • A.O.U Policlinico di Modena

    Modena,
    Italy

    Active - Recruiting

  • A.O.R.N. "A. Cardarelli"

    Napoli,
    Italy

    Active - Recruiting

  • Azienda Ospedaliera dei Colli - P.Monaldi

    Napoli, 80131
    Italy

    Active - Recruiting

  • Istituto Nazionale dei Tumori - Fondazione G. Pascale U.O. Oncologia Medica Senologica

    Napoli, 80131
    Italy

    Active - Recruiting

  • Università di Napoli Federico II - Facoltà di Medicina Dipartimento di Medicina Clinica e Chirurgia - Oncologia

    Napoli, 80131
    Italy

    Active - Recruiting

  • A.O.U. 'Maggiore della Carità'

    Novara,
    Italy

    Active - Recruiting

  • Istituto Oncologico Veneto IRCCS

    Padova,
    Italy

    Active - Recruiting

  • Azienda Ospedaliera Universitaria di Parma - Oncologia Medica

    Parma, 43126
    Italy

    Active - Recruiting

  • Fondazione S. Maugeri IRCCS U.O. Oncologia Medica II

    Pavia, 27100
    Italy

    Active - Recruiting

  • A. O. U. Pisana - Ospedale S. Chiara

    Pisa,
    Italy

    Active - Recruiting

  • IRCCS Arcispedale S.Maria Nuova

    Reggio Emilia,
    Italy

    Active - Recruiting

  • Fondazione Policlinico A. Gemelli

    Roma, 00168
    Italy

    Active - Recruiting

  • Fondazione Policlinico Gemelli

    Roma,
    Italy

    Active - Recruiting

  • Ospedale Sandro Pertini - ASL Roma 2

    Roma, 00157
    Italy

    Active - Recruiting

  • Policlinico Universitario Campus Biomedico

    Roma,
    Italy

    Active - Recruiting

  • Istituto Clinico Humanitas Irccs

    Rozzano,
    Italy

    Active - Recruiting

  • Azienda Ospedaliera 'San Giovanni di Dio e Ruggi D'Aragona' Struttura Complessa di Oncologia

    Salerno, 84131
    Italy

    Active - Recruiting

  • Ospedale Santa Chiara

    Trento,
    Italy

    Active - Recruiting

  • ASST Sette Laghi - Ospedale Di Circolo e Fondazione Macchi

    Varese, 21100
    Italy

    Active - Recruiting

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