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
NCT ID: NCT05754502
Last Updated: 2023-03-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
300 participants
OBSERVATIONAL
2021-07-27
2025-05-02
Brief Summary
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Detailed Description
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Conditions
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Study Design
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OTHER
OTHER
Interventions
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Trastuzumab emtansine
observational 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
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Inclusion Criteria
* Patients who have received T-DM1 treatment within the compassionate use program AL41711 and have completed the entire treatment for at least 90 days or have interrupted it prematurely, due to disease recurrence or unmanageable toxicity, for at least 90 days, corresponding to the wash out period;
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Roche Pharma AG
INDUSTRY
Consorzio Oncotech
OTHER
Responsible Party
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Locations
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Nuovo ospedale di Prato - S. Stefano
Prato, Firenze, Italy
A.O.U. Ospedali Riuniti Umberto I
Ancona, , Italy
IRCCS Istituto Tumori "Giovanni Paolo II"
Bari, , Italy
Humanitas Centro Catanese di Oncologia U.O. Oncologia Medica
Catania, , Italy
Azienda Ospedaliera Istituti Ospitalieri di Cremona
Cremona, , Italy
I.R.C.C.S. A.O.U San Martino - IST
Genova, , Italy
ASST Lecco - P.O. "A. Manzoni"
Lecco, , Italy
Istituto Europeo di Oncologia
Milan, , Italy
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, , Italy
A.O.U Policlinico di Modena
Modena, , Italy
Azienda Ospedaliera dei Colli - P.Monaldi
Napoli, , Italy
Istituto Nazionale dei Tumori - Fondazione G. Pascale U.O. Oncologia Medica Senologica
Napoli, , Italy
Università di Napoli Federico II - Facoltà di Medicina Dipartimento di Medicina Clinica e Chirurgia - Oncologia
Napoli, , Italy
A.O.R.N. "A. Cardarelli"
Napoli, , Italy
A.O.U. 'Maggiore della Carità'
Novara, , Italy
Istituto Oncologico Veneto IRCCS
Padua, , Italy
Azienda Ospedaliera Universitaria di Parma - Oncologia Medica
Parma, , Italy
Fondazione S. Maugeri IRCCS U.O. Oncologia Medica II
Pavia, , Italy
A. O. U. Pisana - Ospedale S. Chiara
Pisa, , Italy
IRCCS Arcispedale S.Maria Nuova
Reggio Emilia, , Italy
Ospedale Sandro Pertini - ASL Roma 2
Roma, , Italy
Fondazione Policlinico A. Gemelli
Roma, , Italy
Fondazione Policlinico Gemelli
Roma, , Italy
Policlinico Universitario Campus Biomedico
Roma, , Italy
Istituto Clinico Humanitas Irccs
Rozzano, , Italy
Azienda Ospedaliera 'San Giovanni di Dio e Ruggi D'Aragona' Struttura Complessa di Oncologia
Salerno, , Italy
Ospedale Santa Chiara
Trento, , Italy
ASST Sette Laghi - Ospedale Di Circolo e Fondazione Macchi
Varese, , Italy
Countries
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Facility Contacts
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Other Identifiers
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GIM26-TRASTHER
Identifier Type: -
Identifier Source: org_study_id
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