Spots Global Cancer Trial Database for 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
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Trial Identification
Brief Title: 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
Official Title: 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
Study ID: NCT05754502
Conditions
Interventions
Study Description
Brief 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.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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, Milano, , Italy
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, , 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, Padova, , 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
Contact Details
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