Ignite Creation Date:
2025-12-25 @ 3:45 AM
Ignite Modification Date:
2025-12-26 @ 2:32 AM
Study NCT ID:
NCT05754502
Status:
UNKNOWN
Last Update Posted:
2023-03-03
First Post:
2023-02-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
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
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000080044', 'term': 'Ado-Trastuzumab Emtansine'}], 'ancestors': [{'id': 'D008453', 'term': 'Maytansine'}, {'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D047029', 'term': 'Lactams, Macrocyclic'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D000068878', 'term': 'Trastuzumab'}, {'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-07-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2025-05-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-03-02', 'studyFirstSubmitDate': '2023-02-21', 'studyFirstSubmitQcDate': '2023-03-02', 'lastUpdatePostDateStruct': {'date': '2023-03-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-21', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Complete response-Effectiveness of treatment with T-DM1', 'timeFrame': 'up to 36 months', 'description': 'assess the long term effectiveness of treatment with T-DM1 as compassionate use in patients with HER2-positive breast cancer that do not reach a complete response following neoadjuvant chemotherapy and anti-HER2 target therapy'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study will include approximately 300 patients with HER2-positive breast cancer that do not reach a pathological complete response following neoadjuvant chemotherapy and anti-HER2 target therapy and received T-DM1 within the compassionate use program AL41711.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Signed written informed consent\n* 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;\n\nExclusion Criteria:\n\n* NA'}, 'identificationModule': {'nctId': 'NCT05754502', 'briefTitle': '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', 'organization': {'class': 'OTHER', 'fullName': 'Consorzio Oncotech'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'GIM26-TRASTHER'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Trastuzumab emtansine', 'type': 'DRUG', 'description': '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.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '59100', 'city': 'Prato', 'state': 'Firenze', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Erica Moretti, MD', 'role': 'CONTACT', 'email': 'erica.moretti@uslcentro.toscana.it', 'phone': '0574802520'}, {'name': 'Giuseppina Sanna, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Nuovo ospedale di Prato - S. Stefano', 'geoPoint': {'lat': 43.8805, 'lon': 11.09699}}, {'zip': '60020', 'city': 'Ancona', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Rossana Berardi, MD', 'role': 'CONTACT', 'email': 'rossana.berardi@ospedaliriuniti.marche.it', 'phone': '0715965715'}, {'name': 'Stefano Cascinu, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'A.O.U. Ospedali Riuniti Umberto I', 'geoPoint': {'lat': 43.60717, 'lon': 13.5103}}, {'city': 'Bari', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Lucia Rinaldi', 'role': 'CONTACT', 'email': 'l.rinaldi@oncologico.bari.it', 'phone': '0805555143'}], 'facility': 'IRCCS Istituto Tumori "Giovanni Paolo II"', 'geoPoint': {'lat': 41.12066, 'lon': 16.86982}}, {'zip': '95126', 'city': 'Catania', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Maria Vita Sanò', 'role': 'CONTACT', 'email': 'maria_vita.sano@ccocatania.it', 'phone': '09573390199'}], 'facility': 'Humanitas Centro Catanese di Oncologia U.O. Oncologia Medica', 'geoPoint': {'lat': 37.49223, 'lon': 15.07041}}, {'zip': '26100', 'city': 'Cremona', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Daniele Generali', 'role': 'CONTACT', 'email': 'daniele.generali@asst-cremona.it', 'phone': '+390372408042'}, {'name': 'Daniele Generali, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Azienda Ospedaliera Istituti Ospitalieri di Cremona', 'geoPoint': {'lat': 45.13325, 'lon': 10.02129}}, {'city': 'Genova', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Lucia Del Mastro, MD', 'role': 'CONTACT', 'email': 'lucia.delmastro@hsanmartino.it', 'phone': '0105558908'}, {'name': 'Lucia Del Mastro, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'I.R.C.C.S. A.O.U San Martino - IST', 'geoPoint': {'lat': 45.21604, 'lon': 11.87211}}, {'city': 'Lecco', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Alessandra Crippa', 'role': 'CONTACT', 'email': 'a.crippa@asst-lecco.it', 'phone': '0341489900'}], 'facility': 'ASST Lecco - P.O. "A. Manzoni"', 'geoPoint': {'lat': 45.85589, 'lon': 9.39704}}, {'zip': '20141', 'city': 'Milan', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Giuseppe Cancello', 'role': 'CONTACT', 'email': 'giuseppe.cancello@ieo.it', 'phone': '02/57489970'}], 'facility': 'Istituto Europeo di Oncologia', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'city': 'Milan', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Giulia Valeria Bianchi, MD', 'role': 'CONTACT', 'email': 'giulia.bianchi@istitutotumori.mi.it', 'phone': '0223902286'}], 'facility': 'Fondazione IRCCS Istituto Nazionale dei Tumori', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'city': 'Modena', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Federico Piacentini', 'role': 'CONTACT', 'email': 'federico.piacentini@unimore.it', 'phone': '0594223221'}], 'facility': 'A.O.U Policlinico di Modena', 'geoPoint': {'lat': 44.64783, 'lon': 10.92539}}, {'zip': '80131', 'city': 'Napoli', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Vincenzo Montesarchio, MD', 'role': 'CONTACT', 'email': 'dott.vincenzomontesarchio@gmail.com', 'phone': '+390817065286'}, {'name': 'Vincenzo Montesarchio, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Azienda Ospedaliera dei Colli - P.Monaldi', 'geoPoint': {'lat': 40.87618, 'lon': 14.5195}}, {'zip': '80131', 'city': 'Napoli', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Michelino De Laurentiis', 'role': 'CONTACT', 'email': 'm.delaurentiis@istitutotumori.na.it', 'phone': '0815903699'}, {'name': 'MICHELINO DE LAURENTIIS, Md', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Istituto Nazionale dei Tumori - Fondazione G. Pascale U.O. Oncologia Medica Senologica', 'geoPoint': {'lat': 40.87618, 'lon': 14.5195}}, {'zip': '80131', 'city': 'Napoli', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Sabino De Placido', 'role': 'CONTACT', 'email': 'deplacid@unina.it', 'phone': '0817463660'}, {'name': 'SABINO DE PLACIDO, Md', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Università di Napoli Federico II - Facoltà di Medicina Dipartimento di Medicina Clinica e Chirurgia - Oncologia', 'geoPoint': {'lat': 40.87618, 'lon': 14.5195}}, {'city': 'Napoli', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Ferdinando Riccardi', 'role': 'CONTACT', 'email': 'ferdinando.riccardi@aocardarelli.it', 'phone': '081/7472223'}], 'facility': 'A.O.R.N. "A. Cardarelli"', 'geoPoint': {'lat': 40.87618, 'lon': 14.5195}}, {'city': 'Novara', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Alessandra Gennari', 'role': 'CONTACT', 'email': 'alessandra.gennari@uniupo.it', 'phone': '03213733822'}], 'facility': "A.O.U. 'Maggiore della Carità'", 'geoPoint': {'lat': 45.44694, 'lon': 8.62118}}, {'city': 'Padua', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Valentina Guarneri', 'role': 'CONTACT', 'email': 'valentina.guarneri@unipd.it', 'phone': '0498215931'}], 'facility': 'Istituto Oncologico Veneto IRCCS', 'geoPoint': {'lat': 45.40797, 'lon': 11.88586}}, {'zip': '43126', 'city': 'Parma', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'ANTONIO MUSOLINO', 'role': 'CONTACT', 'email': 'amusolino@ao.pr.it', 'phone': '0521702660'}, {'name': 'ANTONIO MUSOLINO, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Azienda Ospedaliera Universitaria di Parma - Oncologia Medica', 'geoPoint': {'lat': 44.79935, 'lon': 10.32618}}, {'zip': '27100', 'city': 'Pavia', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Antonio Bernardo', 'role': 'CONTACT', 'email': 'antonio.bernardo@icsmaugeri.it', 'phone': '0382592204'}, {'name': 'ANTONIO BERNARDO, Md', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Fondazione S. Maugeri IRCCS U.O. Oncologia Medica II', 'geoPoint': {'lat': 45.19205, 'lon': 9.15917}}, {'city': 'Pisa', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Andrea Fontana', 'role': 'CONTACT', 'email': 'AN.FONTANA@AO-PISA.TOSCANA.IT', 'phone': '3334139529'}], 'facility': 'A. O. U. Pisana - Ospedale S. Chiara', 'geoPoint': {'lat': 43.70853, 'lon': 10.4036}}, {'city': 'Reggio Emilia', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Giancarlo Bisagni', 'role': 'CONTACT', 'email': 'giancarlo.bisagni@ausl.re.it', 'phone': '0522296858'}], 'facility': 'IRCCS Arcispedale S.Maria Nuova', 'geoPoint': {'lat': 44.69825, 'lon': 10.63125}}, {'zip': '00157', 'city': 'Roma', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': "Giuliana D'Auria", 'role': 'CONTACT', 'email': 'giuliana.dauria@aslroma2.it', 'phone': '0641431'}], 'facility': 'Ospedale Sandro Pertini - ASL Roma 2', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'zip': '00168', 'city': 'Roma', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Ida Paris', 'role': 'CONTACT', 'email': 'ida.paris@policlinicogemelli.it', 'phone': '0630158545'}], 'facility': 'Fondazione Policlinico A. Gemelli', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'city': 'Roma', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Fabio Marazzi', 'role': 'CONTACT', 'email': 'fabio.marazzi@policlinicogemelli.it', 'phone': '0630155887'}], 'facility': 'Fondazione Policlinico Gemelli', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'city': 'Roma', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Giuseppe Tonini', 'role': 'CONTACT', 'email': 'g.tonini@unicampus.it', 'phone': '06225418855'}], 'facility': 'Policlinico Universitario Campus Biomedico', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'city': 'Rozzano', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Rosalba Torrisi', 'role': 'CONTACT', 'email': 'rosalba.torrisi@cancercenter.humanitas.it', 'phone': '0282245918'}], 'facility': 'Istituto Clinico Humanitas Irccs', 'geoPoint': {'lat': 45.38193, 'lon': 9.1559}}, {'zip': '84131', 'city': 'Salerno', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Clementina Savastano', 'role': 'CONTACT', 'email': 'clementina.savastano@sangiovannieruggi.it', 'phone': '089672528'}, {'name': 'CLEMENTINA SAVASTANO, Md', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Azienda Ospedaliera 'San Giovanni di Dio e Ruggi D'Aragona' Struttura Complessa di Oncologia", 'geoPoint': {'lat': 40.67545, 'lon': 14.79328}}, {'city': 'Trento', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Antonella Ferro', 'role': 'CONTACT', 'email': 'antonella.ferro@apss.tn.it', 'phone': '0461902121'}], 'facility': 'Ospedale Santa Chiara', 'geoPoint': {'lat': 46.06787, 'lon': 11.12108}}, {'zip': '21100', 'city': 'Varese', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Elisa Gallerani', 'role': 'CONTACT', 'email': 'elisa.gallerani@asst-settelaghi.it', 'phone': '0332278558'}], 'facility': 'ASST Sette Laghi - Ospedale Di Circolo e Fondazione Macchi', 'geoPoint': {'lat': 45.82058, 'lon': 8.82511}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Consorzio Oncotech', 'class': 'OTHER'}, 'collaborators': [{'name': 'Roche Pharma AG', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}