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This disease registry is a prospective, multicenter non-interventional study designed to observe anti-cancer treatment regimens and clinical outcomes in participants with HER2-positive unresectable LA/mBC. Diagnosis of unresectable LA or mBC can be up to 6 months old prior to registry enrollment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HER2-positive unresectable LA/mBC | Participants with HER2-positive unresectable LA/mBC diagnosed up to 6 months prior to enrollment will be included in the study. Enrolled participants will receive treatment and clinical assessments for their HER2-positive unresectable LA/mBC as determined by their treating physician, according to the standard of care and routine clinical practice at each site. |
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| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival per Anti-cancer Treatment Regimens Assessed According to Site-/Country-Specific Medical Practice | Baseline up to 8 years | |
| Percentage of Participants by Different Anti-cancer Treatment Regimens and Treatment Sequences | Baseline up to 8 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | Baseline up to 8 years | |
| Duration of Response per Anti-cancer Treatment Regimens Assessed According to Site-/Country-Specific Medical Practice | Baseline up to 8 years | |
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Inclusion Criteria:
- Initially diagnosed with HER2-positive unresectable LA/mBC no more than 6 months prior to enrollment, although they can have received anti-cancer treatment during that time
Exclusion Criteria:
- Not applicable
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Participants initially diagnosed with HER2-positive unresectable LA/mBC no more than 6 months prior to enrollment
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lkh-Univ. Klinikum Graz; Klinik Für Gynäkologie | Graz | 8036 | Austria | |||
| LKH-UNIV. KLINIKUM GRAZ; Klinische Abteilung für Onkologie |
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| Percentage of Participants with Best Overall Response of Complete Response (CR) or Partial Response (PR) per Anti-cancer Treatment Regimens Assessed According to Site-/Country-Specific Medical Practice |
| Baseline up to 8 years |
| Total Number of Treatment Regimens Received by Participants | Baseline up to 8 years |
| Percentage of Participants with Adverse Events (AEs), Serious AEs, and Protocol-defined AEs of Special Interest | Baseline up to 8 years |
| Percentage of Participants with HER2 Re-testing of Metastases | Baseline up to 8 years |
| Percentage of Participants with Change in HER2 Status | Baseline up to 8 years |
| Percentage of Participants by Type of HER2 Testing (Immunohistochemistry and/or Fluorescence In situ Hybridization [FISH]) | Baseline up to 8 years |
| Percentage of Participants with Different Anti-Cancer Treatment Regimens by Country | Baseline up to 8 years |
| Percentage of Participants with History of Breast Cancer by Different Anti-Cancer Treatment Regimens | Baseline up to 8 years |
| EuroQol 5-Dimensions Questionnaire (EQ-5D) Score | Baseline up to 8 years |
| Functional Assessment of Cancer Therapy-Breast (FACT-B) Questionnaire Score | Baseline up to 8 years |
| Total Healthcare Cost | Baseline up to 8 years |
| Cost of Treating Associated AEs | Baseline up to 8 years |
| Resource Utilization: Percentage of Participants with Breast Cancer Associated Procedures | Baseline up to 8 years |
| Resource Utilization: Percentage of Participants with Hospitalization | Baseline up to 8 years |
| Resource Utilization: Percentage of Participants with Emergency Room Attendances and Outpatient Visits | Baseline up to 8 years |
| Graz |
| 8036 |
| Austria |
| Klinikum Klagenfurt; Abt. f. Hämatologie u. internistische Onkologie | Klagenfurt | 9020 | Austria |
| LKH Hochsteiermark; Abt. für Hämato-Onkologie | Leoben | 8700 | Austria |
| Ordensklinikum Linz Elisabethinen ; I. INTERNE ABT. | Linz | 4020 | Austria |
| A.Ö. Krankenhaus Der Barmherzigen Schwestern Ried; Interne Abtl. | Ried-innkreis | 4910 | Austria |
| Medizinische Universität Wien; Univ.Klinik für Frauenheilkunde - Klinik für Gynäkologie | Vienna | 1090 | Austria |
| Medizinische Universität Wien; Univ.Klinik für Innere Medizin I | Vienna | 1090 | Austria |
| Hanusch-Krankenhaus; Geburtshilfliche und Gynäkologische Abteilung | Vienna | 1140 | Austria |
| A.Ö. Lhk Villach; Abt. Für Gynäkologie | Villach | 9500 | Austria |
| Landesklinikum Wiener Neustadt; Innere Medizin, Hämatologie u. internistische Onkologie | Wiener Neustadt | 2700 | Austria |
| Multiprofile Hospital for Active Treatment Central Onco Hospital OOD | Plovdiv | 4000 | Bulgaria |
| Complex Oncological Center - Plovdiv, EOOD | Plovdiv | 4004 | Bulgaria |
| Mdozs - Russe | Rousse | 7000 | Bulgaria |
| MHAT Nadezhda | Sofia | 1330 | Bulgaria |
| Tokuda Hospital; Medical Oncology Department | Sofia | 1407 | Bulgaria |
| University Multiprofile Hospital for Active Treatment Tsaritsa Yoanna - ISUL EAD | Sofia | 1527 | Bulgaria |
| SHATOD - Sofia | Sofia | 1784 | Bulgaria |
| Complex Oncology Center-Burgas; Medical Oncology | Sofia | 8018 | Bulgaria |
| District Oncology Dispensary; Dept of Chimiotherapy | Stara Zagora | 8000 | Bulgaria |
| District Oncology Dispensary Wit Stationary | Varna | 9010 | Bulgaria |
| Comprehensive Oncology Center - Vratsa | Vratsa | 3000 | Bulgaria |
| Irccs Ist. Tumori Giovanni Paolo Ii; Dipartimento Oncologia Medica | Bari | Apulia | 70124 | Italy |
| Ospedale Barletta - Mons. Dimiccoli; Dip. Oncologia | Barletta | Apulia | 70051 | Italy |
| A.O. Universitaria Policlinico Di Modena; Oncologia | Modena | Emilia-Romagna | 41124 | Italy |
| RCCS - Centro di Riferimento; Oncologia Medica B | Aviano (PN) | Friuli Venezia Giulia | 33081 | Italy |
| Ospedale S. Maria Goretti; Divisione Di Oncologia Medica | Latina | Lazio | 04100 | Italy |
| Ospedale S.S. Trinità Nuovo; Divisione Oncologia | Sora | Lazio | 03039 | Italy |
| Ospedale Belcolle Di Viterbo; Oncologia | Viterbo | Lazio | 01100 | Italy |
| Az. Osp. Spedali Civili; Divisione Di Oncologia - Iii Medicina | Brescia | Lombardy | 25123 | Italy |
| Ospedale Degli Infermi Di Biella; Reparto Oncologia Medica | Ponderano (BI) | Piedmont | 13875 | Italy |
| Ospedale Cannizzaro, Oncologia | Catania | Sicily | 95126 | Italy |
| Casa Di Cura Di Alta Specialita La Maddalena; Dept. Oncologico Di Iii Livello | Palermo | Sicily | 90146 | Italy |
| A.O.U. Ospedali Riuniti Umberto I-G.M.Lancisi-G.Salesi Ancona;S.O.D. MED.Interna-Clinica Oncologica | Ancona | The Marches | 60121 | Italy |
| Azienda Ospedaliero-Universitaria Careggi; SOD Radioterapia | Florence | Tuscany | 50134 | Italy |
| Ospedale San Luca; Oncologia | Lucca | Tuscany | 55100 | Italy |
| Azienda Ospedaliera Di Perugia Ospedale s. Maria Della Misericordia; Oncologia Medica | Sant'Andrea Delle Fratte (PG) | Umbria | 06132 | Italy |
| Ospedale Civile; Oncologia Medica | Camposampiero | Veneto | 35012 | Italy |
| Azienda Ospedaliero Universitaria di Ferrara - U.O. Di Oncologia | Cona (FE) | Veneto | 44124 | Italy |
| Azienda ULSS 21 Ospedale Mater Salutis; Dip. di Oncologia | Legnago (VR) | Veneto | 37045 | Italy |
| A.O.U. Integrata Verona - Policlinico G.B. Rossi; Oncologia Medica - Dip. di Medicina | Verona | Veneto | 37134 | Italy |
| Hospital Garcia de Orta; Servico de Oncologia Medica | Almada | 2801-951 | Portugal |
| IPO de Coimbra; Servico de Oncologia Medica | Coimbra | 3000-075 | Portugal |
| Hospital Santo Antonio dos Capuchos;Servico de Oncologia Medica | Lisbon | 1150-314 | Portugal |
| Hospital de Santa Maria; Servico de Oncologia Medica | Lisbon | 1649-035 | Portugal |
| Hospital Beatriz Angelo; Departamento de Oncologia | Loures | 2674-514 | Portugal |
| IPO do Porto; Servico de Oncologia Medica | Porto | 4200-072 | Portugal |
| County Hospital Alba; Oncology | Alba Iulia | 510073 | Romania |
| "Filantropia" Clinical Hospital; Gynecological Oncology | Bucharest | 011191 | Romania |
| Institutul Oncologic Prof. Dr. Al. Trestioreanu Bucuresti | Bucharest | 022328 | Romania |
| Cluj-Napoca Emergency Clinical County Hospital; Medical Oncology | Cluj-Napoca | 400006 | Romania |
| Prof. Dr. I. Chiricuta Institute of Oncology | Cluj-Napoca | 400015 | Romania |
| Centrul de Oncologie Sfantul Nectarie | Craiova | 200347 | Romania |
| Oncomed SRL | Timișoara | 300239 | Romania |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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