Breast Cancer Clinical Trial
Official title:
A European Disease Registry Study to Prospectively Observe Treatment Patterns and Outcomes in Patients With HER2-Positive Unresectable Locally Advanced or Metastatic Breast Cancer
| NCT number | NCT02913456 |
| Other study ID # | MO39146 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | November 16, 2016 |
| Est. completion date | January 31, 2024 |
| Verified date | March 2024 |
| Source | Hoffmann-La Roche |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 629 |
| Est. completion date | January 31, 2024 |
| Est. primary completion date | January 31, 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Austria | Lkh-Univ. Klinikum Graz; Klinik Für Gynäkologie | Graz | |
| Austria | LKH-UNIV. KLINIKUM GRAZ; Klinische Abteilung für Onkologie | Graz | |
| Austria | Klinikum Klagenfurt; Abt. f. Hämatologie u. internistische Onkologie | Klagenfurt | |
| Austria | LKH Hochsteiermark; Abt. für Hämato-Onkologie | Leoben | |
| Austria | Ordensklinikum Linz Elisabethinen ; I. INTERNE ABT. | Linz | |
| Austria | A.Ö. Krankenhaus Der Barmherzigen Schwestern Ried; Interne Abtl. | Ried-innkreis | |
| Austria | A.Ö. Lhk Villach; Abt. Für Gynäkologie | Villach | |
| Austria | Hanusch-Krankenhaus; Geburtshilfliche und Gynäkologische Abteilung | Wien | |
| Austria | Medizinische Universität Wien; Univ.Klinik für Frauenheilkunde - Klinik für Gynäkologie | Wien | |
| Austria | Medizinische Universität Wien; Univ.Klinik für Innere Medizin I | Wien | |
| Austria | Landesklinikum Wiener Neustadt; Innere Medizin, Hämatologie u. internistische Onkologie | Wiener Neustadt | |
| Bulgaria | Complex Oncological Center - Plovdiv, EOOD | Plovdiv | |
| Bulgaria | Multiprofile Hospital for Active Treatment Central Onco Hospital OOD | Plovdiv | |
| Bulgaria | Mdozs - Russe | Ruse | |
| Bulgaria | Complex Oncology Center-Burgas; Medical Oncology | Sofia | |
| Bulgaria | MHAT Nadezhda | Sofia | |
| Bulgaria | SHATOD - Sofia | Sofia | |
| Bulgaria | Tokuda Hospital; Medical Oncology Department | Sofia | |
| Bulgaria | University Multiprofile Hospital for Active Treatment Tsaritsa Yoanna - ISUL EAD | Sofia | |
| Bulgaria | District Oncology Dispensary; Dept of Chimiotherapy | Stara Zagora | |
| Bulgaria | District Oncology Dispensary Wit Stationary | Varna | |
| Bulgaria | Comprehensive Oncology Center - Vratsa | Vratza | |
| Italy | A.O.U. Ospedali Riuniti Umberto I-G.M.Lancisi-G.Salesi Ancona;S.O.D. MED.Interna-Clinica Oncologica | Ancona | Marche |
| Italy | RCCS - Centro di Riferimento; Oncologia Medica B | Aviano (PN) | Friuli-Venezia Giulia |
| Italy | Irccs Ist. Tumori Giovanni Paolo Ii; Dipartimento Oncologia Medica | Bari | Puglia |
| Italy | Ospedale Barletta - Mons. Dimiccoli; Dip. Oncologia | Barletta | Puglia |
| Italy | Az. Osp. Spedali Civili; Divisione Di Oncologia - Iii Medicina | Brescia | Lombardia |
| Italy | Ospedale Civile; Oncologia Medica | Camposampiero | Veneto |
| Italy | Ospedale Cannizzaro, Oncologia | Catania | Sicilia |
| Italy | Azienda Ospedaliero Universitaria di Ferrara - U.O. Di Oncologia | Cona (FE) | Veneto |
| Italy | Azienda Ospedaliero-Universitaria Careggi; SOD Radioterapia | Firenze | Toscana |
| Italy | Ospedale S. Maria Goretti; Divisione Di Oncologia Medica | Latina | Lazio |
| Italy | Azienda ULSS 21 Ospedale Mater Salutis; Dip. di Oncologia | Legnago (VR) | Veneto |
| Italy | Ospedale San Luca; Oncologia | Lucca | Toscana |
| Italy | A.O. Universitaria Policlinico Di Modena; Oncologia | Modena | Emilia-Romagna |
| Italy | Casa Di Cura Di Alta Specialita La Maddalena; Dept. Oncologico Di Iii Livello | Palermo | Sicilia |
| Italy | Ospedale Degli Infermi Di Biella; Reparto Oncologia Medica | Ponderano (BI) | Piemonte |
| Italy | Azienda Ospedaliera Di Perugia Ospedale s. Maria Della Misericordia; Oncologia Medica | Sant'Andrea Delle Fratte (PG) | Umbria |
| Italy | Ospedale S.S. Trinità Nuovo; Divisione Oncologia | Sora | Lazio |
| Italy | A.O.U. Integrata Verona - Policlinico G.B. Rossi; Oncologia Medica - Dip. di Medicina | Verona | Veneto |
| Italy | Ospedale Belcolle Di Viterbo; Oncologia | Viterbo | Lazio |
| Portugal | Hospital Garcia de Orta; Servico de Oncologia Medica | Almada | |
| Portugal | IPO de Coimbra; Servico de Oncologia Medica | Coimbra | |
| Portugal | Hospital de Santa Maria; Servico de Oncologia Medica | Lisboa | |
| Portugal | Hospital Santo Antonio dos Capuchos;Servico de Oncologia Medica | Lisboa | |
| Portugal | Hospital Beatriz Angelo; Departamento de Oncologia | Loures | |
| Portugal | IPO do Porto; Servico de Oncologia Medica | Porto | |
| Romania | County Hospital Alba; Oncology | Alba Iulia | |
| Romania | "Filantropia" Clinical Hospital; Gynecological Oncology | Bucharest | |
| Romania | Institutul Oncologic Prof. Dr. Al. Trestioreanu Bucuresti | Bucuresti | |
| Romania | Prof. Dr. I. Chiricuta Institute of Oncology | Cluj Napoca | |
| Romania | Cluj-Napoca Emergency Clinical County Hospital; Medical Oncology | Cluj-Napoca | |
| Romania | Centrul de Oncologie Sfantul Nectarie | Craiova | |
| Romania | Oncomed SRL | Timisoara |
| Lead Sponsor | Collaborator |
|---|---|
| Hoffmann-La Roche |
Austria, Bulgaria, Italy, Portugal, Romania,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Progression-free Survival per Anti-cancer Treatment Regimens Assessed According to Site-/Country-Specific Medical Practice | Baseline up to 8 years | ||
| Primary | Percentage of Participants by Different Anti-cancer Treatment Regimens and Treatment Sequences | Baseline up to 8 years | ||
| Secondary | Overall Survival | Baseline up to 8 years | ||
| Secondary | Duration of Response per Anti-cancer Treatment Regimens Assessed According to Site-/Country-Specific Medical Practice | Baseline up to 8 years | ||
| Secondary | 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 | ||
| Secondary | Total Number of Treatment Regimens Received by Participants | Baseline up to 8 years | ||
| Secondary | Percentage of Participants with Adverse Events (AEs), Serious AEs, and Protocol-defined AEs of Special Interest | Baseline up to 8 years | ||
| Secondary | Percentage of Participants with HER2 Re-testing of Metastases | Baseline up to 8 years | ||
| Secondary | Percentage of Participants with Change in HER2 Status | Baseline up to 8 years | ||
| Secondary | Percentage of Participants by Type of HER2 Testing (Immunohistochemistry and/or Fluorescence In situ Hybridization [FISH]) | Baseline up to 8 years | ||
| Secondary | Percentage of Participants with Different Anti-Cancer Treatment Regimens by Country | Baseline up to 8 years | ||
| Secondary | Percentage of Participants with History of Breast Cancer by Different Anti-Cancer Treatment Regimens | Baseline up to 8 years | ||
| Secondary | EuroQol 5-Dimensions Questionnaire (EQ-5D) Score | Baseline up to 8 years | ||
| Secondary | Functional Assessment of Cancer Therapy-Breast (FACT-B) Questionnaire Score | Baseline up to 8 years | ||
| Secondary | Total Healthcare Cost | Baseline up to 8 years | ||
| Secondary | Cost of Treating Associated AEs | Baseline up to 8 years | ||
| Secondary | Resource Utilization: Percentage of Participants with Breast Cancer Associated Procedures | Baseline up to 8 years | ||
| Secondary | Resource Utilization: Percentage of Participants with Hospitalization | Baseline up to 8 years | ||
| Secondary | Resource Utilization: Percentage of Participants with Emergency Room Attendances and Outpatient Visits | Baseline up to 8 years |
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