A European Registry Study to Prospectively Observe Treatment Patterns and Outcomes in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Unresectable Locally Advanced (LA) or Metastatic Breast Cancer (mBC) (SAMANTHA)
- Conditions
- Breast Cancer
- Registration Number
- NCT02913456
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 629
- 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
- Not applicable
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of Participants by Different Anti-cancer Treatment Regimens and Treatment Sequences Baseline up to 8 years Progression-free Survival per Anti-cancer Treatment Regimens Assessed According to Site-/Country-Specific Medical Practice Baseline up to 8 years
- Secondary Outcome Measures
Name Time Method EuroQol 5-Dimensions Questionnaire (EQ-5D) Score Baseline up to 8 years Total Number of Treatment Regimens Received by Participants 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 Resource Utilization: Percentage of Participants with Emergency Room Attendances and Outpatient Visits Baseline up to 8 years Total Healthcare Cost Baseline up to 8 years Cost of Treating Associated AEs Baseline up to 8 years Overall Survival Baseline up to 8 years 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 Resource Utilization: Percentage of Participants with Hospitalization 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 Percentage of Participants by Type of HER2 Testing (Immunohistochemistry and/or Fluorescence In situ Hybridization [FISH]) Baseline up to 8 years Resource Utilization: Percentage of Participants with Breast Cancer Associated Procedures 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 Functional Assessment of Cancer Therapy-Breast (FACT-B) Questionnaire Score Baseline up to 8 years
Trial Locations
- Locations (54)
MHAT Nadezhda
🇧🇬Sofia, Bulgaria
Klinikum Klagenfurt; Abt. f. Hämatologie u. internistische Onkologie
🇦🇹Klagenfurt, Austria
Mdozs - Russe
🇧🇬Ruse, Bulgaria
Hospital de Santa Maria; Servico de Oncologia Medica
🇵🇹Lisboa, Portugal
Hospital Garcia de Orta; Servico de Oncologia Medica
🇵🇹Almada, Portugal
IPO de Coimbra; Servico de Oncologia Medica
🇵🇹Coimbra, Portugal
"Filantropia" Clinical Hospital; Gynecological Oncology
🇷🇴Bucharest, Romania
A.O.U. Integrata Verona - Policlinico G.B. Rossi; Oncologia Medica - Dip. di Medicina
🇮🇹Verona, Veneto, Italy
County Hospital Alba; Oncology
🇷🇴Alba Iulia, Romania
Cluj-Napoca Emergency Clinical County Hospital; Medical Oncology
🇷🇴Cluj-Napoca, Romania
Azienda ULSS 21 Ospedale Mater Salutis; Dip. di Oncologia
🇮🇹Legnago (VR), Veneto, Italy
Lkh-Univ. Klinikum Graz; Klinik Für Gynäkologie
🇦🇹Graz, Austria
A.Ö. Lhk Villach; Abt. Für Gynäkologie
🇦🇹Villach, Austria
Multiprofile Hospital for Active Treatment Central Onco Hospital OOD
🇧🇬Plovdiv, Bulgaria
Comprehensive Oncology Center - Vratsa
🇧🇬Vratza, Bulgaria
Ospedale Belcolle Di Viterbo; Oncologia
🇮🇹Viterbo, Lazio, Italy
Ospedale S.S. Trinità Nuovo; Divisione Oncologia
🇮🇹Sora, Lazio, Italy
A.O.U. Ospedali Riuniti Umberto I-G.M.Lancisi-G.Salesi Ancona;S.O.D. MED.Interna-Clinica Oncologica
🇮🇹Ancona, Marche, Italy
Ospedale Civile; Oncologia Medica
🇮🇹Camposampiero, Veneto, Italy
Azienda Ospedaliero Universitaria di Ferrara - U.O. Di Oncologia
🇮🇹Cona (FE), Veneto, Italy
Hospital Beatriz Angelo; Departamento de Oncologia
🇵🇹Loures, Portugal
Institutul Oncologic Prof. Dr. Al. Trestioreanu Bucuresti
🇷🇴Bucuresti, Romania
Azienda Ospedaliera Di Perugia Ospedale s. Maria Della Misericordia; Oncologia Medica
🇮🇹Sant'Andrea Delle Fratte (PG), Umbria, Italy
RCCS - Centro di Riferimento; Oncologia Medica B
🇮🇹Aviano (PN), Friuli-Venezia Giulia, Italy
A.O. Universitaria Policlinico Di Modena; Oncologia
🇮🇹Modena, Emilia-Romagna, Italy
Az. Osp. Spedali Civili; Divisione Di Oncologia - Iii Medicina
🇮🇹Brescia, Lombardia, Italy
Ospedale Degli Infermi Di Biella; Reparto Oncologia Medica
🇮🇹Ponderano (BI), Piemonte, Italy
Irccs Ist. Tumori Giovanni Paolo Ii; Dipartimento Oncologia Medica
🇮🇹Bari, Puglia, Italy
Ospedale Barletta - Mons. Dimiccoli; Dip. Oncologia
🇮🇹Barletta, Puglia, Italy
Ospedale Cannizzaro, Oncologia
🇮🇹Catania, Sicilia, Italy
Ospedale San Luca; Oncologia
🇮🇹Lucca, Toscana, Italy
Casa Di Cura Di Alta Specialita La Maddalena; Dept. Oncologico Di Iii Livello
🇮🇹Palermo, Sicilia, Italy
Azienda Ospedaliero-Universitaria Careggi; SOD Radioterapia
🇮🇹Firenze, Toscana, Italy
Ospedale S. Maria Goretti; Divisione Di Oncologia Medica
🇮🇹Latina, Lazio, Italy
LKH Hochsteiermark; Abt. für Hämato-Onkologie
🇦🇹Leoben, Austria
Tokuda Hospital; Medical Oncology Department
🇧🇬Sofia, Bulgaria
University Multiprofile Hospital for Active Treatment Tsaritsa Yoanna - ISUL EAD
🇧🇬Sofia, Bulgaria
LKH-UNIV. KLINIKUM GRAZ; Klinische Abteilung für Onkologie
🇦🇹Graz, Austria
Landesklinikum Wiener Neustadt; Innere Medizin, Hämatologie u. internistische Onkologie
🇦🇹Wiener Neustadt, Austria
SHATOD - Sofia
🇧🇬Sofia, Bulgaria
District Oncology Dispensary; Dept of Chimiotherapy
🇧🇬Stara Zagora, Bulgaria
IPO do Porto; Servico de Oncologia Medica
🇵🇹Porto, Portugal
Ordensklinikum Linz Elisabethinen ; I. INTERNE ABT.
🇦🇹Linz, Austria
A.Ö. Krankenhaus Der Barmherzigen Schwestern Ried; Interne Abtl.
🇦🇹Ried-innkreis, Austria
Centrul de Oncologie Sfantul Nectarie
🇷🇴Craiova, Romania
Medizinische Universität Wien; Univ.Klinik für Frauenheilkunde - Klinik für Gynäkologie
🇦🇹Wien, Austria
Complex Oncological Center - Plovdiv, EOOD
🇧🇬Plovdiv, Bulgaria
Complex Oncology Center-Burgas; Medical Oncology
🇧🇬Sofia, Bulgaria
Hospital Santo Antonio dos Capuchos;Servico de Oncologia Medica
🇵🇹Lisboa, Portugal
Prof. Dr. I. Chiricuta Institute of Oncology
🇷🇴Cluj Napoca, Romania
Medizinische Universität Wien; Univ.Klinik für Innere Medizin I
🇦🇹Wien, Austria
Hanusch-Krankenhaus; Geburtshilfliche und Gynäkologische Abteilung
🇦🇹Wien, Austria
Oncomed SRL
🇷🇴Timisoara, Romania
District Oncology Dispensary Wit Stationary
🇧🇬Varna, Bulgaria