Clinical trial NCT02913456: 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)
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2016-09-23
Enrollment: 629
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants initially diagnosed with HER2-positive unresectable LA/mBC no more than 6 months prior to enrollment

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.


Eligibility criteria: 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

Primary outcomes:
measure: Progression-free Survival per Anti-cancer Treatment Regimens Assessed According to Site-/Country-Specific Medical Practice
timeFrame: Baseline up to 8 years
measure: Percentage of Participants by Different Anti-cancer Treatment Regimens and Treatment Sequences
timeFrame: Baseline up to 8 years
Secondary outcomes:
measure: Overall Survival
timeFrame: Baseline up to 8 years
measure: Duration of Response per Anti-cancer Treatment Regimens Assessed According to Site-/Country-Specific Medical Practice
timeFrame: Baseline up to 8 years
measure: 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
timeFrame: Baseline up to 8 years
measure: Total Number of Treatment Regimens Received by Participants
timeFrame: Baseline up to 8 years
measure: Percentage of Participants with Adverse Events (AEs), Serious AEs, and Protocol-defined AEs of Special Interest
timeFrame: Baseline up to 8 years
measure: Percentage of Participants with HER2 Re-testing of Metastases
timeFrame: Baseline up to 8 years
measure: Percentage of Participants with Change in HER2 Status
timeFrame: Baseline up to 8 years
measure: Percentage of Participants by Type of HER2 Testing (Immunohistochemistry and/or Fluorescence In situ Hybridization [FISH])
timeFrame: Baseline up to 8 years
measure: Percentage of Participants with Different Anti-Cancer Treatment Regimens by Country
timeFrame: Baseline up to 8 years
measure: Percentage of Participants with History of Breast Cancer by Different Anti-Cancer Treatment Regimens
timeFrame: Baseline up to 8 years
measure: EuroQol 5-Dimensions Questionnaire (EQ-5D) Score
timeFrame: Baseline up to 8 years
measure: Functional Assessment of Cancer Therapy-Breast (FACT-B) Questionnaire Score
timeFrame: Baseline up to 8 years
measure: Total Healthcare Cost
timeFrame: Baseline up to 8 years
measure: Cost of Treating Associated AEs
timeFrame: Baseline up to 8 years
measure: Resource Utilization: Percentage of Participants with Breast Cancer Associated Procedures
timeFrame: Baseline up to 8 years
measure: Resource Utilization: Percentage of Participants with Hospitalization
timeFrame: Baseline up to 8 years
measure: Resource Utilization: Percentage of Participants with Emergency Room Attendances and Outpatient Visits
timeFrame: Baseline up to 8 years
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Lkh-Univ. Klinikum Graz; Klinik Für Gynäkologie
city: Graz
country: Austria
facility: LKH-UNIV. KLINIKUM GRAZ; Klinische Abteilung für Onkologie
city: Klagenfurt
country: Austria
facility: Klinikum Klagenfurt; Abt. f. Hämatologie u. internistische Onkologie
city: Leoben
country: Austria
facility: LKH Hochsteiermark; Abt. für Hämato-Onkologie
city: Linz
country: Austria
facility: Ordensklinikum Linz Elisabethinen ; I. INTERNE ABT.
city: Ried-innkreis
country: Austria
facility: A.Ö. Krankenhaus Der Barmherzigen Schwestern Ried; Interne Abtl.
city: Villach
country: Austria
facility: A.Ö. Lhk Villach; Abt. Für Gynäkologie
city: Wiener Neustadt
country: Austria
facility: Landesklinikum Wiener Neustadt; Innere Medizin, Hämatologie u. internistische Onkologie
city: Wien
country: Austria
facility: Medizinische Universität Wien; Univ.Klinik für Frauenheilkunde - Klinik für Gynäkologie
city: Wien
country: Austria
facility: Medizinische Universität Wien; Univ.Klinik für Innere Medizin I
city: Wien
country: Austria
facility: Hanusch-Krankenhaus; Geburtshilfliche und Gynäkologische Abteilung
city: Plovdiv
country: Bulgaria
facility: Multiprofile Hospital for Active Treatment Central Onco Hospital OOD
city: Plovdiv
country: Bulgaria
facility: Complex Oncological Center - Plovdiv, EOOD
city: Ruse
country: Bulgaria
facility: Mdozs - Russe
city: Sofia
country: Bulgaria
facility: MHAT Nadezhda
city: Sofia
country: Bulgaria
facility: Tokuda Hospital; Medical Oncology Department
city: Sofia
country: Bulgaria
facility: University Multiprofile Hospital for Active Treatment Tsaritsa Yoanna - ISUL EAD
city: Sofia
country: Bulgaria
facility: SHATOD - Sofia
city: Sofia
country: Bulgaria
facility: Complex Oncology Center-Burgas; Medical Oncology
city: Stara Zagora
country: Bulgaria
facility: District Oncology Dispensary; Dept of Chimiotherapy
city: Varna
country: Bulgaria
facility: District Oncology Dispensary Wit Stationary
city: Vratza
country: Bulgaria
facility: Comprehensive Oncology Center - Vratsa
city: Modena
country: Italy
facility: A.O. Universitaria Policlinico Di Modena; Oncologia
state: Emilia-Romagna
city: Aviano (PN)
country: Italy
facility: RCCS - Centro di Riferimento; Oncologia Medica B
state: Friuli-Venezia Giulia
city: Latina
country: Italy
facility: Ospedale S. Maria Goretti; Divisione Di Oncologia Medica
state: Lazio
city: Sora
country: Italy
facility: Ospedale S.S. Trinità Nuovo; Divisione Oncologia
state: Lazio
city: Viterbo
country: Italy
facility: Ospedale Belcolle Di Viterbo; Oncologia
state: Lazio
city: Brescia
country: Italy
facility: Az. Osp. Spedali Civili; Divisione Di Oncologia - Iii Medicina
state: Lombardia
city: Ancona
country: Italy
facility: A.O.U. Ospedali Riuniti Umberto I-G.M.Lancisi-G.Salesi Ancona;S.O.D. MED.Interna-Clinica Oncologica
state: Marche
city: Ponderano (BI)
country: Italy
facility: Ospedale Degli Infermi Di Biella; Reparto Oncologia Medica
state: Piemonte
city: Bari
country: Italy
facility: Irccs Ist. Tumori Giovanni Paolo Ii; Dipartimento Oncologia Medica
state: Puglia
city: Barletta
country: Italy
facility: Ospedale Barletta - Mons. Dimiccoli; Dip. Oncologia
state: Puglia
city: Catania
country: Italy
facility: Ospedale Cannizzaro, Oncologia
state: Sicilia
city: Palermo
country: Italy
facility: Casa Di Cura Di Alta Specialita La Maddalena; Dept. Oncologico Di Iii Livello
state: Sicilia
city: Firenze
country: Italy
facility: Azienda Ospedaliero-Universitaria Careggi; SOD Radioterapia
state: Toscana
city: Lucca
country: Italy
facility: Ospedale San Luca; Oncologia
state: Toscana
city: Sant'Andrea Delle Fratte (PG)
country: Italy
facility: Azienda Ospedaliera Di Perugia Ospedale s. Maria Della Misericordia; Oncologia Medica
state: Umbria
city: Camposampiero
country: Italy
facility: Ospedale Civile; Oncologia Medica
state: Veneto
city: Cona (FE)
country: Italy
facility: Azienda Ospedaliero Universitaria di Ferrara - U.O. Di Oncologia
state: Veneto
city: Legnago (VR)
country: Italy
facility: Azienda ULSS 21 Ospedale Mater Salutis; Dip. di Oncologia
state: Veneto
city: Verona
country: Italy
facility: A.O.U. Integrata Verona - Policlinico G.B. Rossi; Oncologia Medica - Dip. di Medicina
state: Veneto
city: Almada
country: Portugal
facility: Hospital Garcia de Orta; Servico de Oncologia Medica
city: Coimbra
country: Portugal
facility: IPO de Coimbra; Servico de Oncologia Medica
city: Lisboa
country: Portugal
facility: Hospital Santo Antonio dos Capuchos;Servico de Oncologia Medica
city: Lisboa
country: Portugal
facility: Hospital de Santa Maria; Servico de Oncologia Medica
city: Loures
country: Portugal
facility: Hospital Beatriz Angelo; Departamento de Oncologia
city: Porto
country: Portugal
facility: IPO do Porto; Servico de Oncologia Medica
city: Alba Iulia
country: Romania
facility: County Hospital Alba; Oncology
city: Bucharest
country: Romania
facility: "Filantropia" Clinical Hospital; Gynecological Oncology
city: Bucuresti
country: Romania
facility: Institutul Oncologic Prof. Dr. Al. Trestioreanu Bucuresti
city: Cluj Napoca
country: Romania
facility: Prof. Dr. I. Chiricuta Institute of Oncology
city: Cluj-Napoca
country: Romania
facility: Cluj-Napoca Emergency Clinical County Hospital; Medical Oncology
city: Craiova
country: Romania
facility: Centrul de Oncologie Sfantul Nectarie
city: Timisoara
country: Romania
facility: Oncomed SRL
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: