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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)

Sponsor
Hoffmann-La Roche (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT02913456
Collaborator
(none)
629
Enrollment
53
Locations
97.1
Anticipated Duration (Months)
11.9
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    629 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    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
    Actual Study Start Date :
    Nov 16, 2016
    Anticipated Primary Completion Date :
    Dec 18, 2024
    Anticipated Study Completion Date :
    Dec 18, 2024

    Arms and Interventions

    Arm Intervention/Treatment
    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.

    Outcome Measures

    Primary Outcome Measures

    1. Progression-free Survival per Anti-cancer Treatment Regimens Assessed According to Site-/Country-Specific Medical Practice [Baseline up to 8 years]

    2. Percentage of Participants by Different Anti-cancer Treatment Regimens and Treatment Sequences [Baseline up to 8 years]

    Secondary Outcome Measures

    1. Overall Survival [Baseline up to 8 years]

    2. Duration of Response per Anti-cancer Treatment Regimens Assessed According to Site-/Country-Specific Medical Practice [Baseline up to 8 years]

    3. 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]

    4. Total Number of Treatment Regimens Received by Participants [Baseline up to 8 years]

    5. Percentage of Participants with Adverse Events (AEs), Serious AEs, and Protocol-defined AEs of Special Interest [Baseline up to 8 years]

    6. Percentage of Participants with HER2 Re-testing of Metastases [Baseline up to 8 years]

    7. Percentage of Participants with Change in HER2 Status [Baseline up to 8 years]

    8. Percentage of Participants by Type of HER2 Testing (Immunohistochemistry and/or Fluorescence In situ Hybridization [FISH]) [Baseline up to 8 years]

    9. Percentage of Participants with Different Anti-Cancer Treatment Regimens by Country [Baseline up to 8 years]

    10. Percentage of Participants with History of Breast Cancer by Different Anti-Cancer Treatment Regimens [Baseline up to 8 years]

    11. EuroQol 5-Dimensions Questionnaire (EQ-5D) Score [Baseline up to 8 years]

    12. Functional Assessment of Cancer Therapy-Breast (FACT-B) Questionnaire Score [Baseline up to 8 years]

    13. Total Healthcare Cost [Baseline up to 8 years]

    14. Cost of Treating Associated AEs [Baseline up to 8 years]

    15. Resource Utilization: Percentage of Participants with Breast Cancer Associated Procedures [Baseline up to 8 years]

    16. Resource Utilization: Percentage of Participants with Hospitalization [Baseline up to 8 years]

    17. Resource Utilization: Percentage of Participants with Emergency Room Attendances and Outpatient Visits [Baseline up to 8 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Lkh-Univ. Klinikum Graz; Klinik Für Gynäkologie Graz Austria 8036
    2 LKH-UNIV. KLINIKUM GRAZ; Klinische Abteilung für Onkologie Graz Austria 8036
    3 Klinikum Klagenfurt; Abt. f. Hämatologie u. internistische Onkologie Klagenfurt Austria 9020
    4 LKH Hochsteiermark; Abt. für Hämato-Onkologie Leoben Austria 8700
    5 Ordensklinikum Linz Elisabethinen ; I. INTERNE ABT. Linz Austria 4020
    6 A.Ö. Krankenhaus Der Barmherzigen Schwestern Ried; Interne Abtl. Ried-innkreis Austria 4910
    7 A.Ö. Lhk Villach; Abt. Für Gynäkologie Villach Austria 9500
    8 Landesklinikum Wiener Neustadt; Innere Medizin, Hämatologie u. internistische Onkologie Wiener Neustadt Austria 2700
    9 Medizinische Universität Wien; Univ.Klinik für Frauenheilkunde - Klinik für Gynäkologie Wien Austria 1090
    10 Medizinische Universität Wien; Univ.Klinik für Innere Medizin I Wien Austria 1090
    11 Hanusch-Krankenhaus; Geburtshilfliche und Gynäkologische Abteilung Wien Austria 1140
    12 Multiprofile Hospital for Active Treatment Central Onco Hospital OOD Plovdiv Bulgaria 4000
    13 Complex Oncological Center - Plovdiv, EOOD Plovdiv Bulgaria 4004
    14 Mdozs - Russe Ruse Bulgaria 7000
    15 MHAT Nadezhda Sofia Bulgaria 1330
    16 Tokuda Hospital; Medical Oncology Department Sofia Bulgaria 1407
    17 University Multiprofile Hospital for Active Treatment Tsaritsa Yoanna - ISUL EAD Sofia Bulgaria 1527
    18 SHATOD - Sofia Sofia Bulgaria 1784
    19 Complex Oncology Center-Burgas; Medical Oncology Sofia Bulgaria 8018
    20 District Oncology Dispensary; Dept of Chimiotherapy Stara Zagora Bulgaria 8000
    21 District Oncology Dispensary Wit Stationary Varna Bulgaria 9010
    22 Comprehensive Oncology Center - Vratsa Vratza Bulgaria 3000
    23 A.O. Universitaria Policlinico Di Modena; Oncologia Modena Emilia-Romagna Italy 41100
    24 RCCS - Centro di Riferimento; Oncologia Medica B Aviano (PN) Friuli-Venezia Giulia Italy 33081
    25 Ospedale S. Maria Goretti; Divisione Di Oncologia Medica Latina Lazio Italy 04100
    26 Ospedale S.S. Trinità Nuovo; Divisione Oncologia Sora Lazio Italy 03039
    27 Ospedale Belcolle Di Viterbo; Oncologia Viterbo Lazio Italy 01100
    28 Az. Osp. Spedali Civili; Divisione Di Oncologia - Iii Medicina Brescia Lombardia Italy 25123
    29 A.O.U. Ospedali Riuniti Umberto I-G.M.Lancisi-G.Salesi Ancona;S.O.D. MED.Interna-Clinica Oncologica Ancona Marche Italy 60121
    30 Ospedale Degli Infermi Di Biella; Reparto Oncologia Medica Ponderano (BI) Piemonte Italy 13875
    31 Irccs Ist. Tumori Giovanni Paolo Ii; Dipartimento Oncologia Medica Bari Puglia Italy 70124
    32 Ospedale Barletta - Mons. Dimiccoli; Dip. Oncologia Barletta Puglia Italy 70051
    33 Ospedale Cannizzaro, Oncologia Catania Sicilia Italy 95126
    34 Casa Di Cura Di Alta Specialita La Maddalena; Dept. Oncologico Di Iii Livello Palermo Sicilia Italy 90146
    35 Azienda Ospedaliero-Universitaria Careggi; SOD Radioterapia Firenze Toscana Italy 50134
    36 Ospedale San Luca; Oncologia Lucca Toscana Italy 55100
    37 Azienda Ospedaliera Di Perugia Ospedale s. Maria Della Misericordia; Oncologia Medica Sant'Andrea Delle Fratte (PG) Umbria Italy 06132
    38 Ospedale Civile; Oncologia Medica Camposampiero Veneto Italy 35012
    39 Azienda Ospedaliero Universitaria di Ferrara - U.O. Di Oncologia Cona (FE) Veneto Italy 44124
    40 Azienda ULSS 21 Ospedale Mater Salutis; Dip. di Oncologia Legnago (VR) Veneto Italy 37045
    41 A.O.U. Integrata Verona - Policlinico G.B. Rossi; Oncologia Medica - Dip. di Medicina Verona Veneto Italy 37134
    42 Hospital Garcia de Orta; Servico de Oncologia Medica Almada Portugal 2801-951
    43 IPO de Coimbra; Servico de Oncologia Medica Coimbra Portugal 3000-075
    44 Hospital Santo Antonio dos Capuchos;Servico de Oncologia Medica Lisboa Portugal 1150-314
    45 Hospital de Santa Maria; Servico de Oncologia Medica Lisboa Portugal 1649-035
    46 Hospital Beatriz Angelo; Departamento de Oncologia Loures Portugal 2674-514
    47 IPO do Porto; Servico de Oncologia Medica Porto Portugal 4200-072
    48 "Filantropia" Clinical Hospital; Gynecological Oncology Bucharest Romania 011191
    49 Institutul Oncologic Prof. Dr. Al. Trestioreanu Bucuresti Bucuresti Romania 022328
    50 Prof. Dr. I. Chiricuta Institute of Oncology Cluj Napoca Romania 400015
    51 Cluj-Napoca Emergency Clinical County Hospital; Medical Oncology Cluj-Napoca Romania 400006
    52 Centrul de Oncologie Sfantul Nectarie Craiova Romania 200347
    53 Oncomed SRL Timisoara Romania 300239

    Sponsors and Collaborators

    • Hoffmann-La Roche

    Investigators

    • Study Director: Clinical Trials, Hoffmann-La Roche

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hoffmann-La Roche
    ClinicalTrials.gov Identifier:
    NCT02913456
    Other Study ID Numbers:
    • MO39146
    First Posted:
    Sep 23, 2016
    Last Update Posted:
    Jun 22, 2022
    Last Verified:
    Jun 1, 2022
    Additional relevant MeSH terms:
    Breast Neoplasms

    Study Results

    No Results Posted as of Jun 22, 2022