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)

NCT ID: NCT02913456

Last Updated: 2024-03-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

629 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-11-16

Study Completion Date

2024-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Breast Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Lkh-Univ. Klinikum Graz; Klinik Für Gynäkologie

Graz, , Austria

Site Status

LKH-UNIV. KLINIKUM GRAZ; Klinische Abteilung für Onkologie

Graz, , Austria

Site Status

Klinikum Klagenfurt; Abt. f. Hämatologie u. internistische Onkologie

Klagenfurt, , Austria

Site Status

LKH Hochsteiermark; Abt. für Hämato-Onkologie

Leoben, , Austria

Site Status

Ordensklinikum Linz Elisabethinen ; I. INTERNE ABT.

Linz, , Austria

Site Status

A.Ö. Krankenhaus Der Barmherzigen Schwestern Ried; Interne Abtl.

Ried-innkreis, , Austria

Site Status

Medizinische Universität Wien; Univ.Klinik für Frauenheilkunde - Klinik für Gynäkologie

Vienna, , Austria

Site Status

Medizinische Universität Wien; Univ.Klinik für Innere Medizin I

Vienna, , Austria

Site Status

Hanusch-Krankenhaus; Geburtshilfliche und Gynäkologische Abteilung

Vienna, , Austria

Site Status

A.Ö. Lhk Villach; Abt. Für Gynäkologie

Villach, , Austria

Site Status

Landesklinikum Wiener Neustadt; Innere Medizin, Hämatologie u. internistische Onkologie

Wiener Neustadt, , Austria

Site Status

Multiprofile Hospital for Active Treatment Central Onco Hospital OOD

Plovdiv, , Bulgaria

Site Status

Complex Oncological Center - Plovdiv, EOOD

Plovdiv, , Bulgaria

Site Status

Mdozs - Russe

Rousse, , Bulgaria

Site Status

MHAT Nadezhda

Sofia, , Bulgaria

Site Status

Tokuda Hospital; Medical Oncology Department

Sofia, , Bulgaria

Site Status

University Multiprofile Hospital for Active Treatment Tsaritsa Yoanna - ISUL EAD

Sofia, , Bulgaria

Site Status

SHATOD - Sofia

Sofia, , Bulgaria

Site Status

Complex Oncology Center-Burgas; Medical Oncology

Sofia, , Bulgaria

Site Status

District Oncology Dispensary; Dept of Chimiotherapy

Stara Zagora, , Bulgaria

Site Status

District Oncology Dispensary Wit Stationary

Varna, , Bulgaria

Site Status

Comprehensive Oncology Center - Vratsa

Vratsa, , Bulgaria

Site Status

Irccs Ist. Tumori Giovanni Paolo Ii; Dipartimento Oncologia Medica

Bari, Apulia, Italy

Site Status

Ospedale Barletta - Mons. Dimiccoli; Dip. Oncologia

Barletta, Apulia, Italy

Site Status

A.O. Universitaria Policlinico Di Modena; Oncologia

Modena, Emilia-Romagna, Italy

Site Status

RCCS - Centro di Riferimento; Oncologia Medica B

Aviano (PN), Friuli Venezia Giulia, Italy

Site Status

Ospedale S. Maria Goretti; Divisione Di Oncologia Medica

Latina, Lazio, Italy

Site Status

Ospedale S.S. Trinità Nuovo; Divisione Oncologia

Sora, Lazio, Italy

Site Status

Ospedale Belcolle Di Viterbo; Oncologia

Viterbo, Lazio, Italy

Site Status

Az. Osp. Spedali Civili; Divisione Di Oncologia - Iii Medicina

Brescia, Lombardy, Italy

Site Status

Ospedale Degli Infermi Di Biella; Reparto Oncologia Medica

Ponderano (BI), Piedmont, Italy

Site Status

Ospedale Cannizzaro, Oncologia

Catania, Sicily, Italy

Site Status

Casa Di Cura Di Alta Specialita La Maddalena; Dept. Oncologico Di Iii Livello

Palermo, Sicily, Italy

Site Status

A.O.U. Ospedali Riuniti Umberto I-G.M.Lancisi-G.Salesi Ancona;S.O.D. MED.Interna-Clinica Oncologica

Ancona, The Marches, Italy

Site Status

Azienda Ospedaliero-Universitaria Careggi; SOD Radioterapia

Florence, Tuscany, Italy

Site Status

Ospedale San Luca; Oncologia

Lucca, Tuscany, Italy

Site Status

Azienda Ospedaliera Di Perugia Ospedale s. Maria Della Misericordia; Oncologia Medica

Sant'Andrea Delle Fratte (PG), Umbria, Italy

Site Status

Ospedale Civile; Oncologia Medica

Camposampiero, Veneto, Italy

Site Status

Azienda Ospedaliero Universitaria di Ferrara - U.O. Di Oncologia

Cona (FE), Veneto, Italy

Site Status

Azienda ULSS 21 Ospedale Mater Salutis; Dip. di Oncologia

Legnago (VR), Veneto, Italy

Site Status

A.O.U. Integrata Verona - Policlinico G.B. Rossi; Oncologia Medica - Dip. di Medicina

Verona, Veneto, Italy

Site Status

Hospital Garcia de Orta; Servico de Oncologia Medica

Almada, , Portugal

Site Status

IPO de Coimbra; Servico de Oncologia Medica

Coimbra, , Portugal

Site Status

Hospital Santo Antonio dos Capuchos;Servico de Oncologia Medica

Lisbon, , Portugal

Site Status

Hospital de Santa Maria; Servico de Oncologia Medica

Lisbon, , Portugal

Site Status

Hospital Beatriz Angelo; Departamento de Oncologia

Loures, , Portugal

Site Status

IPO do Porto; Servico de Oncologia Medica

Porto, , Portugal

Site Status

County Hospital Alba; Oncology

Alba Iulia, , Romania

Site Status

"Filantropia" Clinical Hospital; Gynecological Oncology

Bucharest, , Romania

Site Status

Institutul Oncologic Prof. Dr. Al. Trestioreanu Bucuresti

Bucharest, , Romania

Site Status

Cluj-Napoca Emergency Clinical County Hospital; Medical Oncology

Cluj-Napoca, , Romania

Site Status

Prof. Dr. I. Chiricuta Institute of Oncology

Cluj-Napoca, , Romania

Site Status

Centrul de Oncologie Sfantul Nectarie

Craiova, , Romania

Site Status

Oncomed SRL

Timișoara, , Romania

Site Status

Countries

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Austria Bulgaria Italy Portugal Romania

Other Identifiers

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MO39146

Identifier Type: -

Identifier Source: org_study_id

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