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)
A European Disease Registry Study to Prospectively Observe Treatment Patterns and Outcomes in Patients With HER2-Positive Unresectable Locally Advanced or Metastatic Breast Cancer
1 other identifier
observational
629
5 countries
54
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2016
Longer than P75 for all trials
54 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 22, 2016
CompletedFirst Posted
Study publicly available on registry
September 23, 2016
CompletedStudy Start
First participant enrolled
November 16, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2024
CompletedMarch 6, 2024
March 1, 2024
7.2 years
September 22, 2016
March 5, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
Progression-free Survival per Anti-cancer Treatment Regimens Assessed According to Site-/Country-Specific Medical Practice
Baseline up to 8 years
Percentage of Participants by Different Anti-cancer Treatment Regimens and Treatment Sequences
Baseline up to 8 years
Secondary Outcomes (17)
Overall Survival
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 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
Total Number of Treatment Regimens Received by Participants
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
- +12 more secondary outcomes
Study Arms (1)
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.
Eligibility Criteria
Participants initially diagnosed with HER2-positive unresectable LA/mBC no more than 6 months prior to enrollment
You may qualify if:
- \- 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
You may not qualify if:
- \- Not applicable
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (54)
Lkh-Univ. Klinikum Graz; Klinik Für Gynäkologie
Graz, 8036, Austria
LKH-UNIV. KLINIKUM GRAZ; Klinische Abteilung für Onkologie
Graz, 8036, Austria
Klinikum Klagenfurt; Abt. f. Hämatologie u. internistische Onkologie
Klagenfurt, 9020, Austria
LKH Hochsteiermark; Abt. für Hämato-Onkologie
Leoben, 8700, Austria
Ordensklinikum Linz Elisabethinen ; I. INTERNE ABT.
Linz, 4020, Austria
A.Ö. Krankenhaus Der Barmherzigen Schwestern Ried; Interne Abtl.
Ried-innkreis, 4910, Austria
Medizinische Universität Wien; Univ.Klinik für Frauenheilkunde - Klinik für Gynäkologie
Vienna, 1090, Austria
Medizinische Universität Wien; Univ.Klinik für Innere Medizin I
Vienna, 1090, Austria
Hanusch-Krankenhaus; Geburtshilfliche und Gynäkologische Abteilung
Vienna, 1140, Austria
A.Ö. Lhk Villach; Abt. Für Gynäkologie
Villach, 9500, Austria
Landesklinikum Wiener Neustadt; Innere Medizin, Hämatologie u. internistische Onkologie
Wiener Neustadt, 2700, Austria
Multiprofile Hospital for Active Treatment Central Onco Hospital OOD
Plovdiv, 4000, Bulgaria
Complex Oncological Center - Plovdiv, EOOD
Plovdiv, 4004, Bulgaria
Mdozs - Russe
Rousse, 7000, Bulgaria
MHAT Nadezhda
Sofia, 1330, Bulgaria
Tokuda Hospital; Medical Oncology Department
Sofia, 1407, Bulgaria
University Multiprofile Hospital for Active Treatment Tsaritsa Yoanna - ISUL EAD
Sofia, 1527, Bulgaria
SHATOD - Sofia
Sofia, 1784, Bulgaria
Complex Oncology Center-Burgas; Medical Oncology
Sofia, 8018, Bulgaria
District Oncology Dispensary; Dept of Chimiotherapy
Stara Zagora, 8000, Bulgaria
District Oncology Dispensary Wit Stationary
Varna, 9010, Bulgaria
Comprehensive Oncology Center - Vratsa
Vratsa, 3000, Bulgaria
Irccs Ist. Tumori Giovanni Paolo Ii; Dipartimento Oncologia Medica
Bari, Apulia, 70124, Italy
Ospedale Barletta - Mons. Dimiccoli; Dip. Oncologia
Barletta, Apulia, 70051, Italy
A.O. Universitaria Policlinico Di Modena; Oncologia
Modena, Emilia-Romagna, 41124, Italy
RCCS - Centro di Riferimento; Oncologia Medica B
Aviano (PN), Friuli Venezia Giulia, 33081, Italy
Ospedale S. Maria Goretti; Divisione Di Oncologia Medica
Latina, Lazio, 04100, Italy
Ospedale S.S. Trinità Nuovo; Divisione Oncologia
Sora, Lazio, 03039, Italy
Ospedale Belcolle Di Viterbo; Oncologia
Viterbo, Lazio, 01100, Italy
Az. Osp. Spedali Civili; Divisione Di Oncologia - Iii Medicina
Brescia, Lombardy, 25123, Italy
Ospedale Degli Infermi Di Biella; Reparto Oncologia Medica
Ponderano (BI), Piedmont, 13875, Italy
Ospedale Cannizzaro, Oncologia
Catania, Sicily, 95126, Italy
Casa Di Cura Di Alta Specialita La Maddalena; Dept. Oncologico Di Iii Livello
Palermo, Sicily, 90146, Italy
A.O.U. Ospedali Riuniti Umberto I-G.M.Lancisi-G.Salesi Ancona;S.O.D. MED.Interna-Clinica Oncologica
Ancona, The Marches, 60121, Italy
Azienda Ospedaliero-Universitaria Careggi; SOD Radioterapia
Florence, Tuscany, 50134, Italy
Ospedale San Luca; Oncologia
Lucca, Tuscany, 55100, Italy
Azienda Ospedaliera Di Perugia Ospedale s. Maria Della Misericordia; Oncologia Medica
Sant'Andrea Delle Fratte (PG), Umbria, 06132, Italy
Ospedale Civile; Oncologia Medica
Camposampiero, Veneto, 35012, Italy
Azienda Ospedaliero Universitaria di Ferrara - U.O. Di Oncologia
Cona (FE), Veneto, 44124, Italy
Azienda ULSS 21 Ospedale Mater Salutis; Dip. di Oncologia
Legnago (VR), Veneto, 37045, Italy
A.O.U. Integrata Verona - Policlinico G.B. Rossi; Oncologia Medica - Dip. di Medicina
Verona, Veneto, 37134, Italy
Hospital Garcia de Orta; Servico de Oncologia Medica
Almada, 2801-951, Portugal
IPO de Coimbra; Servico de Oncologia Medica
Coimbra, 3000-075, Portugal
Hospital Santo Antonio dos Capuchos;Servico de Oncologia Medica
Lisbon, 1150-314, Portugal
Hospital de Santa Maria; Servico de Oncologia Medica
Lisbon, 1649-035, Portugal
Hospital Beatriz Angelo; Departamento de Oncologia
Loures, 2674-514, Portugal
IPO do Porto; Servico de Oncologia Medica
Porto, 4200-072, Portugal
County Hospital Alba; Oncology
Alba Iulia, 510073, Romania
"Filantropia" Clinical Hospital; Gynecological Oncology
Bucharest, 011191, Romania
Institutul Oncologic Prof. Dr. Al. Trestioreanu Bucuresti
Bucharest, 022328, Romania
Cluj-Napoca Emergency Clinical County Hospital; Medical Oncology
Cluj-Napoca, 400006, Romania
Prof. Dr. I. Chiricuta Institute of Oncology
Cluj-Napoca, 400015, Romania
Centrul de Oncologie Sfantul Nectarie
Craiova, 200347, Romania
Oncomed SRL
Timișoara, 300239, Romania
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 22, 2016
First Posted
September 23, 2016
Study Start
November 16, 2016
Primary Completion
January 31, 2024
Study Completion
January 31, 2024
Last Updated
March 6, 2024
Record last verified: 2024-03