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)

March 5, 2024 updated by: Hoffmann-La Roche

A European Disease Registry Study to Prospectively Observe Treatment Patterns and Outcomes in Patients With HER2-Positive Unresectable Locally Advanced or Metastatic Breast Cancer

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.

Study Overview

Status

Completed

Conditions

Breast Cancer

Study Type

Observational

Enrollment (Actual)

629

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Austria
- - Graz, Austria, 8036
    - Lkh-Univ. Klinikum Graz; Klinik Für Gynäkologie
  - Graz, Austria, 8036
    - LKH-UNIV. KLINIKUM GRAZ; Klinische Abteilung für Onkologie
  - Klagenfurt, Austria, 9020
    - Klinikum Klagenfurt; Abt. f. Hämatologie u. internistische Onkologie
  - Leoben, Austria, 8700
    - LKH Hochsteiermark; Abt. für Hämato-Onkologie
  - Linz, Austria, 4020
    - Ordensklinikum Linz Elisabethinen ; I. INTERNE ABT.
  - Ried-innkreis, Austria, 4910
    - A.Ö. Krankenhaus Der Barmherzigen Schwestern Ried; Interne Abtl.
  - Villach, Austria, 9500
    - A.Ö. Lhk Villach; Abt. Für Gynäkologie
  - Wien, Austria, 1090
    - Medizinische Universität Wien; Univ.Klinik für Frauenheilkunde - Klinik für Gynäkologie
  - Wien, Austria, 1090
    - Medizinische Universität Wien; Univ.Klinik für Innere Medizin I
  - Wien, Austria, 1140
    - Hanusch-Krankenhaus; Geburtshilfliche und Gynäkologische Abteilung
  - Wiener Neustadt, Austria, 2700
    - Landesklinikum Wiener Neustadt; Innere Medizin, Hämatologie u. internistische Onkologie
Bulgaria
- - Plovdiv, Bulgaria, 4004
    - Complex Oncological Center - Plovdiv, EOOD
  - Plovdiv, Bulgaria, 4000
    - Multiprofile Hospital for Active Treatment Central Onco Hospital OOD
  - Ruse, Bulgaria, 7000
    - Mdozs - Russe
  - Sofia, Bulgaria, 1784
    - SHATOD - Sofia
  - Sofia, Bulgaria, 1527
    - University Multiprofile Hospital for Active Treatment Tsaritsa Yoanna - ISUL EAD
  - Sofia, Bulgaria, 1330
    - MHAT Nadezhda
  - Sofia, Bulgaria, 1407
    - Tokuda Hospital; Medical Oncology Department
  - Sofia, Bulgaria, 8018
    - Complex Oncology Center-Burgas; Medical Oncology
  - Stara Zagora, Bulgaria, 8000
    - District Oncology Dispensary; Dept of Chimiotherapy
  - Varna, Bulgaria, 9010
    - District Oncology Dispensary Wit Stationary
  - Vratza, Bulgaria, 3000
    - Comprehensive Oncology Center - Vratsa
Italy
- Emilia-Romagna
  - Modena, Emilia-Romagna, Italy, 41124
    - A.O. Universitaria Policlinico Di Modena; Oncologia
- Friuli-Venezia Giulia
  - Aviano (PN), Friuli-Venezia Giulia, Italy, 33081
    - RCCS - Centro di Riferimento; Oncologia Medica B
- Lazio
  - Latina, Lazio, Italy, 04100
    - Ospedale S. Maria Goretti; Divisione Di Oncologia Medica
  - Sora, Lazio, Italy, 03039
    - Ospedale S.S. Trinità Nuovo; Divisione Oncologia
  - Viterbo, Lazio, Italy, 01100
    - Ospedale Belcolle Di Viterbo; Oncologia
- Lombardia
  - Brescia, Lombardia, Italy, 25123
    - Az. Osp. Spedali Civili; Divisione Di Oncologia - Iii Medicina
- Marche
  - Ancona, Marche, Italy, 60121
    - A.O.U. Ospedali Riuniti Umberto I-G.M.Lancisi-G.Salesi Ancona;S.O.D. MED.Interna-Clinica Oncologica
- Piemonte
  - Ponderano (BI), Piemonte, Italy, 13875
    - Ospedale Degli Infermi Di Biella; Reparto Oncologia Medica
- Puglia
  - Bari, Puglia, Italy, 70124
    - Irccs Ist. Tumori Giovanni Paolo Ii; Dipartimento Oncologia Medica
  - Barletta, Puglia, Italy, 70051
    - Ospedale Barletta - Mons. Dimiccoli; Dip. Oncologia
- Sicilia
  - Catania, Sicilia, Italy, 95126
    - Ospedale Cannizzaro, Oncologia
  - Palermo, Sicilia, Italy, 90146
    - Casa Di Cura Di Alta Specialita La Maddalena; Dept. Oncologico Di Iii Livello
- Toscana
  - Firenze, Toscana, Italy, 50134
    - Azienda Ospedaliero-Universitaria Careggi; SOD Radioterapia
  - Lucca, Toscana, Italy, 55100
    - Ospedale San Luca; Oncologia
- Umbria
  - Sant'Andrea Delle Fratte (PG), Umbria, Italy, 06132
    - Azienda Ospedaliera Di Perugia Ospedale s. Maria Della Misericordia; Oncologia Medica
- Veneto
  - Camposampiero, Veneto, Italy, 35012
    - Ospedale Civile; Oncologia Medica
  - Cona (FE), Veneto, Italy, 44124
    - Azienda Ospedaliero Universitaria di Ferrara - U.O. Di Oncologia
  - Legnago (VR), Veneto, Italy, 37045
    - Azienda ULSS 21 Ospedale Mater Salutis; Dip. di Oncologia
  - Verona, Veneto, Italy, 37134
    - A.O.U. Integrata Verona - Policlinico G.B. Rossi; Oncologia Medica - Dip. di Medicina
Portugal
- - Almada, Portugal, 2801-951
    - Hospital Garcia de Orta; Servico de Oncologia Medica
  - Coimbra, Portugal, 3000-075
    - IPO de Coimbra; Servico de Oncologia Medica
  - Lisboa, Portugal, 1649-035
    - Hospital de Santa Maria; Servico de Oncologia Medica
  - Lisboa, Portugal, 1150-314
    - Hospital Santo Antonio dos Capuchos;Servico de Oncologia Medica
  - Loures, Portugal, 2674-514
    - Hospital Beatriz Angelo; Departamento de Oncologia
  - Porto, Portugal, 4200-072
    - IPO do Porto; Servico de Oncologia Medica
Romania
- - Alba Iulia, Romania, 510073
    - County Hospital Alba; Oncology
  - Bucharest, Romania, 011191
    - "Filantropia" Clinical Hospital; Gynecological Oncology
  - Bucuresti, Romania, 022328
    - Institutul Oncologic Prof. Dr. Al. Trestioreanu Bucuresti
  - Cluj Napoca, Romania, 400015
    - Prof. Dr. I. Chiricuta Institute of Oncology
  - Cluj-Napoca, Romania, 400006
    - Cluj-Napoca Emergency Clinical County Hospital; Medical Oncology
  - Craiova, Romania, 200347
    - Centrul de Oncologie Sfantul Nectarie
  - Timisoara, Romania, 300239
    - Oncomed SRL

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Sampling Method

Non-Probability Sample

Study Population

Participants initially diagnosed with HER2-positive unresectable LA/mBC no more than 6 months prior to enrollment

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Observational Models: Cohort
Time Perspectives: Prospective

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Progression-free Survival per Anti-cancer Treatment Regimens Assessed According to Site-/Country-Specific Medical Practice Time Frame: Baseline up to 8 years	Baseline up to 8 years
Percentage of Participants by Different Anti-cancer Treatment Regimens and Treatment Sequences Time Frame: Baseline up to 8 years	Baseline up to 8 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Overall Survival Time Frame: Baseline up to 8 years	Baseline up to 8 years
Duration of Response per Anti-cancer Treatment Regimens Assessed According to Site-/Country-Specific Medical Practice Time Frame: Baseline up to 8 years	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 Time Frame: Baseline up to 8 years	Baseline up to 8 years
Total Number of Treatment Regimens Received by Participants Time Frame: Baseline up to 8 years	Baseline up to 8 years
Percentage of Participants with Adverse Events (AEs), Serious AEs, and Protocol-defined AEs of Special Interest Time Frame: Baseline up to 8 years	Baseline up to 8 years
Percentage of Participants with HER2 Re-testing of Metastases Time Frame: Baseline up to 8 years	Baseline up to 8 years
Percentage of Participants with Change in HER2 Status Time Frame: Baseline up to 8 years	Baseline up to 8 years
Percentage of Participants by Type of HER2 Testing (Immunohistochemistry and/or Fluorescence In situ Hybridization [FISH]) Time Frame: Baseline up to 8 years	Baseline up to 8 years
Percentage of Participants with Different Anti-Cancer Treatment Regimens by Country Time Frame: Baseline up to 8 years	Baseline up to 8 years
Percentage of Participants with History of Breast Cancer by Different Anti-Cancer Treatment Regimens Time Frame: Baseline up to 8 years	Baseline up to 8 years
EuroQol 5-Dimensions Questionnaire (EQ-5D) Score Time Frame: Baseline up to 8 years	Baseline up to 8 years
Functional Assessment of Cancer Therapy-Breast (FACT-B) Questionnaire Score Time Frame: Baseline up to 8 years	Baseline up to 8 years
Total Healthcare Cost Time Frame: Baseline up to 8 years	Baseline up to 8 years
Cost of Treating Associated AEs Time Frame: Baseline up to 8 years	Baseline up to 8 years
Resource Utilization: Percentage of Participants with Breast Cancer Associated Procedures Time Frame: Baseline up to 8 years	Baseline up to 8 years
Resource Utilization: Percentage of Participants with Hospitalization Time Frame: Baseline up to 8 years	Baseline up to 8 years
Resource Utilization: Percentage of Participants with Emergency Room Attendances and Outpatient Visits Time Frame: Baseline up to 8 years	Baseline up to 8 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Investigators

Study Director: Clinical Trials, Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 16, 2016

Primary Completion (Actual)

January 31, 2024

Study Completion (Actual)

January 31, 2024

Study Registration Dates

First Submitted

September 22, 2016

First Submitted That Met QC Criteria