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History of Changes for Study: 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)
Latest version (submitted June 20, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 September 22, 2016 None (earliest Version on record)
2 October 6, 2016 Study Status
3 November 9, 2016 Recruitment Status, Study Status and Contacts/Locations
4 May 29, 2017 Contacts/Locations and Study Status
5 June 12, 2017 Contacts/Locations and Study Status
6 July 6, 2017 Study Status and Contacts/Locations
7 August 21, 2017 Study Status and Contacts/Locations
8 September 8, 2017 Study Status and Contacts/Locations
9 October 12, 2017 Contacts/Locations and Study Status
10 November 9, 2017 Study Status and Contacts/Locations
11 December 7, 2017 Study Status and Contacts/Locations
12 January 3, 2018 Contacts/Locations and Study Status
13 December 4, 2019 Recruitment Status, Contacts/Locations, Study Status and Study Design
14 January 16, 2020 Study Status
15 June 10, 2020 Contacts/Locations and Study Status
16 September 24, 2021 Study Status and Contacts/Locations
17 January 4, 2022 Study Status
18 March 23, 2022 Study Status and Study Design
19 June 20, 2022 Study Status
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Study NCT02913456
Submitted Date:  September 22, 2016 (v1)

Open or close this module Study Identification
Unique Protocol ID: MO39146
Brief Title: 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
Secondary IDs:
Open or close this module Study Status
Record Verification: September 2016
Overall Status: Not yet recruiting
Study Start: October 2016
Primary Completion: October 2024 [Anticipated]
Study Completion: October 2024 [Anticipated]
First Submitted: September 22, 2016
First Submitted that
Met QC Criteria:
September 22, 2016
First Posted: September 23, 2016 [Estimate]
Last Update Submitted that
Met QC Criteria:
September 22, 2016
Last Update Posted: September 23, 2016 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Hoffmann-La Roche
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring:
Open or close this module 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.
Detailed Description:
Open or close this module Conditions
Conditions: Breast Cancer
Keywords:
Open or close this module Study Design
Study Type: Observational
Observational Study Model: Cohort
Time Perspective: Prospective
Biospecimen Retention:
Biospecimen Description:
Enrollment: 465 [Anticipated]
Number of Groups/Cohorts 1
Open or close this module Groups and Interventions
Groups/Cohorts Interventions
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.
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Progression-free Survival per Anti-cancer Treatment Regimens Assessed According to Site-/Country-Specific Medical Practice
[ Time Frame: Baseline up to 8 years ]

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

Secondary Outcome Measures:
1. Overall Survival
[ Time Frame: Baseline up to 8 years ]

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Open or close this module Eligibility
Study Population: Participants initially diagnosed with HER2-positive unresectable LA/mBC no more than 6 months prior to enrollment
Sampling Method: Non-Probability Sample
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
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

Open or close this module Contacts/Locations
Central Contact Person: Reference Study ID Number: MO39146 www.roche.com/about_roche/roche_worldwide.htm
Telephone: 888-662-6728 (U.S. and Canada)
Email: global.rochegenentechtrials@roche.com
Study Officials: Clinical Trials
Study Director
Hoffmann-La Roche
Locations: Austria
Graz, Austria, 8036
Linz, Austria, 4020
Ried-innkreis, Austria, 4910
Villach, Austria, 9500
Wien, Austria, 1090
Wien, Austria, 1140
Bulgaria
Plovdiv, Bulgaria, 4004
Sofia, Bulgaria, 1330
Sofia, Bulgaria, 8018
Italy, Campania
Frattamaggiore, Campania, Italy, 80027
Italy, Emilia-Romagna
Modena, Emilia-Romagna, Italy, 41100
Italy, Friuli-Venezia Giulia
Aviano (PN), Friuli-Venezia Giulia, Italy, 33081
Italy, Lazio
Latina, Lazio, Italy, 04100
Sora, Lazio, Italy, 03039
Viterbo, Lazio, Italy, 01100
Italy, Lombardia
Brescia, Lombardia, Italy, 25123
Italy, Marche
Ancona, Marche, Italy, 60121
Italy, Piemonte
Ponderano (BI), Piemonte, Italy, 13875
Italy, Puglia
Bari, Puglia, Italy, 70124
Barletta, Puglia, Italy, 70051
Italy, Sardegna
Cagliari, Sardegna, Italy, 09121
Italy, Sicilia
Catania, Sicilia, Italy, 95126
Palermo, Sicilia, Italy, 90146
Italy, Toscana
Firenze, Toscana, Italy, 50134
Lucca, Toscana, Italy, 55100
Italy, Umbria
Perugia, Umbria, Italy, 06156
Italy, Veneto
Camposampiero, Veneto, Italy, 35012
Cona (FE), Veneto, Italy, 44124
Verona, Veneto, Italy, 37134
Portugal
Almada, Portugal, 2801-951
Coimbra, Portugal, 3000-075
Lisboa, Portugal, 1150-314
Lisboa, Portugal, 1649-035
Loures, Portugal, 2674-514
Porto, Portugal, 4200-072
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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