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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02913456

Enrollment

629

Registered

2016-09-23

Start date

2016-11-16

Completion date

2024-01-31

Last updated

2024-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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
Percentage of Participants with HER2 Re-testing of Metastases	Baseline up to 8 years
Percentage of Participants with Change in HER2 Status	Baseline up to 8 years
Percentage of Participants by Type of HER2 Testing (Immunohistochemistry and/or Fluorescence In situ Hybridization [FISH])	Baseline up to 8 years
Percentage of Participants with Different Anti-Cancer Treatment Regimens by Country	Baseline up to 8 years
EuroQol 5-Dimensions Questionnaire (EQ-5D) Score	Baseline up to 8 years
Functional Assessment of Cancer Therapy-Breast (FACT-B) Questionnaire Score	Baseline up to 8 years
Total Healthcare Cost	Baseline up to 8 years
Cost of Treating Associated AEs	Baseline up to 8 years
Resource Utilization: Percentage of Participants with Breast Cancer Associated Procedures	Baseline up to 8 years
Resource Utilization: Percentage of Participants with Hospitalization	Baseline up to 8 years
Resource Utilization: Percentage of Participants with Emergency Room Attendances and Outpatient Visits	Baseline up to 8 years
Percentage of Participants with History of Breast Cancer by Different Anti-Cancer Treatment Regimens	Baseline up to 8 years
Overall Survival	Baseline up to 8 years

Countries

Austria, Bulgaria, Italy, Portugal, Romania

Outcome results