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

Hoffmann-La Roche54 sites in 5 countries629 target enrollmentNovember 16, 2016

ConditionsBreast Cancer

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Breast Cancer
Sponsor: Hoffmann-La Roche
Enrollment: 629
Locations: 54
Primary Endpoint: Percentage of Participants by Different Anti-cancer Treatment Regimens and Treatment Sequences
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

November 16, 2016

End Date

January 31, 2024

Last Updated

2 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Hoffmann-La Roche

Responsible Party

Sponsor

Eligibility 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

Outcomes

Primary Outcomes

Percentage of Participants by Different Anti-cancer Treatment Regimens and Treatment Sequences

Time Frame: Baseline up to 8 years

Progression-free Survival per Anti-cancer Treatment Regimens Assessed According to Site-/Country-Specific Medical Practice

Time Frame: Baseline up to 8 years

Secondary Outcomes

Total Number of Treatment Regimens Received by Participants(Baseline up to 8 years)
Percentage of Participants with Different Anti-Cancer Treatment Regimens by Country(Baseline up to 8 years)
Percentage of Participants with History of Breast Cancer by Different Anti-Cancer Treatment Regimens(Baseline up to 8 years)
Resource Utilization: Percentage of Participants with Emergency Room Attendances and Outpatient Visits(Baseline up to 8 years)
Total Healthcare Cost(Baseline up to 8 years)
Cost of Treating Associated AEs(Baseline up to 8 years)
Overall Survival(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)
Resource Utilization: Percentage of Participants with Hospitalization(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 by Type of HER2 Testing (Immunohistochemistry and/or Fluorescence In situ Hybridization [FISH])(Baseline up to 8 years)
Resource Utilization: Percentage of Participants with Breast Cancer Associated Procedures(Baseline up to 8 years)
Percentage of Participants with HER2 Re-testing of Metastases(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 Change in HER2 Status(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)