Locally Advanced Breast Cancer, Metastatic Breast Cancer
Conditions
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 locally advanced breast cancer (LABC) or metastatic breast cancer (MBC).
Interventions
None listed
Sponsors
Hoffmann-La Roche
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of HER2-positive unresectable LABC or MBC within 6 months prior to enrollment
Exclusion criteria
* None specified
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-Free Survival (PFS) | From start date of anti-cancer treatment regimen to the date of either disease progression or death (up to approximately 8 years) | Tumor response will be evaluated by the Investigator according to site-/country-specific medical practice. Study protocol does not specify any particular method of assessment. |
| Percentage of Participants Receiving Each Unique Treatment Regimen Overall | Baseline up to approximately 8 years | — |
| Percentage of Participants Receiving Each Unique Treatment Regimen as First-Line Versus Subsequent-Line Therapy | Baseline up to approximately 8 years | — |
| Percentage of Participants Receiving Each Unique Treatment Regimen Sequence | Baseline up to approximately 8 years | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Treatment Regimens Received | Baseline up to approximately 8 years | — |
| Percentage of Participants With Complete Response (CR) or Partial Response (PR) - Objective Response Rate (ORR) | From the date of initiation of treatment to the date of disease progression or death from any cause (up to approximately 8 years) | Tumor response will be evaluated by the Investigator according to site-/country-specific medical practice. Study protocol does not specify any particular method of assessment. |
| Duration of Response (DOR) | From date of first response (CR or PR) to the date of disease progression (up to approximately 8 years) | Tumor response will be evaluated by the Investigator according to site-/country-specific medical practice. Study protocol does not specify any particular method of assessment. |
| Percentage of Participants by Reasons for Treatment Modification | Baseline up to approximately 8 years | — |
| EuroQoL 5-Dimension 5-Level Questionnaire (EQ-5D-5L) Score | Baseline up to approximately 8 years | — |
| Functional Assessment of Cancer Therapy-Breast (FACT-B) Questionnaire Score | Baseline up to approximately 8 years | — |
| Work Productivity and Activity Impairment-General Health (WPAI-GH) Questionnaire Score | Baseline up to approximately 8 years | — |
| Percentage of Participants With HER2 Retesting | Baseline up to approximately 8 years | — |
| Percentage of Participants With HER2 Overexpression, as Assessed Using In Situ Hybridization or Immunohistochemistry | Baseline up to approximately 8 years | — |
| Percentage of Participants With Adverse Events (AEs) and Serious AEs (SAEs) | Baseline up to approximately 8 years | — |
| Healthcare Resource Utilization - Percentage of Participants Who Are Hospitalized | Baseline up to approximately 8 years | — |
| Healthcare Resource Utilization - Length of Hospitalization | Baseline up to approximately 8 years | — |
| Healthcare Resource Utilization - Percentage of Participants With Emergency Room Visit | Baseline up to approximately 8 years | — |
| Healthcare Resource Utilization - Percentage of Participants With Outpatient Visit | Baseline up to approximately 8 years | — |
| Healthcare Resource Utilization - Cost of Disease Related Out-of-Pocket Healthcare Expenditures | Baseline up to approximately 8 years | — |
| Healthcare Resource Utilization - Indirect Disease Related Cost | Baseline up to approximately 8 years | — |
| Healthcare Resource Utilization - Number of Working Hours Missed Among Informal Caregivers due to Disease-Related Caregiving Responsibilities | Baseline up to approximately 8 years | — |
| Healthcare Resource Utilization - Percentage of Participants Receiving Monetary Social Benefits | Baseline up to approximately 8 years | — |
| Healthcare Resource Utilization - Total Healthcare Cost | Baseline up to approximately 8 years | — |
| Percentage of Participants Receiving Each Treatment Regimen, by Participant Characteristics | Baseline up to approximately 8 years | — |
| Percentage of Participants Receiving Each Treatment Regimen, by Country/Region | Baseline up to approximately 8 years | — |
| Overall Survival (OS) | From the date of initiation of treatment to the date of death from any cause (up to approximately 8 years) | — |
Countries
Cyprus, Greece
Outcome results
None listed