A Study of Treatment Patterns and Outcomes in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Unresectable Locally Advanced or Metastatic Breast Cancer
Study Details
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 locally advanced breast cancer (LABC) or metastatic breast cancer (MBC).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Participants With HER2-Positive Breast Cancer Enrolled participants will receive treatment and clinical assessments for their HER2-positive unresectable LABC/MBC as determined by their treating physician, according to the standard of care and routine clinical practice at each site. Participants will be followed until death, withdrawal of consent or study termination, whichever occurs first. Study protocol does not specify any particular drug or treatment regimen. |
Outcome Measures
Primary Outcome Measures
- 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]
- 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.
Secondary Outcome Measures
- Percentage of Participants With Adverse Events (AEs) and Serious AEs (SAEs) [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)]
- 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]
- Healthcare Resource Utilization - Total Healthcare Cost [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]
Eligibility Criteria
Criteria
Inclusion Criteria:
- Diagnosis of HER2-positive unresectable LABC or MBC within 6 months prior to enrollment
Exclusion Criteria:
- None specified
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | ARETAIEION UNIVERSITY HOSPITAL; oncology unit | Athens | Greece | 115 28 | |
| 2 | IASO General Hospital of Athens | Athens | Greece | 155 62 |
Sponsors and Collaborators
- Hoffmann-La Roche
Investigators
- Study Director: Clinical Trials, Hoffmann-La Roche
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ML28801