NCT02595762
Completed
Not Applicable
A Disease Registry Study to Prospectively Observe Treatment Patterns and Outcomes in Patients With HER2-Positive Unresectable Locally Advanced or Metastatic Breast Cancer
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Metastatic Breast Cancer
- Sponsor
- Hoffmann-La Roche
- Enrollment
- 110
- Locations
- 12
- Primary Endpoint
- Percentage of Participants Receiving Each Unique Treatment Regimen as First-Line Versus Subsequent-Line Therapy
- Status
- Completed
- Last Updated
- last year
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 locally advanced breast cancer (LABC) or metastatic breast cancer (MBC).
Investigators
Eligibility Criteria
Inclusion Criteria
- •Diagnosis of HER2-positive unresectable LABC or MBC within 6 months prior to enrollment
Exclusion Criteria
- •None specified
Outcomes
Primary Outcomes
Percentage of Participants Receiving Each Unique Treatment Regimen as First-Line Versus Subsequent-Line Therapy
Time Frame: Baseline up to approximately 8 years
Percentage of Participants Receiving Each Unique Treatment Regimen Overall
Time Frame: Baseline up to approximately 8 years
Percentage of Participants Receiving Each Unique Treatment Regimen Sequence
Time Frame: Baseline up to approximately 8 years
Progression-Free Survival (PFS)
Time Frame: 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 Outcomes
- Number of Treatment Regimens Received(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))
- Percentage of Participants by Reasons for Treatment Modification(Baseline up to approximately 8 years)
- Functional Assessment of Cancer Therapy-Breast (FACT-B) Questionnaire Score(Baseline up to approximately 8 years)
- 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 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))
- Duration of Response (DOR)(From date of first response (CR or PR) to the date of disease progression (up to approximately 8 years))
- EuroQoL 5-Dimension 5-Level Questionnaire (EQ-5D-5L) Score(Baseline up to approximately 8 years)
- Percentage of Participants With HER2 Retesting(Baseline up to approximately 8 years)
- Healthcare Resource Utilization - Total Healthcare Cost(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 - 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)
- Work Productivity and Activity Impairment-General Health (WPAI-GH) Questionnaire Score(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 - Percentage of Participants Who Are Hospitalized(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)
Study Sites (12)
Loading locations...
Similar Trials
Completed
Not Applicable
Human Epidermal Growth Factor Receptor 2 (HER2) Positive Unresectable Locally Advanced or Metastatic Breast Cancer Disease Registry StudyBreast CancerNCT02393924Hoffmann-La Roche311
Completed
Not Applicable
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)Breast CancerNCT02913456Hoffmann-La Roche629
Active, not recruiting
Not Applicable
The REPLACE Registry for Cholbam® (Cholic Acid)Bile Acid Synthesis DisordersNCT03115086Mirum Pharmaceuticals, Inc.55
Withdrawn
Not Applicable
A Study To Observe Treatment Patterns and Outcomes in Patients With HER2-Positive Unresectable Locally Advanced or Metastatic Breast CancerBreast Cancer, HER2 Positive Breast Cancer, Metastatic Breast Cancer, Locally Advanced Breast CancerNCT02616224Hoffmann-La Roche
Completed
Not Applicable
A Retrospective Epidemiologic Registry to Gain Insight Into the Characteristics and Prognosis of AML Patients According to the Routinely Used Genetic and Biologic MarkersAcute Myeloid LeukemiaNCT05541224PETHEMA Foundation6,917