NCT01615068
Completed
Not Applicable
An Observational Cohort Study of Treatment Patterns and Outcomes in Patients With HER2 Positive (HER2+) Metastatic Breast Cancer (SystHERs Registry (Systemic Therapies for HER2+ Metastatic Breast Cancer Study)).
ConditionsBreast Cancer
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Breast Cancer
- Sponsor
- Genentech, Inc.
- Enrollment
- 1007
- Locations
- 142
- Primary Endpoint
- Distribution of patients receiving unique treatment regimen/sequence of treatment regimens
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
This multi-center, prospective observational study will evaluate the treatment patterns, and the safety in patients with HER2-positive (HER2+) metastatic breast cancer (MBC). Eligible patients will have an initial metastatic breast cancer diagnosis that has not been previously treated with systemic therapy; patients may be enrolled up to 6 months after the diagnosis. Data will be collected for up to 8 years.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Adult patients, \>/=18 years of age
- •Initial diagnosis of HER2+ MBC, as diagnosed by the treating physician, no more than 6 months prior to study enrollment
- •Availability of cancer-specific historical data points in the patient's medical records
Exclusion Criteria
- •Any inability to provide informed consent
Outcomes
Primary Outcomes
Distribution of patients receiving unique treatment regimen/sequence of treatment regimens
Time Frame: Up to 8 years
Secondary Outcomes
- Progression-free survival (PFS)(Up to 8 years)
- Time-to-treatment failure (TTF)(Up to 8 years)
- Post-progression survival (PPS)(Up to 8 years)
- Patient-reported outcome assessment (PRO)(Up to 8 years)
- Overall survival (OS)(Up to 8 years)
- Response rate (RR)(Up to 8 years)
- Safety: Incidence of adverse events(Up to 8 years)
Study Sites (142)
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