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Clinical Trials/NCT01615068
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)).

Genentech, Inc.142 sites in 1 country1,007 target enrollmentJune 5, 2012
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.

Registry
clinicaltrials.gov
Start Date
June 5, 2012
End Date
November 16, 2017
Last Updated
7 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

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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