The SystHERs registry: An observational cohort study of treatment patterns and outcomes in patients with human epidermal growth factor receptor 2-positive metastatic breast cancer

Debu Tripathy, Hope S. Rugo, Peter A. Kaufman, Sandra Swain, Joyce O'Shaughnessy, Mohammad Jahanzeb, Ginny Mason, Mary Beattie, Bongin Yoo, Catherine Lai, Anthony Masaquel, Sara Hurvitz

Research output: Contribution to journalArticle

13 Citations (Scopus)

Abstract

Background: Amplification of the human epidermal growth factor receptor 2 (HER2) gene occurs in approximately 20% of invasive breast cancer cases and is associated with a more aggressive disease course than HER2-negative breast cancer. HER2-targeted therapies have altered the natural history of HER2-positive breast cancer, a trend that will likely further improve with the recent approval of new agents. A prospective, observational cohort study was designed and initiated to provide real-world insights into current treatment patterns, long-term survival, and patients' experiences with initial and subsequent treatments for HER2-positive metastatic breast cancer (MBC).Methods/Design: The Systematic Therapies for HER2-positive Metastatic Breast Cancer Study (SystHERs) is a US-based prospective observational cohort study enrolling patients ≥18 years of age with recently diagnosed HER2-positive MBC not previously treated with systemic therapy in the metastatic setting. The primary objective of the study is to identify treatment patterns and clinical outcomes in recently diagnosed patients in a variety of practice settings. Secondary objectives include comparative efficacy, safety, and patient-reported outcomes (PROs). Healthcare resource utilization is an exploratory end point. Tumor tissue and blood sample collection is optional.The SystHERs registry will enroll approximately 1000 patients over a 3-year period, after which the study will continue for ≥5 years, allowing for a maximum follow-up of 8 years. The treating physician will determine all care and the frequency of visits. PRO measures will be completed at study enrollment and every 90 days. Clinical data will be abstracted quarterly from patient records. The first patient was enrolled in June 2012, and preliminary descriptive data based on 25% to 30% of the final study population are expected at the end of 2013, and as of April 25, 2014, 386 patients are enrolled.Discussion: SystHERs is expected to provide in-depth data on demographic, clinicopathological, and treatment patterns and their associations with clinical outcomes, PROs, and healthcare resource utilization. Tumor tissue and DNA repositories will also be established for use in future translational research.Trial registration number: NCT01615068 (ClinicalTrials.gov identifier).

Original languageEnglish
Article number307
JournalBMC Cancer
Volume14
Issue number1
DOIs
StatePublished - May 2 2014
Externally publishedYes

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Observational Studies
Registries
Cohort Studies
Breast Neoplasms
Therapeutics
erbB-1 Genes
Delivery of Health Care
Translational Medical Research
human ERBB2 protein
Natural History
Neoplasms
Demography
Physicians
Safety
Survival
DNA
Population
Patient Reported Outcome Measures

Keywords

  • Ado-trastuzumab emtansine
  • HER2
  • Human epidermal growth factor receptor 2
  • Metastatic breast cancer
  • Observational cohort study
  • Patient-reported outcome
  • Pertuzumab
  • Registry
  • SystHERs
  • Trastuzumab
  • Trastuzumab emtansine

ASJC Scopus subject areas

  • Oncology
  • Cancer Research
  • Genetics

Cite this

The SystHERs registry : An observational cohort study of treatment patterns and outcomes in patients with human epidermal growth factor receptor 2-positive metastatic breast cancer. / Tripathy, Debu; Rugo, Hope S.; Kaufman, Peter A.; Swain, Sandra; O'Shaughnessy, Joyce; Jahanzeb, Mohammad; Mason, Ginny; Beattie, Mary; Yoo, Bongin; Lai, Catherine; Masaquel, Anthony; Hurvitz, Sara.

In: BMC Cancer, Vol. 14, No. 1, 307, 02.05.2014.

Research output: Contribution to journalArticle

Tripathy, Debu ; Rugo, Hope S. ; Kaufman, Peter A. ; Swain, Sandra ; O'Shaughnessy, Joyce ; Jahanzeb, Mohammad ; Mason, Ginny ; Beattie, Mary ; Yoo, Bongin ; Lai, Catherine ; Masaquel, Anthony ; Hurvitz, Sara. / The SystHERs registry : An observational cohort study of treatment patterns and outcomes in patients with human epidermal growth factor receptor 2-positive metastatic breast cancer. In: BMC Cancer. 2014 ; Vol. 14, No. 1.
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