title: 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.
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
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  NCT01615068 (ClinicalTrials.gov identifier).
authors.affiliation: Keck School of Medicine, University of Southern California, USC Norris Comprehensive Cancer Center, Los Angeles, CA, USA. tripathy@med.usc.edu.
authors.forename: Debu
authors.initials: D
authors.lastname: Tripathy
authors.forename: Hope S
authors.initials: HS
authors.lastname: Rugo
authors.forename: Peter A
authors.initials: PA
authors.lastname: Kaufman
authors.forename: Sandra
authors.initials: S
authors.lastname: Swain
authors.forename: Joyce
authors.initials: J
authors.lastname: O'Shaughnessy
authors.forename: Mohammad
authors.initials: M
authors.lastname: Jahanzeb
authors.forename: Ginny
authors.initials: G
authors.lastname: Mason
authors.forename: Mary
authors.initials: M
authors.lastname: Beattie
authors.forename: Bongin
authors.initials: B
authors.lastname: Yoo
authors.forename: Catherine
authors.initials: C
authors.lastname: Lai
authors.forename: Anthony
authors.initials: A
authors.lastname: Masaquel
authors.forename: Sara
authors.initials: S
authors.lastname: Hurvitz
mesh_terms: D000080044:Ado-Trastuzumab Emtansine; D061067:Antibodies, Monoclonal, Humanized / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000235:genetics / Q000401:mortality / Q000473:pathology; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D008453:Maytansine / Q000008:administration & dosage / Q000031:analogs & derivatives; D009362:Neoplasm Metastasis; D018719:Erb-b2 Receptor Tyrosine Kinases / Q000235:genetics; D000068878:Trastuzumab; D016896:Treatment Outcome
chemical_list: D000080044:Ado-Trastuzumab Emtansine; D061067:Antibodies, Monoclonal, Humanized; D008453:Maytansine; D018719:Erb-b2 Receptor Tyrosine Kinases; D000068878:Trastuzumab; C508053:ERBB2 protein, human; C485206:pertuzumab