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Table 1 Timing of data assessments in the SystHERs registry

From: 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

Assessment Time of data collection
  Baseline (enrollment) Follow-up (quarterlya) Death or study discontinuation
Informed consent X   
Demographic data X   
Functional/performance status X X X
Cardiovascular risk factors X   
Other relevant medical history X   
Selected concomitant medications Xb X X
Selected laboratory tests X X X
Breast cancer–specific cancer history Xc   
Prior cancer treatment history X   
Healthcare resource utilization X X X
Healthcare provider type X   
Insurance coverage and provider X X X
PROsd X X Xe
Tissue and blood samplesf X X  
Disease statusg   X X
Chemotherapy treatment status   X X
Interval surgical history   X X
Interval radiotherapy history   X X
Interval hormonal therapy history   X X
Protocol-specified AEsh   X X
Study discontinuation reason (including death)    X
  1. aPatient data should be reported at the time of study termination.
  2. bAll breast cancer treatments (including neoadjuvant and adjuvant treatments and duration) and select concomitant treatments, including those for protocol-specified safety events, will be recorded.
  3. cTo include stage (at time of diagnosis), histology, estrogen receptor/progesterone receptor status, metastatic sites, staging diagnostic work-up, presence or absence of central nervous system metastases.
  4. dPROs will be collected during clinic visits at approximately 90-day intervals (±15 days) and at frequent intervals to capture PRO data around disease progression (see Table 2 for details of PROs).
  5. eAn attempt will be made to collect PROs at study discontinuation.
  6. fConsent is required for collection of blood and tissue samples. Blood and/or tissue sample(s) can be collected at any time while on study.
  7. gSites of disease progression and new metastatic sites will be recorded.
  8. hThese include all SAEs, selected AEs, AEs of special interest, and AEs/SAEs that lead to treatment discontinuation or modification. SAEs, pregnancies, and STIAMPs must be reported to Genentech within 24 hours of learning of the events.
  9. AE, adverse event; PRO, patient-reported outcome; SAE, serious adverse event; STIAMP, suspected transmission of infectious agent by medicinal product, SystHERs, Systematic Therapies for HER2-Positive Metastatic Breast Cancer Study.