ADJUVANT TRIAL DESIGN


The APHINITY trial was a Phase III, large, prospective, randomized, multicenter, double-blind, placebo-controlled trial of patients with HER2+ EBC.1,2

APHINITY trial schema1

PERJETA dosing: 840 mg loading dose, 420 mg for subsequent cycles; Herceptin: 8 mg/kg loading dose, 6 mg/kg for subsequent cycles; chemotherapy: varies per regimen. See Dosing and Administration for more details.

APHINITY endpoints included iDFS and overall survival

Primary efficacy endpoint1

 iDFS defined as the time from randomization to the first occurrence of one of the following events:

  • Ipsilateral local or regional invasive breast cancer recurrence 
  • Distant recurrence
  • Contralateral invasive breast cancer 
  • Death from any cause

Secondary efficacy endpoints1,2

  • iDFS according to standardized definitions for efficacy endpoints (STEEP), including second primary nonbreast cancer 
  • Recurrence-free interval 
  • Distant recurrence-free interval 
  • DFS including noninvasive breast cancers
  • Overall survival 
  • Safety

Learn more about the APHINITY trial outcomes and safety profile.

Patient demographics in APHINITY

Demographics were generally balanced between the 2 treatment arms.1

Select patient baseline characteristics2

  • The median age was 51 years (range, 18-86), 13% of patients were ≥65 years, and 71% were Caucasian1
  • 63% of patients had node-positive disease, and 64% had hormone receptor–positive disease1
  • All patients had an ECOG performance status of 0 or 11
  • 78% received an anthracycline-containing regimen1

ECOG=Eastern Cooperative Oncology Group; ER=estrogen receptor; PR=progesterone receptor.

References