KADCYLA: EMILIA clinical trial design

Efficacy and safety were assessed in HER2+ MBC patients previously treated with trastuzumab and a taxane1

  • The EMILIA trial was a large (N=991), Phase III, open-label, randomized trial in patients with HER2-positive (HER2+), unresectable, locally advanced or metastatic breast cancer (MBC)
  • Patients with a history of symptomatic congestive heart failure (CHF) or serious cardiac arrhythmia requiring treatment were excluded3
EMILIA trial design schema


EMILIA trial endpoints included PFS, OS, and safety6

  • Primary endpoints: Progression-free survival (PFS) by independent review committee (IRC), overall survival (OS), safety
  • Key secondary endpoints: PFS by investigator review, objective response rate (ORR), duration of response (DoR), and time to symptom progression (TTP)

Patient baseline characteristics in EMILIA were balanced between treatment

Most patients (88%) had received one or more lines of systemic therapy in the metastatic setting1

EMILIA trial design patient demographics

EBC=early breast cancer; ECOG PS=Eastern Cooperative Oncology Group performance status; ER=estrogen receptor; MBC=metastatic breast cancer; PR=progesterone receptor.

See the efficacy results

Review the adverse reactions

Dosing for KADCYLA in MBC