KADCYLA clinical trial design

Demonstrated benefit in EMILIA, a well-designed clinical trial

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

  • The EMILIA trial was a large (N=991), Phase III, multi-institutional, 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 excluded9

IV=intravenously.

EMILIA trial endpoints included PFS, OS, and safety3

  • 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
arms1

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

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

KADCYLA survival data

Learn how KADCYLA performed in clinical trials vs lapatinib + capecitabine.

KADCYLA safety profile

Understand the adverse reactions.

Preparing and administering KADCYLA

Instructions for KADCYLA dose calculation, dose adjustments, storage, and more.