Table 1.

Efficacy of single-agent T-DM1 in phase II and III clinical trials of patients with HER2+ advanced breast cancer

TDM4258g (12)TDM4374g (13)TDM4450g (15)EMILIA (14)
Study typeSingle-arm phase IISingle-arm phase IIRandomized phase IIRandomized phase III
Patient #1121106770495496
PopulationPrior TPrior T, L, chemoNo prior Tx for MBCPrior T + taxane
TreatmentT-DM1T-DM1T-DM1Docetaxel/TT-DM1Cape/L
Median PFS4.6 mo6.9 mo14.2 mo9.2 mo9.6 mo6.4 mo
Median OSNRNRNRNR30.9 mo25.1 mo
ORR25.9%34.5%64.2%58.0%43.6%30.8%
DORNE7.2 moNE9.5 mo12.6 mo6.5 mo
ORR (confirmed HER2+)33.8%41.3%NRNRNAaNAa

NOTE: T-DM1 was given at a dosage of 3.6 mg/kg every 3 weeks in all studies.

Abbreviations: Cape, capecitabine; Chemo, chemotherapy (prior anthracycline, taxane, and capecitabine required for TDM4374g); DOR, duration of response; L, lapatinib; MBC, metastatic breast cancer; NA, not applicable; NE, not estimable; NR, not reported; T, trastuzumab; Tx, therapy.

  • aAll patients on EMILIA had centrally confirmed HER2+ cancers.