Table 2.

Ongoing studies with T-DM1 in early breast cancer

Clinicaltrials.gov identifierStudy nameDesignArmsSettingPrimary endpoint
NCT01772472KATHERINE2-arm, randomized, open-label, phase IIIT-DM1 vs trastuzumabAdjuvantIDFS
NCT01196052N/Asingle-arm, open-label, phase IIT-DM1Neoadjuvant and adjuvantSafety
NCT01745965ADAPT2-arm, randomized, open-label, phase IIT-DM1 vs trastuzumabNeoadjuvantpCR
NCT01042379I-SPY 2N-arm, randomized open-label, phase IIT-DM1 and pertuzumab versus standard therapyNeoadjuvantpCR
NCT01904903SAFE-HEaRtopen-label, phase IIT-DM1AnyCardiac safety

Abbreviations: IDFS, invasive disease-free survival; N/A, not applicable; pCR, pathologic complete response rate.