KRISTINE

NCT02131064 📎

Regimen

Experimental
T-DM1 + pertuzumab x 6 cycles neoadjuvant, followed by adjuvant T-DM1 + pertuzumab.
Control
TCHP (docetaxel + carboplatin + trastuzumab + pertuzumab) x 6 cycles, followed by adjuvant HP.

Population

HER2-positive stage II-III operable breast cancer >= 2 cm.

Key finding

KRISTINE was a negative chemotherapy-free neoadjuvant experiment: T-DM1 + pertuzumab was inferior to TCHP for pCR and EFS. Established that chemotherapy backbone remains necessary in neoadjuvant HER2+ disease with current ADCs.

Source: PMID 31157583

Timeline

  • Publication: 2019 Sep 1

Guideline citations

  • NCCN BREAST