HERACLES

EudraCT-2012-002128-33 📎

Regimen

Experimental
Trastuzumab + lapatinib
Control
single-arm

Population

HER2-positive (colorectal-specific criteria), KRAS exon 2 wild-type metastatic CRC, 3L+, refractory to standard care including anti-EGFR.

Key finding

ORR 30% (95% CI 14–50%), 1 CR + 7 PR; disease control 44% stable disease; no grade 4–5 AEs; grade 3 AEs: fatigue, rash, elevated bilirubin in 22% total; median follow-up 94 weeks; 914 patients screened to find 48 HER2-positive (5% prevalence in KRAS-WT).

Source: PMID 27108243

Timeline

    Guideline citations

    • NCCN Colon (p.35)
    • NCCN Rectal (p.46)