HERACLES
Dual-targeted therapy with trastuzumab and lapatinib in treatment-refractory, KRAS codon 12/13 wild-type, HER2-positive metastatic colorectal cancer (HERACLES): a proof-of-concept, multicentre, open-label, phase 2 trial
Phase 2N = 27
- Population
- KRAS exon 2 (codons 12 and 13) wild-type, HER2-positive metastatic colorectal cancer refractory to standard of care including cetuximab or panitumumab
- Design
- Proof-of-concept, multicentre, open-label, single-arm phase 2 trial at four Italian academic cancer centres. Trastuzumab (4 mg/kg loading dose, then 2 mg/kg weekly) plus oral lapatinib 1000 mg daily until progression. HER2 positivity was defined by immunohistochemistry and fluorescence in-situ hybridisation using the investigators' colorectal-cancer-specific criteria. The primary endpoint was objective response by independent central review in the intention-to-treat population. The abstract prints a EudraCT number (2012-002128-33) and no ClinicalTrials.gov identifier.
- Primary endpoint
- ORR
- Arms
- Trastuzumab + lapatinib (experimental, n = 27): Trastuzumab plus lapatinib
- People
- Sartore-Bianchi A
Show the numbers
| Endpoint | Analysis | Trastuzumab + lapatinib | Control | Effect |
|---|---|---|---|---|
| ORRObjective response by independent central review (primary endpoint) | primarySartore-Bianchi 2016 | 30% (14–50%) | — | Eight of 27 patients responded (one complete and seven partial responses); 12 had stable disease. Median follow-up 94 weeks at data cutoff. Of 914 patients screened, 48 (5%) had HER2-positive tumours and 27 were eligible. Single-arm study. |
| Endpoint | Analysis | Trastuzumab + lapatinib | Control | Effect |
|---|---|---|---|---|
| ORRObjective response by independent central review (primary endpoint) | primarySartore-Bianchi 2016 | 30% (14–50%) | — | Eight of 27 patients responded (one complete and seven partial responses); 12 had stable disease. Median follow-up 94 weeks at data cutoff. Of 914 patients screened, 48 (5%) had HER2-positive tumours and 27 were eligible. Single-arm study. |
Appears in
Sources
Sartore-Bianchi A, Trusolino L, Martino C, Bencardino K, Lonardi S, Bergamo F, et al. Dual-targeted therapy with trastuzumab and lapatinib in treatment-refractory, KRAS codon 12/13 wild-type, HER2-positive metastatic colorectal cancer (HERACLES): a proof-of-concept, multicentre, open-label, phase 2 trial. Lancet Oncol. 2016;17(6):738-746.