CLEOPATRA
Clinical Evaluation of Pertuzumab and Trastuzumab
Patient / Population Intervention / Exposure Comparison Outcome
In 808 patients with HER2-positive metastatic breast cancer, first line, pertuzumab + trastuzumab + docetaxel improved progression-free and overall survival compared with placebo + trastuzumab + docetaxel.
N
808
Design
Double-blind RCT
Endpoint
Independent-review PFS; final OS
Relevance
1
ResultPFS 18.5 vs 12.4 months (HR 0.62). Final OS 56.5 vs 40.8 months (HR 0.68).
Baselga J, et al. N Engl J Med. 2012;366(2):109-119; Swain SM, et al. N Engl J Med. 2015;372(8):724-734. 10.1056/NEJMoa1113216
Discussion & critique
Established dual HER2 blockade plus taxane as first-line standard in HER2+ metastatic breast cancer. Later displaced by trastuzumab deruxtecan in the second line (DESTINY-Breast03).