6/28/23, 12:11 AM CLEOPATRA Pathway Feedback Search Clinical Topics Home Studies CLEOPATRA CLEOPATRA Trial question What is the effect of pertuzumab in addition to trastuzumab and docetaxel in patients with HER2- positive metastatic breast cancer? Study design Multi-center Double blinded RCT Population 808 female patients Inclusion criteria: patients with metastatic breast cancer that is positive for HER2 (HER2) Key exclusion criteria: central-nervous-system metastases, LVEF was < 50% during or after previous trastuzumab therapy, or received other anticancer therapy (with the exception of one previous hormonal regimen) or had a cumulative exposure > 360 mg of doxorubicin/m of BSA or its equivalent Interventions N=402 pertuzumab (plus trastuzumab and docetaxel) N=406 placebo (plus trastuzumab and docetaxel) Primary outcome Median overall survival 56.5 months 56.5 42.4 months 40.8 28.3 months 14.1 months Significant increase 0.0 months Pertuzumab Placebo Significant increase in median overall survival (56.5 months vs. 40.8 months; HR 1.47, 95% CI 1.19 to 1.79) Secondary outcomes Significant increase in median progression-free survival (18.7 months vs. 12.4 months; HR 1.47, 95% CI 0.6 to 2.34) https://web.pathway.md/studies/recJfn0uhOkBUmLfp 1/2 6/28/23, 12:11 AM CLEOPATRA Pathway Safety outcomes Significant differences in diarrhea (28.1% vs. 14.2%), rash (18.3% vs. 8.0%), muscle spasm (7.8% vs. 2.3%), pruritus (13.7% vs. 5.7%), and upper respiratory tract infection (18.3% vs. 12.3%). Conclusion In patients with metastatic breast cancer that is positive for HER2 (HER2), pertuzumab was superior to placebo with respect to median overall survival. Reference Swain SM, Baselga J, Kim SB et al. Pertuzumab, trastuzumab, and docetaxel in HER2-positive metastatic breast cancer. N Engl J Med. 2015 Feb 19;372(8):724-34. Open reference URL https://web.pathway.md/studies/recJfn0uhOkBUmLfp 2/2