CLEOPATRA
Trial question
What is the effect of pertuzumab in addition to trastuzumab and docetaxel in patients with HER2+ metastatic breast cancer?
Study design
Multi-center
Double blinded
RCT
Population
808 female patients.
Inclusion criteria: patients with HER2+ metastatic breast cancer.
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/m² of body surface area or its equivalent.
Interventions
N=402 pertuzumab (pertuzumab plus trastuzumab and docetaxel).
N=406 placebo (placebo plus trastuzumab and docetaxel).
Primary outcome
Median overall survival
56.5 months
40.8 months
56.5 months
42.4 months
28.3 months
14.1 months
0.0 months
Pertuzumab
Placebo
Significant
increase ▲
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).
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 HER2+ metastatic breast cancer, 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.
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