Cardiac Tolerability of Pertuzumab Plus Trastuzumab Plus Docetaxel in Patients With HER2-Positive Metastatic Breast Cancer in CLEOPATRA: A Randomized, Double-Blind, Placebo-Controlled Phase III Study
Why the study?
Does pertuzumab plus trastuzumab plus docetaxel increase the incidence of cardiac adverse events in patients with HER2-positive metastatic breast cancer?
Population
Patients with HER2-positive metastatic breast cancer (MBC)
Comparison
Pertuzumab plus trastuzumab plus docetaxel vs Placebo control arm
Design
RCT, Randomized, Double-blind, placebo-controlled
Authors
Discussion
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Member takes
Implication
No excess cardiac events with pertuzumab addition; confirms dual HER2 blockade safety in metastatic disease.
Key Points
- Evaluate the cardiac tolerability and incidence of heart-related adverse events when adding pertuzumab to trastuzumab and docetaxel in HER2-positive metastatic breast cancer.
- Phase III randomized, double-blind, placebo-controlled trial (CLEOPATRA) evaluating patients with HER2-positive metastatic breast cancer.
- Patients received either pertuzumab plus trastuzumab and docetaxel or a control regimen of placebo plus trastuzumab and docetaxel.
- The pertuzumab, trastuzumab, and docetaxel combination did not increase the incidence of cardiac adverse events compared with the control arm.
- Left ventricular systolic dysfunction rates were not increased by the addition of pertuzumab, and the majority of all cardiac adverse events were reversible.
Structured PICO
Does pertuzumab plus trastuzumab plus docetaxel increase the incidence of cardiac adverse events in patients with HER2-positive metastatic breast cancer?
P
Population
Patients with HER2-positive metastatic breast cancer (MBC)
I
Intervention
Pertuzumab plus trastuzumab plus docetaxel
C
Comparator
Placebo control arm
O
Outcome
Incidence of cardiac adverse events, including left ventricular systolic dysfunction (LVSD)safety
The addition of pertuzumab to trastuzumab and docetaxel is well-tolerated from a cardiac standpoint in patients with HER2-positive metastatic breast cancer.
Cite This Study
Swain et al. (2013) studied this question.