ADJUVANT TRIAL OUTCOMES
iDFS: ITT population (primary endpoint)1
Based on the primary analysis, dual anti-HER2 adjuvant therapy with PERJETA + Herceptin® (trastuzumab) + chemotherapy vs placebo + Herceptin + chemotherapy demonstrated a reduction in the risk of recurrence in patients with HER2+ early breast cancer (EBC).*
*Recurrence is defined as an invasive disease
event or death
†All analyses stratified by nodal status, protocol version, central hormone receptor status, and adjuvant chemotherapy regimen.
iDFS=invasive disease-free survival.
‡iDFS was defined as time from randomization to first
occurrence of ipsilateral local or regional invasive breast cancer
recurrence, distant recurrence, contralateral invasive breast
cancer, or death from any cause.1
§All analyses stratified by nodal status, protocol version, central hormone receptor status, and adjuvant chemotherapy regimen.1
Select Important Safety Information: Left Ventricular Dysfunction
- Assess LVEF prior to initiation of PERJETA and at regular intervals during treatment to ensure that LVEF is within normal limits. If LVEF declines and has not improved, or has declined further at the subsequent assessment, discontinuation of PERJETA and trastuzumab should be strongly considered
Median follow-up: 45.4 months (primary analysis)
PERJETA + Herceptin + chemotherapy vs placebo + Herceptin + chemotherapy
iDFS including second primary nonbreast cancer: HR=0.83, 95%
- 3-year event-free rate: 93.5% (95% CI: 92.5-94.5) vs 92.5% (95% CI: 91.4-93.6)
DFS: HR=0.82, 95% CI: 0.68-0.99†
- 3-year event-free rate: 93.4% (95% CI: 92.4-94.4) vs 92.3% (95% CI: 91.2-93.4)
OS: HR=0.89, 95% CI: 0.66-1.21†
- 3-year event-free rate: 97.7% (95% CI: 97.0-98.3) vs 97.7% (95% CI: 97.1-98.3)
Exploratory analysis: iDFS by patient subgroup¶1,2
Exploratory analyses without adjusting for multiple comparisons; therefore, results are considered descriptive.
iDFS in node-positive and node-negative subgroups1,2
There was an inability to show a reduction in risk of recurrence for the node-negative subgroup.1,2
¶The primary analysis was conducted with a clinical cutoﬀ date of 12/19/2016. An updated exploratory iDFS analysis was conducted with a clinical cutoﬀ date of 6/19/2019.