CANKADO PRO-React eHealth support in patients with HR+ HER2- metastatic breast cancer receiving palbociclib and endocrine therapy and the affect on time to deterioration of quality of life: Primary outcome analysis of the multicenter randomized PreCycle trial.

1008 Background: The multicenter, randomized phase IV Intergroup PreCycle trial (NCT03220178) evaluated the impact of CANKADO-based ePRO assessment on quality of life (QoL) in HR+/HER2- locally advanced or metastatic breast cancer (MBC) patients (pts) treated with palbociclib (P) and an aromatase inhibitor or P+fulvestrant. CANKADO PRO-React, an EU- registered medical device, is an autonomous application reacting to changes in pt self- reported QoL. Methods: Between 2017 and 2021, 499 pts (median age 59y) from 71 centers were randomized (2:1, stratified by therapy line) between an active (A; CANKADO PRO-React) or an inactive arm (B; inform; limited CANKADO functionality). 412 pts (271 A; 141 B) were available for analysis of the primary endpoint, i.e. time to deterioration (TTD) of QoL (10-point drop on FACT-G), using an Aalen-Johansen estimator for cumulative incidence function of TTD DQoL with 95% pointwise confidence intervals (CI). Secondary endpoints included PFS, OS, and DQoL (QoL deterioration). Results: In all pts (ITT-ePRO), a significantly decreased risk (HR 0.6982) for the CANKADO active arm A with 95% CI [0.5059, 0.9635] regarding DQoL was observed (p=0.03). In 1 st L pts (n=295), the decreased risk for arm A was 0.7162 (0.4839, 1.06; p=0.09), in 2 nd L pts (n=117) 0.6614 (0.3744, 1.168; p=0.2). Absolute pt numbers declined in later visits; until about visit 30, FACT- G completion rates were 80% and higher; mean total scores were similar between arms; the change from baseline showed a linear decline and a nearly constant offset in favor of arm A, particularly in 1 st L. No significant differences in clinical outcome were observed between arms: Median PFS (ITT population) was 21.4 (95% CI 19.4-23.7) (A) and 18.7 (15.1.-23.5) months (B); median OS was not reached (A) and 42.6 months (B). Conclusions: PreCycle is the first multicenter randomized eHealth trial demonstrating a significant benefit of an interactive autonomous patient empowerment application on QoL in MBC pts receiving oral tumor therapy. Clinical trial information: NCT03220178 .