Abstract OT3-14-02: Impact of CANKADO-based eHealth-support on quality of life in metastatic breast cancer patients treated with palbociclib and endocrine therapy - Precycle
Authors: Degenhardt Tom , Fasching Peter , Luftner Diana , Mueller Volkmar , Thomssen Christoph , Schem Christian , Witzel Isabel , Decker Thomas , Tesch Hans , Kuemmel Sherko , Uleer Christoph , Wuerstlein Rachel , Riese Christoph , Schinköthe Timo , Kates Ronald , Schumacher Johannes , Harbeck Nadia , Schmidt Marcus 
Published: March 2020

Abstract
Background: Efficacy and quality of life (QoL) are key factors when selecting therapies for metastatic breast cancer (MBC) patients. The addition of targeted oral agents such as CDK4/6 inhibitors to endocrine therapy is the new standard for hormone receptor (HR)+ HER2- MBC and substantially prolongs progression-free survival. However more complex oral medication in oncology might require substantial improvement of patient management. Despite several advantages of an oral treatment, patients become increasingly self-responsible and physician/patient contact is reduced. Adherence, maintaining patients’ satisfaction, and early detection and management of side effects become important challenges and new ways of continuous support for oncological patients are needed. An eHealth-based platform could help to support therapy management and physician-patient interaction. Methods: PRECYCLE is a multicenter, randomized, phase IV trial in HR+ HER2- MBC. All patients (n = 960) receive the CDK4/6 inhibitor palbociclib either in first (62.5%) or later line (37.5%) together with endocrine therapy (AI, fulvestrant) according to national guidelines. Primary study aim is the time to deterioration (TTD) of QoL in patients supported by two eHealth systems with substantially different functionality. To date (05/07/2019), 250 patients have been registered in all 72 participating centers and 230 randomized to the different study arms: - CANKADO inform with only a CANKADO-based eHealth service with a personal login, documentation of daily drug intake and passive text information (disease, treatment), but no further functions. vs. - CANKADO active with the fully functional CANKADO-based eHealth treatment support system (+ drug diary, QoL, AEs, automated recommendations, etc.) To evaluate QoL, the FACT-B questionnaire is completed at every visit. Primary objective is to test the hypothesis of superiority for TTD with regards to QoL (FACT-G scale) in patients supported by an eHealth therapy management system (CANKADO active) versus in those merely receiving eHealth-based information (CANKADO inform). As little is known about relationships between behavioral patterns (e.g. adherence), genetic background, and drug efficacy. The trial also includes a large translational program that aims at the discovery and validation of biomarkers concerning efficacy, toxicity, adherence and QoL. Recruitment is ongoing.
Citation Format: Tom Degenhardt, Peter Fasching, Diana Luftner, Volkmar Mueller, Christoph Thomssen, Christian Schem, Isabel Witzel, Thomas Decker, Hans Tesch, Sherko Kuemmel, Christoph Uleer, Rachel Wuerstlein, Christoph Riese, Timo Schinköthe, Ronald Kates, Johannes Schumacher, Nadia Harbeck, Marcus Schmidt. Impact of CANKADO-based eHealth-support on quality of life in metastatic breast cancer patients treated with palbociclib and endocrine therapy - Precycle [abstract]. In: Proceedings of the 2019 San Antonio Breast Cancer Symposium; 2019 Dec 10-14; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2020;80(4 Suppl):Abstract nr OT3-14-02.