Abstract 3592
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 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 oral treatments, patients become increasingly self-responsible and physician-patient contact is reduced. Adherence, maintaining patients’ satisfaction and early detection management of side effects become important challenges and new ways of continuous support are needed. An eHealth-based platform could help to support therapy management and physician-patient interaction.
Trial design
PRECYCLE is a multicenter, randomized, phase IV trial in HR+ HER2- MBC. All patients (n = 960) receive the palbociclib either in first (62.5%) or later line (37.5%) together with endocrine therapy (AI, fulvestrant). Primary study aim is the time to deterioration (TTD) of QoL in patients supported by two eHealth systems with substantially different functionality. To date (02/11/2019) in 64 centers 165 patients have been randomized to the different study arms: - CANKADO inform with only a personal login, documentation of daily drug intake and passive text information, 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 regard 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 discovery and validation of biomarkers concerning efficacy, toxicity, adherence and QoL.
Clinical trial identification
NCT03220178 EudraCT: 2016-004191-22.
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Pfizer.
Disclosure
T. Degenhardt: Advisory / Consultancy: Pfizer; Advisory / Consultancy: Roche; Travel / Accommodation / Expenses: Tesaro; Advisory / Consultancy: GSM; Travel / Accommodation / Expenses: Cellgene; Travel / Accommodation / Expenses: Daichii Synkyo. P.A. Fasching: Honoraria (self), Advisory / Consultancy: Amgen; Honoraria (self), Advisory / Consultancy: Teva; Honoraria (self), Advisory / Consultancy: Celgene; Honoraria (self), Advisory / Consultancy, Research grant / Funding (self): Novartis; Honoraria (self), Advisory / Consultancy: Pfizer; Honoraria (self), Advisory / Consultancy: Roche; Honoraria (self), Advisory / Consultancy: Puma Biotechnology; Honoraria (self), Advisory / Consultancy: Daiichi Sankyo; Honoraria (self), Advisory / Consultancy: Eisai; Honoraria (self), Advisory / Consultancy: Merck Sharp & Dohme; Honoraria (self), Advisory / Consultancy: AstraZeneca; Honoraria (self), Advisory / Consultancy: Hexal; Honoraria (self), Advisory / Consultancy: Myelo Therapeutics GmbH; Research grant / Funding (self): BioNTech AG. D. Lüftner: Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: Amgen; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: astra zeneca; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: Celgene; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: Lilly; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (self): Novartis; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: Pfizer; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: Sanofi; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: tesaro; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: teva; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: L’oreal. V. Müller: Advisory / Consultancy: hexal; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Roche; Honoraria (self), Advisory / Consultancy: Amgen; Honoraria (self), Advisory / Consultancy: Daiichi Sankyo; Advisory / Consultancy: nektar; Honoraria (self), Advisory / Consultancy: eisai; Honoraria (self), Travel / Accommodation / Expenses: Pfizer; Honoraria (self): astra zeneca; Honoraria (self): Novartis; Honoraria (self): teva; Honoraria (self): tesaro. I. Witzel: Honoraria (self): Pierre Fabre; Honoraria (self): Roche; Advisory / Consultancy: Novartis; Advisory / Consultancy: Pfizer; Travel / Accommodation / Expenses: medac. T. Decker: Advisory / Consultancy: Novartis. H. Tesch: Honoraria (self), Travel / Accommodation / Expenses: Roche; Honoraria (self), Travel / Accommodation / Expenses: Pfizer; Honoraria (self), Travel / Accommodation / Expenses: Novartis. S. Kuemmel: Advisory / Consultancy, Travel / Accommodation / Expenses: Roche; Advisory / Consultancy: Genomic Health; Advisory / Consultancy: Novartis; Advisory / Consultancy: astra zeneca; Advisory / Consultancy: Amgen; Advisory / Consultancy: Celgene; Advisory / Consultancy: somatex; Advisory / Consultancy, Travel / Accommodation / Expenses: Daiichi Sankyo; Advisory / Consultancy: puma biotechnology; Advisory / Consultancy: pfm medical; Advisory / Consultancy: Pfizer; Advisory / Consultancy: MSD oncology. R. Wuerstlein: Advisory / Consultancy: Roche; Advisory / Consultancy: Pfizer; Advisory / Consultancy: Novartis; Advisory / Consultancy: Celgene; Advisory / Consultancy: Lilly; Advisory / Consultancy: sandoz; Advisory / Consultancy: Daiichi Sankyo; Advisory / Consultancy: astra zeneca; Advisory / Consultancy: Merck. C. Riese: Full / Part-time employment: CANKADO. T. Schinköthe: Full / Part-time employment: CANKADO. J. Schumacher: Full / Part-time employment: Palleos Healthcare Services Gmbh. N. Harbeck: Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): Roche; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): Novartis; Honoraria (self), Advisory / Consultancy: Celgene; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): Pfizer; Advisory / Consultancy, Research grant / Funding (institution): Lilly; Advisory / Consultancy: sandoz; Advisory / Consultancy: Daiichi Sankyo; Advisory / Consultancy: agendia; Advisory / Consultancy: astra zeneca; Advisory / Consultancy: Merck sharp and dohme; Advisory / Consultancy: odonate therapeutics; Advisory / Consultancy: seattle genetics; Honoraria (self): Genomic Health; Honoraria (self): Amgen; Honoraria (self): nanostring; Research grant / Funding (institution): MSD. M. Schmidt: Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): astra zeneca; Advisory / Consultancy: Amgen; Advisory / Consultancy, Research grant / Funding (institution): pantarhei bioscience; Advisory / Consultancy: myelo therapeutics gmbh; Honoraria (self), Advisory / Consultancy: Novartis; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution), Travel / Accommodation / Expenses: Pfizer; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution), Travel / Accommodation / Expenses: Roche. All other authors have declared no conflicts of interest
Resources from the same session
4331 - STING Agonist, ADU-S100, Yields Potent Antitumor Activity and Therapeutically Favorable Immune Profile in an Esophageal Adenocarcinoma Model
Presenter: Ali Zaidi
Session: Poster Display session 2
Resources:
Abstract
1770 - Increased assessment of HER2 in metastatic gastroesophageal cancer patients: a nationwide population-based cohort study
Presenter: Willemieke Dijksterhuis
Session: Poster Display session 2
Resources:
Abstract
3755 - A new docetaxel (DOC)-based triplet regimen does not improve the outcome of metastatic (M) or locally advanced (LA) gastric cancer (GC) as compared with an epirubicin (EPI) standard triplet regimen: a GISCAD trial.
Presenter: Roberto Labianca
Session: Poster Display session 2
Resources:
Abstract
2439 - The analysis of T cell subsets and clinical efficacy of immune checkpoint blockades in patients with advanced gastric cancer using multiplex immunohistochemistry
Presenter: Tae-yong Kim
Session: Poster Display session 2
Resources:
Abstract
2211 - First-line pembrolizumab (P), trastuzumab (T), capecitabine (C) and oxaliplatin (O) in HER2-positive metastatic esophagogastric adenocarcinoma.
Presenter: Yelena Janjigian
Session: Poster Display session 2
Resources:
Abstract
3046 - Monitoring patient-specific mutation in ctDNA and CTC for tumor response evaluation after neoadjuvant chemotherapy in locally advanced gastric cancer (NCT03425058)
Presenter: Tao Fu
Session: Poster Display session 2
Resources:
Abstract
4628 - Gastric cancer screening in BRCA 2 gene mutation carriers: should it be recommended?
Presenter: Inês Oliveira
Session: Poster Display session 2
Resources:
Abstract
2127 - Interim analysis of an observational/translational study for nivolumab treatment in advanced gastric cancer: JACCRO GC-08 (DELIVER trial)
Presenter: Yu Sunakawa
Session: Poster Display session 2
Resources:
Abstract
2264 - Prediction of S-1 adjuvant chemotherapy efficacy in Stage II/III gastric cancer treatment based on comprehensive gene expression analysis
Presenter: Masanori Terashima
Session: Poster Display session 2
Resources:
Abstract
2444 - Assessing the clinical utility of circulating tumour DNA through longitudinal liquid biopsy sampling in Oesophageal adenocarcinoma
Presenter: Emma Ococks
Session: Poster Display session 2
Resources:
Abstract