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
1058 - Assessment of CPS+EG, Neo-Bioscore and modified Neo-Bioscore in breast cancer patients treated with preoperative systemic therapy: a multicenter cohort study
Presenter: LING XU
Session: Poster Display session 2
Resources:
Abstract
1156 - The concordance of treatment decision guided by Oncotype and the PREDICT tool in early stage breast cancer
Presenter: Hadar Goldvaser
Session: Poster Display session 2
Resources:
Abstract
3447 - Influence of first treatment delay on survival among breast cancer subtypes
Presenter: Irene Zarcos Pedrinaci
Session: Poster Display session 2
Resources:
Abstract
3505 - Clinical features of early-stage (I-III) triple-negative breast cancer (TNBC) patients with tumors exhibiting low-overall change in molecular profile after neoadjuvant therapy.
Presenter: Nour Abuhadra
Session: Poster Display session 2
Resources:
Abstract
5442 - Meta-analysis in HER2+ early breast cancer therapies and cost-effectiveness in a Brazilian perspective
Presenter: Marcos Magalhaes
Session: Poster Display session 2
Resources:
Abstract
1570 - Anti-mullerian hormone (AMH) levels and antral follicle counts (AFC) may predict ovarian reserves before systemic chemotherapy (SC) in women with breast cancer(BC); a prospective clinical study
Presenter: Cetin Ordu
Session: Poster Display session 2
Resources:
Abstract
2698 - Prognosis of selected triple negative apocrine breast cancer patients who did not receive adjuvant chemotherapy.
Presenter: Giuseppe Cancello
Session: Poster Display session 2
Resources:
Abstract
3104 - Novel Blood Based Circulating Tumor Cell Biomarker For Breast Cancer Detection
Presenter: Chun-Yu Liu
Session: Poster Display session 2
Resources:
Abstract
4631 - Multi-Gene Prognostic Signatures and Prediction of Pathological Complete Response of ER-Positive HER2-Negative Breast Cancer Patients to Neo-Adjuvant Chemotherapy
Presenter: Claudia Mazo
Session: Poster Display session 2
Resources:
Abstract
4632 - Impact of menopause status on breast cancer outcomes and amenorrhea incidence during adjuvant tailored dose dense chemotherapy
Presenter: Andri Papakonstantinou
Session: Poster Display session 2
Resources:
Abstract