PRECYCLE
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PRECYCLE : multicenter, randomized phase IV intergroup trial to evaluate the impact of eHealth-based patient-reported outcome (PRO) assessment on quality of life in patients with hormone receptor positive, HER2 negative locally advanced or metastatic breast cancer treated with palbociclib and an aromatase inhibitor or palbociclib and fulvestrant. / Degenhardt, Tom; Fasching, Peter A; Lüftner, Diana; Müller, Volkmar; Thomssen, Christoph; Schem, Christian; Witzel, Isabell; Decker, Thomas; Tesch, Hans; Kümmel, Sherko; Uleer, Christoph; Wuerstlein, Rachel; Hoffmann, Oliver; Warm, Mathias; Marschner, Norbert; Schinköthe, Timo; Kates, Ronald E; Schumacher, Johannes; Otremba, Burkhard; Zaiss, Matthias; Harbeck, Nadia; Schmidt, Marcus; PreCycle Investigators.
in: TRIALS, Jahrgang 24, Nr. 1, 17.05.2023, S. 338.Publikationen: SCORING: Beitrag in Fachzeitschrift/Zeitung › SCORING: Zeitschriftenaufsatz › Forschung › Begutachtung
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TY - JOUR
T1 - PRECYCLE
T2 - multicenter, randomized phase IV intergroup trial to evaluate the impact of eHealth-based patient-reported outcome (PRO) assessment on quality of life in patients with hormone receptor positive, HER2 negative locally advanced or metastatic breast cancer treated with palbociclib and an aromatase inhibitor or palbociclib and fulvestrant
AU - Degenhardt, Tom
AU - Fasching, Peter A
AU - Lüftner, Diana
AU - Müller, Volkmar
AU - Thomssen, Christoph
AU - Schem, Christian
AU - Witzel, Isabell
AU - Decker, Thomas
AU - Tesch, Hans
AU - Kümmel, Sherko
AU - Uleer, Christoph
AU - Wuerstlein, Rachel
AU - Hoffmann, Oliver
AU - Warm, Mathias
AU - Marschner, Norbert
AU - Schinköthe, Timo
AU - Kates, Ronald E
AU - Schumacher, Johannes
AU - Otremba, Burkhard
AU - Zaiss, Matthias
AU - Harbeck, Nadia
AU - Schmidt, Marcus
AU - PreCycle Investigators
N1 - © 2023. The Author(s).
PY - 2023/5/17
Y1 - 2023/5/17
N2 - BACKGROUND: Efficacy and quality of life (QoL) are key criteria for therapy selection in metastatic breast cancer (MBC). In hormone receptor positive (HR +) human epidermal growth factor receptor 2 negative (HER2 -) MBC, addition of targeted oral agents such as everolimus or a cycline-dependent kinase 4/6 (CDK 4/6) inhibitor (e.g., palbociclib, ribociclib, abemaciclib) to endocrine therapy substantially prolongs progression-free survival and in the case of a CDK 4/6i also overall survival. However, the prerequisite is adherence to therapy over the entire course of treatment. However, particularly with new oral drugs, adherence presents a challenge to disease management. In this context, factors influencing adherence include maintaining patients' satisfaction and early detection/management of side effects. New strategies for continuous support of oncological patients are needed. An eHealth-based platform can 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 CDK 4/6 inhibitor palbociclib either in first (62.5%) or later line (37.5%) together with endocrine therapy (AI, fulvestrant) according to national guidelines. PreCycle evaluates and compares the time to deterioration (TTD) of QoL in patients supported by eHealth systems with substantially different functionality: CANKADO active vs. inform. CANKADO active is the fully functional CANKADO-based eHealth treatment support system. CANKADO inform is a CANKADO-based eHealth service with a personal login, documentation of daily drug intake, but no further functions. To evaluate QoL, the FACT-B questionnaire is completed at every visit. As little is known about relationships between behavior (e.g., adherence), genetic background, and drug efficacy, the trial includes both patient-reported outcome and biomarker screening for discovery of forecast models for adherence, symptoms, QoL, progression free survival (PFS), and overall survival (OS).DISCUSSION: The primary objective of PreCycle is to test the hypothesis of superiority for time to deterioration (TTD) in terms of DQoL = "Deterioration of quality of life" (FACT-G scale) in patients supported by an eHealth therapy management system (CANKADO active) versus in patients merely receiving eHealth-based information (CANKADO inform). EudraCT Number: 2016-004191-22.
AB - BACKGROUND: Efficacy and quality of life (QoL) are key criteria for therapy selection in metastatic breast cancer (MBC). In hormone receptor positive (HR +) human epidermal growth factor receptor 2 negative (HER2 -) MBC, addition of targeted oral agents such as everolimus or a cycline-dependent kinase 4/6 (CDK 4/6) inhibitor (e.g., palbociclib, ribociclib, abemaciclib) to endocrine therapy substantially prolongs progression-free survival and in the case of a CDK 4/6i also overall survival. However, the prerequisite is adherence to therapy over the entire course of treatment. However, particularly with new oral drugs, adherence presents a challenge to disease management. In this context, factors influencing adherence include maintaining patients' satisfaction and early detection/management of side effects. New strategies for continuous support of oncological patients are needed. An eHealth-based platform can 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 CDK 4/6 inhibitor palbociclib either in first (62.5%) or later line (37.5%) together with endocrine therapy (AI, fulvestrant) according to national guidelines. PreCycle evaluates and compares the time to deterioration (TTD) of QoL in patients supported by eHealth systems with substantially different functionality: CANKADO active vs. inform. CANKADO active is the fully functional CANKADO-based eHealth treatment support system. CANKADO inform is a CANKADO-based eHealth service with a personal login, documentation of daily drug intake, but no further functions. To evaluate QoL, the FACT-B questionnaire is completed at every visit. As little is known about relationships between behavior (e.g., adherence), genetic background, and drug efficacy, the trial includes both patient-reported outcome and biomarker screening for discovery of forecast models for adherence, symptoms, QoL, progression free survival (PFS), and overall survival (OS).DISCUSSION: The primary objective of PreCycle is to test the hypothesis of superiority for time to deterioration (TTD) in terms of DQoL = "Deterioration of quality of life" (FACT-G scale) in patients supported by an eHealth therapy management system (CANKADO active) versus in patients merely receiving eHealth-based information (CANKADO inform). EudraCT Number: 2016-004191-22.
KW - Humans
KW - Female
KW - Breast Neoplasms/pathology
KW - Fulvestrant/therapeutic use
KW - Aromatase Inhibitors/therapeutic use
KW - Quality of Life
KW - Protein Kinase Inhibitors/adverse effects
KW - Patient Reported Outcome Measures
KW - Antineoplastic Combined Chemotherapy Protocols/adverse effects
KW - Receptor, ErbB-2/metabolism
U2 - 10.1186/s13063-023-07306-z
DO - 10.1186/s13063-023-07306-z
M3 - SCORING: Journal article
C2 - 37198674
VL - 24
SP - 338
JO - TRIALS
JF - TRIALS
SN - 1745-6215
IS - 1
ER -