Observational studyBreast cancer (Tokyo, Japan)2025
Health-related quality of life and physical activity collected via mobile application and wearable device in patients with HR +/HER2 - advanced breast cancer treated with palbociclib plus endocrine therapy or endocrine therapy alone: 6-month longitudinal study (JBCRG-26).
Observational study in Breast cancer (Tokyo, Japan), 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04736576 (Prospective, Multicenter, Observational Study to Evaluate Patient-reported Outcome and Physical Activity Using Smartphone-based Application and Wearable Device in Japanese Patients With HR+/HER2- Advanced Breast Cancer Treated With Palbociclib Plus Endocrine Therapy or Endocrine Monotherapy), which is not on this map. Not yet cited in PubMed.
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Prospective, Multicenter, Observational Study to Evaluate Patient-reported Outcome and Physical Activity Using Smartphone-based Application and Wearable Device in Japanese Patients With HR+/HER2- Advanced Breast Cancer Treated With Palbociclib Plus Endocrine Therapy or Endocrine Monotherapy
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Authors and funding
16 authors.
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Abstract
objectivesTo summarize descriptively health-related quality of life (HRQOL) and physical activity (PA) evaluated with a mobile application and wearable device among patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR + /HER2 -) advanced breast cancer (ABC) treated with first- or second-line palbociclib plus endocrine therapy (ET) or ET alone.
methodsHRQOL was assessed with the EORTC QLQ-C30 at baseline and Day 15 of 6 treatment cycles (~ 24 weeks). PA metrics were averaged on a weekly basis for 24 weeks. Co-primary endpoints were mean change from baseline in Global Health Status (GHS) and sedentary time.
resultsNinety-nine patients were enrolled; 78 received palbociclib plus ET (mean age: 57.2 years; 75.6% initiated first-line treatment) and 21 received ET alone (mean age: 56.3 years; 90.5% initiated first-line treatment). Baseline mean GHS score was 60.9 in the palbociclib plus ET group and 64.3 in the ET alone group; mean changes from baseline to Day 15 of Cycle 6 were +4.8 and +2.9, respectively, and not deteriorated beyond the 10-point clinically significant threshold in either treatment group. Baseline mean sedentary time was 581 min/day in the palbociclib plus ET group and 513 min/day in the ET alone group; mean changes from baseline to Week 24 were -22 and -102 min/day, respectively.
conclusionsIn this real-world study of women with HR+/HER2- ABC in Japan, neither palbociclib plus ET nor ET alone had any substantial detrimental impacts on HRQOL, according to patients' assessments recorded in a smartphone-based mobile application, and PA, as measured by a wearable device.
trial registrationClinicalTrials.gov NCT04736576; registered, February 3, 2021.
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