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JBCRG-26
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
- Status
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No Longer Recruiting
- Objectives
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To assess change in EORTC-QLQ-C30 and physical activity in Japanese patients with HR+/HER2- advanced breast cancer receiving:
1. Palbociclib plus endocrine therapy (Group 1) or
2. Endocrine monotherapy (Group 2)
- Subjects
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Japanese Patients With HR+/HER2- Advanced Breast Cancer Treated With Palbociclib Plus Endocrine Therapy or Endocrine Monotherapy.
- Endpoints
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Primary Outcome Measures
1. EORTC-QLQ-C30 collected via smartphone-based application.
2. Physical activities (sedentary time) as measured by wearable device.
- Trial Period
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February 2021-August 2022
- Lead Principal Investigator
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Hiroko Bando
Dept of Breast, Thyroid and Endocrine Surgery, University of Tsukuba Hospital
- Target Sample Size
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100 participants
- Regimen
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1) Palbociclib plus endocrine therapy group
2) Endocrine monotherapy group
- Source of Funding
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Pfizer Inc.
- Conference Presentation
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- Articles and Publications
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- UMIN-ID
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- jRCT
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- Memo
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ClinicalTrials.gov Identifier: NCT04736576
- COI Disclosure
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