パルボシクリブと内分泌療法併用療法または内分泌療法単剤療法を受けたHR+/HER2-進行乳がんの日本人患者における患者報告アウトカム（PRO）および身体活動を評価する研究

基本情報

NCT ID

NCT04736576

ステータス

完了

試験のフェーズ

該当なし

試験タイプ

介入

目標被験者数

99

治験依頼者名

Pfizer

概要

The study is a prospective, multicenter, observational study to evaluate PRO and physical activity using smartphone-based application and wearable device in Japanese patients with HR+/HER2- advanced breast cancer (ABC). Patients will be enrolled into either palbociclib plus endocrine therapy group (Group 1) or endocrine monotherapy group (Group 2) based on the discretion of the treating physician under routine clinical practice. Total target number of patients is approximately one-hundred in this study (About 50 patients in each group). Enrolled patients will download a smartphone-based application for electronic PRO (ePRO), be provided access to and trained on the use of the application to complete baseline, weekly, and cycle-based assessments for 6 cycles (24 weeks). In addition, enrolled patients will be provided with wearable device and requested to wear the device at all-times, except of while bathing and sleeping, for 6 cycles (24 weeks).

対象疾患

介入

依頼者（Sponsor）

実施施設 (20)