Study to Evaluate Patient Reported Outcome (PRO) and Physical Activity in Japanese Patients With HR+/HER2- Advanced Breast Cancer Treated With Palbociclib Plus Endocrine Therapy or Endocrine Monotherapy

Study Overview
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Brief Summary
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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).

Official Title
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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

Conditions
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Breast Cancer

Intervention / Treatment
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* Device: Wearable device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult women (≥ 20 years of age) Diagnosis of adenocarcinoma of the breast with evidence of metastatic disease or advanced disease not amenable to resection or radiation therapy with curative intent. Documented evidence of HR+/HER2- tumor based on the patient's surgical specimen or most recent tumor biopsy. Initiating first or second line treatment at study entry with one of the following therapies: palbociclib plus endocrine therapy or endocrine monotherapy Eastern Cooperative Oncology Group (ECOG) performance status = 0 1. Owns or has regular access to an Apple iPhone or Android phone. Willing and able to complete collection of data via smartphone-based application. Willing and able to wear the wearable device for approximately 6 months. Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study. Able to read and understand Japanese Exclusion Criteria: The patient is participating in any interventional clinical trial that includes investigational or marketed products. Patients participating in other investigator-initiated research or non-interventional studies can be included as long as their standard of care is not altered by the study. The patient is on active treatment for other malignancies other than ABC. The patient's life style is fluctuating in weekly-basis (eg, shift-time worker), which may have high impact on physical activity assessment based to investigator's discretion

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Group 1<br>Palbociclib plus endocrine therapy | Device: Wearable device<br>* As a low-interventional procedure, 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).<br>|
| Other: Group 2<br>Endocrine monotherapy | Device: Wearable device<br>* As a low-interventional procedure, 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in PRO as measured by EORTC-QLQ-C30 collected via smartphonebased application. | EORTC-QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting) and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties). | Baseline and Day 15 of each cycle (one cycle is 28 days) | 
| Physical activities as measured by wearable device. | Physical activity metrics (eg, sedentary time) will be derived by Actigraph's algorithms based on the raw data collected by the device | Baseline to end of study (6 cycles of initiated treatment) or 24 weeks if patient discontinues initiated treatment before completion of 6 cycles | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in EORTC-QLQ-C30 and physical activity versus patient-reported symptom as measured by Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) collected via smartphone-based application. | PRO-CTCAE: seventy-eight symptom terms that are common in oncology clinical trials can be evaluable, and each of symptom terms is assessed relative to one or more distinct attributes, including frequency, severity, and/or interference with usual or daily activities. | Baseline and Day 15 of each cycle (one cycle is 28 days) | 
| Patient treatment satisfaction question | Treatment satisfaction will be evaluated with single item question | Baseline and Day 15 of each cycle (one cycle is 28 days) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Physical activity, Prospective, Multicenter, Observational study, Japan, hormone receptor - positive/human epidermal growth factor 2 - negative (HR+/HER2-) advanced breast cancer, Palbociclib, European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-30 (items) (EORTC-QLQ-C30)