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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

NCT04736576

Description:

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).

Related Conditions:
  • Breast Adenocarcinoma
Recruiting Status:

Recruiting

Phase:

N/A

Trial Eligibility

Document

Title

  • Brief Title: 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
  • Official Title: 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

Clinical Trial IDs

  • ORG STUDY ID: A5481126
  • NCT ID: NCT04736576

Conditions

  • Breast Cancer

Purpose

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).

Trial Arms

NameTypeDescriptionInterventions
Group 1OtherPalbociclib plus endocrine therapy
    Group 2OtherEndocrine monotherapy

      Eligibility Criteria

              Inclusion Criteria:
      
                1. Adult women (≥ 20 years of age)
      
                2. Diagnosis of adenocarcinoma of the breast with evidence of metastatic disease or
                   advanced disease not amenable to resection or radiation therapy with curative intent.
      
                3. Documented evidence of HR+/HER2- tumor based on the patient's surgical specimen or
                   most recent tumor biopsy.
      
                4. Initiating first or second line treatment at study entry with one of the following
                   therapies:
      
                   palbociclib plus endocrine therapy or endocrine monotherapy
      
                5. Eastern Cooperative Oncology Group (ECOG) performance status = 0~1.
      
                6. Owns or has regular access to an Apple iPhone or Android phone.
      
                7. Willing and able to complete collection of data via smartphone-based application.
      
                8. Willing and able to wear the wearable device for approximately 6 months.
      
                9. Evidence of a personally signed and dated informed consent document indicating that
                   the patient has been informed of all pertinent aspects of the study.
      
               10. Able to read and understand Japanese
      
              Exclusion Criteria:
      
                1. 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.
      
                2. The patient is on active treatment for other malignancies other than ABC.
      
                3. 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
            
      Maximum Eligible Age:N/A
      Minimum Eligible Age:20 Years
      Eligible Gender:Female
      Healthy Volunteers:No

      Primary Outcome Measures

      Measure:Change in PRO as measured by EORTC-QLQ-C30 collected via smartphonebased application.
      Time Frame:Baseline to end of study (6 cycles of initiated treatment) or 24 weeks if patient discontinues initiated treatement before completion of 6 cycles.
      Safety Issue:
      Description: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).

      Secondary Outcome Measures

      Measure: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.
      Time Frame:Baseline to end of study (6 cycles of initiated treatment) or 24 weeks if patient discontinues initiated treatement before completion of 6 cycles.
      Safety Issue:
      Description: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.
      Measure:Patient treatment satisfaction question
      Time Frame:Baseline to end of study (6 cycles of initiated treatment) or 24 weeks if patient discontinues initiated treatement before completion of 6 cycles.
      Safety Issue:
      Description:Treatment satisfaction will be evaluated with single item question

      Details

      Phase:N/A
      Primary Purpose:Interventional
      Overall Status:Recruiting
      Lead Sponsor:Pfizer

      Trial Keywords

      • Prospective
      • Multicenter
      • Observational study
      • Japan
      • HR+/HER2- advanced breast cancer
      • Palbociclib
      • European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-30 (items) (EORTC-QLQ-C30)
      • Physical activity

      Last Updated

      March 16, 2021