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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 (JBCRG-26)

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ClinicalTrials.gov Identifier: NCT04736576
Recruitment Status : Recruiting
First Posted : February 3, 2021
Last Update Posted : February 17, 2022
Sponsor:
Collaborator:
Japan Breast Cancer Research Group (JBCRG)
Information provided by (Responsible Party):
Pfizer

Study Description
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Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Breast Cancer Device: Wearable device Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
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
Actual Study Start Date : February 24, 2021
Estimated Primary Completion Date : May 30, 2023
Estimated Study Completion Date : May 30, 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Palbociclib

Arms and Interventions
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Arm Intervention/treatment
Group 1
Palbociclib plus endocrine therapy
 Device: Wearable device
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).
Group 2
Endocrine monotherapy
 Device: Wearable device
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).


Outcome Measures
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Primary Outcome Measures :
  1. 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. ]
    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).

  2. Physical activities as measured by wearable device. [ 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. ]
    Physical activity metrics (eg, sedentary time) will be derived by Actigraph's algorithms based on the raw data collected by the device


Secondary Outcome Measures :
  1. 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. ]
    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.

  2. 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. ]
    Treatment satisfaction will be evaluated with single item question


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04736576


Contacts
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Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

Locations
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Sponsors and Collaborators
Pfizer
Japan Breast Cancer Research Group (JBCRG)
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
Principal Investigator: Hiroko Bando Dept of Breast, Thyroid and Endocrine Surgery, University of Tsukuba Hospital
More Information
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Additional Information:

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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT04736576    
Other Study ID Numbers: A5481126
First Posted: February 3, 2021    Key Record Dates
Last Update Posted: February 17, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pfizer:
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
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases