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)

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

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).

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Device: Wearable device

• Study Type: Interventional
• Enrollment (Actual): 99
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Japan
  • Akita, Japan, 010-8543
    • Akita University Hospital
  • Fukushima, Japan, 960-1295
    • Fukushima Medical University Hospital
  • Gifu, Japan, 501-1194
    • Gifu University Hospital
  • Hiroshima, Japan, 734-8530
    • Hiroshima Prefectural Hospital
  • Kyoto, Japan, 606-8507
    • Kyoto University Hospital
  • Okayama, Japan, 700-8558
    • Okayama University Hospital
  • Aichi
    • Nagoya, Aichi, Japan, 464-8681
      • Aichi Cancer Center Hospital
    • Nagoya, Aichi, Japan, 467-8602
      • Nagoya City University Hospital
  • Chiba
    • Kashiwa, Chiba, Japan, 277-8577
      • National Cancer Center Hospital East
  • Ehime
    • Matsuyama, Ehime, Japan, 791-0280
      • Shikoku Cancer Center
  • Hokkaido
    • Sapporo, Hokkaido, Japan, 003-0804
      • Hokkaido Cancer Center
    • Sunagawa, Hokkaido, Japan, 073-0196
      • Sunagawa City Medical Center
  • Ibaraki
    • Tsukuba, Ibaraki, Japan, 305-8576
      • University of Tsukuba Hospital
  • Osaka
    • Sakai, Osaka, Japan, 593-8304
      • Sakai City Medical Center
  • Saitama
    • Kita-adachi-gun, Saitama, Japan, 362-0806
      • Saitama Cancer Center
  • Shizuoka
    • Hamamatsu, Shizuoka, Japan, 431-3192
      • Hamamatsu University Hospital
    • Hamamatsu, Shizuoka, Japan, 430-8558
      • Seirei Hamamatsu General Hospital
  • Tokyo
    • Bunkyo-ku, Tokyo, Japan, 113-8677
      • Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
    • Koto-ku, Tokyo, Japan, 135-8550
      • Cancer Institute Hospital of JFCR
    • Minato, Tokyo, Japan, 105-8470
      • Toranomon Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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).
Other: 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).

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Pfizer
• Collaborators: Japan Breast Cancer Research Group (JBCRG)
• Investigators: Principal Investigator: Hiroko Bando, Dept of Breast, Thyroid and Endocrine Surgery, University of Tsukuba Hospital

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): February 24, 2021
• Primary Completion (Actual): March 24, 2023
• Study Completion (Actual): March 24, 2023

Study Registration Dates

• First Submitted: January 29, 2021
• First Submitted That Met QC Criteria: January 29, 2021
• First Posted (Actual): February 3, 2021

Study Record Updates

• Last Update Posted (Actual): April 24, 2023
• Last Update Submitted That Met QC Criteria: April 20, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Physical activity; Observational study; Japan; Multicenter; Prospective; Palbociclib; European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-30 (items) (EORTC-QLQ-C30); hormone receptor - positive/human epidermal growth factor 2 - negative (HR+/HER2-) advanced breast cancer
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: A5481126

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No