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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)

Primary Purpose

Breast Cancer

Status
Completed
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
Wearable device
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Breast Cancer focused on measuring 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), Physical activity

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Aichi Cancer Center Hospital
  • Nagoya City University Hospital
  • National Cancer Center Hospital East
  • Shikoku Cancer Center
  • Hokkaido Cancer Center
  • Sunagawa City Medical Center
  • University of Tsukuba Hospital
  • Sakai City Medical Center
  • Saitama Cancer Center
  • Seirei Hamamatsu General Hospital
  • Hamamatsu University Hospital
  • Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
  • Cancer Institute Hospital of JFCR
  • Toranomon Hospital
  • Akita University Hospital
  • Fukushima Medical University Hospital
  • Gifu University Hospital
  • Hiroshima Prefectural Hospital
  • Kyoto University Hospital
  • Okayama University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Group 1

Group 2

Arm Description

Palbociclib plus endocrine therapy

Endocrine monotherapy

Outcomes

Primary Outcome Measures

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).
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

Secondary Outcome Measures

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.
Patient treatment satisfaction question
Treatment satisfaction will be evaluated with single item question

Full Information

First Posted
January 29, 2021
Last Updated
April 20, 2023
Sponsor
Pfizer
Collaborators
Japan Breast Cancer Research Group (JBCRG)
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1. Study Identification

Unique Protocol Identification Number
NCT04736576
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
Acronym
JBCRG-26
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
February 24, 2021 (Actual)
Primary Completion Date
March 24, 2023 (Actual)
Study Completion Date
March 24, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer
Collaborators
Japan Breast Cancer Research Group (JBCRG)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
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), Physical activity

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
99 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Other
Arm Description
Palbociclib plus endocrine therapy
Arm Title
Group 2
Arm Type
Other
Arm Description
Endocrine monotherapy
Intervention Type
Device
Intervention Name(s)
Wearable device
Intervention Description
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).
Primary Outcome Measure Information:
Title
Change in PRO as measured by EORTC-QLQ-C30 collected via smartphonebased application.
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).
Time Frame
Baseline and Day 15 of each cycle (one cycle is 28 days)
Title
Physical activities as measured by wearable device.
Description
Physical activity metrics (eg, sedentary time) will be derived by Actigraph's algorithms based on the raw data collected by the device
Time Frame
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 Measure Information:
Title
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.
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.
Time Frame
Baseline and Day 15 of each cycle (one cycle is 28 days)
Title
Patient treatment satisfaction question
Description
Treatment satisfaction will be evaluated with single item question
Time Frame
Baseline and Day 15 of each cycle (one cycle is 28 days)

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Hiroko Bando
Organizational Affiliation
Dept of Breast, Thyroid and Endocrine Surgery, University of Tsukuba Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aichi Cancer Center Hospital
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
464-8681
Country
Japan
Facility Name
Nagoya City University Hospital
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
467-8602
Country
Japan
Facility Name
National Cancer Center Hospital East
City
Kashiwa
State/Province
Chiba
ZIP/Postal Code
277-8577
Country
Japan
Facility Name
Shikoku Cancer Center
City
Matsuyama
State/Province
Ehime
ZIP/Postal Code
791-0280
Country
Japan
Facility Name
Hokkaido Cancer Center
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
003-0804
Country
Japan
Facility Name
Sunagawa City Medical Center
City
Sunagawa
State/Province
Hokkaido
ZIP/Postal Code
073-0196
Country
Japan
Facility Name
University of Tsukuba Hospital
City
Tsukuba
State/Province
Ibaraki
ZIP/Postal Code
305-8576
Country
Japan
Facility Name
Sakai City Medical Center
City
Sakai
State/Province
Osaka
ZIP/Postal Code
593-8304
Country
Japan
Facility Name
Saitama Cancer Center
City
Kita-adachi-gun
State/Province
Saitama
ZIP/Postal Code
362-0806
Country
Japan
Facility Name
Seirei Hamamatsu General Hospital
City
Hamamatsu
State/Province
Shizuoka
ZIP/Postal Code
430-8558
Country
Japan
Facility Name
Hamamatsu University Hospital
City
Hamamatsu
State/Province
Shizuoka
ZIP/Postal Code
431-3192
Country
Japan
Facility Name
Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
City
Bunkyo-ku
State/Province
Tokyo
ZIP/Postal Code
113-8677
Country
Japan
Facility Name
Cancer Institute Hospital of JFCR
City
Koto-ku
State/Province
Tokyo
ZIP/Postal Code
135-8550
Country
Japan
Facility Name
Toranomon Hospital
City
Minato
State/Province
Tokyo
ZIP/Postal Code
105-8470
Country
Japan
Facility Name
Akita University Hospital
City
Akita
ZIP/Postal Code
010-8543
Country
Japan
Facility Name
Fukushima Medical University Hospital
City
Fukushima
ZIP/Postal Code
960-1295
Country
Japan
Facility Name
Gifu University Hospital
City
Gifu
ZIP/Postal Code
501-1194
Country
Japan
Facility Name
Hiroshima Prefectural Hospital
City
Hiroshima
ZIP/Postal Code
734-8530
Country
Japan
Facility Name
Kyoto University Hospital
City
Kyoto
ZIP/Postal Code
606-8507
Country
Japan
Facility Name
Okayama University Hospital
City
Okayama
ZIP/Postal Code
700-8558
Country
Japan

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing 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.
Links:
URL
https://pmiform.com/clinical-trial-info-request?StudyID=A5481126
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

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

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