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 From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-30 (Items) [EORTC-QLQ-C30] Global Health Status (GHS) Sub-scale Score for Cycle 1	The EORTC-QLQ-C30 is a 30-item questionnaire to evaluate cancer participants' quality of life (QOL), and it is composed of five multi-item functional subscales (physical, role, emotional, cognitive, and social functioning), three multi-item symptom scales (fatigue, nausea/vomiting, and pain), a global health status scale (GHS)/QOL subscale, and six single item symptom scales assessing other cancer-related symptoms (dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, and the financial impact of cancer). The GHS/QOL was scored on a 7-point Likert scale where 1=very much to 7=not at all. Responses to GHS/QOL subscales were converted to a 0 to 100 scale. For GHS/QOL subscale, higher scores indicated a better QOL. Baseline values were those measured between enrollment and the day before treatment start.	Baseline, Cycle 1 (1 cycle = 4 Weeks)
Change From Baseline in EORTC-QLQ-C30 GHS Sub-scale Score for Cycle 2	The EORTC-QLQ-C30 is a 30-item questionnaire to evaluate cancer participants' QOL, and it is composed of five multi-item functional subscales (physical, role, emotional, cognitive, and social functioning), three multi-item symptom scales (fatigue, nausea/vomiting, and pain), a GHS/QOL subscale, and six single item symptom scales assessing other cancer-related symptoms (dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, and the financial impact of cancer). The GHS/QOL was scored on a 7-point Likert scale where 1=very much to 7=not at all. Responses to GHS/QOL subscales were converted to a 0 to 100 scale. For GHS/QOL subscale, higher scores indicated a better QOL. Baseline values were those measured between enrollment and the day before treatment start.	Baseline, Cycle 2 (1 cycle = 4 weeks)
Change From Baseline in EORTC-QLQ-C30 GHS Sub-scale Score for Cycle 3	The EORTC-QLQ-C30 is a 30-item questionnaire to evaluate cancer participants' QOL, and it is composed of five multi-item functional subscales (physical, role, emotional, cognitive, and social functioning), three multi-item symptom scales (fatigue, nausea/vomiting, and pain), a GHS/QOL subscale, and six single item symptom scales assessing other cancer-related symptoms (dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, and the financial impact of cancer). The GHS/QOL was scored on a 7-point Likert scale where 1=very much to 7=not at all. Responses to GHS/QOL subscales were converted to a 0 to 100 scale. For GHS/QOL subscale, higher scores indicated a better QOL. Baseline values were those measured between enrollment and the day before treatment start.	Baseline, Cycle 3 (1 cycle = 4 Weeks)
Change From Baseline in EORTC-QLQ-C30 GHS Sub-scale Score for Cycle 4	The EORTC-QLQ-C30 is a 30-item questionnaire to evaluate cancer participants' QOL, and it is composed of five multi-item functional subscales (physical, role, emotional, cognitive, and social functioning), three multi-item symptom scales (fatigue, nausea/vomiting, and pain), a GHS/QOL subscale, and six single item symptom scales assessing other cancer-related symptoms (dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, and the financial impact of cancer). The GHS/QOL was scored on a 7-point Likert scale where 1=very much to 7=not at all. Responses to GHS/QOL subscales were converted to a 0 to 100 scale. For GHS/QOL subscale, higher scores indicated a better QOL. Baseline values were those measured between enrollment and the day before treatment start.	Baseline, Cycle 4 (1 cycle = 4 Weeks)
Change From Baseline in EORTC-QLQ-C30 GHS Sub-scale Score for Cycle 5	The EORTC-QLQ-C30 is a 30-item questionnaire to evaluate cancer participants' QOL, and it is composed of five multi-item functional subscales (physical, role, emotional, cognitive, and social functioning), three multi-item symptom scales (fatigue, nausea/vomiting, and pain), a GHS/QOL subscale, and six single item symptom scales assessing other cancer-related symptoms (dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, and the financial impact of cancer). The GHS/QOL was scored on a 7-point Likert scale where 1=very much to 7=not at all. Responses to GHS/QOL subscales were converted to a 0 to 100 scale. For GHS/QOL subscale, higher scores indicated a better QOL. Baseline values were those measured between enrollment and the day before treatment start.	Baseline, Cycle 5 (1 cycle = 4 Weeks)
Change From Baseline in EORTC-QLQ-C30 GHS Sub-scale Score for Cycle 6	The EORTC-QLQ-C30 is a 30-item questionnaire to evaluate cancer participants' QOL, and it is composed of five multi-item functional subscales (physical, role, emotional, cognitive, and social functioning), three multi-item symptom scales (fatigue, nausea/vomiting, and pain), a GHS/QOL subscale, and six single item symptom scales assessing other cancer-related symptoms (dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, and the financial impact of cancer). The GHS/QOL was scored on a 7-point Likert scale where 1=very much to 7=not at all. Responses to GHS/QOL subscales were converted to a 0 to 100 scale. For GHS/QOL subscale, higher scores indicated a better QOL. Baseline values were those measured between enrollment and the day before treatment start.	Baseline, Cycle 6 (1 cycle = 4 Weeks)
Change From Baseline in Sedentary Time Wearing at Week 1	Sedentary time was used to assess physical activity metrics. Sedentary time was derived by Actigraph's algorithm based on raw data collected by Actigraph Insight Watch. Physical activity metrics were averaged at weekly basis which included 5 or more days of wearing the device for 10 hours or longer during a day except for bedtime.	Baseline, Week 1
Change From Baseline in Sedentary Time Wearing at Week 2	Sedentary time was used to assess physical activity metrics. Sedentary time was derived by Actigraph's algorithm based on raw data collected by Actigraph Insight Watch. Physical activity metrics were averaged at weekly basis which included 5 or more days of wearing the device for 10 hours or longer during a day except for bedtime.	Baseline, Week 2
Change From Baseline in Sedentary Time Wearing at Week 3	Sedentary time was used to assess physical activity metrics. Sedentary time was derived by Actigraph's algorithm based on raw data collected by Actigraph Insight Watch. Physical activity metrics were averaged at weekly basis which included 5 or more days of wearing the device for 10 hours or longer during a day except for bedtime.	Baseline, Week 3
Change From Baseline in Sedentary Time Wearing at Week 4	Sedentary time was used to assess physical activity metrics. Sedentary time was derived by Actigraph's algorithm based on raw data collected by Actigraph Insight Watch. Physical activity metrics were averaged at weekly basis which included 5 or more days of wearing the device for 10 hours or longer during a day except for bedtime.	Baseline, Week 4
Change From Baseline in Sedentary Time Wearing at Week 5	Sedentary time was used to assess physical activity metrics. Sedentary time was derived by Actigraph's algorithm based on raw data collected by Actigraph Insight Watch. Physical activity metrics were averaged at weekly basis which included 5 or more days of wearing the device for 10 hours or longer during a day except for bedtime.	Baseline, Week 5
Change From Baseline in Sedentary Time Wearing at Week 6	Sedentary time was used to assess physical activity metrics. Sedentary time was derived by Actigraph's algorithm based on raw data collected by Actigraph Insight Watch. Physical activity metrics were averaged at weekly basis which included 5 or more days of wearing the device for 10 hours or longer during a day except for bedtime.	Baseline, Week 6
Change From Baseline in Sedentary Time Wearing at Week 7	Sedentary time was used to assess physical activity metrics. Sedentary time was derived by Actigraph's algorithm based on raw data collected by Actigraph Insight Watch. Physical activity metrics were averaged at weekly basis which included 5 or more days of wearing the device for 10 hours or longer during a day except for bedtime.	Baseline, Week 7
Change From Baseline in Sedentary Time Wearing at Week 8	Sedentary time was used to assess physical activity metrics. Sedentary time was derived by Actigraph's algorithm based on raw data collected by Actigraph Insight Watch. Physical activity metrics were averaged at weekly basis which included 5 or more days of wearing the device for 10 hours or longer during a day except for bedtime.	Baseline, Week 8
Change From Baseline in Sedentary Time Wearing at Week 9	Sedentary time was used to assess physical activity metrics. Sedentary time was derived by Actigraph's algorithm based on raw data collected by Actigraph Insight Watch. Physical activity metrics were averaged at weekly basis which included 5 or more days of wearing the device for 10 hours or longer during a day except for bedtime.	Baseline, Week 9
Change From Baseline in Sedentary Time Wearing at Week 10	Sedentary time was used to assess physical activity metrics. Sedentary time was derived by Actigraph's algorithm based on raw data collected by Actigraph Insight Watch. Physical activity metrics were averaged at weekly basis which included 5 or more days of wearing the device for 10 hours or longer during a day except for bedtime.	Baseline, Week 10
Change From Baseline in Sedentary Time Wearing at Week 11	Sedentary time was used to assess physical activity metrics. Sedentary time was derived by Actigraph's algorithm based on raw data collected by Actigraph Insight Watch. Physical activity metrics were averaged at weekly basis which included 5 or more days of wearing the device for 10 hours or longer during a day except for bedtime.	Baseline, Week 11
Change From Baseline in Sedentary Time Wearing at Week 12	Sedentary time was used to assess physical activity metrics. Sedentary time was derived by Actigraph's algorithm based on raw data collected by Actigraph Insight Watch. Physical activity metrics were averaged at weekly basis which included 5 or more days of wearing the device for 10 hours or longer during a day except for bedtime.	Baseline, Week 12
Change From Baseline in Sedentary Time Wearing at Week 13	Sedentary time was used to assess physical activity metrics. Sedentary time was derived by Actigraph's algorithm based on raw data collected by Actigraph Insight Watch. Physical activity metrics were averaged at weekly basis which included 5 or more days of wearing the device for 10 hours or longer during a day except for bedtime.	Baseline, Week 13
Change From Baseline in Sedentary Time Wearing at Week 14	Sedentary time was used to assess physical activity metrics. Sedentary time was derived by Actigraph's algorithm based on raw data collected by Actigraph Insight Watch. Physical activity metrics were averaged at weekly basis which included 5 or more days of wearing the device for 10 hours or longer during a day except for bedtime.	Baseline, Week 14
Change From Baseline in Sedentary Time Wearing at Week 15	Sedentary time was used to assess physical activity metrics. Sedentary time was derived by Actigraph's algorithm based on raw data collected by Actigraph Insight Watch. Physical activity metrics were averaged at weekly basis which included 5 or more days of wearing the device for 10 hours or longer during a day except for bedtime.	Baseline, Week 15
Change From Baseline in Sedentary Time Wearing at Week 16	Sedentary time was used to assess physical activity metrics. Sedentary time was derived by Actigraph's algorithm based on raw data collected by Actigraph Insight Watch. Physical activity metrics were averaged at weekly basis which included 5 or more days of wearing the device for 10 hours or longer during a day except for bedtime.	Baseline, Week 16
Change From Baseline in Sedentary Time Wearing at Week 17	Sedentary time was used to assess physical activity metrics. Sedentary time was derived by Actigraph's algorithm based on raw data collected by Actigraph Insight Watch. Physical activity metrics were averaged at weekly basis which included 5 or more days of wearing the device for 10 hours or longer during a day except for bedtime.	Baseline, Week 17
Change From Baseline in Sedentary Time Wearing at Week 18	Sedentary time was used to assess physical activity metrics. Sedentary time was derived by Actigraph's algorithm based on raw data collected by Actigraph Insight Watch. Physical activity metrics were averaged at weekly basis which included 5 or more days of wearing the device for 10 hours or longer during a day except for bedtime.	Baseline, Week 18
Change From Baseline in Sedentary Time Wearing at Week 19	Sedentary time was used to assess physical activity metrics. Sedentary time was derived by Actigraph's algorithm based on raw data collected by Actigraph Insight Watch. Physical activity metrics were averaged at weekly basis which included 5 or more days of wearing the device for 10 hours or longer during a day except for bedtime.	Baseline, Week 19
Change From Baseline in Sedentary Time Wearing at Week 20	Sedentary time was used to assess physical activity metrics. Sedentary time was derived by Actigraph's algorithm based on raw data collected by Actigraph Insight Watch. Physical activity metrics were averaged at weekly basis which included 5 or more days of wearing the device for 10 hours or longer during a day except for bedtime.	Baseline, Week 20
Change From Baseline in Sedentary Time Wearing at Week 21	Sedentary time was used to assess physical activity metrics. Sedentary time was derived by Actigraph's algorithm based on raw data collected by Actigraph Insight Watch. Physical activity metrics were averaged at weekly basis which included 5 or more days of wearing the device for 10 hours or longer during a day except for bedtime.	Baseline, Week 21
Change From Baseline in Sedentary Time Wearing at Week 22	Sedentary time was used to assess physical activity metrics. Sedentary time was derived by Actigraph's algorithm based on raw data collected by Actigraph Insight Watch. Physical activity metrics were averaged at weekly basis which included 5 or more days of wearing the device for 10 hours or longer during a day except for bedtime.	Baseline, Week 22
Change From Baseline in Sedentary Time Wearing at Week 23	Sedentary time was used to assess physical activity metrics. Sedentary time was derived by Actigraph's algorithm based on raw data collected by Actigraph Insight Watch. Physical activity metrics were averaged at weekly basis which included 5 or more days of wearing the device for 10 hours or longer during a day except for bedtime.	Baseline, Week 23
Change From Baseline in Sedentary Time Wearing at Week 24	Sedentary time was used to assess physical activity metrics. Sedentary time was derived by Actigraph's algorithm based on raw data collected by Actigraph Insight Watch. Physical activity metrics were averaged at weekly basis which included 5 or more days of wearing the device for 10 hours or longer during a day except for bedtime.	Baseline, Week 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in EORTC-QLQ-C30 Functional Sub-scale Scores at Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6	The EORTC-QLQ-C30 is a 30-item questionnaire to evaluate cancer patients' QOL, and it's composed of five multi-item functional subscales (physical [P], role [R], emotional [E], cognitive [C], and social [S] functioning [F]). Response to functional scales is based on a 4-point Likert scale and ranges from 'not at all' to 'very much'. Responses to all functional sub-scales were converted to a 0 to 100 scale. For functional sub-scale, higher scores indicated a better level of functioning.	Baseline, Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 (each cycle=4 weeks)
Change From Baseline in EORTC-QLQ-C30 Symptomatic Sub-scale Scores at Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6	The EORTC-QLQ-C30 is a 30-item questionnaire to evaluate cancer patients' QOL, and it's composed of three multi-item symptom scales (fatigue, nausea/vomiting, and pain), a global QOL) subscale, and six single item symptom scales assessing other cancer-related symptoms (dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, and the financial impact of cancer). Response to symptom sub-scales is based on a 4-point Likert scale and a higher score indicated more severe symptoms. Responses to all symptom sub-scales were converted to a 0 to 100 scale. A higher score indicated more severe symptoms. A 10-point or higher change in scores from baseline was considered clinically significant.	Baseline, Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 (each cycle=4 weeks)
Change From Baseline in Steps Taken at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24	Total estimated steps taken per week were reported in this outcome measure.	Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24
Change From Baseline for Moderate to Vigorous Physical Activity (MVPA) Time at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24	Total estimated number of minutes of moderate or higher (moderate to vigorous) physical activity per date as calculated using the Staudenmayer '15 technique were reported in this outcome measure.	Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Grade 3 or Higher AEs and Treatment Related Adverse Events	AE= any untoward medical occurrence,could therefore be any unfavorable,unintended sign (including an abnormal laboratory finding),symptom,or disease,whether or not related to the participant's participation in the study. An SAE was any untoward medical occurrence at any dose that:resulted in death;was life-threatening(LT);required inpatient hospitalization or prolongation of existing hospitalization;resulted in persistent or significant disability/incapacity(substantial disruption of the ability to conduct normal life functions);resulted in congenital anomaly/birth defect;or an important medical event. AEs were graded(G) according to Common Terminology Criteria for AE(CTCAE) version 4.03. G3 (Severe AE),G4 (LT consequences;urgent intervention indicated),G5 (Death related to AE). TEAEs were those events with onset dates occurring during the on-treatment period (the time from start of study treatment up to 28 days after last dose). Relatedness was based on the investigator's judgement.	From start of study treatment up to 28 days after last dose of treatment (Up to 28 weeks)
Number of Participants According to Fatigue Severity Based on Patient Reported Outcome - Common Terminology Criteria for Adverse Events (PRO-CTCAE)	The PRO-CTCAE is a PRO measurement system that includes a library of questions that measures symptomatic adverse events from the participant perspective. Participants were required to provide their responses to the questions on fatigue severity on a five-point Likert scale. For Fatigue Severity (FS) scoring was as follows: 0= None, 10= Mild, 20= Moderate, 30= Severe, 40= Very Severe.	Baseline, Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 (each cycle=4 weeks)
Number of Participants According to Fatigue Interference Based on PRO-CTCAE	The PRO-CTCAE is a PRO measurement system that includes a library of questions that measures symptomatic adverse events from the participant perspective. Participants were required to provide their responses to the questions on fatigue interference on a five-point Likert scale. For Fatigue Interference (FI) scoring was as follows: 0= Not at all/None/Never, 1= A Little bit, 2: Somewhat, 3= Quite a bit, 4= Very much.	Baseline, Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 (each cycle=4 weeks)
Number of Participants According to Pain Severity Based on PRO-CTCAE	The PRO-CTCAE is a PRO measurement system that includes a library of questions that measures symptomatic adverse events from the participant perspective. Participants were required to provide their responses to the questions on pain severity on a five-point Likert scale. For Pain Severity (PS) scoring was as follows: 0= None, 10= Mild, 20= Moderate, 30= Severe, 40= Very Severe.	Baseline, Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 (each cycle=4 weeks)
Number of Participants According to Pain Interference Based on PRO-CTCAE	The PRO-CTCAE is a PRO measurement system that includes a library of questions that measures symptomatic adverse events from the participant perspective. Participants were required to provide their responses to the questions on pain interference on a five-point Likert scale. For Pain Interference (PI) scoring was as follows: 0= Not at all/None/Never, 1= A Little bit, 2: Somewhat, 3= Quite a bit, 4= Very much.	Baseline, Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 (each cycle=4 weeks)
Number of Participants According to Pain Frequency Based on PRO-CTCAE	The PRO-CTCAE is a PRO measurement system that includes a library of questions that measures symptomatic adverse events from the participant perspective. Participants were required to provide their responses to the questions on pain frequency on a five-point Likert scale. For Pain Frequency (PF) scoring was as follows: 0= None, 1= Rarely, 2: Occasionally, 3= Frequently, 4=Almost Constantly.	Baseline, Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 (each cycle=4 weeks)
Sedentary Time Before and After Disease Progression: Group 1 and 2 Pooled	Sedentary time was used to assess physical activity metrics. Sedentary time was derived by Actigraph's algorithm based on raw data collected by Actigraph Insight Watch. Physical activity metrics were averaged at weekly basis which included 5 or more days of wearing the device 10 hours or longer during a day except for bedtime. Disease progression was defined as greater than (>) 25% increase in sum of longest diameter of target lesions compared to baseline.	Before and after disease progression during the observation period (maximum up to 24 weeks)
Steps Taken Before and After Disease Progression: Group 1 and 2 Pooled	Total estimated steps taken per week were reported in this outcome measure. Disease progression was defined as >25% increase in sum of longest diameter of target lesions compared to baseline.	Before and after disease progression during the observation period (maximum up to 24 weeks)
MVPA Before and After Disease Progression: Group 1 and 2 Pooled	Total estimated number of minutes of Moderate or higher (moderate to vigorous) physical activity per date as calculated using the Staudenmayer '15 technique were reported in this outcome measure. Disease progression was defined as >25% increase in sum of longest diameter of target lesions compared to baseline.	Before and after disease progression during the observation period (maximum up to 24 weeks)
EORTC-QLQ-C30 GHS and Functional Sub-scale Score Before and After Disease Progression: Group 1 and 2 Pooled	The EORTC-QLQ-C30 is a 30-item questionnaire to evaluate cancer participants' QOL,it's composed of five multi-item functional subscales (physical [P],role [R],emotional [E],cognitive [C], and social [S] functioning [F], three multi-item symptom scales (fatigue,nausea/vomiting,pain) a GHS/QOL subscale,and six single item symptom scales assessing other cancer-related symptoms (dyspnea, sleep disturbance, appetite loss, constipation,diarrhea,and the financial impact of cancer). The GHS/QOL was scored on a 7-point Likert scale where 1=very much to 7=not at all. Response to functional scales is based on a 4-point Likert scale and ranges from 'not at all' to 'very much'. Responses to GHS/QOL and all functional sub-scales were converted to a 0 to 100 scale. For GHS/QOL and functional subscale, higher scores indicated a better QOL and better level of functioning, respectively. Disease progression was defined as >25% increase in sum of longest diameter of target lesions compared to baseline.	Before and after disease progression during the observation period (maximum up to 24 weeks)
Number of Participants With Treatment Satisfaction	Treatment satisfaction was evaluated with single item question (eg,"How satisfied are you with your current breast cancer treatment?") using the smart phone application. Responses were provided on a four-point Likert scale (dissatisfied, neutral, satisfied, very satisfied).	Day 15 of Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 (each cycle = 4 weeks)
Number of Participants According to Starting Dose of Palbociclib Treatment	Number of participants according to starting dose of palbociclib treatment (125 milligrams [mg], 100 mg and 75 mg) is reported in this outcome measure. Baseline values are those measured between enrollment and the day before treatment start.	Baseline
Number of Participants Who Had Any Palbociclib Dose Reduction		Up to 24 Weeks
Number of Participants Who Had Any Palbociclib Dose Interruption		Up to 24 Weeks
Number of Participants With Cycle Delay in Palbociclib Treatment		Up to 24 Weeks

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; Study Director: Pfizer CT.gov Call Center, Pfizer

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 (Estimated): November 22, 2024
• Last Update Submitted That Met QC Criteria: November 15, 2024
• Last Verified: November 1, 2024

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: Neoplasms by Site; Neoplasms; Skin Diseases; 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