Breast CancerJBCRG-26NCT04736576
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
A study testing Wearable device in people with Breast Cancer, run by Pfizer at 20 sites in Japan.
Trial 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). Read more about this study
- Who is it for?
- Ages 20 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Wearable device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 20 sitesJapan
- Study dates
- 24 Feb 2021to 24 Mar 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
Japan20 sites
Akita University Hospital
Akita, 010-8543
Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
Bunkyo-ku, Tokyo, 113-8677
Fukushima Medical University Hospital
Fukushima, 960-1295
Gifu University Hospital
Gifu, 501-1194
Seirei Hamamatsu General Hospital
Hamamatsu, Shizuoka, 430-8558
Hamamatsu University Hospital
Hamamatsu, Shizuoka, 431-3192
Hiroshima Prefectural Hospital
Hiroshima, 734-8530
National Cancer Center Hospital East
Kashiwa, Chiba, 277-8577
Saitama Cancer Center
Kita-adachi-gun, Saitama, 362-0806
Cancer Institute Hospital of JFCR
Koto-ku, Tokyo, 135-8550
Kyoto University Hospital
Kyoto, 606-8507
Shikoku Cancer Center
Matsuyama, Ehime, 791-0280
Toranomon Hospital
Minato, Tokyo, 105-8470
Aichi Cancer Center Hospital
Nagoya, Aichi-ken, 464-8681
Nagoya City University Hospital
Nagoya, Aichi-ken, 467-8602
Okayama University Hospital
Okayama, 700-8558
Sakai City Medical Center
Sakai, Osaka, 593-8304
Hokkaido Cancer Center
Sapporo, Hokkaido, 003-0804
Sunagawa City Medical Center
Sunagawa, Hokkaido, 073-0196
University of Tsukuba Hospital
Tsukuba, Ibaraki, 305-8576
About this study
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
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).
- Conditions
- Breast Cancer
- Being tested
- Wearable device
- 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
- Medical subject headings
- Breast Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wearable deviceDevice
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).
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Other | Palbociclib plus endocrine therapy Receives: Device: Wearable device |
| Group 2 | Other | Endocrine monotherapy Receives: Device: Wearable device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, Week 24
Secondary outcomes (19)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: Baseline
Number of Participants Who Had Any Palbociclib Dose Reduction
Measured: Up to 24 Weeks
Number of Participants Who Had Any Palbociclib Dose Interruption
Measured: Up to 24 Weeks
Number of Participants With Cycle Delay in Palbociclib Treatment
Measured: Up to 24 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2021
- Study start24 Feb 2021
- Primary completion24 Mar 2023
- Study completion24 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Japan Breast Cancer Research Group
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, PfizerHiroko Bando, Principal investigator, Dept of Breast, Thyroid and Endocrine Surgery, University of Tsukuba Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04736576
- Sponsor's protocol ID
- A5481126
- Acronym
- JBCRG-26
- Status last verified
- Nov 2024
- First submitted
- 29 Jan 2021
- Last updated
- 22 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
Bando H, Ueda A, Terata K, Doi M, Nagai SE, Hattori M, Watanabe K, Tamura N, Futamura M, Koizumi K, Niikura N, Miyaji T, Muramatsu Y, Xu L, Masuda N, Saji S. Health-related quality of life and physical activity collected via mobile application and wearable device in patients with HR +/HER2 - advanced breast cancer treated with palbociclib plus endocrine therapy or endocrine therapy alone: 6-month longitudinal study (JBCRG-26). Breast Cancer. 2025 Sep;32(5):1132-1143. doi: 10.1007/s12282-025-01744-0. Epub 2025 Jul 18.
PubMed 40681949
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04736576
- Acronym / sponsor ID
- JBCRG-26 / A5481126
- Conditions
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Collaborators
- Japan Breast Cancer Research Group
- Study start
- 24 Feb 2021 (actual)
- Primary completion
- 24 Mar 2023 (actual)
- Study completion
- 24 Mar 2023 (actual)
- First posted
- 3 Feb 2021 (actual)
- Results
- Posted 22 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Other | Device: Wearable devicePalbociclib plus endocrine therapy |
| Group 2 | Other | Device: Wearable deviceEndocrine monotherapy |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wearable deviceAs 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). | Device | Group 1, Group 2 |
Primary outcome
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
Time frame: Baseline, Cycle 1 (1 cycle = 4 Weeks)
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.
Change From Baseline in EORTC-QLQ-C30 GHS Sub-scale Score for Cycle 2
Time frame: Baseline, Cycle 2 (1 cycle = 4 weeks)
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.
Change From Baseline in EORTC-QLQ-C30 GHS Sub-scale Score for Cycle 3
Time frame: Baseline, Cycle 3 (1 cycle = 4 Weeks)
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.
Change From Baseline in EORTC-QLQ-C30 GHS Sub-scale Score for Cycle 4
Time frame: Baseline, Cycle 4 (1 cycle = 4 Weeks)
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.
Change From Baseline in EORTC-QLQ-C30 GHS Sub-scale Score for Cycle 5
Time frame: Baseline, Cycle 5 (1 cycle = 4 Weeks)
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.
Change From Baseline in EORTC-QLQ-C30 GHS Sub-scale Score for Cycle 6
Time frame: Baseline, Cycle 6 (1 cycle = 4 Weeks)
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.
Change From Baseline in Sedentary Time Wearing at Week 1
Time frame: Baseline, 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.
Change From Baseline in Sedentary Time Wearing at Week 2
Time frame: Baseline, 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.
Change From Baseline in Sedentary Time Wearing at Week 3
Time frame: Baseline, 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.
Change From Baseline in Sedentary Time Wearing at Week 4
Time frame: Baseline, 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.
Change From Baseline in Sedentary Time Wearing at Week 5
Time frame: Baseline, 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.
Change From Baseline in Sedentary Time Wearing at Week 6
Time frame: Baseline, 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.
Change From Baseline in Sedentary Time Wearing at Week 7
Time frame: Baseline, 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.
Change From Baseline in Sedentary Time Wearing at Week 8
Time frame: Baseline, 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.
Change From Baseline in Sedentary Time Wearing at Week 9
Time frame: Baseline, 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.
Change From Baseline in Sedentary Time Wearing at Week 10
Time frame: Baseline, 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.
Change From Baseline in Sedentary Time Wearing at Week 11
Time frame: Baseline, 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.
Change From Baseline in Sedentary Time Wearing at Week 12
Time frame: Baseline, 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.
Change From Baseline in Sedentary Time Wearing at Week 13
Time frame: Baseline, 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.
Change From Baseline in Sedentary Time Wearing at Week 14
Time frame: Baseline, 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.
Change From Baseline in Sedentary Time Wearing at Week 15
Time frame: Baseline, 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.
Change From Baseline in Sedentary Time Wearing at Week 16
Time frame: Baseline, 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.
Change From Baseline in Sedentary Time Wearing at Week 17
Time frame: Baseline, 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.
Change From Baseline in Sedentary Time Wearing at Week 18
Time frame: Baseline, 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.
Change From Baseline in Sedentary Time Wearing at Week 19
Time frame: Baseline, 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.
Change From Baseline in Sedentary Time Wearing at Week 20
Time frame: Baseline, 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.
Change From Baseline in Sedentary Time Wearing at Week 21
Time frame: Baseline, 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.
Change From Baseline in Sedentary Time Wearing at Week 22
Time frame: Baseline, 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.
Change From Baseline in Sedentary Time Wearing at Week 23
Time frame: Baseline, 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.
Change From Baseline in Sedentary Time Wearing at Week 24
Time frame: Baseline, 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.
19 secondary outcomes
Change From Baseline in EORTC-QLQ-C30 Functional Sub-scale Scores at Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Before and after disease progression during the observation period (maximum up to 24 weeks)
Number of Participants With Treatment Satisfaction
Time frame: 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
Time frame: Baseline
Number of Participants Who Had Any Palbociclib Dose Reduction
Time frame: Up to 24 Weeks
Number of Participants Who Had Any Palbociclib Dose Interruption
Time frame: Up to 24 Weeks
Number of Participants With Cycle Delay in Palbociclib Treatment
Time frame: Up to 24 Weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40681949Bando H, Ueda A, Terata K, Doi M, Nagai SE, Hattori M, Watanabe K, Tamura N, Futamura M, Koizumi K, Niikura N, Miyaji T, Muramatsu Y, Xu L, Masuda N, Saji S. Health-related quality of life and physical activity collected via mobile application and wearable device in patients with HR +/HER2 - advanced breast cancer treated with palbociclib plus endocrine therapy or endocrine therapy alone: 6-month longitudinal study (JBCRG-26). Breast Cancer. 2025 Sep;32(5):1132-1143. doi: 10.1007/s12282-025-01744-0. Epub 2025 Jul 18.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
Hiroko Bando principal investigator
Dept of Breast, Thyroid and Endocrine Surgery, University of Tsukuba Hospital
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wearable device in people with Breast Cancer, run by Pfizer at 20 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: Baseline, Cycle 1 (1 cycle = 4 Weeks)). The study lists 30 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04736576, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2024; AzTrials last refreshed its copy on 29 Oct 2026.