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

NCT04736576 | Completed Results

• 1 other identifier: A5481126
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 20

Brief Summary

The study is a prospective, multicenter, observational study to evaluate PRO and physical activity using smartphone-based application and wearable device in Japanese patients with HR+/HER2- advanced breast cancer (ABC). Patients will be enrolled into either palbociclib plus endocrine therapy group (Group 1) or endocrine monotherapy group (Group 2) based on the discretion of the treating physician under routine clinical practice. Total target number of patients is approximately one-hundred in this study (About 50 patients in each group). Enrolled patients will download a smartphone-based application for electronic PRO (ePRO), be provided access to and trained on the use of the application to complete baseline, weekly, and cycle-based assessments for 6 cycles (24 weeks). In addition, enrolled patients will be provided with wearable device and requested to wear the device at all-times, except of while bathing and sleeping, for 6 cycles (24 weeks).

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

Outcome Measures

Primary Outcomes (30)

• 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 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

  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

  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

  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

  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

  From start of study treatment up to 28 days after last dose of treatment (Up to 28 weeks)

Study Arms (2)

Group 1

OTHER

Palbociclib plus endocrine therapy

Device: Wearable device

Group 2

OTHER

Endocrine monotherapy

Device: Wearable device

Interventions

Wearable device DEVICE

As a low-interventional procedure, enrolled patients will be provided with wearable device and requested to wear the device at all-times, except of while bathing and sleeping, for 6 cycles (24 weeks).

Group 1; Group 2

Eligibility Criteria

• Age: 20 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult women (≥ 20 years of age)
• Diagnosis of adenocarcinoma of the breast with evidence of metastatic disease or advanced disease not amenable to resection or radiation therapy with curative intent.
• Documented evidence of HR+/HER2- tumor based on the patient's surgical specimen or most recent tumor biopsy.
• Initiating first or second line treatment at study entry with one of the following therapies:
• palbociclib plus endocrine therapy or endocrine monotherapy
• Eastern Cooperative Oncology Group (ECOG) performance status = 0\~1.
• Owns or has regular access to an Apple iPhone or Android phone.
• Willing and able to complete collection of data via smartphone-based application.
• Willing and able to wear the wearable device for approximately 6 months.
• Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study.
• Able to read and understand Japanese

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead
• Japan Breast Cancer Research Group: collaborator

Study Sites (20)

Aichi Cancer Center Hospital

Nagoya, Aichi-ken, 464-8681, Japan

Location

Nagoya City University Hospital

Nagoya, Aichi-ken, 467-8602, Japan

Location

National Cancer Center Hospital East

Kashiwa, Chiba, 277-8577, Japan

Location

Shikoku Cancer Center

Matsuyama, Ehime, 791-0280, Japan

Location

Hokkaido Cancer Center

Sapporo, Hokkaido, 003-0804, Japan

Location

Sunagawa City Medical Center

Sunagawa, Hokkaido, 073-0196, Japan

Location

University of Tsukuba Hospital

Tsukuba, Ibaraki, 305-8576, Japan

Location

Sakai City Medical Center

Sakai, Osaka, 593-8304, Japan

Location

Saitama Cancer Center

Kita-adachi-gun, Saitama, 362-0806, Japan

Location

Seirei Hamamatsu General Hospital

Hamamatsu, Shizuoka, 430-8558, Japan

Location

Hamamatsu University Hospital

Hamamatsu, Shizuoka, 431-3192, Japan

Location

Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital

Bunkyo-ku, Tokyo, 113-8677, Japan

Location

Cancer Institute Hospital of JFCR

Koto-ku, Tokyo, 135-8550, Japan

Location

Toranomon Hospital

Minato, Tokyo, 105-8470, Japan

Location

Akita University Hospital

Akita, 010-8543, Japan

Location

Fukushima Medical University Hospital

Fukushima, 960-1295, Japan

Location

Gifu University Hospital

Gifu, 501-1194, Japan

Location

Hiroshima Prefectural Hospital

Hiroshima, 734-8530, Japan

Location

Kyoto University Hospital

Kyoto, 606-8507, Japan

Location

Okayama University Hospital

Okayama, 700-8558, Japan

Location

Related Publications (1)

• 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.

  PMID: 40681949 DERIVED

Related Links

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

MeSH Terms

Conditions

Breast Neoplasms; Motor Activity

Interventions

Wearable Electronic Devices

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Behavior

Intervention Hierarchy (Ancestors)

Electrical Equipment and Supplies; Equipment and Supplies

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

• Hiroko Bando

  Dept of Breast, Thyroid and Endocrine Surgery, University of Tsukuba Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2021
• First Posted: February 3, 2021
• Study Start: February 24, 2021
• Primary Completion: March 24, 2023
• Study Completion: March 24, 2023
• Last Updated: November 22, 2024
• Results First Posted: November 22, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

JP (20)