Clinical Trials/NCT04736576

NCT04736576

Completed

Not Applicable

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

Pfizer20 sites in 1 country99 target enrollmentFebruary 24, 2021

ConditionsBreast Cancer

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Breast Cancer
Sponsor: Pfizer
Enrollment: 99
Locations: 20
Primary Endpoint: 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
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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).

Registry

clinicaltrials.gov

Start Date

February 24, 2021

End Date

March 24, 2023

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

Female

Investigators

Sponsor

Pfizer

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Adult women (≥ 20 years of age)
•Diagnosis of adenocarcinoma of the breast with evidence of metastatic disease or advanced disease not amenable to resection or radiation therapy with curative intent.
•Documented evidence of HR+/HER2- tumor based on the patient's surgical specimen or most recent tumor biopsy.
•Initiating first or second line treatment at study entry with one of the following therapies:
•palbociclib plus endocrine therapy or endocrine monotherapy
•Eastern Cooperative Oncology Group (ECOG) performance status = 0\~
•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.

Exclusion Criteria

•The patient is participating in any interventional clinical trial that includes investigational or marketed products. Patients participating in other investigator-initiated research or non-interventional studies can be included as long as their standard of care is not altered by the study.
•The patient is on active treatment for other malignancies other than ABC.
•The patient's life style is fluctuating in weekly-basis (eg, shift-time worker), which may have high impact on physical activity assessment based to investigator's discretion

Outcomes

Primary Outcomes

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)

Change From Baseline in EORTC-QLQ-C30 GHS Sub-scale Score for Cycle 4

Time Frame: Baseline, Cycle 4 (1 cycle = 4 Weeks)

Change From Baseline in EORTC-QLQ-C30 GHS Sub-scale Score for Cycle 5

Time Frame: Baseline, Cycle 5 (1 cycle = 4 Weeks)

Change From Baseline in EORTC-QLQ-C30 GHS Sub-scale Score for Cycle 6

Time Frame: Baseline, Cycle 6 (1 cycle = 4 Weeks)

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

Change From Baseline in Sedentary Time Wearing at Week 3

Time Frame: Baseline, Week 3

Change From Baseline in Sedentary Time Wearing at Week 4

Time Frame: Baseline, Week 4

Change From Baseline in Sedentary Time Wearing at Week 5

Time Frame: Baseline, Week 5

Change From Baseline in Sedentary Time Wearing at Week 6

Time Frame: Baseline, Week 6

Change From Baseline in Sedentary Time Wearing at Week 7

Time Frame: Baseline, Week 7

Change From Baseline in Sedentary Time Wearing at Week 8

Time Frame: Baseline, Week 8

Change From Baseline in Sedentary Time Wearing at Week 9

Time Frame: Baseline, Week 9

Change From Baseline in Sedentary Time Wearing at Week 10

Time Frame: Baseline, Week 10

Change From Baseline in Sedentary Time Wearing at Week 11

Time Frame: Baseline, Week 11

Change From Baseline in Sedentary Time Wearing at Week 12

Time Frame: Baseline, Week 12

Change From Baseline in Sedentary Time Wearing at Week 13

Time Frame: Baseline, Week 13

Change From Baseline in Sedentary Time Wearing at Week 14

Time Frame: Baseline, Week 14

Change From Baseline in Sedentary Time Wearing at Week 15

Time Frame: Baseline, Week 15

Change From Baseline in Sedentary Time Wearing at Week 16

Time Frame: Baseline, Week 16

Change From Baseline in Sedentary Time Wearing at Week 17

Time Frame: Baseline, Week 17

Change From Baseline in Sedentary Time Wearing at Week 18

Time Frame: Baseline, Week 18

Change From Baseline in Sedentary Time Wearing at Week 19

Time Frame: Baseline, Week 19

Change From Baseline in Sedentary Time Wearing at Week 20

Time Frame: Baseline, Week 20

Change From Baseline in Sedentary Time Wearing at Week 21

Time Frame: Baseline, Week 21

Change From Baseline in Sedentary Time Wearing at Week 22

Time Frame: Baseline, Week 22

Change From Baseline in Sedentary Time Wearing at Week 23

Time Frame: Baseline, Week 23

Change From Baseline in Sedentary Time Wearing at Week 24

Time Frame: Baseline, Week 24

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(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))
Number of Participants According to Fatigue Severity Based on Patient Reported Outcome - Common Terminology Criteria for Adverse Events (PRO-CTCAE)(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(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(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(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(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(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(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(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(Before and after disease progression during the observation period (maximum up to 24 weeks))
Number of Participants With Treatment Satisfaction(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(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)