Clinical trial NCT04736576: 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
Official title: Prospective, Multicenter, Observational Study to Evaluate Patient-reported Outcome and Physical Activity Using Smartphone-based Application and Wearable Device in Japanese Patients With HR+/HER2- Advanced Breast Cancer Treated With Palbociclib Plus Endocrine Therapy or Endocrine Monotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
Collaborators: name: Japan Breast Cancer Research Group
First posted: 2021-02-03
Enrollment: 99
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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).


Eligibility criteria: Inclusion Criteria:

1. Adult women (≥ 20 years of age)
2. Diagnosis of adenocarcinoma of the breast with evidence of metastatic disease or advanced disease not amenable to resection or radiation therapy with curative intent.
3. Documented evidence of HR+/HER2- tumor based on the patient's surgical specimen or most recent tumor biopsy.
4. Initiating first or second line treatment at study entry with one of the following therapies:

   palbociclib plus endocrine therapy or endocrine monotherapy
5. Eastern Cooperative Oncology Group (ECOG) performance status = 0\~1.
6. Owns or has regular access to an Apple iPhone or Android phone.
7. Willing and able to complete collection of data via smartphone-based application.
8. Willing and able to wear the wearable device for approximately 6 months.
9. Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study.
10. Able to read and understand Japanese

Exclusion Criteria:

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

Primary outcomes:
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
timeFrame: Baseline, Cycle 1 (1 cycle = 4 Weeks)
measure: Change From Baseline in EORTC-QLQ-C30 GHS Sub-scale Score for Cycle 2
timeFrame: Baseline, Cycle 2 (1 cycle = 4 weeks)
measure: Change From Baseline in EORTC-QLQ-C30 GHS Sub-scale Score for Cycle 3
timeFrame: Baseline, Cycle 3 (1 cycle = 4 Weeks)
measure: Change From Baseline in EORTC-QLQ-C30 GHS Sub-scale Score for Cycle 4
timeFrame: Baseline, Cycle 4 (1 cycle = 4 Weeks)
measure: Change From Baseline in EORTC-QLQ-C30 GHS Sub-scale Score for Cycle 5
timeFrame: Baseline, Cycle 5 (1 cycle = 4 Weeks)
measure: Change From Baseline in EORTC-QLQ-C30 GHS Sub-scale Score for Cycle 6
timeFrame: Baseline, Cycle 6 (1 cycle = 4 Weeks)
measure: Change From Baseline in Sedentary Time Wearing at Week 1
timeFrame: Baseline, Week 1
measure: Change From Baseline in Sedentary Time Wearing at Week 2
timeFrame: Baseline, Week 2
measure: Change From Baseline in Sedentary Time Wearing at Week 3
timeFrame: Baseline, Week 3
measure: Change From Baseline in Sedentary Time Wearing at Week 4
timeFrame: Baseline, Week 4
measure: Change From Baseline in Sedentary Time Wearing at Week 5
timeFrame: Baseline, Week 5
measure: Change From Baseline in Sedentary Time Wearing at Week 6
timeFrame: Baseline, Week 6
measure: Change From Baseline in Sedentary Time Wearing at Week 7
timeFrame: Baseline, Week 7
measure: Change From Baseline in Sedentary Time Wearing at Week 8
timeFrame: Baseline, Week 8
measure: Change From Baseline in Sedentary Time Wearing at Week 9
timeFrame: Baseline, Week 9
measure: Change From Baseline in Sedentary Time Wearing at Week 10
timeFrame: Baseline, Week 10
measure: Change From Baseline in Sedentary Time Wearing at Week 11
timeFrame: Baseline, Week 11
measure: Change From Baseline in Sedentary Time Wearing at Week 12
timeFrame: Baseline, Week 12
measure: Change From Baseline in Sedentary Time Wearing at Week 13
timeFrame: Baseline, Week 13
measure: Change From Baseline in Sedentary Time Wearing at Week 14
timeFrame: Baseline, Week 14
measure: Change From Baseline in Sedentary Time Wearing at Week 15
timeFrame: Baseline, Week 15
measure: Change From Baseline in Sedentary Time Wearing at Week 16
timeFrame: Baseline, Week 16
measure: Change From Baseline in Sedentary Time Wearing at Week 17
timeFrame: Baseline, Week 17
measure: Change From Baseline in Sedentary Time Wearing at Week 18
timeFrame: Baseline, Week 18
measure: Change From Baseline in Sedentary Time Wearing at Week 19
timeFrame: Baseline, Week 19
measure: Change From Baseline in Sedentary Time Wearing at Week 20
timeFrame: Baseline, Week 20
measure: Change From Baseline in Sedentary Time Wearing at Week 21
timeFrame: Baseline, Week 21
measure: Change From Baseline in Sedentary Time Wearing at Week 22
timeFrame: Baseline, Week 22
measure: Change From Baseline in Sedentary Time Wearing at Week 23
timeFrame: Baseline, Week 23
measure: Change From Baseline in Sedentary Time Wearing at Week 24
timeFrame: Baseline, Week 24
Secondary outcomes:
measure: Change From Baseline in EORTC-QLQ-C30 Functional Sub-scale Scores at Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6
timeFrame: Baseline, Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 (each cycle=4 weeks)
measure: Change From Baseline in EORTC-QLQ-C30 Symptomatic Sub-scale Scores at Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6
timeFrame: Baseline, Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 (each cycle=4 weeks)
measure: 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
timeFrame: 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
measure: 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
timeFrame: 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
measure: Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Grade 3 or Higher AEs and Treatment Related Adverse Events
timeFrame: From start of study treatment up to 28 days after last dose of treatment (Up to 28 weeks)
measure: Number of Participants According to Fatigue Severity Based on Patient Reported Outcome - Common Terminology Criteria for Adverse Events (PRO-CTCAE)
timeFrame: Baseline, Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 (each cycle=4 weeks)
measure: Number of Participants According to Fatigue Interference Based on PRO-CTCAE
timeFrame: Baseline, Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 (each cycle=4 weeks)
measure: Number of Participants According to Pain Severity Based on PRO-CTCAE
timeFrame: Baseline, Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 (each cycle=4 weeks)
measure: Number of Participants According to Pain Interference Based on PRO-CTCAE
timeFrame: Baseline, Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 (each cycle=4 weeks)
measure: Number of Participants According to Pain Frequency Based on PRO-CTCAE
timeFrame: Baseline, Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 (each cycle=4 weeks)
measure: Sedentary Time Before and After Disease Progression: Group 1 and 2 Pooled
timeFrame: Before and after disease progression during the observation period (maximum up to 24 weeks)
measure: Steps Taken Before and After Disease Progression: Group 1 and 2 Pooled
timeFrame: Before and after disease progression during the observation period (maximum up to 24 weeks)
measure: MVPA Before and After Disease Progression: Group 1 and 2 Pooled
timeFrame: Before and after disease progression during the observation period (maximum up to 24 weeks)
measure: EORTC-QLQ-C30 GHS and Functional Sub-scale Score Before and After Disease Progression: Group 1 and 2 Pooled
timeFrame: Before and after disease progression during the observation period (maximum up to 24 weeks)
measure: Number of Participants With Treatment Satisfaction
timeFrame: Day 15 of Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 (each cycle = 4 weeks)
measure: Number of Participants According to Starting Dose of Palbociclib Treatment
timeFrame: Baseline
measure: Number of Participants Who Had Any Palbociclib Dose Reduction
timeFrame: Up to 24 Weeks
measure: Number of Participants Who Had Any Palbociclib Dose Interruption
timeFrame: Up to 24 Weeks
measure: Number of Participants With Cycle Delay in Palbociclib Treatment
timeFrame: Up to 24 Weeks
Other outcomes:
Locations:
city: Nagoya
country: Japan
facility: Aichi Cancer Center Hospital
state: Aichi
city: Nagoya
country: Japan
facility: Nagoya City University Hospital
state: Aichi
city: Kashiwa
country: Japan
facility: National Cancer Center Hospital East
state: Chiba
city: Matsuyama
country: Japan
facility: Shikoku Cancer Center
state: Ehime
city: Sapporo
country: Japan
facility: Hokkaido Cancer Center
state: Hokkaido
city: Sunagawa
country: Japan
facility: Sunagawa City Medical Center
state: Hokkaido
city: Tsukuba
country: Japan
facility: University of Tsukuba Hospital
state: Ibaraki
city: Sakai
country: Japan
facility: Sakai City Medical Center
state: Osaka
city: Kita-adachi-gun
country: Japan
facility: Saitama Cancer Center
state: Saitama
city: Hamamatsu
country: Japan
facility: Seirei Hamamatsu General Hospital
state: Shizuoka
city: Hamamatsu
country: Japan
facility: Hamamatsu University Hospital
state: Shizuoka
city: Bunkyo-ku
country: Japan
facility: Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
state: Tokyo
city: Koto-ku
country: Japan
facility: Cancer Institute Hospital of JFCR
state: Tokyo
city: Minato
country: Japan
facility: Toranomon Hospital
state: Tokyo
city: Akita
country: Japan
facility: Akita University Hospital
city: Fukushima
country: Japan
facility: Fukushima Medical University Hospital
city: Gifu
country: Japan
facility: Gifu University Hospital
city: Hiroshima
country: Japan
facility: Hiroshima Prefectural Hospital
city: Kyoto
country: Japan
facility: Kyoto University Hospital
city: Okayama
country: Japan
facility: Okayama University Hospital
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
affiliation: Dept of Breast, Thyroid and Endocrine Surgery, University of Tsukuba Hospital
name: Hiroko Bando
role: PRINCIPAL_INVESTIGATOR
References: