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

Breast Cancer Clinical Trial

— JBCRG-26  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04736576
• Other study ID #: A5481126
• Status: Completed
• Phase: N/A
• Start date: February 24, 2021
• Est. completion date: March 24, 2023

Study information

• Verified date: April 2023
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: March 24, 2023
• Est. primary completion date: March 24, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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

Locations

Country	Name	City	State
Japan	Akita University Hospital	Akita
Japan	Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital	Bunkyo-ku	Tokyo
Japan	Fukushima Medical University Hospital	Fukushima
Japan	Gifu University Hospital	Gifu
Japan	Hamamatsu University Hospital	Hamamatsu	Shizuoka
Japan	Seirei Hamamatsu General Hospital	Hamamatsu	Shizuoka
Japan	Hiroshima Prefectural Hospital	Hiroshima
Japan	National Cancer Center Hospital East	Kashiwa	Chiba
Japan	Saitama Cancer Center	Kita-adachi-gun	Saitama
Japan	Cancer Institute Hospital of JFCR	Koto-ku	Tokyo
Japan	Kyoto University Hospital	Kyoto
Japan	Shikoku Cancer Center	Matsuyama	Ehime
Japan	Toranomon Hospital	Minato	Tokyo
Japan	Aichi Cancer Center Hospital	Nagoya	Aichi
Japan	Nagoya City University Hospital	Nagoya	Aichi
Japan	Okayama University Hospital	Okayama
Japan	Sakai City Medical Center	Sakai	Osaka
Japan	Hokkaido Cancer Center	Sapporo	Hokkaido
Japan	Sunagawa City Medical Center	Sunagawa	Hokkaido
Japan	University of Tsukuba Hospital	Tsukuba	Ibaraki

Sponsors (2)

Lead Sponsor	Collaborator
Pfizer	Japan Breast Cancer Research Group (JBCRG)

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in PRO as measured by EORTC-QLQ-C30 collected via smartphonebased application.	EORTC-QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting) and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties).	Baseline and Day 15 of each cycle (one cycle is 28 days)
Primary	Physical activities as measured by wearable device.	Physical activity metrics (eg, sedentary time) will be derived by Actigraph's algorithms based on the raw data collected by the device	Baseline to end of study (6 cycles of initiated treatment) or 24 weeks if patient discontinues initiated treatment before completion of 6 cycles
Secondary	Change in EORTC-QLQ-C30 and physical activity versus patient-reported symptom as measured by Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) collected via smartphone-based application.	PRO-CTCAE: seventy-eight symptom terms that are common in oncology clinical trials can be evaluable, and each of symptom terms is assessed relative to one or more distinct attributes, including frequency, severity, and/or interference with usual or daily activities.	Baseline and Day 15 of each cycle (one cycle is 28 days)
Secondary	Patient treatment satisfaction question	Treatment satisfaction will be evaluated with single item question	Baseline and Day 15 of each cycle (one cycle is 28 days)

External Links

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