Description:
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).
Title
- Brief Title: 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
Clinical Trial IDs
- ORG STUDY ID:
A5481126
- NCT ID:
NCT04736576
Conditions
Purpose
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).
Trial Arms
Name | Type | Description | Interventions |
---|
Group 1 | Other | Palbociclib plus endocrine therapy | |
Group 2 | Other | Endocrine monotherapy | |
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
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 20 Years |
Eligible Gender: | Female |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Change in PRO as measured by EORTC-QLQ-C30 collected via smartphonebased application. |
Time Frame: | Baseline to end of study (6 cycles of initiated treatment) or 24 weeks if patient discontinues initiated treatement before completion of 6 cycles. |
Safety Issue: | |
Description: | 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). |
Secondary Outcome Measures
Measure: | 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. |
Time Frame: | Baseline to end of study (6 cycles of initiated treatment) or 24 weeks if patient discontinues initiated treatement before completion of 6 cycles. |
Safety Issue: | |
Description: | 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. |
Measure: | Patient treatment satisfaction question |
Time Frame: | Baseline to end of study (6 cycles of initiated treatment) or 24 weeks if patient discontinues initiated treatement before completion of 6 cycles. |
Safety Issue: | |
Description: | Treatment satisfaction will be evaluated with single item question |
Details
Phase: | N/A |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Pfizer |
Trial Keywords
- Prospective
- Multicenter
- Observational study
- Japan
- 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
Last Updated
March 16, 2021