Status:
COMPLETED
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
Lead Sponsor:
Pfizer
Collaborating Sponsors:
Japan Breast Cancer Research Group
Conditions:
Breast Cancer
Eligibility:
FEMALE
20+ years
Phase:
NA
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 b...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
February 24 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 24 2023
Estimated Enrollment :
99 Patients enrolled
Trial Details
Trial ID
NCT04736576
Start Date
February 24 2021
End Date
March 24 2023
Last Update
November 22 2024
Active Locations (20)
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1
Aichi Cancer Center Hospital
Nagoya, Aichi-ken, Japan, 464-8681
2
Nagoya City University Hospital
Nagoya, Aichi-ken, Japan, 467-8602
3
National Cancer Center Hospital East
Kashiwa, Chiba, Japan, 277-8577
4
Shikoku Cancer Center
Matsuyama, Ehime, Japan, 791-0280