Clareo Health | 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
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
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Pfizer
With
Japan Breast Cancer Research Group
Age
20–any
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
