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
NCT04736576
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Adult Trials: 18+ Years
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
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
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| Descriptive Information | |||||||
|---|---|---|---|---|---|---|---|
| Brief Title ICMJE | 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 ICMJE | 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 | ||||||
| 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). | ||||||
| Detailed Description | Not Provided | ||||||
| Study Type ICMJE | Interventional | ||||||
| Study Phase ICMJE | Not Applicable | ||||||
| Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Other | ||||||
| Condition ICMJE | Breast Cancer | ||||||
| Intervention ICMJE | 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). | ||||||
| Study Arms ICMJE |
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| Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||||
| Recruitment Information | |||||||
| Recruitment Status ICMJE | Recruiting | ||||||
| Estimated Enrollment ICMJE | 100 | ||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||
| Estimated Study Completion Date ICMJE | May 30, 2023 | ||||||
| Estimated Primary Completion Date | July 31, 2021 (Final data collection date for primary outcome measure) | ||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 20 Years and older (Adult, Older Adult) | ||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | Japan | ||||||
| Removed Location Countries | |||||||
| Administrative Information | |||||||
| NCT Number ICMJE | NCT04736576 | ||||||
| Other Study ID Numbers ICMJE | A5481126 | ||||||
| Has Data Monitoring Committee | Not Provided | ||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Pfizer | ||||||
| Study Sponsor ICMJE | Pfizer | ||||||
| Collaborators ICMJE | Japan Breast Cancer Research Group (JBCRG) | ||||||
| Investigators ICMJE |
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| PRS Account | Pfizer | ||||||
| Verification Date | March 2021 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | |||||||