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
NCT ID: NCT04736576
Last Updated: 2024-11-22
Study Results
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View full resultsBasic Information
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COMPLETED
NA
99 participants
INTERVENTIONAL
2021-02-24
2023-03-24
Brief Summary
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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).
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
OTHER
NONE
Study Groups
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Group 1
Palbociclib plus endocrine therapy
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).
Group 2
Endocrine monotherapy
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).
Interventions
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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).
Eligibility Criteria
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Inclusion Criteria
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
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
20 Years
FEMALE
No
Sponsors
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Japan Breast Cancer Research Group
OTHER
Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Hiroko Bando
Role: PRINCIPAL_INVESTIGATOR
Dept of Breast, Thyroid and Endocrine Surgery, University of Tsukuba Hospital
Locations
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Aichi Cancer Center Hospital
Nagoya, Aichi-ken, Japan
Nagoya City University Hospital
Nagoya, Aichi-ken, Japan
National Cancer Center Hospital East
Kashiwa, Chiba, Japan
Shikoku Cancer Center
Matsuyama, Ehime, Japan
Hokkaido Cancer Center
Sapporo, Hokkaido, Japan
Sunagawa City Medical Center
Sunagawa, Hokkaido, Japan
University of Tsukuba Hospital
Tsukuba, Ibaraki, Japan
Sakai City Medical Center
Sakai, Osaka, Japan
Saitama Cancer Center
Kita-adachi-gun, Saitama, Japan
Seirei Hamamatsu General Hospital
Hamamatsu, Shizuoka, Japan
Hamamatsu University Hospital
Hamamatsu, Shizuoka, Japan
Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
Bunkyo-ku, Tokyo, Japan
Cancer Institute Hospital of JFCR
Koto-ku, Tokyo, Japan
Toranomon Hospital
Minato, Tokyo, Japan
Akita University Hospital
Akita, , Japan
Fukushima Medical University Hospital
Fukushima, , Japan
Gifu University Hospital
Gifu, , Japan
Hiroshima Prefectural Hospital
Hiroshima, , Japan
Kyoto University Hospital
Kyoto, , Japan
Okayama University Hospital
Okayama, , Japan
Countries
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References
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Bando H, Ueda A, Terata K, Doi M, Nagai SE, Hattori M, Watanabe K, Tamura N, Futamura M, Koizumi K, Niikura N, Miyaji T, Muramatsu Y, Xu L, Masuda N, Saji S. Health-related quality of life and physical activity collected via mobile application and wearable device in patients with HR +/HER2 - advanced breast cancer treated with palbociclib plus endocrine therapy or endocrine therapy alone: 6-month longitudinal study (JBCRG-26). Breast Cancer. 2025 Sep;32(5):1132-1143. doi: 10.1007/s12282-025-01744-0. Epub 2025 Jul 18.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Other Identifiers
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A5481126
Identifier Type: -
Identifier Source: org_study_id
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