Spots Global Cancer Trial Database for 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
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Trial Identification
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
Study ID: NCT04736576
Conditions
Interventions
Study Description
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:
Keywords
Eligibility
Minimum Age: 20 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Aichi Cancer Center Hospital, Nagoya, Aichi, Japan
Nagoya City University Hospital, Nagoya, Aichi, 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
Contact Details
Name: Pfizer CT.gov Call Center
Affiliation: Pfizer
Role: STUDY_DIRECTOR
Name: Hiroko Bando
Affiliation: Dept of Breast, Thyroid and Endocrine Surgery, University of Tsukuba Hospital
Role: PRINCIPAL_INVESTIGATOR
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