Study to Evaluate Real-world Effectiveness With Palbociclib Plus Endocrine Therapy as First-line/Second-line Treatment for HR+/HER2- Advanced Breast Cancer in Japan
NCT ID: NCT05399329
Last Updated: 2025-07-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
688 participants
OBSERVATIONAL
2022-04-20
2025-06-27
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Interventions
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Palbociclib
Palbociclib plus ET as first-line/second-line treatment for hormone receptor positive/human epidermal growth factor receptor 2 negative (HR+/HER2-) ABC
Endocrine therapy
Palbociclib plus ET as first-line/second-line treatment for HR+/HER2- ABC
Eligibility Criteria
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Inclusion Criteria
* Age of 20 years or older at diagnosis of ABC
* Patients that received palbociclib plus ET in the first line or second line
* Patients who meet the criteria regarding the medical record below:
* Patients with any medical records (regardless of palbociclib use) for more than 6 months from palbociclib initiation OR
* Patients with any medical records for less than 6 months from palbociclib initiation AND who had specific events (death, disease progression, or treatment discontinuation of palbociclib due to adverse events) in the available records
Exclusion Criteria
* Patients who have previously participated or are participating in any interventional clinical trials that include investigational or marketed products.
(Interventional clinical trials for early breast cancer and later line after palbociclib will be acceptable, Besides, patients participating in other investigator-initiated research or noninterventional studies can be included as long as their standard of care is not altered by the study.)
20 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Nagoya University Hospital
Nagoya, Aichi-ken, Japan
National Hospital Organization Shikoku Cancer Center
Matsuyama, Ehime, Japan
Japan Community Health care Organization Kurume General Hospital
Kurume, Fukuoka, Japan
Hokkaido Cancer Center
Sapporo, Hokkaido, Japan
Ishikawa Prefectural Central Hospital
Kanazawa, Ishikawa-ken, Japan
Kitasato University Hospital
Sagamihara, Kanagawa, Japan
Tohoku University Hospital
Sendai, Miyagi, Japan
Kaizuka City Hospital
Kaizuka, Osaka, Japan
Osaka International Cancer Institute
Osaka, Osaka, Japan
Osaka University Hospital
Suita, Osaka, Japan
Saitama Prefectural Cancer Center
Kita-adachi-gun, Saitama, Japan
Seirei Hamamatsu General Hospital
Hamamatsu, Shizuoka, Japan
Jichi Medical University Hospital
Shimotsuke, Tochigi, Japan
Gifu University Hospital
Gifu, , Japan
Hiroshima University Hospital
Hiroshima, , Japan
Tokai University Hospital
Kanagawa, , Japan
Aichi Cancer Center
Nagoya, , Japan
National Hospital Organization Osaka National Hospital
Osaka, , Japan
Shizuoka Prefectural Hospital Organization
Shizuoka, , Japan
Showa University Hospital
Tokyo, , Japan
Countries
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Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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NCT05399329
Identifier Type: REGISTRY
Identifier Source: secondary_id
A5481166
Identifier Type: -
Identifier Source: org_study_id
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