Status:
COMPLETED
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
Lead Sponsor:
Pfizer
Conditions:
Breast Cancer
Eligibility:
All Genders
20+ years
Brief Summary
This is a retrospective, multicenter, observational study in Japan by medical record review of advanced breast cancer (ABC) patients who have received palbociclib plus endocrine therapy (ET) as first ...
Eligibility Criteria
Inclusion
- Diagnosis of HR+/HER2- ABC
- 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
- Patients who received chemotherapy as first line treatment.
- 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.)
Key Trial Info
Start Date :
April 20 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 27 2025
Estimated Enrollment :
688 Patients enrolled
Trial Details
Trial ID
NCT05399329
Start Date
April 20 2022
End Date
June 27 2025
Last Update
July 11 2025
Active Locations (20)
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1
Nagoya University Hospital
Nagoya, Aichi-ken, Japan, 466-8560
2
National Hospital Organization Shikoku Cancer Center
Matsuyama, Ehime, Japan, 791-0280
3
Japan Community Health care Organization Kurume General Hospital
Kurume, Fukuoka, Japan, 830-0013
4
Hokkaido Cancer Center
Sapporo, Hokkaido, Japan, 003-0804