NCT05399329Completed
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
Retrospective, Multicenter, Observational Study to Evaluate Real-World Effectiveness of Palbociclib Plus Endocrine Therapy in Japanese Patients With HR+/HER2- Advanced Breast Cancer in First Line or Second Line Settings
Source: ClinicalTrials.gov · Last updated 9 Apr 2026
Brief summary (registry, in English)
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 line or second line setting. For the purposes of this study, analyses will be descriptive in nature. No formal hypothesis testing is planned.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 693 (actual)
- First submitted
- 26 May 2022
- Start date
- 20 Apr 2022
- Primary completion date
- 27 Jun 2025
- Lead sponsor
- Pfizer
- Diseases
- Metastatic breast cancer
- NCT number
- NCT05399329
What you commit to
- Study type: Observational
- Participants enrolled: 693
- From 20 Apr 2022 to the primary completion date, 27 Jun 2025
- 20 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.)
Who the study is looking for
- 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
Age in the registry: 20 years to - · Sex: All · Does not accept healthy volunteers
Sites (20)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Gifu University Hospital Coordinator of this site? Confirm its status | Gifu | Japan | Unknown status |
| Seirei Hamamatsu General Hospital Coordinator of this site? Confirm its status | Hamamatsu | Japan | Unknown status |
| Hiroshima University Hospital Coordinator of this site? Confirm its status | Hiroshima | Japan | Unknown status |
| Kaizuka City Hospital Coordinator of this site? Confirm its status | Kaizuka | Japan | Unknown status |
| Tokai University Hospital Coordinator of this site? Confirm its status | Kanagawa | Japan | Unknown status |
| Ishikawa Prefectural Central Hospital Coordinator of this site? Confirm its status | Kanazawa | Japan | Unknown status |
| Saitama Prefectural Cancer Center Coordinator of this site? Confirm its status | Kita-adachi-gun | Japan | Unknown status |
| Japan Community Health care Organization Kurume General Hospital Coordinator of this site? Confirm its status | Kurume | Japan | Unknown status |
| National Hospital Organization Shikoku Cancer Center Coordinator of this site? Confirm its status | Matsuyama | Japan | Unknown status |
| Nagoya University Hospital Coordinator of this site? Confirm its status | Nagoya | Japan | Unknown status |
| Aichi Cancer Center Coordinator of this site? Confirm its status | Nagoya | Japan | Unknown status |
| National Hospital Organization Osaka National Hospital Coordinator of this site? Confirm its status | Osaka | Japan | Unknown status |
| Osaka International Cancer Institute Coordinator of this site? Confirm its status | Osaka | Japan | Unknown status |
| Kitasato University Hospital Coordinator of this site? Confirm its status | Sagamihara | Japan | Unknown status |
| Hokkaido Cancer Center Coordinator of this site? Confirm its status | Sapporo | Japan | Unknown status |
| Tohoku University Hospital Coordinator of this site? Confirm its status | Sendai | Japan | Unknown status |
| Jichi Medical University Hospital Coordinator of this site? Confirm its status | Shimotsuke | Japan | Unknown status |
| Shizuoka Prefectural Hospital Organization Coordinator of this site? Confirm its status | Shizuoka | Japan | Unknown status |
| Osaka University Hospital Coordinator of this site? Confirm its status | Suita | Japan | Unknown status |
| Showa University Hospital Coordinator of this site? Confirm its status | Tokyo | Japan | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.