Real-world data on palbociclib combo for breast cancer in japan
NCT ID NCT05399329
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study looked back at medical records of 693 Japanese patients with a certain type of advanced breast cancer (HR+/HER2-) who received palbociclib plus endocrine therapy as their first or second treatment. Researchers measured how long patients lived without the cancer getting worse and overall survival. The goal is to see how well this treatment works in everyday practice, not just in clinical trials.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- palbociclib plus endocrine therapy
- What this could lead to
- If successful, this study could confirm that palbociclib plus endocrine therapy works well in real-world Japanese patients, supporting its continued use.
- What could go wrong
- This is a retrospective observational study, not a controlled trial, so results may be influenced by patient selection or missing data. It cannot prove cause and effect.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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693 people
The number who actually took part.
- Started
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Apr 2022
- Finished
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Jun 2025
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
This study uses secondary data of multiple sites by utilizing medical record review approach for those who have been diagnosed with ABC in Japan.
- Ages
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20 years and older
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 Criteria: * 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.)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Aichi Cancer Center
Nagoya, 464-8681, Japan
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Gifu University Hospital
Gifu, 501-1194, Japan
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Hiroshima University Hospital
Hiroshima, 734-8551, Japan
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Hokkaido Cancer Center
Sapporo, Hokkaido, 003-0804, Japan
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Ishikawa Prefectural Central Hospital
Kanazawa, Ishikawa-ken, 920-8530, Japan
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Japan Community Health care Organization Kurume General Hospital
Kurume, Fukuoka, 830-0013, Japan
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Jichi Medical University Hospital
Shimotsuke, Tochigi, 329 0498, Japan
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Kaizuka City Hospital
Kaizuka, Osaka, 597-0015, Japan
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Kitasato University Hospital
Sagamihara, Kanagawa, 252-0329, Japan
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Nagoya University Hospital
Nagoya, Aichi-ken, 466-8560, Japan
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National Hospital Organization Osaka National Hospital
Osaka, 540-0006, Japan
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National Hospital Organization Shikoku Cancer Center
Matsuyama, Ehime, 791-0280, Japan
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Osaka International Cancer Institute
Osaka, Osaka, 541-8567, Japan
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Osaka University Hospital
Suita, Osaka, 565-0871, Japan
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Saitama Prefectural Cancer Center
Kita-adachi-gun, Saitama, 362-0806, Japan
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Seirei Hamamatsu General Hospital
Hamamatsu, Shizuoka, 430-8558, Japan
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Shizuoka Prefectural Hospital Organization
Shizuoka, 420-8527, Japan
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Showa University Hospital
Tokyo, 142-8666, Japan
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Tohoku University Hospital
Sendai, Miyagi, 980-8574, Japan
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Tokai University Hospital
Kanagawa, 259-1193, Japan
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