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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
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

Full criteria on ClinicalTrials.gov

Sites (20)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Gifu University Hospital
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GifuJapanUnknown status
Seirei Hamamatsu General Hospital
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HamamatsuJapanUnknown status
Hiroshima University Hospital
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HiroshimaJapanUnknown status
Kaizuka City Hospital
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KaizukaJapanUnknown status
Tokai University Hospital
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KanagawaJapanUnknown status
Ishikawa Prefectural Central Hospital
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KanazawaJapanUnknown status
Saitama Prefectural Cancer Center
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Kita-adachi-gunJapanUnknown status
Japan Community Health care Organization Kurume General Hospital
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KurumeJapanUnknown status
National Hospital Organization Shikoku Cancer Center
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MatsuyamaJapanUnknown status
Nagoya University Hospital
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NagoyaJapanUnknown status
Aichi Cancer Center
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NagoyaJapanUnknown status
National Hospital Organization Osaka National Hospital
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OsakaJapanUnknown status
Osaka International Cancer Institute
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OsakaJapanUnknown status
Kitasato University Hospital
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SagamiharaJapanUnknown status
Hokkaido Cancer Center
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SapporoJapanUnknown status
Tohoku University Hospital
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SendaiJapanUnknown status
Jichi Medical University Hospital
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ShimotsukeJapanUnknown status
Shizuoka Prefectural Hospital Organization
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ShizuokaJapanUnknown status
Osaka University Hospital
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SuitaJapanUnknown status
Showa University Hospital
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TokyoJapanUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.