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Completed

NCT Number: NCT05399329

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

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.

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Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Nagoya University Hospital, Nagoya, Aichi-ken, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

Palbociclib

Drug

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

Drug

Palbociclib plus ET as first-line/second-line treatment for HR+/HER2- ABC

Primary outcomes

  1. Real-World Progression-Free Survival (rwPFS) of palbociclib plus ET as first line treatment for HR+/HER2- ABC

    Time frame: 15 December 2017 to 31 August 2023

  2. rePFS of palbociclib plus ET as second line treatment for HR+/HER2- ABC

    Time frame: 15 December 2017 to 31 August 2023

Secondary outcomes

  1. Landmark overall survival (OS) (defined from palbociclib initiation to death) of palbociclib plus ET as first line treatment for HR+/HER2- ABC

    Time frame: 15 December 2017 to 31 August 2023

  2. Landmark OS (defined from palbociclib initiation to death)of palbociclib plus ET as second line treatment for HR+/HER2- ABC

    Time frame: 15 December 2017 to 31 August 2023

  3. Landmark OS (defined from treatment initiation of first line to death) when palbociclib plus ET were used as second line treatment for HR+/HER2- ABC

    Time frame: 15 December 2017 to 31 August 2023

  4. Time to treatment discontinuation (TTD) of palbociclib plus ET as first line or second line treatment for HR+/HER2- ABC

    Time frame: 15 December 2017 to 31 August 2023

  5. TTD of first subsequent treatment for HR+/HER2- ABC patients who were treated with palbociclib plus ET

    Time frame: 15 December 2017 to 31 August 2023

  6. Time to chemotherapy (TTC: defined as the time from treatment initiation of first or second line for HR+/HER2- ABC to first use of chemotherapy)

    Time frame: 15 December 2017 to 31 August 2023

  7. Real-world objective response rate (rwORR) of palbociclib plus ET as first line or second line treatment for HR+/HER2- ABC

    Time frame: 15 December 2017 to 31 August 2023

  8. Demographic of HR+/HER2- ABC patients who were treated with palbociclib plus ET in routine clinical practice in Japan

    Time frame: 15 December 2017 to 31 August 2023

  9. Clinical characteristics of HR+/HER2- ABC patients who were treated with palbociclib plus ET in routine clinical practice in Japan

    Time frame: 15 December 2017 to 31 August 2023

  10. Treatment patterns of palbociclib plus ET in routine clinical practice in Japan

    Time frame: 15 December 2017 to 31 August 2023

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Jun 1, 2022
Registry last updated
Apr 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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