NCT05399329

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 line or second line setting. For the purposes of this study, analyses will be descriptive in nature. No formal hypothesis testing is planned.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
693

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2022

Typical duration for all trials

Geographic Reach
1 country

20 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 20, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 26, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 1, 2022

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 27, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 27, 2025

Completed
Last Updated

April 9, 2026

Status Verified

April 1, 2026

Enrollment Period

3.2 years

First QC Date

May 26, 2022

Last Update Submit

April 7, 2026

Conditions

Breast Cancer

Keywords

RetrospectiveMulticenterObservationalEffectivenessReal-world progression free survivalPalbociclibEndocrine therapyJapanHormone receptor positive/ human epidermal growth factor negative (HR+/HER2-)Advanced Breast CancerFirst-line therapySecond-Line therapy

Outcome Measures

Primary Outcomes (2)

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

    15 December 2017 to 31 August 2023

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

    15 December 2017 to 31 August 2023

Secondary Outcomes (10)

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

    15 December 2017 to 31 August 2023

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

    15 December 2017 to 31 August 2023

  • 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

    15 December 2017 to 31 August 2023

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

    15 December 2017 to 31 August 2023

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

    15 December 2017 to 31 August 2023

  • +5 more secondary outcomes

Interventions

PalbociclibDRUG

Palbociclib plus ET as first-line/second-line treatment for hormone receptor positive/human epidermal growth factor receptor 2 negative (HR+/HER2-) ABC

Endocrine therapyDRUG

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

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This study uses secondary data of multiple sites by utilizing medical record review approach for those who have been diagnosed with ABC in Japan.

You may qualify if:

  • 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

You may not qualify if:

  • 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.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

Nagoya University Hospital

Nagoya, Aichi-ken, 466-8560, Japan

Location

National Hospital Organization Shikoku Cancer Center

Matsuyama, Ehime, 791-0280, Japan

Location

Japan Community Health care Organization Kurume General Hospital

Kurume, Fukuoka, 830-0013, Japan

Location

Hokkaido Cancer Center

Sapporo, Hokkaido, 003-0804, Japan

Location

Ishikawa Prefectural Central Hospital

Kanazawa, Ishikawa-ken, 920-8530, Japan

Location

Kitasato University Hospital

Sagamihara, Kanagawa, 252-0329, Japan

Location

Tohoku University Hospital

Sendai, Miyagi, 980-8574, Japan

Location

Kaizuka City Hospital

Kaizuka, Osaka, 597-0015, Japan

Location

Osaka International Cancer Institute

Osaka, Osaka, 541-8567, Japan

Location

Osaka University Hospital

Suita, Osaka, 565-0871, Japan

Location

Saitama Prefectural Cancer Center

Kita-adachi-gun, Saitama, 362-0806, Japan

Location

Seirei Hamamatsu General Hospital

Hamamatsu, Shizuoka, 430-8558, Japan

Location

Jichi Medical University Hospital

Shimotsuke, Tochigi, 329 0498, Japan

Location

Gifu University Hospital

Gifu, 501-1194, Japan

Location

Hiroshima University Hospital

Hiroshima, 734-8551, Japan

Location

Tokai University Hospital

Kanagawa, 259-1193, Japan

Location

Aichi Cancer Center

Nagoya, 464-8681, Japan

Location

National Hospital Organization Osaka National Hospital

Osaka, 540-0006, Japan

Location

Shizuoka Prefectural Hospital Organization

Shizuoka, 420-8527, Japan

Location

Showa University Hospital

Tokyo, 142-8666, Japan

Location

Related Links

MeSH Terms

Conditions

Breast Neoplasms

Interventions

palbociclib

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 26, 2022

First Posted

June 1, 2022

Study Start

April 20, 2022

Primary Completion

June 27, 2025

Study Completion

June 27, 2025

Last Updated

April 9, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Locations

JP(20)