Real-world Treatment Patterns of Endocrine Based Therapy Among Patients With Hormone Receptor-positive/Human Epidermal Growth Factor Receptor-2-negative (HR+/HER2-) Advanced Breast Cancer: An Analysis of Administrative Claims Data in Japan

NCT05153187 | Completed Results

• 2 other identifiers: A5481115NCT05153187
• Study Type: observational
• Target: 1,170
• Locations: 1 country
• Sites: 1

Brief Summary

This is a retrospective observational study focusing on patients diagnosed with advanced breast cancer(ABC) in Japan using de-identified claim data from Medical Data Vision (MDV) database. The primary objective of this study is to describe patient demographics, treatment patterns and treatment duration of palbociclib, and subsequent treatment patterns and treatment duration after palbociclib-based therapy among ABC patients in Japan The secondary objective of the study is to describe patient demographics, treatment patterns of ABC patients and treatment duration of endocrine therapy, and subsequent treatment patterns and treatment duration after endocrine therapy among ABC patients in Japan.

Conditions

Breast Cancer

Keywords

Advanced breast cancer; Hormone receptor positive (HR+); Human Epidermal Growth Factor Receptor 2 Negative (HER2-)

Outcome Measures

Primary Outcomes (6)

• Percentage of Participants According to Number of Blood Tests at 1 to 4 Weeks From Palbociclib Treatment Initiation

  Percentage of participants according to number of blood tests (0, 1, 2, 3, 4 and \>=5) at 1 to 4 weeks after administration of palbociclib is reported in this outcome measure.

  Anytime between 1 to 4 weeks from palbociclib treatment initiation; available data observed retrospectively over approximately 22 months in this study

• Percentage of Participants According to Number of Blood Tests at 5 to 8 Weeks From Palbociclib Treatment Initiation

  Percentage of participants according to number of blood tests (0, 1, 2, 3, 4 and \>=5) at 5 to 8 weeks after administration of palbociclib is reported in this outcome measure.

  Anytime between 5 to 8 weeks from palbociclib treatment initiation; available data observed retrospectively over approximately 22 months in this study

• Percentage of Participants According to Number of Blood Tests at 9 to 12 Weeks From Palbociclib Treatment Initiation

  Percentage of participants according to number of blood tests (0, 1, 2, 3, 4 and \>=5) at 9 to 12 weeks after administration of palbociclib is reported in this outcome measure.

  Anytime between 9 to 12 weeks from palbociclib treatment initiation; available data observed retrospectively over approximately 22 months in this study

• Percentage of Participants According to Number of Blood Tests at 13 to 16 Weeks From Palbociclib Treatment Initiation

  Percentage of participants according to number of blood tests (0, 1, 2, 3, 4 and \>=5) at 13 to 16 weeks after administration of palbociclib is reported in this outcome measure.

  Anytime between 13 to 16 weeks from palbociclib treatment initiation; available data observed retrospectively over approximately 22 months in this study

• Percentage of Participants According to Number of Blood Tests at 17 to 20 Weeks From Palbociclib Treatment Initiation

  Percentage of participants according to number of blood tests (0, 1, 2, 3, 4 and \>=5) at 17 to 20 weeks after administration of palbociclib is reported in this outcome measure.

  Anytime between 17 to 20 weeks from palbociclib treatment initiation; available data observed retrospectively over approximately 22 months in this study

• Time to Treatment Failure of Palbociclib

  Time to treatment failure of palbociclib was defined as time from the date of first palbociclib prescription to the date of lost to follow-up or to the date of the next line of therapy, defined as the end of palbociclib treatment. Time to treatment failure of palbociclib was censored at participant disenrollment or end of study period.

  From start of palbociclib treatment until end of palbociclib treatment or censoring date (maximum up to 42.5 months); available data observed retrospectively over approximately 22 months in this study

Secondary Outcomes (3)

• Mean Palbociclib Daily Dose

  From start of palbociclib treatment until end of palbociclib treatment or end of study period (maximum up to 42.5 months); available data observed retrospectively over approximately 22 months in this study

• Number of Participants According to Regimen of First Subsequent Therapy After End of Palbociclib

  From first subsequent therapy until end of study period (maximum up to 38.1 months); available data observed retrospectively over approximately 22 months in this study

• Time to Treatment Failure of Subsequent Therapy After End of Palbociclib

  From start of first subsequent therapy until date of lost to follow-up or date of next line of therapy or censoring date (maximum up to 38.1 months); available data observed retrospectively over approximately 22 months in this study

Other Outcomes (7)

• Body Mass Index (BMI) at Palbociclib Initiation

  At palbociclib initiation; available data observed retrospectively over approximately 22 months in this study

• Charlson Comorbidity Index at Palbociclib Initiation

  At palbociclib initiation; available data observed retrospectively over approximately 22 months in this study

• Number of Participants According to Index Year for Palbociclib Initiation

  Palbociclib initiation in 2017, 2018, 2019, 2020, 2021; available data observed retrospectively over approximately 22 months in this study

Study Arms (1)

Patients with HR+/HER2- advanced breast cancer

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Japanese patients with diagnosis of breast cancer, diagnosis of secondary malignant neoplasm and who received endocrine therapy drugs and who didn't receive anti-HER2 therapy drugs (defined as HR+/HER2- breast cancer) and whose data were registered into the MDV database from April 2008

You may qualify if:

• Diagnosis of breast cancer based on International statistical classification of diseases and related health problems 10th revision (International Statistical Classification of Diseases and Related Health Problems \[ICD-10\]) (C50.xx)
• Received at least one prescription of endocrine therapy drugs
• Diagnosis of secondary malignant neoplasm based on ICD-10 (C77.x, C78.x, C79.x )

You may not qualify if:

• Received a prescription of anti-HER2 therapy (Trastuzumab, Trastuzumab emtansine, Pertuzumab, and Lapatinib tosilate hydrate)

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer Japan

Tokyo, Japan

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov.Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: November 29, 2021
• First Posted: December 10, 2021
• Study Start: August 31, 2019
• Primary Completion: June 30, 2021
• Study Completion: June 30, 2021
• Last Updated: April 21, 2026
• Results First Posted: April 21, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)