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Completed

NCT Number: NCT05153187

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

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.

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Key information

Conditions

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

Sex eligibility

All sexes

Study type

Observational

Primary location

Pfizer Japan

Tokyo, Japan

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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 )

Exclusion criteria

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

Treatment and study plan

Primary outcomes

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

    Time frame: 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 (0, 1, 2, 3, 4 and >=5) at 1 to 4 weeks after administration of palbociclib is reported in this outcome measure.

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

    Time frame: 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 (0, 1, 2, 3, 4 and >=5) at 5 to 8 weeks after administration of palbociclib is reported in this outcome measure.

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

    Time frame: 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 (0, 1, 2, 3, 4 and >=5) at 9 to 12 weeks after administration of palbociclib is reported in this outcome measure.

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

    Time frame: 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 (0, 1, 2, 3, 4 and >=5) at 13 to 16 weeks after administration of palbociclib is reported in this outcome measure.

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

    Time frame: Anytime between 17 to 20 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 (0, 1, 2, 3, 4 and >=5) at 17 to 20 weeks after administration of palbociclib is reported in this outcome measure.

  6. Time to Treatment Failure of Palbociclib

    Time frame: 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

    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.

Secondary outcomes

  1. Mean Palbociclib Daily Dose

    Time frame: 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

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

    Time frame: 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

    Number of participants according to regimen of first subsequent therapy after end of palbociclib at first line and second line are reported in this outcome measure. The regimen was defined as any breast cancer treatment(s) received within 30 days of earlier treatment initiation. Only regimens used by >=3 participants in participants treated with palbociclib in the first or second line settings were reported. One participant may be included in more than one regimen.

  3. Time to Treatment Failure of Subsequent Therapy After End of Palbociclib

    Time frame: 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

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

Other outcomes

  1. Body Mass Index (BMI) at Palbociclib Initiation

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

    BMI was calculated using the formula: BMI=(weight)/(height/100)^2.

  2. Charlson Comorbidity Index at Palbociclib Initiation

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

    Charlson Comorbidity Index predicts the ten-year mortality for a participant who may have a range of comorbid conditions. 17 comorbidities were assessed with associated weights from 1 to 6, based on the adjusted risk of mortality. The total score is derived by summing up the weights of comorbid conditions presented. The minimum score value is 0 and maximum is 37. A higher score means a greater mortality risk.

  3. Number of Participants According to Index Year for Palbociclib Initiation

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

    Index year was considered as the year corresponding to the start date of the first palbociclib line. Number of participants according to index year (2017, 2018, 2019, 2020, 2021) are reported in this outcome measure.

  4. Percentage of Participants According to Type of First Subsequent Breast Cancer Treatment After End of Palbociclib as First Line

    Time frame: 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

    One participant may be included in more than one breast cancer treatment.

  5. Number of Participants With Antibiotic Use During Palbociclib Treatment

    Time frame: 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

  6. Number of Participants With Granulocyte-Colony Stimulating Factor (G-CSF) Use During Palbociclib Treatment

    Time frame: 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

  7. Number of Participants According to Type of Endocrine Therapy Combined With Palbociclib

    Time frame: 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 the type of endocrine therapy (fulvestrant, letrozole, exemestane, anastrozole, tamoxifen, toremifen and other) combined with palbociclib at first line, second line and third line is reported in this outcome measure. "Other" included participants prescribed >=1 endocrine therapies and those prescribed medroxyprogesterone.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

Descriptive Analyses of Clinical Characteristics and Treatment Patterns of Breast Cancer Patients Initiating Palbociclib (Ibrance(Registered)) Treatment in Japan by Using MDV Database

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Dec 10, 2021
Registry last updated
Apr 21, 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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