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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05153187

Enrollment

1170

Registered

2021-12-10

Start date

2019-08-31

Completion date

2021-06-30

Last updated

2026-04-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

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

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame	Description
Percentage of Participants According to Number of Blood Tests at 1 to 4 Weeks From Palbociclib Treatment Initiation	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.
Percentage of Participants According to Number of Blood Tests at 5 to 8 Weeks From Palbociclib Treatment Initiation	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.
Percentage of Participants According to Number of Blood Tests at 9 to 12 Weeks From Palbociclib Treatment Initiation	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.
Percentage of Participants According to Number of Blood Tests at 13 to 16 Weeks From Palbociclib Treatment Initiation	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.
Percentage of Participants According to Number of Blood Tests at 17 to 20 Weeks From Palbociclib Treatment Initiation	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.
Time to Treatment Failure of Palbociclib	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

Measure	Time frame	Description
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	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.
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	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.

Countries

Japan

Contacts

STUDY_DIRECTORPfizer CT.gov Call Center

Pfizer

Participant flow

Recruitment details

Data from Japanese participants diagnosed with breast cancer and whose data were entered into Medical Data Vision (MDV) database from Apr-2008 and had at least one record of palbociclib treatment from 15-Dec-2017 were included in this study. Data was collected from 15-Dec-2017 (launch date of palbociclib in Japan) until 30-Jun-2021. Available retrospective data was evaluated in approximately 22 months (from 31-Aug-2019 to 30-Jun-2021) in this observational study as per its objective.

Baseline characteristics

Characteristic	—
Age, Continuous	61.6 Years STANDARD_DEVIATION 11.9
Sex: Female, Male Female	1163 Participants
Sex: Female, Male Male	7 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	0 / 0
other Total, other adverse events	0 / 0
serious Total, serious adverse events	0 / 0

Outcome results