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

Pfizer1,170 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

1,170

Conditions

Breast Cancer

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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)

Locations (1)

Pfizer Japan

Outcomes

Primary Outcomes

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.

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 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.

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 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.

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 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.

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 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.

Time frame: 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.

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

Secondary Outcomes

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

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

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 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

Time to Treatment Failure of Subsequent Therapy After End of Palbociclib

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.

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