Clinical trial 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
Official title: Descriptive Analyses of Clinical Characteristics and Treatment Patterns of Breast Cancer Patients Initiating Palbociclib (Ibrance(Registered)) Treatment in Japan by Using MDV Database
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: Advanced breast cancer
Hormone receptor positive (HR+)
Human Epidermal Growth Factor Receptor 2 Negative (HER2-)
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2021-12-10
Enrollment: 1170
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Demographic and clinical characteristics of ABC patients at the initiation of treatment with palbociclib
timeFrame: Date of first prescription to the date of last patient record or to the end of data collection (Oct 2022)
measure: Treatment patterns of palbociclib, including line of therapy and type of endocrine therapy combined with palbociclib, and initial dosage
timeFrame: Date of first prescription to the date of last patient record or to the end of data collection (Oct 2022)
measure: Time to treatment failure (TTF) of palbociclib in combination with endocrine therapy by the line of therapy
timeFrame: Date of first prescription to the date of last patient record or to the end of data collection (Oct 2022)
measure: Treatment patterns of subsequent therapy after end of palbociclib treatment, including line of therapy and type of treatment
timeFrame: Date of first prescription to the date of last patient record or to the end of data collection (Oct 2022)
measure: TTF of subsequent therapy after end of palbociclib treatment
timeFrame: Date of first prescription to the date of last patient record or to the end of data collection (Oct 2022)
measure: Changes in treatment pattern before and after the launch of palbociclib, the revision of clinical guideline in Japan
timeFrame: Date of first prescription to the date of last patient record or to the end of data collection (Oct 2022)
measure: Use of antibiotics and/or granulocyte-colony stimulating factor (G-CSF) during treatment with palbociclib
timeFrame: Date of first prescription to the date of last patient record or to the end of data collection (Oct 2022)
measure: Frequency of blood tests during treatment with palbociclib
timeFrame: Date of first prescription to the date of last patient record or to the end of data collection (Oct 2022)
Secondary outcomes:
measure: Demographic and clinical characteristics of ABC patients at the initiation of treatment for ABC
timeFrame: Date of first prescription to the date of last patient record or to the end of data collection (Oct 2022)
measure: Treatment patterns of each line of therapy for ABC patients
timeFrame: Date of first prescription to the date of last patient record or to the end of data collection (Oct 2022)
measure: TTF of endocrine therapy for ABC patients
timeFrame: Date of first prescription to the date of last patient record or to the end of data collection (Oct 2022)
measure: Treatment patterns of subsequent therapy after end of endocrine therapy for ABC patients, including line of therapy and type of treatment
timeFrame: Date of first prescription to the date of last patient record or to the end of data collection (Oct 2022)
measure: TTF of subsequent therapy after end of endocrine therapy for ABC patients
timeFrame: Date of first prescription to the date of last patient record or to the end of data collection (Oct 2022)
measure: Use of antibiotics and/or G-CSF during treatment with endocrine therapy for ABC
timeFrame: Date of first prescription to the date of last patient record or to the end of data collection (Oct 2022)
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Pfizer Japan Inc.
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: