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

• ClinicalTrials.gov Identifier: NCT05153187
• Recruitment Status: Recruiting
• First Posted: December 10, 2021
• Last Update Posted: December 10, 2021
• Sponsor: Pfizer
• Information provided by (Responsible Party): Pfizer

Study Description

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.

Condition or disease
Breast Cancer

Study Design

• Study Type: Observational
• Estimated Enrollment: 1 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• 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
• Actual Study Start Date: August 31, 2019
• Estimated Primary Completion Date: November 30, 2023
• Estimated Study Completion Date: November 30, 2023

Groups and Cohorts

Group/Cohort
Patients with HR+/HER2- advanced breast cancer

Outcome Measures

Primary Outcome Measures :

1. Demographic and clinical characteristics of ABC patients at the initiation of treatment with palbociclib [ Time Frame: Date of first prescription to the date of last patient record or to the end of data collection (Oct 2022) ]
2. Treatment patterns of palbociclib, including line of therapy and type of endocrine therapy combined with palbociclib, and initial dosage [ Time Frame: Date of first prescription to the date of last patient record or to the end of data collection (Oct 2022) ]
3. Time to treatment failure (TTF) of palbociclib in combination with endocrine therapy by the line of therapy [ Time Frame: Date of first prescription to the date of last patient record or to the end of data collection (Oct 2022) ]
4. Treatment patterns of subsequent therapy after end of palbociclib treatment, including line of therapy and type of treatment [ Time Frame: Date of first prescription to the date of last patient record or to the end of data collection (Oct 2022) ]
5. TTF of subsequent therapy after end of palbociclib treatment [ Time Frame: Date of first prescription to the date of last patient record or to the end of data collection (Oct 2022) ]
6. Changes in treatment pattern before and after the launch of palbociclib, the revision of clinical guideline in Japan [ Time Frame: Date of first prescription to the date of last patient record or to the end of data collection (Oct 2022) ]
7. Use of antibiotics and/or granulocyte-colony stimulating factor (G-CSF) during treatment with palbociclib [ Time Frame: Date of first prescription to the date of last patient record or to the end of data collection (Oct 2022) ]
8. Frequency of blood tests during treatment with palbociclib [ Time Frame: Date of first prescription to the date of last patient record or to the end of data collection (Oct 2022) ]

Secondary Outcome Measures :

1. Demographic and clinical characteristics of ABC patients at the initiation of treatment for ABC [ Time Frame: Date of first prescription to the date of last patient record or to the end of data collection (Oct 2022) ]
2. Treatment patterns of each line of therapy for ABC patients [ Time Frame: Date of first prescription to the date of last patient record or to the end of data collection (Oct 2022) ]
3. TTF of endocrine therapy for ABC patients [ Time Frame: Date of first prescription to the date of last patient record or to the end of data collection (Oct 2022) ]
4. Treatment patterns of subsequent therapy after end of endocrine therapy for ABC patients, including line of therapy and type of treatment [ Time Frame: Date of first prescription to the date of last patient record or to the end of data collection (Oct 2022) ]
5. TTF of subsequent therapy after end of endocrine therapy for ABC patients [ Time Frame: Date of first prescription to the date of last patient record or to the end of data collection (Oct 2022) ]
6. Use of antibiotics and/or G-CSF during treatment with endocrine therapy for ABC [ Time Frame: Date of first prescription to the date of last patient record or to the end of data collection (Oct 2022) ]

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• 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

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)

Contacts and Locations

Contacts

Contact: Pfizer CT.gov Call Center; 1-800-718-1021; ClinicalTrials.gov_Inquiries@pfizer.com

Locations

Japan

Pfizer Japan Inc.; Recruiting

Tokyo, Japan

Sponsors and Collaborators

Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

More Information

Additional Information:

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

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT05153187
• Other Study ID Numbers: A5481115
• First Posted: December 10, 2021
• Last Update Posted: December 10, 2021
• Last Verified: November 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Keywords provided by Pfizer:

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

Additional relevant MeSH terms:

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases