Study to Evaluate Real-world Effectiveness With Palbociclib Plus Endocrine Therapy as First-line/Second-line Treatment for HR+/HER2- Advanced Breast Cancer in Japan

Breast Cancer Clinical Trial

Official title:

Retrospective, Multicenter, Observational Study to Evaluate Real-World Effectiveness of Palbociclib Plus Endocrine Therapy in Japanese Patients With HR+/HER2- Advanced Breast Cancer in First Line or Second Line Settings

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05399329
• Other study ID #: A5481166
• Status: Recruiting
• Start date: April 20, 2022
• Est. completion date: May 31, 2025

Study information

• Verified date: May 2024
• Source: Pfizer
• Contact: Pfizer CT.gov Call Center
• Phone: 1-800-718-1021
• Email: ClinicalTrials.gov_Inquiries[@]pfizer.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is a retrospective, multicenter, observational study in Japan by medical record review of advanced breast cancer (ABC) patients who have received palbociclib plus endocrine therapy (ET) as first line or second line setting. For the purposes of this study, analyses will be descriptive in nature. No formal hypothesis testing is planned.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: May 31, 2025
• Est. primary completion date: May 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of HR+/HER2- ABC

• Age of 20 years or older at diagnosis of ABC

• Patients that received palbociclib plus ET in the first line or second line

• Patients who meet the criteria regarding the medical record below:

• Patients with any medical records (regardless of palbociclib use) for more than 6 months from palbociclib initiation OR

• Patients with any medical records for less than 6 months from palbociclib initiation AND who had specific events (death, disease progression, or treatment discontinuation of palbociclib due to adverse events) in the available records

Exclusion Criteria:

• Patients who received chemotherapy as first line treatment.

• Patients who have previously participated or are participating in any interventional clinical trials that include investigational or marketed products.

(Interventional clinical trials for early breast cancer and later line after palbociclib will be acceptable, Besides, patients participating in other investigator-initiated research or noninterventional studies can be included as long as their standard of care is not altered by the study.)

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Palbociclib
Palbociclib plus ET as first-line/second-line treatment for hormone receptor positive/human epidermal growth factor receptor 2 negative (HR+/HER2-) ABC
• Endocrine therapy
Palbociclib plus ET as first-line/second-line treatment for HR+/HER2- ABC

Locations

Country	Name	City	State
Japan	Gifu University Hospital	Gifu
Japan	Seirei Hamamatsu General Hospital	Hamamatsu	Shizuoka
Japan	Hiroshima University Hospital	Hiroshima
Japan	Kaizuka City Hospital	Kaizuka	Osaka
Japan	Tokai University Hospital	Kanagawa
Japan	Ishikawa Prefectural Central Hospital	Kanazawa	Ishikawa
Japan	Saitama Prefectural Cancer Center	Kita-adachi-gun	Saitama
Japan	Japan Community Health care Organization Kurume General Hospital	Kurume-city	Fukuoka
Japan	National Hospital Organization Shikoku Cancer Center	Matsuyama-city	Ehime
Japan	Aichi Cancer Center	Nagoya
Japan	Nagoya University Hospital	Nagoya	Aichi
Japan	National Hospital Organization Osaka National Hospital	Osaka
Japan	Osaka International Cancer Institute	Osaka-shi	Osaka
Japan	Kitasato University Hospital	Sagamihara	Kanagawa
Japan	Hokkaido Cancer Center	Sapporo	Hokkaido
Japan	Tohoku University Hospital	Sendai	Miyagi
Japan	Jichi Medical University Hospital	Shimotsuke	Tochigi
Japan	Shizuoka Prefectural Hospital Organization	Shizuoka
Japan	Osaka University Hospital	Suita-city	Osaka
Japan	Showa University Hospital	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Real-World Progression-Free Survival (rwPFS) of palbociclib plus ET as first line treatment for HR+/HER2- ABC		15 December 2017 to 31 August 2023
Primary	rePFS of palbociclib plus ET as second line treatment for HR+/HER2- ABC		15 December 2017 to 31 August 2023
Secondary	Landmark overall survival (OS) (defined from palbociclib initiation to death) of palbociclib plus ET as first line treatment for HR+/HER2- ABC		15 December 2017 to 31 August 2023
Secondary	Landmark OS (defined from palbociclib initiation to death)of palbociclib plus ET as second line treatment for HR+/HER2- ABC		15 December 2017 to 31 August 2023
Secondary	Landmark OS (defined from treatment initiation of first line to death) when palbociclib plus ET were used as second line treatment for HR+/HER2- ABC		15 December 2017 to 31 August 2023
Secondary	Time to treatment discontinuation (TTD) of palbociclib plus ET as first line or second line treatment for HR+/HER2- ABC		15 December 2017 to 31 August 2023
Secondary	TTD of first subsequent treatment for HR+/HER2- ABC patients who were treated with palbociclib plus ET		15 December 2017 to 31 August 2023
Secondary	Time to chemotherapy (TTC: defined as the time from treatment initiation of first or second line for HR+/HER2- ABC to first use of chemotherapy)		15 December 2017 to 31 August 2023
Secondary	Real-world objective response rate (rwORR) of palbociclib plus ET as first line or second line treatment for HR+/HER2- ABC		15 December 2017 to 31 August 2023
Secondary	Demographic of HR+/HER2- ABC patients who were treated with palbociclib plus ET in routine clinical practice in Japan		15 December 2017 to 31 August 2023
Secondary	Clinical characteristics of HR+/HER2- ABC patients who were treated with palbociclib plus ET in routine clinical practice in Japan		15 December 2017 to 31 August 2023
Secondary	Treatment patterns of palbociclib plus ET in routine clinical practice in Japan		15 December 2017 to 31 August 2023

External Links

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