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

Sponsor

Pfizer (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05399329

Collaborator

(none)

500

Enrollment

Locations

14.5

Anticipated Duration (Months)

Patients Per Site

1.7

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer	Drug: Palbociclib Drug: Endocrine therapy

Study Design

Study Type:

Observational

Anticipated Enrollment :

500 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

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

Anticipated Study Start Date :

Jun 15, 2022

Anticipated Primary Completion Date :

Aug 31, 2023

Anticipated Study Completion Date :

Aug 31, 2023

Outcome Measures

Primary Outcome Measures

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]
rePFS of palbociclib plus ET as second line treatment for HR+/HER2- ABC [15 December 2017 to 31 August 2023]

Secondary Outcome Measures

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]
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]
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]
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]
TTD of first subsequent treatment for HR+/HER2- ABC patients who were treated with palbociclib plus ET [15 December 2017 to 31 August 2023]
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]
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]
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]
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]
Treatment patterns of palbociclib plus ET in routine clinical practice in Japan [15 December 2017 to 31 August 2023]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Aichi Cancer Center Hospital	Nagoya	Aichi	Japan	464-8681
2	Nagoya University Hospital	Nagoya	Aichi	Japan	466-8560
3	National Hospital Organization Shikoku Cancer Center	Matsuyama	Ehime	Japan	791-0280
4	Japan Community Health care Organization Kurume General Hospital	Kurume	Fukuoka	Japan	830-0013
5	Gifu University Hospital	Gifu-shi	Gifu	Japan	501-1194
6	Hiroshima University Hospital	Hiroshima-shi	Hiroshima	Japan	734-8551
7	National Hospital Organization Hokkaido Cancer Center	Sapporo	Hokkaido	Japan	003-0804
8	Ishikawa Prefectural Central Hospital	Kanazawa	Ishikawa	Japan	920-8530
9	Tokai University Hospital	Isehara	Kanagawa	Japan	259-1193
10	Kitasato University Hospital	Sagamihara	Kanagawa	Japan	259-1193
11	Tohoku University Hospital	Sendai	Miyagi	Japan	980-8574
12	National Hospital Organization Osaka National Hospital	Chuo-ku	Osaka	Japan	540-0006
13	Kaizuka City Hospital	Kaizuka	Osaka	Japan	597-0015
14	Osaka Prefectural Hospital Organization Osaka International Cancer Institute	Osaka-shi	Osaka	Japan	541-8567
15	Osaka University Hospital	Suita	Osaka	Japan	565-0871
16	Saitama Cancer Center	Kitaadachi-gun Inamachi	Saitama	Japan	362-0806
17	Seirei Social Welfare Community Seirei Hamamatsu General Hospital	Hamamatsu-shi	Shizuoka	Japan	430-8558
18	Shizuoka Prefectural Hospital Organization Shizuoka General Hospital	Shizuoka-shi	Shizuoka	Japan	420-8527
19	Jichi Medical University Hospital	Shimotsuke-shi	Tochigi	Japan	329-0498
20	Showa University Hospital	Shinagawa-ku	Tokyo	Japan	142-8666