Clinical trial NCT05399329: 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
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
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Breast Cancer
Keywords: Retrospective
Multicenter
Observational
Effectiveness
Real-world progression free survival
Palbociclib
Endocrine therapy
Japan
Hormone receptor positive/ human epidermal growth factor negative (HR+/HER2-)
Advanced Breast Cancer
First-line therapy
Second-Line therapy
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2022-06-01
Enrollment: 688
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study uses secondary data of multiple sites by utilizing medical record review approach for those who have been diagnosed with ABC in Japan.

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.


Eligibility criteria: 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.)

Primary outcomes:
measure: Real-World Progression-Free Survival (rwPFS) of palbociclib plus ET as first line treatment for HR+/HER2- ABC
timeFrame: 15 December 2017 to 31 August 2023
measure: rePFS of palbociclib plus ET as second line treatment for HR+/HER2- ABC
timeFrame: 15 December 2017 to 31 August 2023
Secondary outcomes:
measure: Landmark overall survival (OS) (defined from palbociclib initiation to death) of palbociclib plus ET as first line treatment for HR+/HER2- ABC
timeFrame: 15 December 2017 to 31 August 2023
measure: Landmark OS (defined from palbociclib initiation to death)of palbociclib plus ET as second line treatment for HR+/HER2- ABC
timeFrame: 15 December 2017 to 31 August 2023
measure: 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
timeFrame: 15 December 2017 to 31 August 2023
measure: Time to treatment discontinuation (TTD) of palbociclib plus ET as first line or second line treatment for HR+/HER2- ABC
timeFrame: 15 December 2017 to 31 August 2023
measure: TTD of first subsequent treatment for HR+/HER2- ABC patients who were treated with palbociclib plus ET
timeFrame: 15 December 2017 to 31 August 2023
measure: 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)
timeFrame: 15 December 2017 to 31 August 2023
measure: Real-world objective response rate (rwORR) of palbociclib plus ET as first line or second line treatment for HR+/HER2- ABC
timeFrame: 15 December 2017 to 31 August 2023
measure: Demographic of HR+/HER2- ABC patients who were treated with palbociclib plus ET in routine clinical practice in Japan
timeFrame: 15 December 2017 to 31 August 2023
measure: Clinical characteristics of HR+/HER2- ABC patients who were treated with palbociclib plus ET in routine clinical practice in Japan
timeFrame: 15 December 2017 to 31 August 2023
measure: Treatment patterns of palbociclib plus ET in routine clinical practice in Japan
timeFrame: 15 December 2017 to 31 August 2023
Other outcomes:
Locations:
city: Nagoya
country: Japan
facility: Nagoya University Hospital
state: Aichi
city: Matsuyama-city
country: Japan
facility: National Hospital Organization Shikoku Cancer Center
state: Ehime
city: Kurume-city
country: Japan
facility: Japan Community Health care Organization Kurume General Hospital
state: Fukuoka
city: Sapporo
country: Japan
facility: Hokkaido Cancer Center
state: Hokkaido
city: Kanazawa
country: Japan
facility: Ishikawa Prefectural Central Hospital
state: Ishikawa
city: Sagamihara
country: Japan
facility: Kitasato University Hospital
state: Kanagawa
city: Sendai
country: Japan
facility: Tohoku University Hospital
state: Miyagi
city: Kaizuka
country: Japan
facility: Kaizuka City Hospital
state: Osaka
city: Osaka-shi
country: Japan
facility: Osaka International Cancer Institute
state: Osaka
city: Suita-city
country: Japan
facility: Osaka University Hospital
state: Osaka
city: Kita-adachi-gun
country: Japan
facility: Saitama Prefectural Cancer Center
state: Saitama
city: Hamamatsu
country: Japan
facility: Seirei Hamamatsu General Hospital
state: Shizuoka
city: Shimotsuke
country: Japan
facility: Jichi Medical University Hospital
state: Tochigi
city: Gifu
country: Japan
facility: Gifu University Hospital
city: Hiroshima
country: Japan
facility: Hiroshima University Hospital
city: Kanagawa
country: Japan
facility: Tokai University Hospital
city: Nagoya
country: Japan
facility: Aichi Cancer Center
city: Osaka
country: Japan
facility: National Hospital Organization Osaka National Hospital
city: Shizuoka
country: Japan
facility: Shizuoka Prefectural Hospital Organization
city: Tokyo
country: Japan
facility: Showa University Hospital
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: