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
- Conditions
- Breast Cancer
- Registration Number
- NCT05399329
- Lead Sponsor
- Pfizer
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 688
- 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
- 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.)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method rePFS of palbociclib plus ET as second line treatment for HR+/HER2- ABC 15 December 2017 to 31 August 2023 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
- Secondary Outcome Measures
Name Time Method 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 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 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 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 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 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 TTD of first subsequent treatment for HR+/HER2- ABC patients who were treated with palbociclib plus ET 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 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
Trial Locations
- Locations (20)
Japan Community Health care Organization Kurume General Hospital
🇯🇵Kurume-city, Fukuoka, Japan
Tohoku University Hospital
🇯🇵Sendai, Miyagi, Japan
Osaka International Cancer Institute
🇯🇵Osaka-shi, Osaka, Japan
Osaka University Hospital
🇯🇵Suita-city, Osaka, Japan
Hiroshima University Hospital
🇯🇵Hiroshima, Japan
Tokai University Hospital
🇯🇵Kanagawa, Japan
Gifu University Hospital
🇯🇵Gifu, Japan
Aichi Cancer Center
🇯🇵Nagoya, Japan
National Hospital Organization Osaka National Hospital
🇯🇵Osaka, Japan
Shizuoka Prefectural Hospital Organization
🇯🇵Shizuoka, Japan
Showa University Hospital
🇯🇵Tokyo, Japan
National Hospital Organization Shikoku Cancer Center
🇯🇵Matsuyama-city, Ehime, Japan
Saitama Prefectural Cancer Center
🇯🇵Kita-adachi-gun, Saitama, Japan
Nagoya University Hospital
🇯🇵Nagoya, Aichi, Japan
Seirei Hamamatsu General Hospital
🇯🇵Hamamatsu, Shizuoka, Japan
Jichi Medical University Hospital
🇯🇵Shimotsuke, Tochigi, Japan
Hokkaido Cancer Center
🇯🇵Sapporo, Hokkaido, Japan
Ishikawa Prefectural Central Hospital
🇯🇵Kanazawa, Ishikawa, Japan
Kitasato University Hospital
🇯🇵Sagamihara, Kanagawa, Japan
Kaizuka City Hospital
🇯🇵Kaizuka, Osaka, Japan