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| ID | Type | Description | Link |
|---|---|---|---|
| NCT05399329 | Registry Identifier | ClinicalTrials.gov |
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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Palbociclib | Drug | 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 | Drug | Palbociclib plus ET as first-line/second-line treatment for HR+/HER2- ABC |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
(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.)
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This study uses secondary data of multiple sites by utilizing medical record review approach for those who have been diagnosed with ABC in Japan.
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nagoya University Hospital | Nagoya | Aichi-ken | 466-8560 | Japan | ||
| National Hospital Organization Shikoku Cancer Center |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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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.
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| 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 |
| Matsuyama |
| Ehime |
| 791-0280 |
| Japan |
| Japan Community Health care Organization Kurume General Hospital | Kurume | Fukuoka | 830-0013 | Japan |
| Hokkaido Cancer Center | Sapporo | Hokkaido | 003-0804 | Japan |
| Ishikawa Prefectural Central Hospital | Kanazawa | Ishikawa-ken | 920-8530 | Japan |
| Kitasato University Hospital | Sagamihara | Kanagawa | 252-0329 | Japan |
| Tohoku University Hospital | Sendai | Miyagi | 980-8574 | Japan |
| Kaizuka City Hospital | Kaizuka | Osaka | 597-0015 | Japan |
| Osaka International Cancer Institute | Osaka | Osaka | 541-8567 | Japan |
| Osaka University Hospital | Suita | Osaka | 565-0871 | Japan |
| Saitama Prefectural Cancer Center | Kita-adachi-gun | Saitama | 362-0806 | Japan |
| Seirei Hamamatsu General Hospital | Hamamatsu | Shizuoka | 430-8558 | Japan |
| Jichi Medical University Hospital | Shimotsuke | Tochigi | 329 0498 | Japan |
| Gifu University Hospital | Gifu | 501-1194 | Japan |
| Hiroshima University Hospital | Hiroshima | 734-8551 | Japan |
| Tokai University Hospital | Kanagawa | 259-1193 | Japan |
| Aichi Cancer Center | Nagoya | 464-8681 | Japan |
| National Hospital Organization Osaka National Hospital | Osaka | 540-0006 | Japan |
| Shizuoka Prefectural Hospital Organization | Shizuoka | 420-8527 | Japan |
| Showa University Hospital | Tokyo | 142-8666 | Japan |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C500026 | palbociclib |
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