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| ID | Type | Description | Link |
|---|---|---|---|
| NCT04735367 | Registry Identifier | ClinicalTrials.gov |
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This is a retrospective, multicenter, observational study in Japan. The primary objective is to evaluate overall survival (OS) in Japanese patients with HR+/HER2- advanced breast cancer who have been treated with palbociclib plus letrozole. This observational study was planned as follow-up study of Japanese phase 2 study of palbociclib (NCT01684215, phase 2 portion of A5481010 study).
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| palbociclib plus letrozole | Drug | palbociclib plus letrozole |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | OS was defined as the time from the date of the first dose of the investigational product in Japanese Phase 2 study (A5481010) to the date of any-cause death. In the absence of confirmation of death, survival time was censored to last date the participant was known to be alive. Kaplan-Meier method was used for analysis. | From the date of the first dose of the treatment in study A5481010 to the date of any-cause death or censoring date (maximum of 103.16 months of follow-up); data collected and observed retrospectively over 32 months in A5481154 study |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants According to Types and Line of Subsequent Treatment | Participants were classified based on types of subsequent treatment and by line of subsequent treatment. Subsequent treatments included: endocrine therapy-based, chemotherapy-based and others (Investigational drug + Endocrine therapy/Chemotherapy). | From start of subsequent treatment in study A5481010 until date of death, withdrawal of consent or end of study (maximum of 103.16 months of follow-up); data collected and observed retrospectively over 32 months in A5481154 study |
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Inclusion Criteria:
Exclusion Criteria:
1. There are no exclusion criteria for this study.
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Patients who participated, treated with palbociclib plus letrozole, and under follow-up for survival in J-Ph2
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chiba cancer center | Chiba | Chiba | 260-8717 | Japan | ||
| National Hospital Organization Shikoku Cancer Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40841781 | Derived | Takahashi M, Yasojima H, Osako T, Inoue K, Kawashima M, Maeda H, Ito M, Sagara Y, Yonemori K, Hattori M, Yamamoto N, Muramatsu Y, Matsui A, Masuda N. Overall survival and subsequent therapy patterns in Japanese patients with ER+/HER2- advanced breast cancer treated with palbociclib plus letrozole in the first-line setting: a final analysis. Breast Cancer. 2025 Nov;32(6):1482-1490. doi: 10.1007/s12282-025-01760-0. Epub 2025 Aug 21. | |
| 37882974 |
| 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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Data was collected from participants who were treated with palbociclib plus letrozole in Japanese Phase 2 study A5481010 (NCT01684215). Data was collected retrospectively from individual participant medical records for participants under survival follow up at the time of completion of study A5481010 and for participants who died or refused follow-up in study A5481010, data collected in Phase 2 study was used for analysis.
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| ID | Title | Description |
|---|---|---|
| FG000 | Palbociclib+ Letrozole | Participants with hormone receptor positive/human epidermal growth factor receptor 2 negative (HR+/HER2-) advanced breast cancer who were treated with palbociclib plus letrozole in study A5481010 (NCT01684215). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 7, 2022 | Sep 26, 2024 |
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| Duration of Subsequent Therapy by Line of Therapy | Duration of subsequent therapy defined as time from the start date to the end date of each line of treatment among participants who received subsequent treatment. Kaplan-Meier method was used. | From start of subsequent treatment in study A5481010 until date of death, withdrawal of consent or end of study (maximum of 103.16 months of follow-up); data collected and observed retrospectively over 32 months in A5481154 study |
| Matsuyama |
| Ehime |
| 791-0280 |
| Japan |
| Hiroshima City Hiroshima Citizens Hospital | Hiroshima | Hiroshima | 730-8518 | Japan |
| National Hospital Organization Hokkaido Cancer Center | Sapporo | Hokkaido | 003-0804 | Japan |
| Kumamoto University Hospital | Kumamoto | Kumamoto | 860-8556 | Japan |
| Saitama Cancer Center | Kita-adachi-gun | Saitama | 362-0806 | Japan |
| National Cancer Center Hospital | Chuo-ku | Tokyo | 104-0045 | Japan |
| National Hospital Organization Kyushu Cancer Center | Fukuoka | 811-1395 | Japan |
| Hakuaikai Medical Corporation Sagara Hospital | Kagoshima | 892-0833 | Japan |
| Kumamoto Shinto General Hospital | Kumamoto | 862-8655 | Japan |
| Kyoto University Hospital | Kyoto | 606-8507 | Japan |
| Aichi Cancer Center | Nagoya | 464-8681 | Japan |
| National Hospital Organization - Osaka National Hospital - Institute For Clinical Research | Osaka | 540-0006 | Japan |
| Derived |
| Takahashi M, Osako T, Yasojima H, Inoue K, Kawashima M, Maeda H, Ichikawa A, Muramatsu Y, Masuda N. Overall survival in Japanese patients with ER+/HER2- advanced breast cancer treated with first-line palbociclib plus letrozole. Breast Cancer. 2024 Jan;31(1):53-62. doi: 10.1007/s12282-023-01511-z. Epub 2023 Oct 26. |
| COMPLETED |
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| NOT COMPLETED |
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Analysis set included participants who were enrolled in Japanese Phase 2 (J-Ph2) study and received the investigational product, excluding surviving participants who did not give written or oral consent.
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| ID | Title | Description |
|---|---|---|
| BG000 | Palbociclib+ Letrozole | Participants with HR+/HER2- advanced breast cancer who were treated with palbociclib plus letrozole in study A5481010 (NCT01684215). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Overall Survival (OS) | OS was defined as the time from the date of the first dose of the investigational product in Japanese Phase 2 study (A5481010) to the date of any-cause death. In the absence of confirmation of death, survival time was censored to last date the participant was known to be alive. Kaplan-Meier method was used for analysis. | Analysis set included participants who were enrolled in J-Ph2 and received the investigational product excluding surviving participants who did not give written or oral consent. | Posted | Median | 95% Confidence Interval | Months | From the date of the first dose of the treatment in study A5481010 to the date of any-cause death or censoring date (maximum of 103.16 months of follow-up); data collected and observed retrospectively over 32 months in A5481154 study |
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| Secondary | Percentage of Participants According to Types and Line of Subsequent Treatment | Participants were classified based on types of subsequent treatment and by line of subsequent treatment. Subsequent treatments included: endocrine therapy-based, chemotherapy-based and others (Investigational drug + Endocrine therapy/Chemotherapy). | Analysis set included participants who were enrolled in J-Ph2 and received the investigational product excluding surviving participants who did not give written or oral consent. | Posted | Number | Percentage of participants | From start of subsequent treatment in study A5481010 until date of death, withdrawal of consent or end of study (maximum of 103.16 months of follow-up); data collected and observed retrospectively over 32 months in A5481154 study |
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| Secondary | Duration of Subsequent Therapy by Line of Therapy | Duration of subsequent therapy defined as time from the start date to the end date of each line of treatment among participants who received subsequent treatment. Kaplan-Meier method was used. | Analysis set included participants who were enrolled in J-Ph2 and received the investigational product excluding surviving participants who did not give written or oral consent. All participants reported under "Number of Participants Analyzed" contributed data to the table; however, may not have evaluable data for every row. Here "Number Analyzed" refers to the number of participants evaluable for the specified rows. | Posted | Median | 95% Confidence Interval | Months | From start of subsequent treatment in study A5481010 until date of death, withdrawal of consent or end of study (maximum of 103.16 months of follow-up); data collected and observed retrospectively over 32 months in A5481154 study |
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For all-cause mortality: From start of subsequent treatment in study A5481010 until date of death, withdrawal of consent or end of study (maximum of 103.16 months of follow-up); data collected and observed retrospectively over 32 months in study A5481154. Data for non-serious adverse events and serious adverse events (SAEs) were not collected and evaluated during the study; hence timeframe is not applicable for non-SAEs and SAEs.
This observational retrospective study retrieved data from medical records and the data existed as unstructured data. In these data sources, individual participant data were not retrieved or validated. Hence adverse events were not assessed/collected.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Palbociclib+ Letrozole | Participants with HR+/HER2- advanced breast cancer who were treated with palbociclib plus letrozole in study A5481010 (NCT01684215). | 20 | 42 | 0 | 0 | 0 | 0 |
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Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publication until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 9, 2023 | Sep 26, 2024 | SAP_001.pdf |
| 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 |
| D000077289 | Letrozole |
| ID | Term |
|---|---|
| D009570 | Nitriles |
| D009930 | Organic Chemicals |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| >=65 years |
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