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A retrospective observational analysis of de-identified Flatiron Health Analytic Database to describe patient characteristics, treatment patterns and effectiveness of Palbociclib + AI as first-line therapy in HR+/HER2- metastatic breast cancer (MBC) in the US clinical practices.
Utilizing de-identified data derived from the Flatiron Health Analytic Database, the retrospective observational study is to describe patient characteristics, treatment patterns and effectiveness of Palbociclib + AI as first-line therapy in HR+/HER2-MBC in the US real-world clinical practice setting. Patients will be evaluated retrospectively from index therapy date to death, or last visit in the database, whichever comes first. Descriptive and multivariate statistical analyses will be performed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Palbociclib + an aromatase inhibitor | Adult metastatic breast cancer patients who initiated Palbociclib + an aromatase inhibitor as first line therapy between Feb 3, 2015 to 3 months prior to date of data cutoff in the Flatiron Health Analytic Database. |
| |
| Palbociclib + Letrozole | Adult metastatic breast cancer patients who initiated Palbociclib +Letrozole as first line therapy between Feb 3, 2015 to 3 months prior to date of data cutoff in the Flatiron Health Analytic Database. |
| |
| Letrozole | Adult metastatic breast cancer patients who initiated Letrozole as first line therapy between Feb 3, 2015 to 3 months prior to date of data cutoff in the Flatiron Health Analytic Database. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Palbociclib + an aromatase inhibitor | Drug | Palbociclib + an aromatase inhibitor therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Real-World Progression Free Survival (rwPFS): Using Kaplan-Meier Method | rwPFS was defined as time (in months) from index date to death or disease progression (growth or worsening in the disease concluded by the treating clinician based on radiology, laboratory evidence, pathology, or clinical assessment) or end of record or end of data availability, whichever occurred first. If participants did not die or had disease progression, they were censored at the date of initiation of next line of therapy for participants with two or more lines of therapy or their last visit date for participants with only one line of therapy. Index date was defined as the start date of the first line therapy for Palbociclib + AI. Kaplan-Meier method was used for analysis. | From index date to death or disease progression or end of record/data availability or censored date, whichever occurred first, maximum up to approximately 43 months (data was retrieved and observed during 9 months of this retrospective study) |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS): Using Kaplan-Meier Method | OS was defined as time (in months) from index date to the date of death. Participants who did not die during the period were censored at the time of data cut-off. Index date was defined as the start date of the first line therapy for Palbociclib + AI. Kaplan-Meier method was used for analysis. | From index date to death, maximum up to approximately 43 months (data was retrieved and observed during 9 months of this retrospective study) |
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Inclusion Criteria:
Female sex
At least 18 years old at MBC diagnosis
Diagnosis of MBC at any point in patient history
HR+/HER2-
Palbociclib + AI or letrozole as first-line therapy for MBC during the period from February/2015 through August /31/2018 (or 3 months prior to study cut-off date) to allow for a possible minimum follow-up time of 90 days until the study cutoff date. AI was administered within (±) 28 days of Palbociclib index date.
Exclusion Criteria:
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HR+/HER2- MBC female adult patients treated with Palbociclib + AI or Letrozole alone between February2015 and end of 2018 or data cut-off date
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer | New York | New York | 10017 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35860587 | Derived | Brufsky A, Liu X, Li B, McRoy L, Layman RM. Real-World Effectiveness of Palbociclib Plus Letrozole vs Letrozole Alone for Metastatic Breast Cancer With Lung or Liver Metastases: Flatiron Database Analysis. Front Oncol. 2022 Jul 4;12:865292. doi: 10.3389/fonc.2022.865292. eCollection 2022. | |
| 35643624 | Derived |
| 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 of participants was retrieved from Flatiron Health Analytic database. Available data was evaluated in 9 months of retrospective observational study.
Data of participants diagnosed with hormone receptor positive(HR+)/human epidermal growth factor receptor 2negative (HER2-)metastatic breast cancer(MBC),who received palbociclib in combination with aromatase inhibitor(AI)[letrozole,anastrozole or exemestane]during 03-February-2015 to 31-August-2018(approximately 3.6years)were observed retrospectively.
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| ID | Title | Description |
|---|---|---|
| FG000 | Palbociclib + AI | Participants who received palbociclib in combination with AI under standard real world clinical practice for HR+/HER2- MBC during the period 03-February-2015 to 31-August-2018 were included in this retrospective observational study. Available data were evaluated in 9 months of this retrospective, observational study. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Analysis population included all eligible participants whose data were retrieved and observed in this study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Palbociclib + AI | Participants who received palbociclib in combination with AI under standard real world clinical practice for HR+/HER2- MBC during the period 03-February-2015 to 31-August-2018 were included in this retrospective observational study. Available data were evaluated in 9 months of this retrospective, observational study. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Real-World Progression Free Survival (rwPFS): Using Kaplan-Meier Method | rwPFS was defined as time (in months) from index date to death or disease progression (growth or worsening in the disease concluded by the treating clinician based on radiology, laboratory evidence, pathology, or clinical assessment) or end of record or end of data availability, whichever occurred first. If participants did not die or had disease progression, they were censored at the date of initiation of next line of therapy for participants with two or more lines of therapy or their last visit date for participants with only one line of therapy. Index date was defined as the start date of the first line therapy for Palbociclib + AI. Kaplan-Meier method was used for analysis. | Analysis population included all eligible participants whose data were retrieved and observed in this study. | Posted | Median | 95% Confidence Interval | Months | From index date to death or disease progression or end of record/data availability or censored date, whichever occurred first, maximum up to approximately 43 months (data was retrieved and observed during 9 months of this retrospective study) |
|
All-cause mortality: from index date to death or disease progression or end of record/data availability or censored date, whichever occurred first, maximum up to approximately 43 months (data was retrieved and observed during 9 months of this retrospective study); 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
Due to non-interventional nature of the study, data for non-SAEs and SAEs were not 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 + AI | Participants who received palbociclib in combination with AI under standard real world clinical practice for HR+/HER2- MBC during the period 03-February-2015 to 31-August-2018 were included in this retrospective observational study. Available data were evaluated in 9 months of this retrospective, observational study. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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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 | Nov 10, 2019 | Mar 23, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 22, 2020 | Mar 23, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| C500026 | palbociclib |
| D000077289 | Letrozole |
| ID | Term |
|---|---|
| D009570 | Nitriles |
| D009930 | Organic Chemicals |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 |
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| Palbociclib + Letrozole | Drug | Palbociclib + Letrozole therapy |
|
| Letrozole | Drug | Letrozole monotherapy |
|
| Number of Participants With Real World Tumour Response (rwTR) | rwTR was determined based on complete response (CR), partial response (PR), stable disease (SD), progressive disease(PD), indeterminate and not documented. CR was defined as complete resolution of all visible disease. PR was defined as partial reduction in size of visible disease in some or all areas without any areas of increase in visible disease. SD was defined as no change in overall size of visible disease; also included cases where some lesions increased in size and some lesions decreased in size. PD was determined based on growth or worsening in the disease concluded by the treating clinician based on radiology, laboratory evidence, pathology, or clinical assessment. Index date was defined as the start date of the first line therapy for Palbociclib + AI. | From index date to CR/PR/PD/SD pr PD, maximum up to approximately 43 months (data was retrieved and observed during 9 months of this retrospective study) |
| Response Rate | Response rate was defined as number of participants with complete response or partial response divided by the number of participants with at least one tumor assessment while on the index treatment. Index date was defined as the start date of the first line therapy for Palbociclib + AI. The result of this outcome measure was measured in terms of proportion of participants. | From index date to CR or PR, maximum up to approximately 43 months (data was retrieved and observed during 9 months of this retrospective study) |
| Real-World Duration of Treatment (rwDOT): Using Kaplan-Meier Method | rwDOT was defined as time (in months) from index treatment initiation to end of the treatment. Index date was defined as the start date of the first line therapy for Palbociclib + AI. Kaplan-Meier method was used for analysis. | From index treatment initiation up to end of treatment, maximum up to approximately 43 months (data was retrieved and observed during 9 months of this retrospective study) |
| Time From Index Date to Next Line of Anti-Cancer Therapy: Using Kaplan-Meier Method | The time (in months) from index treatment initiation to next line of anti-cancer therapy or death from any cause, whichever occurred first was reported in this outcome measure. Index date was defined as the start date of the first line therapy for Palbociclib + AI. Kaplan-Meier method was used for analysis. | From index treatment initiation up to next line of anti-cancer therapy or death from any cause, whichever occurred first, maximum up to approximately 43 months (data was retrieved and observed during 9 months of this retrospective study) |
| Time to First Use of Chemotherapy: Using Kaplan-Meier Method | The time (in months) from index treatment initiation to first use of chemotherapy or death from any cause, whichever occurred first was reported in this outcome measure. Index date was defined as the start date of the first line therapy for Palbociclib + AI. Kaplan-Meier method was used for analysis. | From index treatment initiation to first use of chemotherapy or death from any cause, whichever occurred first, maximum up to approximately 43 months (data was retrieved and observed during 9 months of this retrospective study) |
| Patt D, Liu X, Li B, McRoy L, Layman RM, Brufsky A. Real-World Treatment Patterns and Outcomes of Palbociclib Plus an Aromatase Inhibitor for Metastatic Breast Cancer: Flatiron Database Analysis. Clin Breast Cancer. 2022 Aug;22(6):601-610. doi: 10.1016/j.clbc.2022.05.002. Epub 2022 May 5. |
| 34338965 | Derived | Brufsky A, Liu X, Li B, McRoy L, Layman RM. Real-World Tumor Response of Palbociclib Plus Letrozole Versus Letrozole for Metastatic Breast Cancer in US Clinical Practice. Target Oncol. 2021 Sep;16(5):601-611. doi: 10.1007/s11523-021-00826-1. Epub 2021 Aug 2. |
| 33761995 | Derived | DeMichele A, Cristofanilli M, Brufsky A, Liu X, Mardekian J, McRoy L, Layman RM, Emir B, Torres MA, Rugo HS, Finn RS. Comparative effectiveness of first-line palbociclib plus letrozole versus letrozole alone for HR+/HER2- metastatic breast cancer in US real-world clinical practice. Breast Cancer Res. 2021 Mar 24;23(1):37. doi: 10.1186/s13058-021-01409-8. |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Title |
|---|
| Description |
|---|
| OG000 | Palbociclib + AI | Participants who received palbociclib in combination with AI under standard real world clinical practice for HR+/HER2- MBC during the period 03-February-2015 to 31-August-2018 were included in this retrospective observational study. Available data were evaluated in 9 months of this retrospective, observational study. |
|
|
| Secondary | Overall Survival (OS): Using Kaplan-Meier Method | OS was defined as time (in months) from index date to the date of death. Participants who did not die during the period were censored at the time of data cut-off. Index date was defined as the start date of the first line therapy for Palbociclib + AI. Kaplan-Meier method was used for analysis. | Analysis population included all eligible participants whose data were retrieved and observed in this study. | Posted | Median | 95% Confidence Interval | Months | From index date to death, maximum up to approximately 43 months (data was retrieved and observed during 9 months of this retrospective study) |
|
|
|
| Secondary | Number of Participants With Real World Tumour Response (rwTR) | rwTR was determined based on complete response (CR), partial response (PR), stable disease (SD), progressive disease(PD), indeterminate and not documented. CR was defined as complete resolution of all visible disease. PR was defined as partial reduction in size of visible disease in some or all areas without any areas of increase in visible disease. SD was defined as no change in overall size of visible disease; also included cases where some lesions increased in size and some lesions decreased in size. PD was determined based on growth or worsening in the disease concluded by the treating clinician based on radiology, laboratory evidence, pathology, or clinical assessment. Index date was defined as the start date of the first line therapy for Palbociclib + AI. | Analysis population included all eligible participants whose data were retrieved and observed in this study. | Posted | Count of Participants | Participants | From index date to CR/PR/PD/SD pr PD, maximum up to approximately 43 months (data was retrieved and observed during 9 months of this retrospective study) |
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| Secondary | Response Rate | Response rate was defined as number of participants with complete response or partial response divided by the number of participants with at least one tumor assessment while on the index treatment. Index date was defined as the start date of the first line therapy for Palbociclib + AI. The result of this outcome measure was measured in terms of proportion of participants. | Analysis population included all eligible participants whose data were retrieved and observed in this study. | Posted | Number | Proportion of participants | From index date to CR or PR, maximum up to approximately 43 months (data was retrieved and observed during 9 months of this retrospective study) |
|
|
|
| Secondary | Real-World Duration of Treatment (rwDOT): Using Kaplan-Meier Method | rwDOT was defined as time (in months) from index treatment initiation to end of the treatment. Index date was defined as the start date of the first line therapy for Palbociclib + AI. Kaplan-Meier method was used for analysis. | Analysis population included all eligible participants whose data were retrieved and observed in this study. | Posted | Median | 95% Confidence Interval | Months | From index treatment initiation up to end of treatment, maximum up to approximately 43 months (data was retrieved and observed during 9 months of this retrospective study) |
|
|
|
| Secondary | Time From Index Date to Next Line of Anti-Cancer Therapy: Using Kaplan-Meier Method | The time (in months) from index treatment initiation to next line of anti-cancer therapy or death from any cause, whichever occurred first was reported in this outcome measure. Index date was defined as the start date of the first line therapy for Palbociclib + AI. Kaplan-Meier method was used for analysis. | Analysis population included all eligible participants whose data were retrieved and observed in this study. | Posted | Median | 95% Confidence Interval | Months | From index treatment initiation up to next line of anti-cancer therapy or death from any cause, whichever occurred first, maximum up to approximately 43 months (data was retrieved and observed during 9 months of this retrospective study) |
|
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| Secondary | Time to First Use of Chemotherapy: Using Kaplan-Meier Method | The time (in months) from index treatment initiation to first use of chemotherapy or death from any cause, whichever occurred first was reported in this outcome measure. Index date was defined as the start date of the first line therapy for Palbociclib + AI. Kaplan-Meier method was used for analysis. | Analysis population included all eligible participants whose data were retrieved and observed in this study. | Posted | Median | 95% Confidence Interval | Months | From index treatment initiation to first use of chemotherapy or death from any cause, whichever occurred first, maximum up to approximately 43 months (data was retrieved and observed during 9 months of this retrospective study) |
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Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications 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.
| D017437 |
| Skin and Connective Tissue Diseases |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| PD |
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| Indeterminate |
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| Not documented |
|