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| ID | Type | Description | Link |
|---|---|---|---|
| Henri 3 | Other Identifier | Alias Study Number |
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A retrospective study of de-identified (to preserve patient privacy) patient information from the SEER-Medicare Database to compare overall survival of first line palbociclib + aromatase inhibitor (AI) therapy versus AI therapy alone treatment in women or men aged 65 and older with newly diagnosed hormone receptor positive/human epidermal growth factor receptor 2 negative (HR+/HER2-) metastatic breast cancer (MBC) in the United States
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Palbociclib + AI | Adult metastatic breast cancer patients who initiated Palbociclib + an aromatase inhibitor as first line therapy in SEER-Medicare |
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| AI alone | Adult metastatic breast cancer patients who initiated an aromatase inhibitor (alone) as first line therapy |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Palbociclib | Drug | Palbociclib with an aromatase inhibitor therapy |
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| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival According to Unadjusted Analysis | Overall survival was defined as time in months from the study index date to all cause death. Study index date in this outcome measure was the date of first line of treatment initiation with palbociclib + AI or AI alone after the de novo mBC diagnosis. De novo mBC referred to breast cancer that physician diagnosed for the first time after it had already spread outside of the breast to distant parts of the body. Unadjusted analysis: analysis not considering any covariates, specifically potential differences in baseline characteristics that could confound the association between treatment and survival. Overall survival was assessed using Kaplan-Meier analysis. | From index date to death (approximately 69.9 months); retrospective data evaluated in 4 months (approximately) of this study |
| Overall Survival According to Stabilized Inverse Probability of Treatment Weighted (sIPTW) Analysis | Overall survival was defined as time in months from the study index date to all cause death. Study index date in this outcome measure was the date of first line of treatment initiation with palbociclib + AI or AI alone after the de novo mBC diagnosis. De novo mBC referred to breast cancer that physician diagnosed for the first time after it had already spread outside of the breast to distant parts of the body. sIPTW analysis: stabilized inverse probability treatment weighting. This is a statistical method that reweights participants to create groups with similar baseline characteristics. The analysis therefore adjusts for differences in baseline characteristics that could confound the association between treatment and survival. Overall survival was assessed using Kaplan-Meier analysis. | From index date to death (approximately 69.9 months); retrospective data evaluated in 4 months (approximately) of this study |
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Inclusion Criteria:
Exclusion Criteria:
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Medicare recipients with HR+/HER2- with De Novo metastatic breast cancer
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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 | New York | 10001 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40145289 | Derived | Brufsky AM, Sandin R, Stergiopoulos S, Chen C, Karanth S, Li B, Esterberg E, Makari D, Candrilli SD, Goyal RK, Rugo HS. Overall Survival With Palbociclib and Aromatase Inhibitor Versus Aromatase Inhibitor Alone in Older Patients With HR+/HER2- Metastatic Breast Cancer. Cancer Med. 2025 Apr;14(7):e70719. doi: 10.1002/cam4.70719. |
| 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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Available data from eligible participants was evaluated in approximately 4 months of this retrospective observational study.
Data of eligible participants diagnosed with hormone receptor (HR+)/ human epidermal growth factor receptor 2-negative (HER2) metastatic breast cancer (mBC) treated with palbociclib in combination with aromatase inhibitor (AI) was extracted from clinical and administrative claims data from the linked surveillance, epidemiology, and end results (SEER)-Medicare database from 1-August-2014 until 31-December-2020 were observed retrospectively.
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| ID | Title | Description |
|---|---|---|
| FG000 | AI Alone | Participants who received an AI (alone) as first line therapy under standard real world routine clinical practice for HR+/HER2- mBC during the period 1-February-2015 to 30-June-2020 were included in this retrospective observational study. |
| FG001 | Palbociclib + AI |
| 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 | Sep 6, 2023 | Jan 15, 2025 |
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| Aromatase Inhibitor | Drug | Aromatase Inhibitor Therapy |
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Participants who received Palbociclib in combination with an AI under standard real world routine clinical practice for HR+/HER2- mBC during the period 1-February-2015 to 30-June-2020 were included in this retrospective observational study. |
| COMPLETED |
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| NOT COMPLETED |
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Analysis population included all eligible participants whose data was extracted and evaluated for the retrospective analysis.
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| ID | Title | Description |
|---|---|---|
| BG000 | AI Alone | Participants who received an AI (alone) as first line therapy under standard real world routine clinical practice for HR+/HER2- mBC during the period 1-February-2015 to 30-June-2020 were included in this retrospective observational study. |
| BG001 | Palbociclib + AI | Participants who received Palbociclib in combination with an AI under standard real world routine clinical practice for HR+/HER2- mBC during the period 1-February-2015 to 30-June-2020 were included in this retrospective observational study. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants | Participants |
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| Sex: Female, Male | Here "number analyzed" signifies participant evaluable for this baseline measure. | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Here "number analyzed" signifies participant evaluable for this baseline measure. | 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 According to Unadjusted Analysis | Overall survival was defined as time in months from the study index date to all cause death. Study index date in this outcome measure was the date of first line of treatment initiation with palbociclib + AI or AI alone after the de novo mBC diagnosis. De novo mBC referred to breast cancer that physician diagnosed for the first time after it had already spread outside of the breast to distant parts of the body. Unadjusted analysis: analysis not considering any covariates, specifically potential differences in baseline characteristics that could confound the association between treatment and survival. Overall survival was assessed using Kaplan-Meier analysis. | Analysis population included all eligible participants whose data was extracted and evaluated for the retrospective analysis. | Posted | Median | 95% Confidence Interval | Months | From index date to death (approximately 69.9 months); retrospective data evaluated in 4 months (approximately) of this study |
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| Primary | Overall Survival According to Stabilized Inverse Probability of Treatment Weighted (sIPTW) Analysis | Overall survival was defined as time in months from the study index date to all cause death. Study index date in this outcome measure was the date of first line of treatment initiation with palbociclib + AI or AI alone after the de novo mBC diagnosis. De novo mBC referred to breast cancer that physician diagnosed for the first time after it had already spread outside of the breast to distant parts of the body. sIPTW analysis: stabilized inverse probability treatment weighting. This is a statistical method that reweights participants to create groups with similar baseline characteristics. The analysis therefore adjusts for differences in baseline characteristics that could confound the association between treatment and survival. Overall survival was assessed using Kaplan-Meier analysis. | Analysis population included all eligible participants whose data was extracted and evaluated for the retrospective analysis. | Posted | Median | 95% Confidence Interval | Months | From index date to death (approximately 69.9 months); retrospective data evaluated in 4 months (approximately) of this study |
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Adverse events were not monitored; hence time frame is not applicable. For all-cause mortality: from index date to death (approximately 69.9 months); retrospective data evaluated in 4 months (approximately) of this study
Due to non-interventional nature of study, the minimum criteria for reporting an adverse event (i.e., identifiable participant, identifiable reporter, a suspect product, and event) were not met, hence adverse events were not monitored. Thus, participants at risk are zero for adverse events.
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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 | AI Alone | Participants who received an AI (alone) as first line therapy under standard real world routine clinical practice for HR+/HER2- mBC during the period 1-February-2015 to 30-June-2020 were included in this retrospective observational study. | 279 | 483 | 0 | 0 | 0 | 0 |
| EG001 | Palbociclib + AI | Participants who received Palbociclib in combination with an AI under standard real world routine clinical practice for HR+/HER2- mBC during the period 1-February-2015 to 30-June-2020 were included in this retrospective observational study. | 113 | 296 | 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 26, 2023 | Jan 15, 2025 | SAP_001.pdf |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C500026 | palbociclib |
| D047072 | Aromatase Inhibitors |
| D000077289 | Letrozole |
| D000077384 | Anastrozole |
| C056516 | exemestane |
| ID | Term |
|---|---|
| D065088 | Steroid Synthesis Inhibitors |
| D004791 | Enzyme Inhibitors |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D004965 | Estrogen Antagonists |
| D006727 | Hormone Antagonists |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D045505 | Physiological Effects of Drugs |
| D009570 | Nitriles |
| D009930 | Organic Chemicals |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| 70-74 years |
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| 75-79 years |
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| Greater than or equal to (>=) 80 years |
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Participants who received Palbociclib in combination with an AI under standard real world routine clinical practice for HR+/HER2- mBC during the period 1-February-2015 to 30-June-2020 were included in this retrospective observational study.
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