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A retrospective study of de-identified (to preserve patient privacy) patient information from the Flatiron Health Analytic Database to compare effectiveness (i.e., overall survival) of first line palbociclib + aromatase inhibitor (AI) versus AI alone treatment in postmenopausal women or men with hormone receptor positive/human epidermal growth factor receptor 2 negative (HR+/HER2-) metastatic breast cancer (MBC) in the United States clinical practices.
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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 March 31, 2020 in the Flatiron Health Analytic Database. |
| |
| Aromatase inhibitor | Adult metastatic breast cancer patients who initiated an aromatase inhibitor as first line therapy between Feb 3, 2015 to March 31, 2020 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 |
|---|---|---|
| Overall Survival (OS) in Postmenopausal Female or Male Participants With Metastatic Breast Cancer | OS was defined as the time from the index date (start of palbociclib + AI or AI alone) to death. Participants who did not die, were censored at the end of study date (30-Sep-2020). Kaplan-Meier method adjusted by stabilized inverse probability of treatment weighting (sIPTW) was used. | From index date to death due to any cause or censoring date of 30-Sep-2020 (approximately up to 68 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Real-World Progression Free Survival (rwPFS) in Postmenopausal Female or in Male Participants With Metastatic Breast Cancer | Real-world PFS was defined as the number of months from start of palbociclib + AI or AI alone to death from any cause or disease progression (based on clinical assessment or by radiographic scan/tissue biopsy), whichever occurred first. Disease progression was defined as at least a 20 percentage (%) increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that was the smallest on study). Participants who did not die and did not have disease progression were censored at the date of initiation of next line of therapy for participants with 2 or more lines of therapy or at the date of their last visit during the study period (February 2015-September 2020) for participants with only 1 line of therapy. Kaplan-Meier method adjusted by stabilized IPTW was used. |
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Inclusion Criteria:
Exclusion Criteria:
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HR+/HER2- MBC adult patients treated with Palbociclib + AI or AI alone between February2015 and September, 2020
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 10017 | New York | New York | 10017 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42324685 | Derived | Rugo HS, Liu X, Li B, McRoy L, Chen C, Makari D, Layman RM, Brufsky A. Treatment outcomes with palbociclib plus an aromatase inhibitor in patients with metastatic breast cancer who also have cardiovascular diseases: a plain language summary. Future Oncol. 2026 Jun 21:1-11. doi: 10.1080/14796694.2026.2672130. Online ahead of print. | |
| 40138984 |
| 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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All participants who were eligible for the retrospective database analysis were included for the study (i.e., 2888).
Postmenopausal women or men with human epidermal growth factor receptor positive(HR+)/human epidermal growth factor receptor 2 negative(HER2-)metastatic breast cancer(MBC)who initiated first line treatment with palbociclib + aromatase inhibitor(AI)or AI alone from February 2015 through March 2020 and were registered in the Flatiron Health Analytic Database were included in the study. Participants were followed until death or study end (date of data cutoff, 30-Sep-2020), whichever occurred first.
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| ID | Title | Description |
|---|---|---|
| FG000 | Palbociclib + Aromatase Inhibitor | Participants with HR+/HER2- MBC who initiated first line treatment with palbociclib + aromatase inhibitor between 03 Feb 2015 to 31 Mar 2020 were included and observed. |
| FG001 | Aromatase Inhibitor | Participants with HR+/HER2- MBC who initiated first line treatment with aromatase inhibitor alone between 03 Feb 2015 to March 2020 were included and observed. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Full analysis set (FAS) population comprised of all eligible participants enrolled in the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Palbociclib + Aromatase Inhibitor | Participants with HR+/HER2- MBC who initiated first line treatment with palbociclib + aromatase inhibitor between 03 Feb 2015 to 31 Mar 2020 were included and observed. |
| BG001 | Aromatase Inhibitor |
| 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 |
| 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) in Postmenopausal Female or Male Participants With Metastatic Breast Cancer | OS was defined as the time from the index date (start of palbociclib + AI or AI alone) to death. Participants who did not die, were censored at the end of study date (30-Sep-2020). Kaplan-Meier method adjusted by stabilized inverse probability of treatment weighting (sIPTW) was used. | FAS population comprised of all eligible participants enrolled in the study. Analysis was performed using sIPTW method to balance participant characteristics among reporting groups. sIPTW method created balanced virtual groups and hence overall number of participants analyzed was different from numbers in participant flow (not balanced). | Posted | Median | 95% Confidence Interval | Months | From index date to death due to any cause or censoring date of 30-Sep-2020 (approximately up to 68 months) |
|
Overall survival: An outcome measures in the study, estimated from index date to death due to any cause or end of study (up to 68 months). However, in the retrospective deidentified database analysis, individual identifying information, cause of death, and data for non-serious adverse events and serious adverse events (SAEs) were not available and hence were not evaluated during the study.
In this observational retrospective study of deidentified database individual identifying information was not available. Minimum criteria for reporting an adverse event could not be met, hence SAEs and other AEs were not planned to be collected and reported.
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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 + Aromatase Inhibitor | Participants with HR+/HER2- MBC who initiated first line treatment with palbociclib + aromatase inhibitor between 03 Feb 2015 to 31 Mar 2020 were included and observed. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquires@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 | Feb 16, 2022 | Sep 29, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 5, 2021 | Sep 29, 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 |
| D047072 | Aromatase Inhibitors |
| ID | Term |
|---|---|
| D065088 | Steroid Synthesis Inhibitors |
| D004791 | Enzyme Inhibitors |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
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| Aromatase inhibitor | Drug | Aromatase inhibitor therapy |
|
| From index date until disease progression or death due to any cause or censoring date (approximately up to 68 months) |
| Number of Participants According to Real-World Tumor Responses (rwTR): Postmenopausal Female or in Male Participants With Metastatic Breast Cancer | Real-world best responses were assessed based on treating clinician's assessment of radiological evidence for change in burden of disease over course of treatment after 1 month of index treatment initiation. Responses were classified as complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD), indeterminate response (IR). CR=Complete resolution of all visible disease. PR=partial reduction in size of visible disease in some or all areas without any areas of increase in visible disease. SD=no change in overall size of visible disease. PD: an increase in visible disease; also included cases where some lesions increased in size and some lesions decreased in size; included cases where clinician indicated progressive disease; IR=study data not available for evaluation of efficacy for any reason, including participants lost to follow-up or assessment not undertaken or death. Analysis was performed using sIPTW method to balance participant characteristics. | From 30 days after index treatment initiation until CR, PR, SD or PD (approximately 67 months) |
| Real-World Response Rate (rwTR) in Postmenopausal Female or in Male Participants With Metastatic Breast Cancer | Real-world tumor response rate (rwTR) was defined as the percentage of participants with a real world complete response (rwCR) or real-world partial response (rwPR). CR: complete resolution of all visible disease. PR: partial reduction in size of visible disease in some or all areas without any areas of increase in visible disease. Analysis was performed using sIPTW method to balance participant characteristics. | From 30 days after index treatment initiation until disease progression or death due to any cause or censoring date (approximately up to 67 months) |
| Number of Participants According to Initial Dose of Palbociclib: Palbociclib + Aromatase Inhibitor Arm Only | Number of participants according to the initial dose of palbociclib (75 milligrams [mg]/day, 100mg/day, 125 mg/day or missing dose) are reported in this outcome measure. | At index (anytime between 03-Feb-2015 to 31-Mar-2020, approximately up to 62 months) |
| Time to Dose Adjustment for Palbociclib- Palbociclib + Aromatase Inhibitor Arm Only | Time to dose adjustment for participants who received palbociclib 125 mg/day, 100 mg/day, or 75 mg/day as initial dose was presented in this outcome measure. | At index (anytime between 03-Feb-2015 to 30-Sep-2020, approximately up to 68 months) |
| Duration of Treatment | Duration of treatment was defined as days from index prescription order date to end of treatment, start of subsequent line of therapy, or death from any cause, whichever occurred first. Kaplan-Meier method adjusted by stabilized IPTW was used. | From start of study treatment to end of treatment, start of subsequent line of therapy, or death from any cause, whichever occurred first (up to 68 months) |
| Time to Next Line of Treatment | Time to next line of treatment represents the interval from commencement of one treatment to initiation of the next line of therapy. Analysis was performed using sIPTW method to balance participant characteristics among reporting groups. | From start of study treatment to start of next line of therapy (up to 68 months) |
| Time to Subsequent Chemotherapy | Time to subsequent chemotherapy represents the time interval to administration of a different chemotherapeutic agent after the first course of therapy was administered. Analysis was performed using sIPTW method to balance participant characteristics among reporting groups. | From start of study treatment to administration of different chemotherapeutic agent (up to 68 months) |
| Real-World Progression Free Survival 2 (rwPFS2) in Postmenopausal Female or in Male Participants With Metastatic Breast Cancer | rwPFS2 was defined as the time from the index date to the date of the first documentation of a rwPD or death due to any cause after starting second line of therapy, whichever occurs first. Disease progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that was the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Analysis was performed using sIPTW method to balance participant characteristics among reporting groups. | From start of study treatment until disease progression, or death from any cause following second line of therapy, whichever occurred first (approximately up to 68 months) |
| Layman RM, Liu X, Li B, McRoy L, Brufsky A. Real-world palbociclib dose modifications and clinical outcomes in patients with HR+/HER2- metastatic breast cancer: A Flatiron Health database analysis. Breast. 2025 Jun;81:104448. doi: 10.1016/j.breast.2025.104448. Epub 2025 Mar 17. |
| 39418346 | Derived | Brufsky A, Liu X, Li B, McRoy L, Chen C, Makari D, Layman RM, Rugo HS. Palbociclib plus aromatase inhibitors in patients with metastatic breast cancer and cardiovascular diseases: real-world effectiveness. Oncologist. 2024 Dec 6;29(12):1032-1043. doi: 10.1093/oncolo/oyae273. |
| 38517416 | Derived | Rugo HS, Liu X, Li B, McRoy L, Chen C, Layman RM, Tomlin-Harris T, Brufsky A. Prolonging the lives of African-Americans with metastatic breast cancer by adding palbociclib to an aromatase inhibitor in routine clinical practice: a plain language summary of a real-world database study. Future Oncol. 2024;20(19):1299-1307. doi: 10.2217/fon-2023-1079. Epub 2024 Mar 22. |
| 37487056 | Derived | Rugo HS, Liu X, Li B, McRoy L, Chen C, Layman RM, Brufsky A. Real-World Effectiveness of Palbociclib Plus Aromatase Inhibitors in African American Patients With Metastatic Breast Cancer. Oncologist. 2023 Oct 3;28(10):866-874. doi: 10.1093/oncolo/oyad209. |
| 36892508 | Derived | Rugo HS, Brufsky A, Liu X, Li B, McRoy L, Chen C, Layman RM, Cristofanilli M, Torres MA, Curigliano G, Finn RS, DeMichele A. Prolonging the life of people with metastatic breast cancer in routine clinical practice by adding palbociclib to an aromatase inhibitor from a real-world database analysis: a plain language summary. Future Oncol. 2023 Mar;19(7):489-498. doi: 10.2217/fon-2022-1192. Epub 2023 Mar 9. |
| 36220852 | Derived | Rugo HS, Brufsky A, Liu X, Li B, McRoy L, Chen C, Layman RM, Cristofanilli M, Torres MA, Curigliano G, Finn RS, DeMichele A. Real-world study of overall survival with palbociclib plus aromatase inhibitor in HR+/HER2- metastatic breast cancer. NPJ Breast Cancer. 2022 Oct 11;8(1):114. doi: 10.1038/s41523-022-00479-x. |
Participants with HR+/HER2- MBC who initiated first line treatment with aromatase inhibitor alone between 03 Feb 2015 to March 2020 were included and observed.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
Participants with HR+/HER2- MBC who initiated first line treatment with palbociclib + aromatase inhibitor between 03 Feb 2015 to 31 Mar 2020 were included and observed.
| OG001 | Aromatase Inhibitor | Participants with HR+/HER2- MBC who initiated first line treatment with aromatase inhibitor alone between 03 Feb 2015 to March 2020 were included and observed. |
|
|
|
| Secondary | Real-World Progression Free Survival (rwPFS) in Postmenopausal Female or in Male Participants With Metastatic Breast Cancer | Real-world PFS was defined as the number of months from start of palbociclib + AI or AI alone to death from any cause or disease progression (based on clinical assessment or by radiographic scan/tissue biopsy), whichever occurred first. Disease progression was defined as at least a 20 percentage (%) increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that was the smallest on study). Participants who did not die and did not have disease progression were censored at the date of initiation of next line of therapy for participants with 2 or more lines of therapy or at the date of their last visit during the study period (February 2015-September 2020) for participants with only 1 line of therapy. Kaplan-Meier method adjusted by stabilized IPTW was used. | FAS population comprised of all eligible participants enrolled in the study. Analysis was performed using sIPTW method to balance participant characteristics among reporting groups. sIPTW method created balanced virtual groups and hence overall number of participants analyzed was different from numbers in participant flow(not balanced). | Posted | Median | 95% Confidence Interval | Months | From index date until disease progression or death due to any cause or censoring date (approximately up to 68 months) |
|
|
|
|
| Secondary | Number of Participants According to Real-World Tumor Responses (rwTR): Postmenopausal Female or in Male Participants With Metastatic Breast Cancer | Real-world best responses were assessed based on treating clinician's assessment of radiological evidence for change in burden of disease over course of treatment after 1 month of index treatment initiation. Responses were classified as complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD), indeterminate response (IR). CR=Complete resolution of all visible disease. PR=partial reduction in size of visible disease in some or all areas without any areas of increase in visible disease. SD=no change in overall size of visible disease. PD: an increase in visible disease; also included cases where some lesions increased in size and some lesions decreased in size; included cases where clinician indicated progressive disease; IR=study data not available for evaluation of efficacy for any reason, including participants lost to follow-up or assessment not undertaken or death. Analysis was performed using sIPTW method to balance participant characteristics. | FAS population comprised of all eligible participants enrolled in the study. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure. | Posted | Count of Participants | Participants | From 30 days after index treatment initiation until CR, PR, SD or PD (approximately 67 months) |
|
|
|
| Secondary | Real-World Response Rate (rwTR) in Postmenopausal Female or in Male Participants With Metastatic Breast Cancer | Real-world tumor response rate (rwTR) was defined as the percentage of participants with a real world complete response (rwCR) or real-world partial response (rwPR). CR: complete resolution of all visible disease. PR: partial reduction in size of visible disease in some or all areas without any areas of increase in visible disease. Analysis was performed using sIPTW method to balance participant characteristics. | FAS population comprised of all eligible participants enrolled in the study. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure. | Posted | Number | Percentage of participants | From 30 days after index treatment initiation until disease progression or death due to any cause or censoring date (approximately up to 67 months) |
|
|
|
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| Secondary | Number of Participants According to Initial Dose of Palbociclib: Palbociclib + Aromatase Inhibitor Arm Only | Number of participants according to the initial dose of palbociclib (75 milligrams [mg]/day, 100mg/day, 125 mg/day or missing dose) are reported in this outcome measure. | FAS population comprised of all eligible participants enrolled in the study. | Posted | Count of Participants | Participants | At index (anytime between 03-Feb-2015 to 31-Mar-2020, approximately up to 62 months) |
|
|
|
| Secondary | Time to Dose Adjustment for Palbociclib- Palbociclib + Aromatase Inhibitor Arm Only | Time to dose adjustment for participants who received palbociclib 125 mg/day, 100 mg/day, or 75 mg/day as initial dose was presented in this outcome measure. | FAS population comprised of all eligible participants enrolled in the study. Here 'Overall Number of Participants Analyzed' signifies the total number of participants evaluable for this outcome measure. | Posted | Median | Inter-Quartile Range | Days | At index (anytime between 03-Feb-2015 to 30-Sep-2020, approximately up to 68 months) |
|
|
|
| Secondary | Duration of Treatment | Duration of treatment was defined as days from index prescription order date to end of treatment, start of subsequent line of therapy, or death from any cause, whichever occurred first. Kaplan-Meier method adjusted by stabilized IPTW was used. | FAS population comprised of all eligible participants enrolled in the study. sIPTW method created balanced virtual groups and hence overall number of participants analyzed was different from numbers in participant flow (not balanced). | Posted | Median | 95% Confidence Interval | Months | From start of study treatment to end of treatment, start of subsequent line of therapy, or death from any cause, whichever occurred first (up to 68 months) |
|
|
|
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| Secondary | Time to Next Line of Treatment | Time to next line of treatment represents the interval from commencement of one treatment to initiation of the next line of therapy. Analysis was performed using sIPTW method to balance participant characteristics among reporting groups. | FAS population comprised of all eligible participants enrolled in the study. sIPTW method created balanced virtual groups and hence overall number of participants analyzed was different from numbers in participant flow (not balanced). | Posted | Median | 95% Confidence Interval | Months | From start of study treatment to start of next line of therapy (up to 68 months) |
|
|
|
|
| Secondary | Time to Subsequent Chemotherapy | Time to subsequent chemotherapy represents the time interval to administration of a different chemotherapeutic agent after the first course of therapy was administered. Analysis was performed using sIPTW method to balance participant characteristics among reporting groups. | FAS population comprised of all eligible participants enrolled in the study. sIPTW method created balanced virtual groups and hence overall number of participants analyzed was different from numbers in participant flow (not balanced). | Posted | Median | 95% Confidence Interval | Months | From start of study treatment to administration of different chemotherapeutic agent (up to 68 months) |
|
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| Secondary | Real-World Progression Free Survival 2 (rwPFS2) in Postmenopausal Female or in Male Participants With Metastatic Breast Cancer | rwPFS2 was defined as the time from the index date to the date of the first documentation of a rwPD or death due to any cause after starting second line of therapy, whichever occurs first. Disease progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that was the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Analysis was performed using sIPTW method to balance participant characteristics among reporting groups. | FAS population comprised of all eligible participants enrolled in the study. sIPTW method created balanced virtual groups and hence overall number of participants analyzed was different from numbers in participant flow (not balanced). | Posted | Median | 95% Confidence Interval | Months | From start of study treatment until disease progression, or death from any cause following second line of therapy, whichever occurred first (approximately up to 68 months) |
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|
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| 420 |
| 1,324 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Aromatase Inhibitor | Participants with HR+/HER2- MBC who initiated first line treatment with aromatase inhibitor alone between 03 Feb 2015 to March 2020 were included and observed. | 736 | 1,564 | 0 | 0 | 0 | 0 |
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 |
| D020164 | Chemical Actions and Uses |
| D004965 | Estrogen Antagonists |
| D006727 | Hormone Antagonists |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D045505 | Physiological Effects of Drugs |
| Stable disease |
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| Progressive disease |
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| Indeterminate response |
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| Missing |
|
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| Initial dose of 75mg/day |
|
|