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| ID | Type | Description | Link |
|---|---|---|---|
| NCT06495164 | Registry Identifier | ClinicalTrials.gov |
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Palbociclib, the first oral CDK4/6 inhibitor, is an approved medicine indicated for the treatment of a kind of advanced/metastatic breast cancer (MBC), called hormone receptors positive (HR+)/ Human epidermal growth factor receptor 2 negative (HER2-) disease. Palbociclib is given orally in combination with hormonal therapies.
The purpose of this study is to better understand how Palbociclib combination is used in real-life conditions and its clinical impact compared with hormonal therapy. The study will also evaluate how long patients take the different CDK 4/6 inhibitor drugs and whether using those drugs impacts the use of chemotherapy later.
Male and female patients aged 18 years old or more presenting the following conditions will be selected for the study:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Palbociclib + aromatase inhibitor (AI) | Oral palbociclib + AI combination treatment regimen as decided by physician |
| |
| Aromatase inhibitor (AI) | Oral AI treatment regimen as decided by physician |
| |
| Abemaciclib plus aromatase inhibitor (AI) | Oral abemaciclib plus AI treatment regimen as decided by physician |
| |
| Ribociclib plus aromatase inhibitor (AI) | Oral ribociclib plus AI as decided by physician |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Palbociclib | Drug | CDK4/6 inhibitor |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | From start of index line of therapy to death, February 2015 - December 2022 or data cutoff |
| Measure | Description | Time Frame |
|---|---|---|
| Real Progression Free Survival (rwPFS) | From start of index line of therapy to death or disease progression, February 2015 - December 2022 or data cutoff | |
| Progression Free Survival 2 | from start of index treatment to disease progression on the 2nd line of therapy or death, February 2015 - December 2022 or data cutoff |
| Measure | Description | Time Frame |
|---|---|---|
| Early discontinuation | from index treatment initiation to discontinuation between February 2015 - December 2022 or data cutoff | |
| Dose adjustment | from index treatment initiation to initial dose change, February 2015 - December 2022 or data cutoff |
Patients are eligible for the study if they were 18 years of age or older at MBC diagnosis, had HR+/HER2- confirmed and initiated first line therapy (CDK4/6i, ET, CT, or other) in the metastatic setting during the period from February 2015 through June 2022 or data cutoff.
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Flatiron Health Database is a longitudinal, demographically, and geographically diverse dataset derived from EHR data from over 280 cancer clinics (~800 sites of care) including more than 3.0 million active US cancer patients available for analysis. This study uses secondary de-identified Flatiron Health data that involve men and women who had been diagnosed with HR+/HER2-MBC in the United States.
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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 |
|---|---|---|---|
| 42324670 | Derived | Rugo HS, Layman RM, Lynce F, Liu X, Li B, McRoy L, Cohen AB, Estevez M, Curigliano G, Brufsky A. Comparison of survival outcomes for people with HR+/HER2- metastatic breast cancer who received palbociclib, ribociclib, or abemaciclib with an aromatase inhibitor: a plain language summary. Future Oncol. 2026 Jun 21:1-11. doi: 10.1080/14796694.2026.2674970. Online ahead of print. | |
| 42095602 |
| 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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| 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 |
| D000077289 | Letrozole |
| D000077384 | Anastrozole |
| C056516 | exemestane |
| C000589651 | ribociclib |
| C000590451 | abemaciclib |
| 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 |
|
|
| Ribociclib | Drug | CDK4/6 inhibitor |
|
|
| Abemaciclib | Drug | CDK4/6 inhibitor |
|
|
| Real-World Tumor Response (rwTR) | From start of index treatment to tumor response, February 2015 - December 2022 or data cutoff |
| Duration of treatment | from index treatment initiation to end of the treatment, February 2015 - December 2022 or data cutoff |
| Time to chemotherapy | from index treatment initiation to subsequent chemotherapy, February 2015 - December 2022 or data cutoff |
| Derived |
| Brufsky A, Layman RM, Liu X, Li B, McRoy L, Cohen A, Estevez M, Cottu P, Thill M, Curigliano G, Rugo HS. Real-world treatment durations, subsequent treatments, and switching of CDK4/6 inhibitors among patients with HR+/HER2- metastatic breast cancer. Oncologist. 2026 May 8;31(6):oyag182. doi: 10.1093/oncolo/oyag182. |
| 41950642 | Derived | Rugo HS, Brufsky A, Layman RM, Liu X, Li B, McRoy L, Cohen AB, Estevez M, Lynce F, Cottu P, Thill M, Curigliano G. Real-world progression-free survival 2 (PFS2) and tumor response of CDK4/6 inhibitors plus an aromatase inhibitor in patients with HR+/HER2- metastatic breast cancer in US routine clinical practice. Breast. 2026 Jun;87:104780. doi: 10.1016/j.breast.2026.104780. Epub 2026 Mar 30. |
| 41830752 | Derived | Brufsky A, Layman RM, Liu X, Li B, McRoy L, Cohen AB, Estevez M, Cottu P, Curigliano G, Rugo HS. Real-world effectiveness of palbociclib in combination with an aromatase inhibitor in HR+/HER2- bone-only metastatic breast cancer. Breast. 2026 Apr;86:104744. doi: 10.1016/j.breast.2026.104744. Epub 2026 Feb 24. |
| 40691446 | Derived | Lynce F, Liu X, Li B, McRoy L, Chen C, Liu R, Rugo HS. Real-world effectiveness of palbociclib plus an aromatase inhibitor in HR+/HER2- MBC patients living in disadvantaged neighborhoods. NPJ Breast Cancer. 2025 Jul 21;11(1):75. doi: 10.1038/s41523-025-00786-z. |
| 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 |
| D009570 | Nitriles |
| D009930 | Organic Chemicals |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |