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This is a retrospective, observational study that will document the treatment and monitoring patterns and clinical outcomes of patients diagnosed with HR+/HER2- a/mBC who received Palbociclib combination therapy with aromatase inhibitors or fulvestrant in the a/mBC community oncology setting.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Breast cancer patients | HR+/HER2- advanced/metastatic breast cancer patients in the USA. |
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| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients receiving various cancer treatment regimens | A/MBC diagnosis through end of study (assessed up to 24 months) | |
| Proportion of patients receiving each therapy sequence across lines | A/MBC diagnosis through end of study (assessed up to 24 months) | |
| Treatment persistence | A/MBC diagnosis through end of study (assessed up to 24 months) | |
| Progression Free Survival (PFS) | A/MBC diagnosis through end of study (assessed up to 24 months) | |
| Overall Survival (OS) | A/MBC diagnosis through end of study (assessed up to 24 months) | |
| Tumor response rate | A/MBC diagnosis through end of study (assessed up to 24 months) | |
| Proportion of patients that experience dose adjustment | A/MBC diagnosis through end of study (assessed up to 24 months) | |
| Proportion of patients who discontinue therapy | A/MBC diagnosis through end of study (assessed up to 24 months) |
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Inclusion Criteria:
Patients who are represented in the Vector Oncology Data Warehouse who meet all of the following criteria will be eligible for inclusion in the study.
Exclusion Criteria:
-There are no exclusion criteria for this study.
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The study will include adult patients aged 18 years and older, diagnosed with HR+/HER2- a/mBC who received Palbociclib combination therapy with AI or fulvestrant on or after 2/3/2015.
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer United States | New York | New York | 10017 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39810652 | Derived | Robert N, Chen C, Doan J, Venkatasetty D, Espirito JL, Aguilar KM. Real-world study of patients with HR+/ HER2- metastatic breast cancer treated with palbociclib and fulvestrant. Future Oncol. 2025 Jan;21(1):83-94. doi: 10.1080/14796694.2024.2442302. Epub 2025 Jan 15. |
| 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 |
| D017437 | Skin and Connective Tissue Diseases |
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