Real-World Effectiveness of Palbociclib in Combination With an Aromatase Inhibitor
Study Details
Study Description
Brief Summary
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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. |
Drug: Palbociclib + an aromatase inhibitor
Palbociclib + an aromatase inhibitor therapy
|
| 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. |
Drug: Aromatase inhibitor
Aromatase inhibitor therapy
|
Outcome Measures
Primary Outcome Measures
- Overall survival [From date of index treatment until date of death from any cause or end of study, whichever came first, assessed up to 68 months]
Median time (months) from date of index treatment to date of death. Patients who did not die in the study period are censored at their last date in the study
Secondary Outcome Measures
- Real-world progression free survival (rwPFS) [From date of index treatment to death, disease progression, or end of study, whichever came first, assessed up to 68 months]
rwPFS2 is the number of months from start of palbociclib + AI or AI alone to disease progression (based on clinical assessment or by radiographic scan/tissue biopsy) on the 2nd line of therapy or death from any cause, whichever occurred first
- Real-world tumor responses (rwTR) [From date of index treatment to death, disease progression, or end of study, whichever came first, assessed up to 68 months]
Real-world best responses are assessed based on treating clinician's assessment of radiological evidence for change in burden of disease over the course of treatment after 1 month of index treatment initiation
- Initial dose of palbociclib [From date of index treatment up to 68 months]
Describe initial dose of palbociclib treatment pattern
- Time to dose adjustment [From date of index treatment to dose adjustment, assessed up to 68 months]
- Duration of treatment [From date of index treatment to end of the treatment, death, or end of study, whichever came first, assessed up to 68 months]
- Time to subsequent treatments [From date of index treatment to subsequent treatment, death, or end of study, whichever came first, assessed up to 68 months]
- Time to chemotherapy [From date of index treatment to subsequent chemotherapy, death, or end of study, whichever came first, assessed up to 68 months]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Confirmed HR+/HER2- status after MBC diagnosis.
-
Received palbociclib + AI or AI as first-line therapy
Exclusion Criteria:
-
Evidence of prior treatment with other CDK4/6I, AI, tamoxifen, raloxifene, toremifene, or Fulvestrant for MBC
-
First structured activity greater than 90 days after MBC diagnostic date
-
Treatment with a CDK4/6 inhibitor as part of a clinical trial
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | 10017 | New York | New York | United States | 10017 |
Sponsors and Collaborators
- Pfizer
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- A5481151