Real-World Effectiveness of Palbociclib in Combination With an Aromatase Inhibitor

Metastatic Breast Cancer Clinical Trial

Official title:

Real-World Treatment Effectiveness of Palbociclib in Combination With an Aromatase Inhibitor as 1st Line Therapy in Metastatic Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05361655
• Other study ID #: A5481151
• Status: Completed
• Start date: September 1, 2021
• Est. completion date: September 1, 2021

Study information

• Verified date: March 2023
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: September 1, 2021
• Est. primary completion date: September 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Metastatic Breast Cancer

Intervention

Drug:
• Palbociclib + an aromatase inhibitor
Palbociclib + an aromatase inhibitor therapy
• Aromatase inhibitor
Aromatase inhibitor therapy

Locations

Country	Name	City	State
United States	10017	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival	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	From date of index treatment until date of death from any cause or end of study, whichever came first, assessed up to 68 months
Secondary	Real-world progression free survival (rwPFS)	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	From date of index treatment to death, disease progression, or end of study, whichever came first, assessed up to 68 months
Secondary	Real-world tumor responses (rwTR)	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	From date of index treatment to death, disease progression, or end of study, whichever came first, assessed up to 68 months
Secondary	Initial dose of palbociclib	Describe initial dose of palbociclib treatment pattern	From date of index treatment up to 68 months
Secondary	Time to dose adjustment		From date of index treatment to dose adjustment, assessed up to 68 months
Secondary	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
Secondary	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
Secondary	Time to chemotherapy		From date of index treatment to subsequent chemotherapy, death, or end of study, whichever came first, assessed up to 68 months

External Links

•   To obtain contact information for a study center near you, click here.