Palbociclib Treatment Patterns and Outcomes in HR+/HER2- MBC: Flatiron Database Analysis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Pfizer
- Enrollment
- 1
- Locations
- 1
- Primary Endpoint
- Overall Survival (OS)
Study Overview
Brief Summary
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:
- HR+/HER2- MBC
- First treatment with Palbociclib, hormonal therapy, or other CDK4/6 inhibitors after MBC diagnosis The study will use data without personal identity, which were obtained from medical records in routine clinical practice.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Palbociclib + aromatase inhibitor (AI)
Oral palbociclib + AI combination treatment regimen as decided by physician
Intervention: Palbociclib (Drug)
Palbociclib + aromatase inhibitor (AI)
Oral palbociclib + AI combination treatment regimen as decided by physician
Intervention: Aromatase inhibitor (Drug)
Aromatase inhibitor (AI)
Oral AI treatment regimen as decided by physician
Intervention: Aromatase inhibitor (Drug)
Abemaciclib plus aromatase inhibitor (AI)
Oral abemaciclib plus AI treatment regimen as decided by physician
Intervention: Palbociclib (Drug)
Abemaciclib plus aromatase inhibitor (AI)
Oral abemaciclib plus AI treatment regimen as decided by physician
Intervention: Aromatase inhibitor (Drug)
Abemaciclib plus aromatase inhibitor (AI)
Oral abemaciclib plus AI treatment regimen as decided by physician
Intervention: Abemaciclib (Drug)
Ribociclib plus aromatase inhibitor (AI)
Oral ribociclib plus AI as decided by physician
Intervention: Aromatase inhibitor (Drug)
Ribociclib plus aromatase inhibitor (AI)
Oral ribociclib plus AI as decided by physician
Intervention: Ribociclib (Drug)
Outcomes
Primary Outcomes
Overall Survival (OS)
Time Frame: From start of index line of therapy to death, February 2015 - December 2022 or data cutoff
Secondary Outcomes
- Real Progression Free Survival (rwPFS)(From start of index line of therapy to death or disease progression, February 2015 - December 2022 or data cutoff)
- 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)
- 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)