A Real-life Study to Understand the Use and Effects of Palbociclib in US Patients With Breast Cancer
- Conditions
- Breast CancerMalignant Neoplasm of Breast
- Interventions
- Registration Number
- NCT06495164
- Lead Sponsor
- Pfizer
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 5087
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Abemaciclib plus aromatase inhibitor (AI) Aromatase inhibitor Oral abemaciclib plus AI treatment regimen as decided by physician Ribociclib plus aromatase inhibitor (AI) Aromatase inhibitor Oral ribociclib plus AI as decided by physician Aromatase inhibitor (AI) Aromatase inhibitor Oral AI treatment regimen as decided by physician Palbociclib + aromatase inhibitor (AI) Aromatase inhibitor Oral palbociclib + AI combination treatment regimen as decided by physician Palbociclib + aromatase inhibitor (AI) Palbociclib Oral palbociclib + AI combination treatment regimen as decided by physician Abemaciclib plus aromatase inhibitor (AI) Palbociclib Oral abemaciclib plus AI treatment regimen as decided by physician Abemaciclib plus aromatase inhibitor (AI) Abemaciclib Oral abemaciclib plus AI treatment regimen as decided by physician Ribociclib plus aromatase inhibitor (AI) Ribociclib Oral ribociclib plus AI as decided by physician
- Primary Outcome Measures
Name Time Method Overall Survival (OS) From start of index line of therapy to death, February 2015 - December 2022 or data cutoff
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Pfizer New York
🇺🇸New York, New York, United States