Breast Cancer, Malignant Neoplasm of Breast
Conditions
Keywords
Metastatic breast cancer, CDK4/6 inhibitor, Real-world data, Retrospective observational study, Palbociclib, Overall survival
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.
Interventions
DRUGPalbociclib
CDK4/6 inhibitor
DRUGAromatase inhibitor
Aromatase inhibitor
DRUGRibociclib
CDK4/6 inhibitor
DRUGAbemaciclib
CDK4/6 inhibitor
Sponsors
Pfizer
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients are eligible for the study if they were 18 years of age or older at MBC diagnosis, had HR+/HER2- confirmed and initiated first line therapy (CDK4/6i, ET, CT, or other) in the metastatic setting during the period from February 2015 through June 2022 or data cutoff.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Survival (OS) | From start of index line of therapy to death, February 2015 - December 2022 or data cutoff |
Secondary
| Measure | Time frame |
|---|---|
| Real Progression Free Survival (rwPFS) | From start of index line of therapy to death or disease progression, 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 |
| 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 |
Other
| Measure | Time frame |
|---|---|
| Early discontinuation | from index treatment initiation to discontinuation between February 2015 - December 2022 or data cutoff |
| Dose adjustment | from index treatment initiation to initial dose change, February 2015 - December 2022 or data cutoff |
Countries
United States
Outcome results
None listed