Clinical trial NCT06495164: A Real-life Study to Understand the Use and Effects of Palbociclib in US Patients With Breast Cancer
Official title: Palbociclib Treatment Patterns and Outcomes in HR+/HER2- MBC: Flatiron Database Analysis
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Breast Cancer
Malignant Neoplasm of Breast
Keywords: Metastatic breast cancer
CDK4/6 inhibitor
Real-world data
Retrospective observational study
Palbociclib
Overall survival
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2024-07-10
Enrollment: 5087
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Flatiron Health Database is a longitudinal, demographically, and geographically diverse dataset derived from EHR data from over 280 cancer clinics (\~800 sites of care) including more than 3.0 million active US cancer patients available for analysis. This study uses secondary de-identified Flatiron Health data that involve men and women who had been diagnosed with HR+/HER2-MBC in the United States.

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.


Eligibility 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.

Primary outcomes:
measure: Overall Survival (OS)
timeFrame: From start of index line of therapy to death, February 2015 - December 2022 or data cutoff
Secondary outcomes:
measure: Real Progression Free Survival (rwPFS)
timeFrame: From start of index line of therapy to death or disease progression, February 2015 - December 2022 or data cutoff
measure: Progression Free Survival 2
timeFrame: from start of index treatment to disease progression on the 2nd line of therapy or death, February 2015 - December 2022 or data cutoff
measure: Real-World Tumor Response (rwTR)
timeFrame: From start of index treatment to tumor response, February 2015 - December 2022 or data cutoff
measure: Duration of treatment
timeFrame: from index treatment initiation to end of the treatment, February 2015 - December 2022 or data cutoff
measure: Time to chemotherapy
timeFrame: from index treatment initiation to subsequent chemotherapy, February 2015 - December 2022 or data cutoff
Other outcomes:
measure: Early discontinuation
timeFrame: from index treatment initiation to discontinuation between February 2015 - December 2022 or data cutoff
measure: Dose adjustment
timeFrame: from index treatment initiation to initial dose change, February 2015 - December 2022 or data cutoff
Locations:
city: New York
country: United States
facility: Pfizer New York
state: New York
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: