This study investigates the clinical course of CDK4/6 inhibitor treated patients in the real-world setting among patients with breast cancer. CDK4/6 inhibitors may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Studying samples of blood, tissue, ascites or pleural effusions, and fresh body fluids or fresh biopsy, from patients with breast cancer that has spread to the other places in the body (metastatic) may help doctors learn more about cancer and the development of drug resistance in patients, and predict how well patients will respond to treatment.
PRIMARY OBJECTIVES: I. Delineate clinical features of disease progression and responses to subsequent therapy following progression on ciclib-based therapy. II. Define pharmacogenomics relationships that could provide a more precise approach to drug dosing. III. Interrogate biomarkers related to response and acquired resistance in standard clinical practice. IV. Develop patient-derived models from resistant disease to functionally assess the mechanisms occurring with resistance. V. Elucidate the socio-demographic features related to the use of ciclibs clinically in the Roswell Park catchment area. OUTLINE: Patients electronic medical records are reviewed to capture clinical information, and patients undergo collection of blood, tissue, ascites or pleural effusions, and fresh body fluids or fresh biopsy samples for diagnosis/treatment decision, biomarker assessments, and description of mechanisms of resistance/response related to ciclib-therapy.
Study Type
OBSERVATIONAL
Enrollment
700
Undergo collection of blood, tissue, ascites or pleural effusions, and fresh body fluids or fresh biopsy samples
Correlative studies
Patient's electronic health records are reviewed
Roswell Park Cancer Institute
Buffalo, New York, United States
RECRUITINGCollection of clinical characteristics
Will be summarized by ciclib treatment regimen using the appropriate descriptive statistics. Differences will be evaluated using the Kruskal-Wallis and Chi-square tests, as appropriate.
Time frame: Up to 5 years
Overall survival on ciclib
Will be summarized by treatment regimen using standard Kaplan-Meier methods, with comparisons made using the log rank test. Cox regression models with time-dependent variables may be considered to account for changing treatment regimens and other patient characteristics.
Time frame: Up to 15 years
Progression-free survival on ciclib
Will be summarized by treatment regimen using standard Kaplan-Meier methods, with comparisons made using the log rank test. Cox regression models may be considered to adjust for prior therapies and other patient characteristics.
Time frame: Up to 15 years
Progression-free survival on subsequent therapies
Will be summarized by treatment regimen using standard Kaplan-Meier methods, with comparisons made using the logrank test. Cox regression models may be considered to adjust for prior therapies and other patient characteristics.
Time frame: Up to 15 years
Site of the metastatic disease and time to progression
Development of and location of metastatic disease will be summarized using the appropriate descriptive statistics.
Time frame: Up to 5 years
Incidence of treatment related toxicities
Will be summarized by ciclib treatment regimen using frequencies and relative frequencies. Comparisons may be made using Fisher's exact test. Associations between toxicity rates and patient demographic/clinical characteristics may be evaluated using logistic regression models.
Time frame: Up to 5 years
Genetic variance of genes associated with ciclib metabolism
Will be summarized in the overall sample and by treatment regimen using the appropriate descriptive statistics and graphical summaries. The association between these genetic features and toxicity and survival outcomes will be evaluated using stratified Cox regression models, where genotype will be the stratification factor. Additional models may be considered to account for other demographic or clinical characteristics. Hazard ratios with 95% confidence intervals will be obtained from model estimates.
Time frame: Up to 5 years
Quantitative biomarker expressions
Will be summarized in the overall sample and by treatment regimen using the appropriate descriptive statistics and graphical summaries. The association between baseline biomarkers and survival outcomes will be evaluated using stratified Cox regression models, where treatment regimen will be the stratification factor. Additional models may be considered to account for other demographic or clinical characteristics. Hazard ratios with 95% confidence intervals will be obtained from model estimates.
Time frame: Up to 5 years
Development of patient-derived models from resistant disease
Will be evaluated to functionally assess the mechanisms occurring with resistance. No formal statistical analyses will be performed in regards to the development of organoid and patient-derived xenograft (PDX) models.
Time frame: Up to 5 years
Socio-economic features related to the use of ciclibs
Will be elucidated clinically in the Roswell Park catchment area. Treatment regimens and sequences may be summarized by patient demographic and socio-economic characteristics using frequencies and relative frequencies. Associations may be evaluated using Chi-square tests.
Time frame: Up to 5 years
Clinical course of CDK4/6 inhibitor treated patients in the "real-world" setting
Will involve interrogating ciclib treatment patterns, treatment choices post progression, toxicities, clinical responses following progression, and ultimately differences in overall survival.
Time frame: Up to 5 years
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