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.
All adult patients with ER+/HER2- metastatic breast cancer or HR+/HER2-node positive, high risk early breast cancer who are being or have been treated with ciclib-based therapies are eligible for inclusion in this study
This includes patients receiving standard of care therapy for ER+/HER2- metastatic breast cancer, as well as those who would be eligible to participate in a non-interventional study while on a clinical study open at Roswell Park or St. Vincent's Hospital
Screening will occur in breast oncology clinic, by review of patient medical records for the pending, ongoing, or past treatment with ciclib-based therapy
Participant must understand the prospective nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form
Pregnant of nursing female subjects
Unwilling or unable to follow protocol requirements
Patients with estrogen receptor positive (ER+)/HER2 negative (-) metastatic breast cancer, who are being or have been treated with ciclib-based therapies
Cohort
Prospective
Cytology Specimen Collection Procedure
Other interventionUndergo collection of blood, tissue, ascites or pleural effusions, and fresh body fluids or fresh biopsy samples
Diagnostic Laboratory Biomarker Analysis
Other interventionCorrelative studies
Medical Chart Review
Other interventionPatient's electronic health records are reviewed
Collection 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.
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.
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.
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.
Examination of biomarkers of response
Will examine biomarkers of response/resistance and association with long term outcomes relative to pretreatment controls.
Single-nucleotide polymorphisms
Blood will be collected to interrogate single-nucleotide polymorphisms in CYP3A4 and related genes associated with metabolism of ciclib compounds. These polymorphisms will be related to dose limiting toxicities and dose interruptions. Blood samples for pharmacokinetic and pharmacogenomic analysis will be drawn during regular laboratory blood draws.
Circulating cell free DNA (cfDNA)
Serial peripheral blood samples will be prospectively collected at specified time points and processed for cfDNA and circulating tumor cells (CTC) isolation. CTCs will be utilized for the development of 3-dimensional (3D) organoid cultures and CTC-derived xenograft models.
Development of functional models (patient-derived models) from individuals with progressive disease
Will only employ tissues and /or body fluids that are being discarded or do not involve any additional procedures for the patients. This includes, excess tissue that is not required for diagnosis or pleural effusions or peritoneal ascites. Cells isolated from the samples will be used for the development of organoid or PDX models.
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