Biomarkers and Clinical Features of Metastatic Breast Cancer in Patients Treated With CDK4/6 Inhibitors
- Conditions
- Metastatic Breast CarcinomaPrognostic Stage IV Breast Cancer AJCC v8Anatomic Stage IV Breast Cancer AJCC v8
- Interventions
- Other: Cytology Specimen Collection ProcedureOther: Diagnostic Laboratory Biomarker AnalysisOther: Medical Chart Review
- Registration Number
- NCT04526587
- Lead Sponsor
- Roswell Park Cancer Institute
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 400
-
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Basic science (medical chart review, biospecimen collection) Cytology Specimen Collection Procedure 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. Basic science (medical chart review, biospecimen collection) Diagnostic Laboratory Biomarker Analysis 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. Basic science (medical chart review, biospecimen collection) Medical Chart Review 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.
- Primary Outcome Measures
Name Time Method Collection of clinical characteristics Up to 5 years 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.
Site of the metastatic disease and time to progression Up to 5 years Development of and location of metastatic disease will be summarized using the appropriate descriptive statistics.
Overall survival on ciclib Up to 15 years 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 Up to 15 years 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.
Development of patient-derived models from resistant disease Up to 5 years 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.
Progression-free survival on subsequent therapies Up to 15 years 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.
Quantitative biomarker expressions Up to 5 years 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.
Incidence of treatment related toxicities Up to 5 years 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.
Socio-economic features related to the use of ciclibs Up to 5 years 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.
Genetic variance of genes associated with ciclib metabolism Up to 5 years 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.
Clinical course of CDK4/6 inhibitor treated patients in the "real-world" setting Up to 5 years Will involve interrogating ciclib treatment patterns, treatment choices post progression, toxicities, clinical responses following progression, and ultimately differences in overall survival.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Roswell Park Cancer Institute
🇺🇸Buffalo, New York, United States