Observational Study of CDK4/6 Inhibitors in Metastatic Breast Cancer
This study is looking at how patients with metastatic breast cancer (cancer that has spread) respond to treatments called CDK4/6 inhibitors (like ciclib) in real-world settings. Doctors want to understand how these medicines affect the growth of tumor cells by blocking certain enzymes. By studying samples of your blood, tissue, and other body fluids, researchers hope to learn more about how cancer develops resistance to treatment and predict how well patients will respond. You may be able to join if you are an adult with ER+/HER2- metastatic breast cancer or HR+/HER2- node-positive, high-risk early breast cancer, and are being or have been treated with ciclib-based therapies. The study will track how long you live and how long your cancer is controlled while on ciclib, for up to 15 years.
- Study design
- This is an observational study planning to enroll 700 participants. It involves reviewing medical records and collecting samples.
- What's involved
- You would provide samples of blood, tissue, ascites or pleural effusions, and fresh body fluids or fresh biopsy samples. Your electronic health records will also be reviewed.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study will track your overall survival and progression-free survival on ciclib for up to 15 years.
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Biomarkers and Clinical Features of Metastatic Breast Cancer in Patients Treated With CDK4/6 Inhibitors
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Agnieszka K Witkiewicz · PRINCIPAL_INVESTIGATOR · Roswell Park Cancer Institute
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Collection of clinical characteristicsUp 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.
- Overall survival on ciclibUp 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 ciclibUp 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.
- Progression-free survival on subsequent therapiesUp 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.
- Site of the metastatic disease and time to progressionUp to 5 years
Development of and location of metastatic disease will be summarized using the appropriate descriptive statistics.
- Incidence of treatment related toxicitiesUp 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.
- Genetic variance of genes associated with ciclib metabolismUp 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.
- Quantitative biomarker expressionsUp 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.
- Development of patient-derived models from resistant diseaseUp 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.
- Socio-economic features related to the use of ciclibsUp 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.
- Clinical course of CDK4/6 inhibitor treated patients in the "real-world" settingUp to 5 years
Will involve interrogating ciclib treatment patterns, treatment choices post progression, toxicities, clinical responses following progression, and ultimately differences in overall survival.