Investigating biomarkers and clinical features in metastatic breast cancer patients treated with CDK4/6 inhibitors
The Roswell Park Ciclib Study: A Prospective Study of Biomarkers and Clinical Features of Advanced/Metastatic Breast Cancer Treated With CDK4/6 Inhibitors
This study is trying to learn more about how metastatic breast cancer patients respond to CDK4/6 inhibitors by looking at their medical records and collecting blood and tissue samples to understand the cancer better.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 700 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Roswell Park Cancer Institute Academic / other |
| Locations | 1 site (Buffalo, New York) |
| Trial ID | NCT04526587 on ClinicalTrials.gov |
What this trial studies
This observational study examines the clinical progression and treatment responses of patients with metastatic breast cancer who are treated with CDK4/6 inhibitors. It aims to collect and analyze various biological samples, including blood and tissue, to understand cancer behavior and drug resistance. The study will also explore pharmacogenomic relationships to optimize drug dosing and develop patient-derived models to assess resistance mechanisms. Data will be gathered from electronic medical records and through direct sample collection to inform clinical practice.
Who should consider this trial
Good fit: Ideal candidates include adult patients with ER+/HER2- metastatic breast cancer or high-risk early breast cancer who are currently being treated or have been treated with CDK4/6 inhibitors.
Not a fit: Patients who are pregnant or nursing, or those unwilling to comply with the study protocol, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of treatment responses and resistance in metastatic breast cancer, leading to more personalized and effective therapies.
How similar studies have performed: Other studies have shown promise in understanding drug resistance and treatment responses in similar patient populations, indicating that this approach is both relevant and potentially impactful.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * Pregnant of nursing female subjects * Unwilling or unable to follow protocol requirements
Where this trial is running
Buffalo, New York
- Roswell Park Cancer Institute — Buffalo, New York, United States (Recruiting)
Study contacts
- Principal investigator: Agnieszka K Witkiewicz — Roswell Park Cancer Institute
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.