What this study is
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.
What's being tested
- Cytology Specimen Collection Procedure
Intervention · OTHER
Undergo collection of blood, tissue, ascites or pleural effusions, and fresh body fluids or fresh biopsy samples
- Diagnostic Laboratory Biomarker Analysis
Intervention · OTHER
Correlative studies
- Medical Chart Review
Intervention · OTHER
Patient's electronic health records are reviewed
Study details
- Official title
- The Roswell Park Ciclib Study: A Prospective Study of Biomarkers and Clinical Features of Advanced/Metastatic Breast Cancer Treated With CDK4/6 Inhibitors
- Sponsor
- Roswell Park Cancer Institute
- Conditions
- Anatomic Stage IV Breast Cancer AJCC v8 · Metastatic Breast Carcinoma · Prognostic Stage IV Breast Cancer AJCC v8
- Enrolling
- 700 people
- Starts
- 2020-07-03
- Est. completion
- 2035-07-03
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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
You can't join if
- Pregnant of nursing female subjects
- Unwilling or unable to follow protocol requirements
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openRoswell Park Cancer Institute
Buffalo, New York, United States
- Agnieszka K. Witkiewicz · Contact716-845-1224Agnieszka.Witkiewicz@roswellpark.org
- Agnieszka K. Witkiewicz · Principal investigator
Recruiting
Study team
Sponsor
Roswell Park Cancer Institute
Study ID I 571719
Principal investigator
Agnieszka K Witkiewicz
Roswell Park Cancer Institute
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.