Biomarkers and Clinical Features of Metastatic Breast Cancer in Patients Treated With CDK4/6 Inhibitors
NCT ID: NCT04526587
Last Updated: 2025-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
700 participants
OBSERVATIONAL
2020-07-03
2035-07-03
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Basic science (medical chart review, biospecimen collection)
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.
Cytology Specimen Collection Procedure
Undergo collection of blood, tissue, ascites or pleural effusions, and fresh body fluids or fresh biopsy samples
Diagnostic Laboratory Biomarker Analysis
Correlative studies
Medical Chart Review
Patient's electronic health records are reviewed
Interventions
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Cytology Specimen Collection Procedure
Undergo collection of blood, tissue, ascites or pleural effusions, and fresh body fluids or fresh biopsy samples
Diagnostic Laboratory Biomarker Analysis
Correlative studies
Medical Chart Review
Patient's electronic health records are reviewed
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Unwilling or unable to follow protocol requirements
18 Years
ALL
No
Sponsors
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Roswell Park Cancer Institute
OTHER
Responsible Party
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Principal Investigators
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Agnieszka K Witkiewicz
Role: PRINCIPAL_INVESTIGATOR
Roswell Park Cancer Institute
Locations
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Roswell Park Cancer Institute
Buffalo, New York, United States
Countries
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Facility Contacts
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Agnieszka K. Witkiewicz
Role: primary
References
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Tzetzo SL, Schultz E, Wang J, Rosenheck HR, Mahan S, Knudsen ES, Witkiewicz AK. Baseline cell cycle and immune profiles indicate CDK4/6 inhibitor response in metastatic HR + /HER2- breast cancer. NPJ Breast Cancer. 2025 Jun 12;11(1):54. doi: 10.1038/s41523-025-00767-2.
Witkiewicz AK, Schultz E, Wang J, Hamilton D, Levine E, O'Connor T, Knudsen ES. Determinants of response to CDK4/6 inhibitors in the real-world setting. NPJ Precis Oncol. 2023 Sep 13;7(1):90. doi: 10.1038/s41698-023-00438-0.
Other Identifiers
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NCI-2020-05682
Identifier Type: REGISTRY
Identifier Source: secondary_id
I 571719
Identifier Type: OTHER
Identifier Source: secondary_id
I 571719
Identifier Type: -
Identifier Source: org_study_id