Biomarkers and Clinical Features of Metastatic Breast Cancer in Patients Treated With CDK4/6 Inhibitors

Официальное название

The Roswell Park Ciclib Study: A Prospective Study of Biomarkers and Clinical Features of Advanced/Metastatic Breast Cancer Treated With CDK4/6 Inhibitors

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое Cytology Specimen Collection Procedure
  Undergo collection of blood, tissue, ascites or pleural effusions, and fresh body fluids or fresh biopsy samples
• Другое Diagnostic Laboratory Biomarker Analysis
  Correlative studies
• Другое Medical Chart Review
  Patient's electronic health records are reviewed

Первичные конечные точки

• Collection of clinical characteristics [Срок оценки: Up to 5 years]
• Overall survival on ciclib [Срок оценки: Up to 15 years]
• Progression-free survival on ciclib [Срок оценки: Up to 15 years]
• Progression-free survival on subsequent therapies [Срок оценки: Up to 15 years]
• Site of the metastatic disease and time to progression [Срок оценки: Up to 5 years]
• Incidence of treatment related toxicities [Срок оценки: Up to 5 years]
• Genetic variance of genes associated with ciclib metabolism [Срок оценки: Up to 5 years]
• Quantitative biomarker expressions [Срок оценки: Up to 5 years]
• Development of patient-derived models from resistant disease [Срок оценки: Up to 5 years]
• Socio-economic features related to the use of ciclibs [Срок оценки: Up to 5 years]

Критерии участия

Критерии включения

• 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

Критерии исключения

• Pregnant of nursing female subjects
• Unwilling or unable to follow protocol requirements

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 1 центр

• Roswell Park Cancer Institute — Buffalo

Публикации

• O'Connor TN, Schultz E, Kabraji S, Levine E, Williams AJ, Knudsen ES, Witkiewicz AK. Real-World Plasma Thymidine Kinase Activity in High-Risk and Metastatic Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Breast Cancer Treated With Cyclin-Dependent Kinase 4/6 Inhibitors. JCO Precis Oncol. 2026 Jan;10:e2500346. doi: 10.1200/PO-25-00346. Epub 2026 Jan 23. PMID 41576303
• 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. PMID 40506447
• 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. PMID 37704753

Идентификаторы

NCT: NCT04526587 · I 571719 · NCI-2020-05682 · I 571719

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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