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

Study Results

Results pending

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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Recruitment Status

RECRUITING

Total Enrollment

700 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-07-03

Study Completion Date

2035-07-03

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Anatomic Stage IV Breast Cancer AJCC v8 Metastatic Breast Carcinoma Prognostic Stage IV Breast Cancer AJCC v8

Study Design

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Observational Model Type

COHORT

Study Time Perspective

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

Intervention Type OTHER

Undergo collection of blood, tissue, ascites or pleural effusions, and fresh body fluids or fresh biopsy samples

Diagnostic Laboratory Biomarker Analysis

Intervention Type OTHER

Correlative studies

Medical Chart Review

Intervention Type OTHER

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

Intervention Type OTHER

Diagnostic Laboratory Biomarker Analysis

Correlative studies

Intervention Type OTHER

Medical Chart Review

Patient's electronic health records are reviewed

Intervention Type OTHER

Other Intervention Names

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Cytologic Sampling Chart Review

Eligibility Criteria

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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