Blood Glycan Biomarkers in Women With Stage IV Breast Cancer

Study Overview
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Brief Summary
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RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors learn more about changes that occur and identify biomarkers related to cancer. PURPOSE: This research study is looking at blood glycan biomarkers in women with stage IV breast cancer.

Detailed Description
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OBJECTIVES: To profile serum glycan biomarkers in women with metastatic stage IV breast cancer, healthy controls, and patients with noncancer medical illness. To determine whether serial serum glycan biomarkers correlate with response of metastatic disease to treatment. OUTLINE: This is a multicenter study. Blood is collected from patients with metastatic breast cancer, patients with noncancerous illness, and healthy volunteers. Samples are analyzed for serum glycan biomarkers by matrix-assisted laser desorption/ionization (MALDI) and Fourier transform ion-cyclotron resonance mass spectrometry (FT ICR MS) methods. Blood samples are collected every 3 months for up to 18 months from patients with metastatic breast cancer. Patients without cancer have a single sample collected.

Official Title
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Serum Glycan Analysis in Breast Cancer

Conditions
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Breast Cancer

Intervention / Treatment
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* Other: Healthy Controls
* Other: Metastatic Breast Cancer
* Other: Non-cancer medical illness


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Patient or participant at the Women's Health Clinic, the Internal Medicine Clinic, or at the UC Davis Cancer Center, meeting 1 of the following criteria: Diagnosis of stage IV metastatic breast cancer, receiving active treatment with chemotherapy, endocrine therapy, or targeted therapy Patients/participants without cancer Healthy control being seen for annual exams, meeting the following criteria: No chronic disease Not on regular prescribed medications Patient without cancer being seen in the Internal Medicine Clinic Hormone receptor status not specified PATIENT CHARACTERISTICS: Menopausal status not specified Not pregnant or breast feeding No other active cancer PRIOR CONCURRENT THERAPY: See Disease Characteristics

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Metastatic Breast Cancer<br>Patients with metastatic breast cancer receiving treatment with chemotherapy, endocrine therapy or targeted therapy | Other: Metastatic Breast Cancer<br>* Blood samples will be drawn every 3 months, for up to 18 months.<br>|
| Non-cancer medical illness<br>Patients with non-cancer medical condition | Other: Non-cancer medical illness<br>* One blood draw (2 teaspoons)<br>|
| Healthy Controls<br>Healthy patients being seen for an annual exam | Other: Healthy Controls<br>* One blood draw (2 teaspoons)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Profiling serum glycan biomarkers in patients with metastatic breast cancer, healthy controls, and patients with noncancer medical illness |  | up to 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Predictability of serial serum biomarkers in determining disease response and/or progression |  | Up to 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage IV breast cancer