Breast Cancer Survivorship Biorepository

Study Overview
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Brief Summary
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This study collects blood samples as well as clinical and self-report data from stage I-III breast cancer survivors to create a biorepository for future use. The creation of this biorepository will allow for future research into links between individual, molecular, and genomic signatures and cancer outcomes.

Detailed Description
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PRIMARY OBJECTIVE: I. To create an annotated biorepository with prospectively collected blood samples from breast cancer survivors. SECONDARY OBJECTIVES: I. To collect comprehensive data on social determinants of health (e.g., race/ethnicity, acculturation, socioeconomic status, and access to care), environmental exposures (based on zip codes/geocoding), lifestyle (e.g., diet, tobacco use), clinicopathologic characteristics, treatment history, follow-up and current disease status, survivorship-related issues. II. To establish an efficient process for researchers to utilize the biorepository for breast cancer and survivorship-related studies. OUTLINE: Patients complete surveys, undergo collection of blood samples, and review of medical records on study.

Official Title
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A Comprehensive Breast Cancer Survivorship Biorepository

Conditions
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Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8, Invasive Breast Carcinoma

Intervention / Treatment
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* Procedure: Biospecimen Collection
* Other: Electronic Health Record Review
* Other: Quality-of-Life Assessment
* Other: Survey Administration


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women of all racial and ethnic groups 18 years of age or older Women with a diagnosis of invasive breast cancer (stages I-III) within the past 7 years Women who have completed active treatment for breast cancer (surgery, chemotherapy, HER2-directed therapy and radiation) Prior participation on clinical trials is allowed Exclusion Criteria: Current receipt of interventional clinical trial participation Stage IV (metastatic) cancer Prior history of recurrence (except recurrence following ductal carcinoma in situ) Inability to give informed consent Unable to speak English, Spanish, Chinese, or Korean

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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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Observational (survey, biospecimen collection, record review)<br>Patients complete surveys, undergo collection of blood samples, and review of medical records on study. | Procedure: Biospecimen Collection<br>* Undergo collection of blood samples<br>* Other names: Specimen Collection;Other: Electronic Health Record Review<br>* Review of records<br>Other: Quality-of-Life Assessment<br>* Complete quality-of-life questionnaires<br>* Other names: Quality of Life Assessment;Other: Survey Administration<br>* Complete surveys<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biorepository | Number of biological samples collected and stored (blood) | 5 years |