Prospective Breast Cancer Biospecimen Collection

Study Overview
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Brief Summary
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Tissue will be procured during a standard of care procedure the patient will already be scheduled to undergo. A one time blood draw will be performed at this time and an optional rectal swab for biome analysis may occur. Follow Up will only consist of chart review to determine date of recurrence, metastases, and/or death

Official Title
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Prospective Breast Cancer Biospecimen Collection

Conditions
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Breast Cancer, Invasive Breast Cancer, Carcinoma in Situ of the Breast

Intervention / Treatment
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* Procedure: Tissue Sample collection
* Other: Blood Sample Collection
* Other: Rectal Swab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults >18 years old at time of consent Subject must be capable to giving informed consent or have an acceptable surrogate capable of giving consent on the subject behalf. Patients with carcinoma in situ or invasive breast cancer Patient must be undergoing one of the following: definitive surgical tumor resection for breast cancer OR placement of a vascular access device as a prelude to neoadjuvant therapy for breast cancer OR neurosurgical resection of a brain metastasis from primary breast cancer. Exclusion Criteria: <18 years old Not able to give informed consent and does not have acceptable surrogate capable to giving informed consent. Active drug/alcohol dependence or abuse history

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Standard of Care<br>patients will have tissue procured after a standard of care procedure, a one time blood draw performed, and optional rectal swab | Procedure: Tissue Sample collection<br>* Tissue sample collected following standard of care procedure patient was already scheduled to have<br>Other: Blood Sample Collection<br>* A one time sample of blood will be collected on day of standard of care procedure<br>Other: Rectal Swab<br>* optional rectal swab may be collected on day of standard of care procedure<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumor biomarker identification | Collected biospecimens will be analyzed using current laboratory techniques to identify the presence of breast cancer biomarkers such as estrogen receptor (ER) and human epidermal growth factor receptor 2 (HER2). | Up to 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Laboratory-based breast cancer tumor genomic profile | Genomic profile will be based on laboratory analysis of the collected tumor tissue biospecimens to identify how genes interact with the tumor and its environment. | Up to 5 years |