Effect of Neoadjuvant or Adjuvant Systemic Therapy on Breast Cancers, Bone Marrow Cancer Cells, and Circulating Cancer Cells

Study Overview
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Brief Summary
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The main purpose of this study is to compare genetic markers present on tumor cells before and after chemotherapy.

Detailed Description
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In this study, the investigators propose that persistent disseminated tumor cells (DTC) present after systemic therapy represent a unique subpopulation of all DTC, are predictors of a poor response to systemic therapy and correlate with poor clinical outcome. The investigators hypothesize that systemic therapy-resistant DTC can be identified by their expression of a unique constellation of tumor marker proteins which may be similar to those expressed by breast cancer stem cells. In this research, the investigators' specific aims are : 1) to characterize tumor markers expressed by DTC which are present after systemic therapy, 2) to compare the expression of these markers to that on DTC detected prior to systemic therapy, 3) to correlate expression of the defined tumor markers on DTC with clinical outcome of breast cancer patients to identify those markers that are predictive of disease recurrence, 4) to utilize biomarkers identified in Specific Aims 1 and 2 to isolate purified DTC for further molecular analysis.

Official Title
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Effect of Neoadjuvant or Adjuvant Systemic Therapy on Breast Cancers, Bone Marrow Cancer Cells, and Circulating Cancer Cells

Conditions
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Breast Neoplasms

Intervention / Treatment
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* Procedure: Peripheral blood draw
* Procedure: Breast tissue collection
* Procedure: Bone marrow biopsy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Recently diagnosed with clinical stage II, III, or IV breast cancer Planning to undergo neoadjuvant or adjuvant systemic therapy; patients who have already completed neoadjuvant systemic therapy are also eligible Must be >= 18 years of age If female, must not be pregnant Must not have Hepatitis B, C, or HIV Must be willing and able to sign informed consent document

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Tissue, blood, and bone marrow (optional) collection<br>Undergo neoadjuvant systemic therapy initial surgery for sentinel lymph node biopsy/portacath placement definitive cancer surgery (if applicable) when portacath is removed (1 year, if available) if metastatic disease develops or is present in accessible sites, a sample may be collected at the time of specimen collection for diagnosis Undergo Adjuvant Systemic Therapy initial surgery for a sentinel lymph node biopsy/portacath placement when portacath is removed (1 year, if available) If metastatic disease develops or is present in accessible sites, a sample may be collected at the time of specimen collection for diagnosis. Undergone neoadjuvant systemic therapy during definitive cancer surgery/portacath removal (if available) if metastatic disease develops or is present in accessible sites, a sample may be collected at the time of specimen collection for diagnosis | Procedure: Peripheral blood draw<br> <br> Procedure: Breast tissue collection<br> <br> Procedure: Bone marrow biopsy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Characterize tumor markers expressed by DTC which are present after systemic therapy |  | Approximately 6 years | 
| Compare the expression of these markers to that on DTC detected prior to systemic therapy |  | Approximately 6 years | 
| Correlate expression of the defined tumor markers on DTC with clinical outcome of breast cancer patients to identify those markers that are predictive of disease recurrence. |  | Approximately 6 years | 
| Compare the tumor markers present on DTC before and after chemotherapy with the tumor marker expression of the primary tumor and post-treatment tumor. |  | Approximately 6 years. | 
| To xenograft tumor cells into mice for further genetic and phenotypic characterization. |  | Approximately 6 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast Cancer, Neoadjuvant