A Study of Effect of Megakaryocytes and Platelets in Breast Cancer

Study Overview
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Brief Summary
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Determining if Megakaryocytes and Platelets are Harmful or Helpful in Breast Cancer Cell Metastasis

Detailed Description
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The purpose of this study is to determine how megakaryocytes (cells in the bone marrow responsible for making platelets, which are necessary for blood clotting) affect the survival and growth/division patterns of breast cancer stem cells, and the effects of breast cancer cells on megakaryocyte survival and function. Through chart review, the study team will look at the relationship between different blood components and different breast cancer diagnoses.

Official Title
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Megakaryocytes and Platelets, Harmful or Helpful in Breast Cancer Cell Metastasis

Conditions
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Breast Cancer

Intervention / Treatment
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* Other: Blood draw


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Cohort 1-Biopsy negative -Females age 18 and above Cohort 2-Biopsy positive for carcinoma in situ (ductal, lobular, or other) Females age 18 and above Any subtype of breast cancer Cohort 3-Biopsy positive for Stage 1, 2, or 3 invasive carcinoma (ductal, lobular, or other) Females age 18 and above Any subtype of breast cancer Have no distant metastases Cohort 4-Stage 4 Metastatic Disease Females age 18 and above Any subtype of breast cancer Exclusion Criteria: Cohort 1-Biopsy negative Males Females less than age 18 Cohort 2-Biopsy positive for carcinoma in situ (ductal, lobular, or other) Males Females less than age 18 Currently undergoing neoadjuvant therapy Cohort 3-Biopsy positive for Stage 1, 2, or 3 invasive carcinoma (ductal, lobular, or other) Males Females less than age 18 Presence of distant metastases Currently undergoing neoadjuvant therapy Cohort 4-Stage 4 Metastatic Disease Males Females less than age 18 Currently undergoing neoadjuvant therapy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Biopsy Negative<br>Female age 18 and above with negative breast biopsy | Other: Blood draw<br>* 10-12mL of blood will be drawn one time, unless a redraw is needed, in which case up to 24 mL will be drawn (10-12 mL each draw)<br>|
| Biopsy positive for carcinoma in situ (ductal, lobular, or other)<br>Females age 18 and above with any subtype of breast cancer (ductal, lobular, or other) | Other: Blood draw<br>* 10-12mL of blood will be drawn one time, unless a redraw is needed, in which case up to 24 mL will be drawn (10-12 mL each draw)<br>|
| Biopsy positive for Stage 1, 2, or 3 invasive carcinoma (ductal, lobular, or other)<br>Females age 18 and above with any subtype of breast cancer (HER2+, ER/PR, TNBC, BRCA1 +/-, other). | Other: Blood draw<br>* 10-12mL of blood will be drawn one time, unless a redraw is needed, in which case up to 24 mL will be drawn (10-12 mL each draw)<br>|
| Metastatic Stage IV<br>Females age 18 and above with any subtype of breast cancer, including metastases | Other: Blood draw<br>* 10-12mL of blood will be drawn one time, unless a redraw is needed, in which case up to 24 mL will be drawn (10-12 mL each draw)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Platelet Counts | Measure of the number of platelets in the blood, reported as platelets per microliter of blood. | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Corpuscular Volume (MCV) | Measures the average size of red blood cells, reported as femtoliters (fl). | Baseline | 
| Lymphocyte to neutrophil ratio | Ratio between the neutrophil and lymphocyte counts measured in peripheral blood. | Baseline | 
| Levels of tumor educated platelets | Number of tumor educated platelets, measured by the analysis of cell surface markers for expression of certain markers such as VEGF, PDGFR, MMP1, TGFb, and or other cell adhesion molecules. | Baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Megakaryocytes, Platelets