Bone Marrow Micrometastases in Patients With Early Stage Breast Cancer

Study Overview
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Brief Summary
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Operable early stage breast cancer patients staged according to NCCN guidelines are subjected to bone marrow aspiration/trephine biopsy at the time of the definitive operation under general anesthesia. The specimen will be fixated in neutral tamponaded formalin and the sections will be examined by H&E and cytokeratin immunohistochemically. If disseminated tumor cells are identified ER (estrogen receptor), PR (progesterone receptor), HER2/neu will be studied. Disseminated tumor cells will be recorded quantitively and semiquantitatively. Results of the pilot study will be evaluated as observational study.

Official Title
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Bone Marrow Micrometastases in Patients With Early Stage Breast Cancer

Conditions
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Breast Cancer

Intervention / Treatment
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* Procedure: bone marrow aspiration /trephine biopsy


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Patients over 18 years old and who have given informed consent to enter the study. ASA I-II patients Patients who have not been diagnosed as breast cancer or received any type of treatment regarding breast cancer before the time of study Patients who are appropriate for bone marrow biopsy Menopausal status is not relevant. Exclusion criteria: Active collagen tissue disorders Patients who are diagnosed having breast cancer and received any type of treatment regarding breast cancer before the time of study Pregnancy Patients with bleeding disorders, who are receiving antiaggregant or anticoagulant medication. Patients who refused to enter the study protocol and refused to give informed consent.

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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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: all<br>All patients with early breast cancer | Procedure: bone marrow aspiration /trephine biopsy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of bone marrow metastases in early stage breast cancer | Number of patients with bone marrow metastases/ total number of enrolled patients | up to 5 years | 
| Rate of sentinel lymph node metastases in early stage breast cancer |  | up to 5 years | 
| Rate of sentinel lymph node metastases in patients with bone marrow metastasis operated for early stage breast cancer |  | up to 5 years | 
| Incidence of bone marrow metastasis in HER-2 positive early stage breast cancer |  | up to 5 years | 
| Incidence of bone marrow metastases in triple negative early stage breast cancer |  | up to 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of axillary recurrence in patients with negative sentinel lymph node biopsy |  | Up to 10 years | 
| Overall survival |  | up to 10 years |