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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
1,000
Acibadem University School of Medicine
Istanbul, Turkey (Türkiye)
RECRUITINGRate of bone marrow metastases in early stage breast cancer
Number of patients with bone marrow metastases/ total number of enrolled patients
Time frame: up to 5 years
Rate of sentinel lymph node metastases in early stage breast cancer
Time frame: up to 5 years
Rate of sentinel lymph node metastases in patients with bone marrow metastasis operated for early stage breast cancer
Time frame: up to 5 years
Incidence of bone marrow metastasis in HER-2 positive early stage breast cancer
Time frame: up to 5 years
Incidence of bone marrow metastases in triple negative early stage breast cancer
Time frame: up to 5 years
Incidence of axillary recurrence in patients with negative sentinel lymph node biopsy
Time frame: Up to 10 years
Overall survival
Time frame: up to 10 years
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