Breast Cancer
Conditions
Brief summary
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.
Interventions
PROCEDUREbone marrow aspiration /trephine biopsy
Sponsors
Acibadem University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients over 18 years old and who have given informed consent to enter the study. 2. ASA I-II patients 3. Patients who have not been diagnosed as breast cancer or received any type of treatment regarding breast cancer before the time of study 4. Patients who are appropriate for bone marrow biopsy 5. Menopausal status is not relevant.
Exclusion criteria
1. Active collagen tissue disorders 2. Patients who are diagnosed having breast cancer and received any type of treatment regarding breast cancer before the time of study 3. Pregnancy 4. Patients with bleeding disorders, who are receiving antiaggregant or anticoagulant medication. 5. Patients who refused to enter the study protocol and refused to give informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of bone marrow metastases in triple negative early stage breast cancer | 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 | — |
| Rate of bone marrow metastases in early stage breast cancer | up to 5 years | Number of patients with bone marrow metastases/ total number of enrolled patients |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of axillary recurrence in patients with negative sentinel lymph node biopsy | Up to 10 years |
| Overall survival | up to 10 years |
Other
| Measure | Time frame |
|---|---|
| Disease free survival | up to 10 years |
Countries
Turkey (Türkiye)
Outcome results
None listed