Medical device diagnostic procedures are primarily used to clarify abnormal palpatory findings.
1st-order laboratory parameters-obligatory laboratory tests.
- Exfoliative cytology to detect Paget’s cells (evidential).
If genetic burden is suspected
- BRCA gene status (BRCA1, BRCA2, BRCA3/RAD51C gene).
* For women with a BRCA mutation, the risk of developing breast cancer – over the course of a lifetime – is circa 60 to 80 percent.The risk of developing ovarian cancer is circa 40 to 60 percent for BRCA1 mutation carriers and circa 10 to 30 percent for BRCA2 mutation carriers. Carriers of the BRCA3 mutation (RAD51C) also have a high risk of breast cancer of approximately 20 to 40 percent. 2nd-order laboratory parameters (for follow-up/therapy monitoring).
- Tumor markers: CA 15-3 (therapy and follow-up control of metastatic breast carcinoma; often indicates recurrences before they become clinically apparent), CEA, and HER-2.
- Tissue:
- HER2 protein (synonyms: Her2 protein; cerbB 2, Her 2/neu; HER-2; human epidermal growth factor receptor; human epidermal growth factor receptor-2/neuroblastoma).
- PAI-1 (plasminogen activator inhibitor 1) to assess prognosis in nodal-negative breast carcinoma; may also be used in meatstasis process* .
- UPA (urokinase activator) to assess the prognosis in nodal-negative breast carcinoma.
- In serum: HER2 protein for prognosis assessment in breast carcinoma or in the absence of tumor tissue status for HER2 protein expression.
- 17-Beta estradiol (E, estradiol) – Women with breast carcinoma recurrence had twice as high serum 17-beta estradiol levels than the comparison group without recurrence (22.7 versus 10.8 pg/ml
* During the course of breast carcinoma metastasis, there is a possibility of clonal selection of HER2 protein-positive cells, i.e.an initially HER2 protein-negative tumor may overexpress HER2 protein in its metastases (i.e. increased protein biosynthesis, which may lead to an increased concentration of this protein in the cell; this overexpression may be caused by defective gene regulation). Therefore, even if the HER2 protein status of the primary tumor is initially negative, serum analysis of HER2 protein is recommended in tissue examination during further follow-up.
