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Primary carcinoma of the breast, the most common type of breast malignancy, usually begins as a neoplastic proliferation of epithelial cells lining the ducts or lobules of the breast.
Tests generally appear in the order most useful for common clinical situations
| Test name: Consultation, Surgical Pathology |
| ARUP #: |
| Methodology: |
| Use: Establish initial diagnosis of carcinoma |
| Test name: Estrogen/Progesterone Receptor Assay, Paraffin |
| ARUP #: 0049210 |
| Methodology: Immunohistochemistry |
| Use: Triage for anti-estrogen therapy For paraffin-embedded, formalin-fixed tissue Stained and resulted by ARUP |
| Test name: HER-2/neu Quantitative by ELISA |
| ARUP #: 2004672 |
| Methodology: Quantitative Enzyme-Linked Immunosorbent Assay |
| Use: Triage for trastuzumab therapy in metastatic breast cancer when solid tissue unavailable |
| Limitations: Positive results are reliable; however, this serum assay has a 30% false-negative rate |
| Test name: ERBB2 (HercepTest®) Tissue Assay, Paraffin |
| ARUP #: 0049174 |
| Methodology: Immunohistochemistry |
| Use: Triage for trastuzumab therapy (predictive indicator) Results graded 0-3 in a semi-quantitative manner Stained and resulted by ARUP |
| Limitations: FDA approved for formalin-fixed tissue only |
| Follow-up: If HER2+, order FISH testing to confirm gene amplification |
| Test name: ERBB2 (HER-2/neu) (4B5) Tissue Assay, Paraffin |
| ARUP #: 2002218 |
| Methodology: Immunohistochemistry |
| Use: Histologic prognostic and predictive indicator Results graded 0-3 in a semi-quantitative manner Stained and resulted by ARUP |
| Follow-up: If HER2+, order FISH testing to confirm gene amplification |
| Test name: ERBB2 (HER-2/neu) Gene Amplification by FISH |
| ARUP #: 0049218 |
| Methodology: Fluorescence in situ Hybridization |
| Use: Triage for trastuzumab therapy (predictive indicator, FDA approved) Confirm positive immunohistochemical result |
| Limitations: FDA approved for formalin-fixed tissue only |
| Test name: ERBB2 (HER-2/neu) Gene Amplification by CISH |
| ARUP #: 2002443 |
| Methodology: Chromogenic in situ Hybridization |
| Use: Determine response to trastuzumab therapy (FDA approved) Alternative to HER-2 FISH for quantitative determination of HER-2 gene amplification in formalin-fixed, paraffin-embedded tissue 95-100% result concordance between HER-2 FISH and HER-2 CISH |
| Test name: p53 Tissue Assay, Paraffin |
| ARUP #: 0049250 |
| Methodology: Immunohistochemistry |
| Use: Histologic prognosis of breast cancer Determine treatment method for node-negative breast cancer Stained and resulted by ARUP |
| Test name: Ki-67 Tissue Assay, Paraffin |
| ARUP #: 0049270 |
| Methodology: Immunohistochemistry |
| Use: Histologic prognostic indicator for node-negative breast cancer Stained and resulted by ARUP |
| Test name: DNA Content/Cell Cycle Analysis, Breast (Paraffin) |
| ARUP #: 0095735 |
| Methodology: Quantitative Flow Cytometry |
| Use: Prognostic indicator for node-negative breast cancer |
| Limitations: Tumor-specific S-phase used when possible Average histogram S-phase used:
|
| Test name: Circulating Tumor Cell Count (Cell Search™) |
| ARUP #: 0093399 |
| Methodology: Immunomagnetic Separation/Immunofluorescence Staining/Computer Assisted Analysis |
| Use: Monitor metastatic tumors in conjunction with clinical data and imaging Serially monitor disease progression and response to therapy; assess prognosis when compared to baseline values Prognostic marker for recurrent disease and overall survival |
| Limitations: Prognostic marker, do not use for diagnosis CTCs not detected for cells with
Results should be interpreted with caution if specimens drawn within 7 days of doxorubicin therapy |
| Test name: Breast Cancer Biomarkers Profile, Quantitative by PCR |
| ARUP #: 2005451 |
| Methodology: Reverse Transcription/Quantitative Polymerase Chain Reaction |
| Use: Order for qualitative and quantitative values for ESR1 (ER), PGR (PR), ERBB2 (HER2), and proliferation |
| Test name: NOT FOUND |
| ARUP #: 8209730 |
| Methodology: NOT FOUND |
| Use: Cytomorphologic screening for breast cancer cells and precursor lesions Risk assessment in women at high risk |
| Test name: Cytology, Breast Nipple Secretion |
| ARUP #: 8209700 |
| Methodology: Routine Cytopathologic Evaluation |
| Use: Cytomorphologic screening for breast cancer cells and precursor lesions Potential risk-assessment tool |
| Limitations: Known false negatives and false positives |
| Test name: Keratin 903 (K903) High Molecular Weight by Immunohistochemistry |
| ARUP #: 2003978 |
| Methodology: Immunohistochemistry |
| Use: Histologic diagnosis of adenocarcinomas of ductal origin in breast Stained and returned to client pathologist for interpretation; consultation available if required |
| Test name: E-Cadherin by Immunohistochemistry |
| ARUP #: 2003869 |
| Methodology: Immunohistochemistry |
| Use: Histologic diagnosis of breast cancer Stained and returned to client pathologist for interpretation; consultation available if required |
| Test name: Cytokeratin 8,18 Low Molecular Weight (CAM 5.2) by Immunohistochemistry |
| ARUP #: 2003493 |
| Methodology: Immunohistochemistry |
| Use: Histologic diagnosis of breast cancer Stained and returned to client pathologist for interpretation; consultation available if required |
| Test name: Cytochrome P450 2D6 (CYP2D6) 14 Mutations & Gene Duplication |
| ARUP #: 0051232 |
| Methodology: Polymerase Chain Reaction/Primer Extension |
| Use: Detect CYP2D6 mutations affecting tamoxifen metabolism; determine risk of impaired benefit from adjuvant tamoxifen therapy >95% clinical sensitivity in Caucasians; sensitivity unknown in other ethnicities |
| Limitations: Only the targeted CYP2D6 mutations will be detected Mutation detection is not a substitute for therapeutic drug monitoring |
| Test name: Cytochrome P450 2C19 (CYP2C19) 9 Mutations |
| ARUP #: 0051104 |
| Methodology: Polymerase Chain Reaction/Detection Primer Extension |
| Use: Detect CYP2C19 mutations affecting drug metabolism |
| Limitations: Only the targeted CYP2C19 mutations will be detected Mutation detection is not a substitute for therapeutic drug monitoring |
| Test name: PIK3CA Mutation Detection |
| ARUP #: 2004510 |
| Methodology: Polymerase Chain Reaction/Pyrosequencing |
| Use: |
| Test name: ERBB2 (HER-2/neu) (4B5) with Reflex to ERBB2 (HER-2/neu) Gene Amplification by FISH if 2+ |
| ARUP #: 2002217 |
| Methodology: Immunohistochemistry |
| Comments: |
| Test name: ERBB2 (HER-2/neu) (4B5) with Reflex to ERBB2 (HER-2/neu) Gene Amplification by FISH if 2+ or 3+ |
| ARUP #: 2002216 |
| Methodology: Immunohistochemistry |
| Comments: |
| Test name: ERBB2 (HercepTest®) with Reflex to ERBB2 (HER-2/neu) Gene Amplification by FISH if 2+ |
| ARUP #: 0049178 |
| Methodology: Immunohistochemistry |
| Comments: |
| Test name: ERBB2 (HercepTest®) with Reflex to ERBB2 (HER-2/neu) Gene Amplification by FISH if 2+ or 3+ |
| ARUP #: 0049172 |
| Methodology: Immunohistochemistry |
| Comments: |
| Test name: Cytology, Fine Needle Aspirate |
| ARUP #: 8209706 |
| Methodology: Routine Cytopathologic Evaluation |
| Comments: |
| Test name: IGH-BCL2 (BCL-2/JH) Translocation, t(14;18) by PCR, Tissue |
| ARUP #: 0055619 |
| Methodology: Polymerase Chain Reaction |
| Comments: Prognostic marker in some studies; recently less utilized Offered only in conjunction with consultation |
| Test name: Cancer Antigen-Breast (CA 15-3) |
| ARUP #: 0080464 |
| Methodology: Quantitative Electrochemiluminescent Immunoassay |
| Comments: May be used to monitor stage II-III breast cancer Use in conjunction with other clinical methods |
| Test name: Cancer Antigen 27.29 |
| ARUP #: 0080392 |
| Methodology: Quantitative Chemiluminescent Immunoassay |
| Comments: May be used to monitor patients treated previously for stage II-III breast cancer and who are clinically free of disease Use in conjunction with other clinical methods for early detection of recurrent disease May be used to monitor disease progress and response to therapy in patients with metastatic disease |
| Test name: Carcinoembryonic Antigen |
| ARUP #: 0080080 |
| Methodology: Quantitative Electrochemiluminescent Immunoassay |
| Comments: May be used to monitor stage II-III breast cancer Serial testing should be used in conjunction with other clinical methods |
| Test name: PAM50 Breast Cancer Intrinsic Classifier |
| ARUP #: 2004700 |
| Methodology: Reverse Transcription/Quantitative Polymerase Chain Reaction |
| Comments: |