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IHC Panels with reporting Breast-III ER, PR, c-erb-B2, Ki 67

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Tumor immunohistochemistry panels.

₹9,028₹12,897

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IHC Panels with reporting Breast-III ER PR c-erb-B2 Ki 67

  • Why is it done?
    • This immunohistochemistry (IHC) panel detects and quantifies protein expression in breast cancer tissue, specifically measuring four key biomarkers that are critical for breast cancer prognosis and treatment planning.
    • The test is performed on breast cancer tissue samples obtained via biopsy or surgical resection to determine hormone receptor status and HER2 gene amplification.
    • Ordered to guide therapeutic decisions including hormone therapy, HER2-targeted therapy, and chemotherapy selection.
    • Performed routinely on all newly diagnosed invasive breast cancers to establish molecular subtype classification.
    • Used to assess proliferation rate (Ki-67) for prognostic stratification and treatment intensity determination.
  • Normal Range
    • Estrogen Receptor (ER): Negative (<1% nuclear staining) or Positive (≥1% nuclear staining). Values ≥1% are considered positive and indicate hormone responsiveness.
    • Progesterone Receptor (PR): Negative (<1% nuclear staining) or Positive (≥1% nuclear staining). Similar interpretation to ER with ≥1% considered positive.
    • HER2/c-erb-B2: Scored 0-3+ by IHC (0 = negative, 1+ = weak positive, 2+ = equivocal, 3+ = positive). Scores of 2+ typically require reflex to FISH/CISH for confirmation.
    • Ki-67 Proliferation Index: Percentage of nuclei staining positive for Ki-67. Low (<14%), Intermediate (14-30%), High (>30%). Higher percentages indicate more aggressive tumors.
    • Normal/benign breast tissue: ER positive, PR positive, HER2 negative or 0-1+, Ki-67 low (<14%).
  • Interpretation
    • Luminal A Breast Cancer: ER+, PR+, HER2-, Ki-67 low. Most common subtype (60-70% of cases). Generally has better prognosis and responds to endocrine therapy.
    • Luminal B Breast Cancer: ER+, HER2+/- with high Ki-67 or PR-negative. More aggressive than Luminal A. May require chemotherapy plus endocrine therapy or HER2-targeted agents.
    • HER2-Enriched Breast Cancer: ER-, PR-, HER2 3+ or 2+ with FISH confirmation. Represents 15-20% of cases. Requires HER2-targeted therapy (trastuzumab, pertuzumab) plus chemotherapy.
    • Triple-Negative Breast Cancer (TNBC): ER-, PR-, HER2-. Represents 10-15% of cases. Most aggressive subtype with poorer prognosis. Treated with chemotherapy; immunotherapy increasingly used for early-stage disease.
    • Ki-67 Proliferation Assessment: Low Ki-67 (<14%) indicates slower growth and better prognosis. High Ki-67 (>30%) indicates rapid proliferation, aggressive behavior, and poorer prognosis. Influences chemotherapy recommendations.
    • HER2 2+ Equivocal Cases: Reflex testing to fluorescence in situ hybridization (FISH) or chromogenic in situ hybridization (CISH) is necessary to determine true HER2 amplification status for treatment planning.
    • Factors Affecting Results: Tissue fixation time, processing methods, antigen retrieval techniques, antibody quality, and tumor heterogeneity can influence staining intensity and interpretation.
  • Associated Organs
    • Primary Organ System: Mammary gland (breast tissue). This test specifically analyzes breast epithelial cancer cells.
    • Breast Cancer Diagnosis: Invasive ductal carcinoma (IDC), invasive lobular carcinoma (ILC), and other histological variants of breast cancer.
    • Metastatic Disease Sites: Bone, lung, liver, brain, and lymph nodes. ER/PR status may change in metastatic disease, requiring repeat testing of metastatic lesions.
    • Endocrine System Involvement: ER+ and PR+ cancers are hormone-dependent and responsive to estrogen and progesterone. May involve hypothalamic-pituitary-ovarian axis in premenopausal women.
    • Associated Complications: Local recurrence, distant metastasis, bone marrow infiltration, cardiac toxicity from HER2-targeted therapy, endocrine resistance, and treatment-related complications.
    • Cardiac Considerations: HER2+ cancers treated with trastuzumab may cause cardiotoxicity; baseline and periodic cardiac assessment required.
    • Lymph Node Involvement: Sentinel lymph nodes and regional lymph nodes may harbor metastatic disease; IHC panels help confirm diagnosis in involved nodes.
  • Follow-up Tests
    • Reflex Molecular Testing: FISH or CISH (chromogenic in situ hybridization) for HER2 2+ equivocal cases; gene amplification studies for triple-negative cancers (BRCA1/2 status, PDL1 expression).
    • Genetic Testing: BRCA1/2 mutation testing particularly for triple-negative or early-onset cancers; PTEN loss assessment; tumor sequencing (somatic mutations).
    • Prognostic Assays: Oncotype DX, Mammaprint, Prosigna (PAM50), EndoPredict for additional risk stratification and treatment planning recommendations.
    • Imaging Studies: Staging imaging: CT chest/abdomen/pelvis, bone scan, PET-CT for metastatic disease workup; baseline cardiac echo or MUGA scan for HER2+ patients.
    • Blood Biomarker Tests: Carcinoembryonic antigen (CEA), cancer antigen 15-3 (CA 15-3), circulating tumor cells (CTC) for monitoring response and detecting recurrence.
    • Monitoring Frequency: Baseline testing at diagnosis; repeat testing if metastatic disease suspected (receptor status may change); ongoing surveillance per oncology protocols (typically 3-6 month intervals initially, then annually).
    • Repeat IHC Testing: Recommended if metastatic lesions are biopsied, as receptor status may convert in 10-20% of metastatic cases requiring therapeutic modification.
    • Pathology Review: Secondary histological review may be warranted for diagnostic confirmation or discordant results.
  • Fasting Required?
    • Fasting Required: No fasting is required for IHC panel analysis.
    • Specimen Collection: This test is performed on fixed tissue (formalin-fixed paraffin-embedded; FFPE) obtained from breast biopsy or surgical resection, not on blood.
    • Patient Preparation: For biopsy procedures, standard pre-procedure guidelines apply (local anesthesia requirements, sterile technique). If surgical resection, general anesthesia and standard surgical preparation required.
    • Tissue Handling: Tissue must be promptly fixed in 10% neutral buffered formalin, minimum 6-8 hours. Adequate fixation is critical for optimal antigen preservation and staining quality.
    • Medications: No medications need to be withheld specifically for tissue IHC analysis. Anticoagulants may need adjustment if biopsy is planned; consult with interventional radiologist or surgeon.
    • Timing: Turnaround time is typically 5-7 business days from receipt of tissue, though stat processing can achieve results in 24-48 hours if clinically urgent.

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