Breast Cancer Predictive Markers (Online Course)

Author: Joelle Weaver MAOM, HTL(ASCP), QIHC
Reviewer: Donna Hedger, BS, HT(ASCP)

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Continuing Education Credits


  • Recognize the value of predictive test results to clinical treatment decisions in human breast cancer.
  • Identify the main types of predictive testing performed in the histology laboratory.
  • Determine test methodologies used to identify the expression and amplification of human epidermal growth receptor 2 (HER2).
  • Examine current test methodologies used to identify the expression and amplification of HER2.
  • Identify compliance standards for validation, correlation, and proficiency testing under the guidelines set by the College of American Pathologists (CAP).

Course Outline

  • Introduction
      • Predictive Testing is the Basis of Personalized Treatment
      • Predictive versus Prognostic
      • Response Rates to Common Therapies
      • Patient Benefit from Targeted Treatment Plans
      • A prognostic factor is information concerning the patient that is used to help the clinician select the appropriate individuals for treatment with a s...
      • Researchers have determined that only patients with tumors that demonstrate greater than 70% estrogen receptor (ER) positive cells will respond to hor...
  • Types of Breast Cancer
      • Incidence and Risk Factors
      • Breast Cancer Classification
      • Tumor Staging
      • Use of Immunohistochemistry (IHC) for Breast Tumor Classification
      • Adenocarcinoma is a very rare type of human breast cancer.
      • Obesity, alcohol, and tobacco use are believed to have no impact on the risk for developing breast cancer.
  • Theoretical Basis of Immunohistochemical Testing
      • Basics of Immunohistochemistry (IHC)
      • Variables Affecting Immunohistochemistry (IHC)
      • Types of Antibodies
      • Staining Patterns
      • Which factors may impact staining by IHC techniques? (Select all that apply.)
      • IHC alone is used to determine a primary diagnosis.
  • Hormone Receptor Testing
      • Introduction to Estrogen Receptors and Progesterone Receptors
      • Hormonal Factors in Breast Cancer
      • Clinical Application of Estrogen Receptor (ER) and Progesterone Receptor (PR) Testing
      • Use of Immunohistochemistry (IHC) for Determining Estrogen Receptor (ER) and Progesterone Receptor (PR) Status
      • Scoring and Reporting of Estrogen Receptor (ER) and Progesterone Receptor (PR) Testing
      • Response Rates to Targeted Therapy
      • The pattern for ER staining by IHC is localized within which part of the cell?
      • There are no specific guidelines concerning how ER and PR results are scored or reported.
  • Human Epidermal Growth Factor Receptor 2 (HER2)
      • Introduction to Human Epidermal Growth Factor Receptor 2 (HER2)
      • Immunohistochemistry (IHC) Testing Options For HER2
      • Complimentary Testing Helps Assess HER2 Status
      • Targeted Treatment Based on HER2 Status
      • Impact of Variation in Test Results
      • 2013 IHC Scoring Criteria from the American Society of Clinical Oncologists (ASCO) and the College of American Pathologists (CAP)
      • HER2 over-expression in breast cancer is localized to chromosome 17.
      • Only patients who over-express HER2 (eg, positive scores by IHC, CISH, or FISH) are candidates to receive Herceptin® (trastuzumab) treatment.
  • HER2 Testing by In Situ Hybridization
      • Introduction
      • Specimen Handling and Fixation for Molecular and In Situ Methods
      • Introduction to HER2 Methods Using In Situ Hybridization (ISH)
      • Introduction to Fluorescent In Situ Hybridization (FISH) Methods
      • Fluorescence
      • Details of Fluorescent In Situ Hybridization (FISH)
      • Chromogenic In Situ Hybridization (CISH) Method for HER2
      • HER2 Test Method: Advantages and Disadvantages
      • CISH and FISH Scoring Criteria from the 2013 American Society of Clinical Oncologists (ASCO) and College of American Pathologists (CAP) Guideline Reco...
      • Using chromogenic in situ hybridization (CISH), a single copy of HER2 amplification appears under the light microscope as which of the following?
      • What is the most commonly used, rapid, and cost effective method to assess HER2 status in clinical histology?
  • Regulation and Compliance with Predictive Markers
      • Validation, Quality Control, Regulations -- Why?
      • Regulation
      • Validation Purpose
      • Compliance Documentation
      • Mandatory Proficiency Testing
      • Comparison of 2007 to 2013 ASCO-CAP Guidelines for HER2 Testing
      • Laboratories which are accredited by the College of American Pathologists (CAP) who perform HER2 testing are not required to participate in proficienc...
      • Validation is required for all new test systems used in the laboratory prior to their use in patient testing.
  • References
      • References

Additional Information

Level of instruction: Intermediate

Intended audience: This course is intended for histology bench technicians and technologists, supervisors, and administrators.

Author information: Joelle Weaver MAOM, HTL(ASCP), QIHC is a certified histotechnologist with a broad range of practical histology experience within the clinical histopathology setting. She has received qualification in immunohistochemistry from the American Society for Clinical Pathology and Green Belt certification from Purdue University, West Lafayette, Indiana. Joelle's bachelor's degree was received from Bowling Green State University in Bowling Green, Ohio and her Master's Degree was awarded from Bluffton University in Bluffton, Ohio. She is a graduate of a NAACLS accredited histotechnology program, where she also served as a lead instructor, education coordinator, and program director. Joelle is currently an adjunct instructor in the Histotechnology Program with Harcum College in Bryn Mawr, PA. 

Reviewer information: Donna M. Hedger, BS, HT(ASCP) is the Pathology Manager at Gwinnett Hospital System in Lawrenceville, Georgia. She graduated from Georgia Southern University with a Bachelor of Science in Biology. She is a certified histotechnician.

Course description: Toxicity, side effects, and unpredictable effectiveness have been the hallmark of anti-cancer therapies used in the past to treat breast and other primary cancers. Targeted therapies have been developed which reduce patient risk and provide remarkable improvement in patient outcomes. This course will discuss how predictive markers/testing are used to select patients who are most likely to respond positively to a specific breast cancer treatment, including current testing methodologies and compliance standards.

Metastatic breast cancer

Female white tech uses microscope (computer in background)

DAB (brown) chromogen localized to cell membrane in HER2 stain using clone CB11. Counterstain is hematoxylin.

Adenovirus infected liver demonstrated with mouse IgG1 monoclonal antibody cocktail of clones 2/6 and 20/11. DAB chromogen.

HER2/<i>neu</i> gene FISH

3+ HER2 breast cancer detected with the Dako HercepTest. Image courtesy of Jim Burchette.