Accreditation/Credit Designation

Physicians' Education Resource®, LLC, is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.

Physicians' Education Resource®, LLC, designates this enduring material for a maximum of 1.5 AMA PRA Category 1 Credit™. Physicians should claim only the credit commensurate with the extent of their participation in the activity

Acknowledgement of Commercial Support

This activity is supported by educational grants from AstraZeneca and Novartis Pharmaceuticals Corporation.

Medical Crossfire®: Establishing the Role of Predictive Biomarkers and Testing Strategies for Breast Cancer Management

Release Date: August 31, 2017
Expiration Date: August 31, 2018
Media: Internet - based


Activity Overview

With improved understanding of genotypic and phenotypic methods to characterize breast cancer, clinicians have an ever-increasing ability to personalize care and individualize treatment strategies. There are several biomarkers that have been established as essential to guide the treatment of patients with breast cancer, including the estrogen and progesterone hormonal receptors, as well as HER2. In addition, BRCA mutations assist decision making concerning the potential application of PARP inhibitors for these patients. Clinical trials have also identified other biomarkers of interest, and the search for further prognostic markers and driver mutations is ongoing. It is critical for clinicians to maintain their knowledge and competence concerning the use of biomarkers and tumor testing strategies to optimize outcomes for their patients with these tumors. This Medical Crossfire® activity has been developed to provide clinicians with updates on the latest information regarding biomarkers that may shape treatment selection for their patients. Our panel of experts will discuss and debate key topics, using a balance of didactic presentation and informative interactive discussion.


Acknowledgement of Commercial Support

This activity is supported by educational grants from AstraZeneca and Novartis Pharmaceuticals Corporation.

Requirements for Successful Completion

  • You will need to login to participate in the activity.
  • Each presentation may contain an interactive question(s). You may move forward through the presentation; however, you may not go back to change answers or review videos/content until you finish the presentation.
  • At the end of the activity, “educational content/video” will be available for your reference.
  • In order to receive a CME certificate, participants must complete the activity.
  • Complete the posttest and pass with a score of 70% or higher, complete the evaluation and then click on request for credit. Participants may immediately download a CME certificate upon completion of these steps.

Target Audience

This educational activity is directed toward medical oncologists, gynecologic oncologists, and fellows who treat patients with breast cancer. Nurse practitioners, nurses, physician assistants, pharmacists, researchers, and other healthcare professionals interested in the treatment of breast cancer are also invited to participate.

Learning Objectives

At the conclusion of this activity, you should be better prepared to:

  • Evaluate current and evolving biomarkers, as well as testing methods by which these can be identified, in the setting of breast cancer
  • Examine clinical trials that have utilized biomarkers and molecular approaches in patients with breast cancer
  • Apply evidence concerning prognostic and predictive markers to inform treatment decisions in multiple lines of care for patients with breast cancer

Faculty, Staff, and Planners' Disclosures


William J. Gradishar, MD, FASCO, FACP
Betsy Bramsen Professor of Breast Oncology
Interim Chief, Division of Hematology/Oncology
Robert H. Lurie Comprehensive Cancer Center of the Feinberg School of Medicine
Northwestern University
Chicago, IL

Disclosure: No relevant financial relationships with commercial interests.


Aditya Bardia, MD, MPH
Director of Precision Medicine, Center for Breast Oncology
Attending Physician, Massachusetts General Hospital
Assistant Professor, Harvard Medical School
Boston, MA

Disclosure: Consultant: Novartis, Pfizer, Spectrum

Baljit Singh, MD
Director of Pathology
White Plains Hospital
White Plains, NY

Disclosure: Speaker’s Bureau: Genomic Health Inc.

Tiffany A. Traina, MD
Clinical Director, Breast Medicine Service
Section Head, TNBC Clinical Research Program
Associate Attending, Memorial Sloan Kettering Cancer Center
Assistant Professor, Weill Cornell College of Medicine
New York, NY

Disclosure: Grant/Research Support: Medivation, Eisai, Pfizer, Novartis, Myriad Genetics, Innocrin Pharmaceuticals, AstraZeneca. Consultant: Genentech, Eisai, Halozyme, Mundipharma, Medivation, Pfizer, AstraZeneca, Bayer, Research to Practice, Immunomedics, Merck, Puma, Astellas

The staff of Physicians' Education Resource®, LLC have no relevant financial relationships with commercial interests to disclose.

Disclosure Policy and Resolution of Conflicts of Interest (COI)

As a sponsor accredited by the ACCME, it is the policy of PER® to ensure fair balance, independence, objectivity, and scientific rigor in all of its CME activities. In compliance with ACCME guidelines, PER® requires everyone who is in a position to control the content of a CME activity to disclose all relevant financial relationships with commercial interests. The ACCME defines “relevant financial relationships” as financial relationships in any amount occurring within the past 12 months that creates a COI.

Additionally, PER® is required by ACCME to resolve all COI. PER® has identified and resolved all COI prior to the start of this activity by using a multistep process.

Off-Label Disclosure and Disclaimer

This CME activity may or may not discuss investigational, unapproved, or off-label use of drugs. Participants are advised to consult prescribing information for any products discussed. The information provided in this CME activity is for continuing education purposes only, and is not meant to substitute for the independent medical judgment of a physician or nurse relative to diagnostic, treatment, or management options for a specific patient's medical condition.

The opinions expressed in the content are solely those of the individual faculty members and do not reflect those of PER® or any of the companies that provided commercial support for this activity.

PER Pulse™ Recap

PER Pulse™ Recap (1 of 3)

Overview of Tumor Molecular Profiling in Breast Cancer

This first of 3 PER Pulse™ Recaps focuses on the evolution of the molecular assessment of breast cancer, beginning with ASCO-CAP guideline recommendations. Preanalytic, analytic, and postanalytic variables may all be sources of variability, and these guidelines help to optimize assessment, including guidance regarding the appropriate handling of tissue specimens.1,2 Specific parameters and algorithms regarding immunohistochemistry assessment of estrogen receptor [ER], progesterone receptor [PR], and HER2 are also provided in these guidelines, which may help to inform decisions, particularly in the case of equivocal reporting. All breast tumors should receive this testing, including metastatic tumors.

Molecular assessment continues to evolve with the inclusion of biomarkers in the American Joint Committee on Cancer 8th edition guidance on breast cancer evaluation. The evidence to support the inclusion of biomarkers has come from multiple studies, including a study of 3327 patients with breast cancer from The University of Texas MD Anderson Cancer Center,3 as well as an analysis performed by Dr David Winchester of 238,265 women diagnosed with invasive breast cancer in the National Cancer Database.4 The new prognostic group staging assessment incorporates traditional TNM factors as well as expanded nonanatomic factors such as tumor grade, HER2 status, ER status, and PR status.5 This new system and results from prognostic studies such as TAILORx may help to personalize breast cancer staging and prognosis.5,6

For additional commentary about these topics and others, visit to access more resources.


  1. Wolff AC, Hammond ME, Schwartz JN, et al. American Society of Clinical Oncology/College of American Pathologists guideline recommendations for human epidermal growth factor receptor 2 testing in breast cancer. J Clin Oncol. 2007;25(1):118-145.
  2. Wolff AC, Hammond ME, Hicks DG, et al. Recommendations for human epidermal growth factor receptor 2 testing in breast cancer: American Society of Clinical Oncology/College of American Pathologists clinical practice guideline update. J Clin Oncol. 2013;31(31):3997-4013. doi: 10.1200/JCO.2013.50.9984.
  3. Mittendorf EA, Chavez-MacGregor M, Vila J, et al. Bioscore: a staging system for breast cancer patients that reflects the prognostic significance of underlying tumor biology. Ann Surg Oncol. 2017 Jul 9. doi: 10.1245/s10434-017-6009-x.
  4. Giuliano AE, Connolly JL, Edge SB, et al. Breast cancer – major changes in the American Joint Committee on Cancer eighth edition cancer staging manual. CA Cancer J Clin. 2017;67(4):290-303. doi: 10.3322/caac.21393.
  5. Amin MB, Greene FL, Edge SB, et al. The eighth edition AJCC cancer staging manual: continuing to build a bridge from a population-based to a more “personalized“ approach to cancer staging. CA Cancer J Clin. 2017;67(2):93-99. doi: 10.3322/caac.21388.
  6. Sparano JA, Gray RJ, Makower DF, et al. Prospective validation of a 21-gene expression assay in breast cancer. N Engl J Med. 2015;373(21):2005-2014. doi: 10.1056/NEJMoa1510764.

PER Pulse™ Recap (2 of 3)

Personalizing Care by Integrating Advances in Biomarkers

This second of 3 PER Pulse™ Recaps focuses on the potential for integration of biomarker assessment in clinical practice. Determination of the presence of actionable biomarkers is a key component of establishing personalized care; not all tumors have mutations, and not all mutations have a targeted therapy.1 Clinical decision making may be guided by germline and tumor genomic profiles. Two key areas where biomarkers have been studied are triple-negative breast cancer, where BRCA mutations have been studied, as well as estrogen receptor [ER]-positive breast cancer, where a variety of somatic mutations have been studied.2,3

PARP inhibitor therapy is a key class of treatment that has been shown to be influenced by BRCA mutation status in trials of patients with ovarian cancer. Although PARP inhibitor therapy has not yet been approved in breast cancer, recent studies have examined the efficacy of PARP inhibitors in patients with germline BRCA mutations. In the recent OlympiAD study, patients with HER2-negative breast cancer treated with prior anthracycline/taxane treatment and a deleterious or suspected germline BRCA mutation were randomized to olaparib or standard chemotherapy.2 Patients in the olaparib arm had a greater median PFS (7.0 versus 4.2 months), with a hazard ratio for disease progression/death of 0.58.2

In patients with ER-positive breast cancer, endocrine therapy alone or in combinations with CDK4/6 inhibitor therapy is often used.4 A variety of somatic tests, including the implications of ESR1 mutations on treatment efficacy, have been studied in this patient population.3 Genomic profiling may help to guide sequencing decisions for these and other patients.3

For additional commentary about these topics and others, visit to access more resources.


  1. Shah SP, Roth A, Goya R, et al. The clonal and mutational evolution spectrum of primary triple-negative breast cancers. Nature. 2012;486(7403):395-399. doi: 10.1038/nature10933.
  2. Robson M, Im SA, Senkus E, et al. Olaparib for metastatic breast cancer in patients with a germline BRCA mutation. N Engl J Med. 2017;377(6):523-533. doi: 10.1056/NEJMoa1706450.
  3. Fribbens C, O’Leary B, Kilburn L, et al. Plasma ESR1 mutations and the treatment of estrogen receptor-positive advanced breast cancer. J Clin Oncol. 2016;34(25):2961-2968. doi: 10.1200/JCO.2016.67.3061.
  4. NCCN Clinical Practice Guidelines in Oncology – Breast Cancer. Version 2.2017.

PER Pulse™ Recap (3 of 3)

Tumor Testing Strategies: Current and Future Roles

This third of 3 PER Pulse™ Recaps focuses on the current state of tumor-testing strategies and recent advancements that may shape clinical practice for patients with breast cancer. The concept of personalized breast cancer relies on the identification of molecular profiles associated with therapeutic benefits, enabling selection of patients whose outcomes may be improved with specific therapies.1 There are limitations to the application of precision medicine in breast cancer, which are addressed by the faculty.2

Advancements in testing technology may have the potential to guide therapy selection. Currently, there is no standard of care recommendation for next generation sequencing and proteomic testing. Circulating tumor cells and circulating tumor DNA may have potential applications for patients with breast cancer.3,4 Tumor genotyping (by tissue or blood) has been utilized for selection of matched therapy in clinical trials. Monitoring of tumor mutations by circulating tumor DNA can provide early evidence of pharmacodynamics effect related to matched targeted therapy, but clinical utility has not yet been established. Tumor genotyping may provide insight into tumor changes over time, which may help to guide subsequent lines of therapy.

For additional commentary about these topics and others, visit to access more resources.


  1. André F, Bachelot T, Commo F, et al. Comparative genomic hybridisation array and DNA sequencing to direct treatment of metastatic breast cancer: a multicenter, prospective trial (SAFIR01/UNICANCER). Lancet Oncol. 2014;15(3):267-274. doi: 10.1016/S1470-2045(13)70611-9.
  2. Arnedos M, Vicier C, Loi S, et al. Precision medicine for metastatic breast cancer—limitations and solutions. Nat Rev Clin Oncol. 2015;12(12):693-704. doi: 10.1038/nrclinonc.2015.123.
  3. Haber DA, Velculescu VE. Blood-based analyses of cancer: circulating tumor cells and circulating tumor DNA. Cancer Discov. 2014;4(6):650-661. doi: 10.1158/2159-8290.CD-13-1014.
  4. Malvarosa G, Spring L, Juric D, et al. Comparison of genotyping results from tissue and circulating DNA (ctDNA) in patients with metastatic breast cancer. 2016 San Antonio Breast Cancer Symposium. Abstract P1-05-05.

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