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U.S. National Institutes of Health
Last Updated: 11/09/09

Breast Cancer Correlative Science Committee Biomarker Workshop

Bethesda, Maryland
February 23-24, 2009


  1. To develop consistent strategies and planning for evaluation of clinical utility of tumor markers by breast cancer cooperative groups

  2. To specifically address two separate markers as examples:

    • Intrinsic subtype (basal, luminal A, B, etc) signatures as prognostic factors
    • Chemotherapy predictive signatures
  3. To review currently available technologies for high throughput assays for DNA, RNA, and/or protein abnormalities designed to identify new signatures for prognosis or prediction


Day 1: Monday, February 23, 2009

SESSION I: Tumor Marker Studies 101 Speaker Affiliation
Review of Current NABCG CSC Activities and Results
  • overall review of CSC activities
  • brief review of current PRCT addressing tumor markers
    Other trials?
Introduction to Tumor Marker Research:
Dan Hayes MD U. Michigan
Tumor Marker Trial Designs
Discuss prospective trial designs for tumor markers
Richard Simon, PhD NCI
Use of Archived Specimens Rather Than New Prospective Trials:
Discuss hierarchy of archived specimen studies. Include assessment of cohort studies vs. case controls, especially when using prospective randomized clinical trials.
Richard Simon, PhD NCI
Technical Aspects of Tumor Marker Studies
Discuss analytical accuracy, reliability, reproducibility, and practicality: i.e. what does it take to have a "clinical grade" assay
Mitch Dowsett, PhD Royal Marsden/London
In situ Assays: Can Data from TMAs Be Used to Change Clinical Practice
Discuss the status of the field regarding whether data generated from TMA = whole sections; include published data, data from BCCA, current BCCA strategy for BC, and 9344 if any data available comparing "first 1500" whole sections (Hayes, et al NEJM 2007) with same pts by TMA for HER2.
Torsten Nielson, MD BCCA/Vancouver
Development of Multi-parameter Marker Assays
Discuss power and pitfalls of multiparameter assays; Importance and strategies for validation; Construction of algorithms for individualizing clinical care using RNA, DNA and protein-based assays
Lisa McShane, PhD NCI
Validation and Reporting of Tumor Marker Studies: REMARK
Discuss importance of transparent reporting patient selection and study designs as well as analytical methods
Lisa McShane, PhD NCI
Regulatory Issues of Tumor Markers: FDA/CLIA/etc
Discuss Devices structure and difference between Devices and Therapeutic Branches; Discuss meaning of FDA approval or clearance, with emphasis on new vs. equivalent submissions
Discuss "home brew" rule and current status of need for FDA approval or not to market test.
Bob Becker, MD FDA


SESSION II: Think Tank: New High-throughput Technologies Speaker Affiliation
Review of Afternoon's Objectives:
Are there high-throughput technologies that we might consider adopting now to profile all breast cancer tissues in Cooperative Group banks
Dan Hayes, MD U. Michigan
  • Almac — Kevin Ellison
  • Roche/Affymetrix — Jeff Lawrence Walter Koch, PhD
  • Agilent — Condie Carmack
  • Illumina — Omead Ostadan
    Gary Schroth
  • Nanostring — Gary Geiss
  • GHI — Steve Shak

Day 2: Tuesday, February 24, 2009

SESSION III: Discussion of Specific New Trials/Studies of 2 New Assays Speaker Affiliation
Overview of Goals for each assay highlighting issues brought forward from previous day's discussions:
Potential Utilities
Specific Studies
Gabe Hortobagyi  
Intrinsic Subtypes
Moderator: Matt Ellis
1. Charles Perou
Intrinsic breast cancer subtypes, what are they and do they matter?
University of North Carolina
2. Phil Bernard
A qPCR based clinical assay for the Intrinsic Breast Cancer Subtypes
University of Utah
3. Torsten Nielsen
Application of the intrinsic subtype assay qPCR assay to an ER+ cohort
British Columbia Cancer Agency
4. Matthew Ellis
Clinical trial designs based on intrinsic subtypes
Washington University, St. Louis
Predictors of Chemotherapy
Moderator: Lajos Pusztai
MD Anderson
1. Jae K. Lee
Are vitro-derived predictive signatures ready for clinical use in breast cancer?
University of Virginia
2. W. Fraser Symmans
Are genomic predictive signatures developed from human genomic data ready for clinical testing?
MD Anderson
3. Donald Berry
Adaptive trial designs to facilitate identifying effective therapies and their associated predictive markers
MD Anderson
4. Lajos Pusztai
Tandem, two-step Phase II design to rapidly evaluate candidate predictors and novel drugs
MD Anderson

SESSION IV: Wrap-up/Discussion of Action Items

  1. Should we consider such new studies from what we've heard
  2. Should we consider high throughput profile discover studies of all or selected sets of specimens in Cooperative Group Banks?
  3. What are political implications from various groups?
  4. Who would do it?
  5. How to fund?