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Last Updated: 06/23/09

Breast Cancer Correlative Science Committee Biomarker Workshop

Bethesda, Maryland
February 23-24, 2009

Objectives:

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

To specifically address two separate markers as examples:
- Intrinsic subtype (basal, luminal A, B, etc) signatures as prognostic factors
- Chemotherapy predictive signatures

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

Agenda

Day 1: Monday, February 23, 2009
SESSION I: Tumor Marker Studies 101	Speaker	Affiliation
Review of Current TBCI CSC Activities and Results overall review of CSC activities brief review of current PRCT addressing tumor markers S0500 TailorRx Other trials? Introduction to Tumor Marker Research: Perils/Pitfalls/Potential	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: Definition Potential Utilities Assays Specific Studies	Gabe Hortobagyi
Intrinsic Subtypes Moderator: Matt Ellis mellis@dom.wustl.edu	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 lpusztai@mdanderson.org	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 Itmes
Should we consider such new studies from what we've heard Should we consider high throughput profile discover studies of all or selected sets of specimens in Cooperative Group Banks? What are political implications from various groups? Who would do it? How to fund?