September 9, 2010

Co-Chairs

George W. Sledge, Jr., MD

Ballve-Lantero Professor of Oncology
Co-Director, Breast Cancer Program
Indiana University Cancer Center, Indianapolis, IN
Co-Chair, Breast Committee, The Eastern Oncology Cooperative Group (ECOG)

Dennis J. Slamon, MD, PhD

Chief, Division of Hematology-Oncology
Professor and Executive Vice Chair, Department of Medicine
Director for Clinical Research
Jonsson Comprehensive Cancer Center
Director, Revlon/UCLA Women’s Health Research and Cancer Research Programs
University of California at Los Angeles School of Medicine
Los Angeles, California

CME CREDIT INFORMATION

Release Date: 03/03/08

Expiration Date: 03/03/09

Physicians: maximum of 14.5 AMA PRA Category 1 Credit(s)™

CME-Accredited Webcasts, PowerPoint® Slide and Audio Downloads, and
i-Tunes Podcast Downloads

All 35 presentations, plus 8 interactive panel discussions, and 2 Point-Counterpoint debates from the

"First Annual North American Symposium on Personalized Therapies for Breast Cancer"

Miami, FL, January 19-20, 2008

You may participate in any or all of the 10 sessions of enduring materials for CME credit or Certificate of Attendance after you review the required ACCME (Accreditation Council on Continuing Medical Education) information on this and the following Web pages.

Overview and Faculty Disclosures

Sessions

Evaluation & Certificate

Overview of CME-Accredited Educational Enduring Materials

Your Options for Methods of Participation are:

View and/or listen to any of the 45 sessions (listed below) via an Adobe Flash Webcast
Download any slides as PowerPoint Presentations
Download any audio only as MP3s or Podcasts
Request a DVD-ROM of all 45 sessions

These educational enduring materials are the complete on-line, Web-based version of the “First Annual North American Symposium on Personalized Therapies for Breast Cancer” conducted January 19 -20, 2008 in Miami, FL. These materials will provide participants with the most current information regarding personalizing drug, radiation and surgical therapies for breast cancer, by integrating molecular diagnostics, and surgical/biopsy techniques for improving patient care.

There are 35 didactic presentations, 8 Q&A interactive panel discussions between the faculty and audience with both clinical cases and audience questions, and 2 Point-Counter Point debates between key academic clinical and scientific thought leaders in breast cancer research which comprise the complete list of educational enduring materials. Each of these 45 sessions is approximately 20 minutes in length, and each will permit you to earn 0.25 hours of AMA PRA Category 1 Credits™. Sessions can be individually reviewed for credit. You can participate in as few or as many as you desire.

Educational Enduring Material Dates and Time to Complete

Date of release: March 3, 2008

Date expires (CME credit will not be avaliable): March 3, 2009

Average time to complete each individual session: 20 minutes

Time to complete entire activity: 14.5 hours

Statement of Need

There is a critical need for providing physicians treating breast cancer with the most up-to-date, scientifically-based and practical information on the various strategies for personalizing therapies for this malignancy. There is a large number of effective drug, radiation and surgical therapies for treating breast cancer. And because there is also an increasing number of novel molecular diagnostic techniques such as gene micro arrays and other gene profiling tests, molecular diagnostics measuring phosphorylation in cell signaling, tests measuring circulating tumor cells, digital mammography, and various other tests, physicians are now better equipped to better predict which targeted therapies and chemotherapies will be optimal or ineffective for specific patient sub-populations with breast cancer.

The following is a complete listing of all 45 sessions of educational enduring materials. You may partici[pate by viewing or listening to any or all of these 45 sessions after reviewing the following pages containing the ACCME-required information for any CME enduring educational material. And you may doenload the slides, MP3s, PodCasts, and even order a DVD-ROM of the entire program (all 45 sessions).

The following is list of all 45 sessions categorized by Chapter

Chapter 1 Introduction & Overview CHAIRS: George Sledge and Dennis Slamon
a.	Personalizing breast cancer therapy in the USA and Canada George Sledge
b.	The BIG strategy for personalizing breast cancer therapy Martine Piccart-Gebhart
c.	Perspectives of breast cancer survivors Mary Lou Smith
Chapter 2 Personalizing Therapies for the Prevention of Breast Cancer CHAIR: Julie Gralow
a.	Predicting who will develop breast cancer and the influence of endocrine therapy on the risk for developing breast cancer Malcolm Pike
b.	The role of genetics and breast cancer prevention Jeff Weitzel
c.	Drug prevention strategies for patients at risk of developing breast cancer Powel Brown
d.	Lifestyle and behavior modification for prevention of breast cancer Graham Coldvitz
e.	Patients with a genetic predisposition for developing breast cancer Olufunmilayo Olopade
f.	Interactive Panel Discussion with Faculty and Audience Q&A
Chapter 3 Diagnosis and Molecular Classification of Breast Cancer for Personalizing Therapies CHAIR: Eric Winer
a.	What is the role of gene expression arrays as prognostic biomarkers? Charles Perou
b.	What are the clinical roles of biomarkers as predictors of drug response? Soonmyung Paik
c.	Interactive Panel Discussion with Faculty and Audience Q&A
d.	Circulating tumor cells (CTCs) as predictive and prognostic markers Massimo Cristofanilli
e.	The evolving role of histopathology in era of gene arrays Sunil Badve
f.	Prediction of therapeutic response and prognosis: Mammaprint®* and beyond Martine Piccart-Gebhart
g.	Prediction of therapeutic response and prognosis utilizing OncotypeDX®* George Sledge
h.	Interactive Panel Discussion with Faculty and Audience Q&A
i.	Anatomy still matters in the "Biologic Era" Eric Winer
j.	ASCO CAP guidelines as predictors of response Mark Pegram
k.	"Point-Counter-Point:" Classical Histology versus Molecular Classification for selection of specific drug therapies? Sunil Badve versus Soonmyung Paik
l.	Future directions in developing predictors and individualization therapy Lajos Pusztai
m.	What are the optimal statistical aspects for biomarkers and clinical trial design? Donald Berry
n	Interactive Panel Discussion with Faculty and Audience Q&A
Chapter 4 Personalized Approaches to Local-Regional Control of Breast Cancer CHAIR: Lori Pierce
a.	Personalized surgical therapy and future directions Armando Giuliano
b.	Personalized radiation therapy in the treatment of breast cancer Lori Pierce
c.	Update on accelerated partial breast irradiation (APBI) Frank Vicini
d.	Individualizing loco-regional therapy with the use of neoadjuvant chemotherapy Eleftherios Mamounas

Chapter 5 Clinical Applications of Personalized Therapies of ER+ Breast Cancers CHAIR: Edith Perez
a.	Personalized approaches using SNPs (single nucleotide polymorphisms) to selecting agents for patients with metastatic ER+ breast cancer Edith Perez
b.	Molecular predictors of response to adjuvant endocrine therapy in ER+ breast cancer Lajos Pusztai
c.	Interactive Panel Discussion with Faculty and Audience Q&A
Chapter 6 Clinical Applications of Personalized Therapies of HER2+ Breast Cancers CHAIR: Dennis Slamon
a.	The role of Topo-II and prediction of response to anthracyclines Kathleen Pritchard
b.	Personalized approaches to selecting targeted therapies and other chemotherapies for patients with metastatic HER2+ breast cancer Dennis Slamon
c.	Predictors of response and personalized approaches to selecting patients for adjuvant and neo-adjuvant trastuzumab therapy in HER2+ breast cancer Francisco Esteva
d.	Clinical applications of inhibiting Heat Shock Protein-90 Clifford Hudis
e.	"Point-Counter-Point:" FISH versus IHC? George Sledge versus Michael Press
f.	Interactive Panel Discussion with Faculty and Audience Q&A
Chapter 7 Clinical Applications of Personalized Therapies of Triple-Negative Breast Cancers CHAIR: Lisa Carey
a.	Triple negative breast cancer: personalized approaches to therapy of advanced disease Lisa Carey
b.	Predictors of response and personalized approaches to selecting patients for adjuvant chemotherapy and targeted therapy in ER-negative breast cancer (adjuvant taxanes) Joseph Sparano
c.	Androgen receptor positive (AR+) breast cancers Clifford Hudis
d.	Interactive Panel Discussion with Faculty and Audience Q&A
Chapter 8 New Targets and Future Directions for Personalized Therapies of Breast Cancer CHAIR: Peter Ravdin
a.	Therapeutic individualization for antiangiogenic therapy George Sledge
b.	Personalizing treatment of bone metastases, and can biomarkers predict metastatic sites? Julie Gralow
c.	Antiemetics in 2008 - Targeting antiemetic agents and doses for appropriate breast cancer patients Richard Gralla
d.	Designing optimal clinical trials: selecting and prioritizing which patients and which similar new drugs for inclusion in clinical trials Peter Ravdin
e.	Interactive Panel Discussion with Faculty and Audience Q&A

Educational Objectives

At the conclusion of all of these enduring materials, you should be able to:

Assess the personalized therapeutic approaches for the prevention of breast cancer.
Evaluate the impact of molecular classification of breast cancers for personalizing therapies.
Evaluate the clinical data regarding the selection of the most appropriate agent for the treatment of bone metastases in the era of personalized therapy approaches for breast cancers.
Evaluate the clinical data for personalizing the selection of anti-emetic therapy for breast cancer patients.
Analyze the clinical applications of personalized adjuvant and neo-adjuvant therapies for breast cancer.
Describe the personalized approaches to local-regional control of breast cancer.
Devise strategies to incorporate the clinical applications of personalized therapy of breast cancer into the daily management of patients with this malignancy as well as the design of newer clinical trials for breast cancer.
Describe the use of molecular-based techniques in defining prognostic sub-groups in breast cancer clinical trials.

Target Audience

These enduring materials are designed for breast cancer medical, surgical, and radiation oncologists, especially in community/private practice. Fellows, nurses, and pharmacists with an interest in the treatment of breast cancer may also benefit.

CME Accreditation & Credit Designation

The Oncology Learning Center is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.

The Oncology Learning Center designates this educational activity for a maximum of 14.5 AMA PRA Category 1 Credit(s)™. Physicians should only claim credit commensurate with the extent of their participation in the activity.

CME Certificate or Certificate of Participation

The relevant section(s) of the Evaluation Form pertaining to the session(s) of the enduring materials you have viewed or listened to, and the Request for Credit Form must be completed and submitted to the Oncology Learning Center following your participation in the enduring material educational activity to obtain CME credit. Physicians and other participants will be able to print their certificates after they complete these Forms.

Disclosure of Conflicts of Interest

In accordance with the Accreditation Council for Continuing Medical Education (ACCME) Standards for Commercial Support, educational programs sponsored by the Oncology Learning Center must demonstrate balance, independence, objectivity, and scientific rigor. All faculty, authors, editors, and planning committee members participating in an OLC-sponsored activity are required to disclose any relevant financial interest or other relationship with the manufacturer(s) of any commercial product(s) and/or provider(s) of commercial services that are discussed in an educational activity.

Faculty Disclosures

It is the policy of The Oncology Learning Center™, Inc. (OLC) to ensure that all of its educational activities and materials are of the highest quality, and are balanced, objective, independent, free of commercial bias, and planned and developed with scientific rigor with strict adherence to all Accreditation Council for Continuing Medical Education (ACCME) rules and policies. The OLC evaluates all content, faculty and faculty disclosures for any potential conflicts of interest. Should any conflicts of interest be identified these conflicts are resolved in advance of the educational activity by independent peer reviewers who are experts in the subjects of the educational activity.

All faculty and OLC staff participating in the content, planning or implementation of an educational CME activity are required to disclose to the audience of the educational activity any relevant financial relationships or interests and to assist in the resolution of any conflict of interest that may arise from the relationship(s) or interest(s). It is also the policy of the OLC to require all faculty presenters to make a meaningful disclosure to the audience of their discussions of unlabeled or FDA unapproved drugs, products, tests or devices. This information will be available as part of the educational activity and related material.

The following faculty and OLC staff have reported real or potential relevant conflicts of interest and these conflicts have been resolved, prior to this educational activity through a peer-review process by two medical oncologists who have had no affiliation with this educational activity other than the peer review process. This is documented on this page immediately following the financial disclosures below.

Sunil Badve, MD

I have no real or apparent conflicts of interest to report. I intend to reference unlabeled/unapproved uses of drugs or products in my presentation.

Donald A. Berry, PhD

Consultant : Abbott, Sanofi-Aventis, Schering-Plough, Astra-Zeneca, Pfizer, Taiho, OSI, Takeda, GlaxoSmithKline, Keryx, Biogen Idec, Eisai, Merck, Eil Lilly, Wyeth, Bristol-Myers Squibb

Chris Brown

I have no real or apparent conflicts of interest to report.

Powel H. Brown, MD, PhD

Consultant: Eli Lilly, Syndax Pharmaceuticals

Grant/Research Support: Astra-Zeneca

Lisa A. Carey, MD

Consultant: Roche, Pfizer, GlaxoSmithKline, Genentech

Contracted Research: BHS, GlaxoSmithKline, Boehringer Ingelheim

Graham A. Colditz, MD, DrPH

I have no real or apparent conflicts of interest to report.

Massimo Cristofanilli, MD

Fees for Non-CME Services Received Directly from Commercial Interest or their Agents: Veride

Ownership Interest: Cellexicon

Francisco J. Esteva, MD, PhD

Fees for Non-CME Services Received Directly from Commercial Interest or their Agents: Genentech

Armando E. Giuliano, MD

I have no real or apparent conflicts of interest to report.

Richard J. Gralla, MD

Consultant: GlaxoSmithKline, Sanofi-Aventis, Merck, MGI Pharma

Grant/Research Support: Sanofi-Aventis

Julie R. Gralow, MD

Consultant: Novartis, Roche, Amgen

Contracted Research: Amgen, Bristol-Myers, Roche, Novartis, GlaxoSmithKline

Ora Guy

I have no real or apparent conflicts of interest to report.

Clifford A. Hudis, MD

Consultant: Amgen, AstraZeneca, Bristol-Myers Squibb Company, Genentech, Lilly , Novartis, Pfizer, Roche, Sanofi-Aventis

Fees for Non-CME Services Received Directly from Commercial Interest or their Agents: AstraZeneca, Genentech, Novartis, Roche

Contracted Research: Kosan

Ownership Interest: Genomic Health

Steve Madison, RPh, MBA

Fees for Market Research & Training: Amgen, Novartis, Prometheus

Catherine MaGill, PhD

Consulting Fees: Proteolix, Translational Oncology, Charles Sholtz (husband), Liquid Agency

Eleftherios P. Mamounas, MD, MPH, FA CS

Consultant: Bristol-Myers Squibb Company, Aventis, Roche, Genentech, Pfizer, GlaxoSmithKline, GHI, Lilly, Novartis

Fees for Non-CME Services Received Directly from Commercial Interest or their Agents: Genentech, GHI, Aventis

Olufunmilayo Olopade, MB, BS

Contracted Research: Roche

Soonmyung Paik, MD

Receipt of Intellectual Property Rights/Patent Holder: Genomic Health Inc.

Consultant: Genentech, GlaxoSmithKline

Mark Pegram, MD

Consultant: Genentech, Inc.

Edith A. Perez, MD

Contracted Research: Genentech, GlaxoSmithKline, Novartis, Sanofi-Avenits

Charles M. Perou, PhD

Consultant: Eli Lilly, Roche, PharmaMar

Contracted Research: Roche, Eli Lilly, BMS

Martine Piccart-Gebhart, MD, PhD

Consultant: Lippincott William & Wilkins, Pfizer

Lori J. Pierce, MD

I have no real or apparent conflicts of interest to report.

Malcolm Pike, MD

I have no real or apparent conflicts of interest to report. I intend to reference unlabeled/unapproved uses of drugs or products in my presentation.

Michael Press, MD

Consultant: GlaxoSmithKline, Genentech

Fees for Non-CME Services Received Directly from Commercial Interest or their Agents: Genentech

Contracted Research: GlaxoSmithKline, Genentech

Kathleen I. Pritchard, MD

Consultant: AstraZeneca, Sanofi-Aventis, Roche, Pfizer, Novartis

Lajos Pusztai, MD, DPhil

Consultant: Bristol-Myers Squibb Company, Roche Laboratories, Pfizer

Ownership Interest: Nuvera Biosciences Inc.

Peter M. Ravdin, MD, PhD

Consultant: Sanofi-Aventis

Ownership Interest: Adjuvant Incorporated

Other: Educational Grant � AstraZeneca

Phillip Renner

I have no real or apparent conflicts of interest to report.

Daphne Rhea

I have no real or apparent conflicts of interest to report.

Sandra Roeling

I have no real or apparent conflicts of interest to report.

Dennis J. Slamon, MD, PhD

Fees for Non-CME Services Received Directly from Commercial Interest or their Agents: Genetech

Ownership Interest: Amgen/Schering Plough

George W. Sledge, Jr., MD

Consultant: Genentech, Pfizer

Contracted Research: Eli Lilly, Sanofi-Aventis

Mary Lou Smith

Other Grants: AstraZeneca, Lilly, Genomic Health, Genentech

Joseph Sparano, MD

I have no real or apparent conflicts of interest to report.

Suzette Stewart

I have no real or apparent conflicts of interest to report.

Frank A. Vicini, MD, FA CR

I have no real or apparent conflicts of interest to report.

Jeffrey N. Weitzel, MD

I have no real or apparent conflicts of interest to report.

Eric P. Winer, MD

I have no real or apparent conflicts of interest to report.

Faculty Affiliations

Sunil Badve, MD Associate Professor of Pathology Clarian Pathology Laboratory Indiana University Cancer Center		Charles M. Perou, PhD Associate Professor Department of Genetics University of North Carolina At Chapel Hill
Donald A. Berry, MD, PhD Head, Division of Quantitative Sciences Professor and Frank T. McGraw Memorial Chair for Cancer Research Chairman, Department of Biostatistics MD Anderson Cancer Center		Martine Piccart-Gebhart, MD, PhD Head of the Chemotherapy Department Jules Bordet Institute President, European Organization for the Research and Treatment of Cancer (EORTC)
Powel H. Brown, MD, PhD Professor of Medicine, Baylor College of Medicine Associate Director of Cancer Prevention, Dan L. Duncan Cancer Center Director of Cancer Prevention and Population Sciences Program, Dan L. Duncan Cancer Center Associate Director of Research, Breast Center Baylor College of Medicine		Lori J. Pierce, MD Vice Provost for Academic and Faculty Affairs Professor, Department of Radiation Oncology University of Michigan
Lisa A. Carey, MD Medical Director, UNC Breast Center University of North Carolina - Lineberger Comprehensive Cancer Center		Malcolm Pike, MD Professor and Acting Chair, Flora L. Thornton Professor USC Norris Cancer Center
Graham A. Colditz, MD, DrPH Niess-Gain Professor in the School of Medicine Department of Surgery Associate Director Prevention and Control Alvin J. Siteman Cancer Center Washington University School of Medicine		Michael F. Press, MD, PhD Harold E. Lee Chair in Cancer Research Professor, Pathology USC/Norris Comprehensive Cancer Center
Massimo Cristofanilli, MD Associate Professor, Breast Medical Oncology MD Anderson Cancer Center		Kathleen I. Pritchard, MD Chair of the Breast Cancer Site Group Toronto-Sunnybrook Regional Cancer Center
Francisco J. Esteva, MD, PhD Associate Professor of Medicine Department of Breast Medical Oncology Department of Molecular and Cellular Oncology MD Anderson Cancer Center, University of Texas		Lajos Pusztai, MD, DPhil Associate Professor of Medicine Department of Breast Medical Oncology MD Anderson Cancer Center
Armando E. Giuliano, MD Chief of Science and Medicine Breast and Endocrine Program John Wayne Cancer Institute		Peter Ravdin, MD Research Professor, Department of Biostatistics MD Anderson Cancer Center
Richard J. Gralla, MD President, Multinational Association of Supportive Care in Cancer (MASCC) Past President and Current Board Member, New York Lung Cancer Alliance New York, NY		Dennis J. Slamon, MD, PhD Chief, Division of Hematology-Oncology Professor and Executive Vice Chair, Department of Medicine Director for Clinical Research Jonsson Comprehensive Cancer Center Director, Revlon/UCLA Women’s Health Research and Cancer Research Programs University of California at Los Angeles School of Medicine Los Angeles, California
Julie R. Gralow, MD Associate Professor of Medical Oncology University of Washington School of Medicine Cancer Care Alliance Seattle, WA Co-Chair, Breast Committee, The Southwest Oncology Group (SWOG)		George Sledge, Jr., MD Ballve-Lantero Professor of Oncology Co-Director, Breast Cancer Program Indiana University Cancer Center Indianapolis, IN Co-Chair, Breast Committee, The Eastern Oncology Cooperative Group (ECOG)
Clifford A. Hudis, MD Chief, Breast Cancer Medicine Service Memorial Sloan-Kettering Cancer Center New York, NY Co-Chair, Breast Committee, The Cancer and Leukemia Group B (CALGB)		Mary Lou Smith Co-chair of the ECOG Patient Representative Committee Co-Founder Research Advocacy Network
Eleftherios P. Mamounas, MD, MPH, FA CS Associate Professor of Surgery Cancer Center, Aultman Health Foundation Northeastern Ohio Universities College of Medicine		Joseph A. Sparano, MD Professor of Medicine, Albert Einstein College of Medicine, Director, Breast Evaluation Center, Montefiore-Einstein Cancer Center
Olufunmilayo Olopade, MB, BS Walter L. Palmer Distinguished Service Professor in Medicine and Human Genetics Director, Hematology/Oncology University of Chicago		Frank A. Vicini, MD Chief of Oncology Service Program Director, Radiation Oncology William Beaumont Hospital
Soonmyung Paik, MD Director, Division of Pathology NSABP Foundation		Jeffrey N. Weitzel, MD Professor of Oncology and Population Sciences Director, Department of Clinical Cancer Genetics City of Hope Cancer Center
Mark Pegram, MD Associate Professor of Medicine University of Miami		Eric P. Winer, MD Director, Breast Oncology Center Thompson Investigator in Breast Cancer Research Department of Medical Oncology Dana-Farber Cancer Institute / Harvard Cancer Center Boston, MA Co-Chair, Breast Committee, The Cancer and Leukemia Group B (CALGB)
Edith A. Perez, MD Professor of Medicine Director, Clinical Research, Mayo Clinic Jacksonville, FL Chair, Breast Committee, The North Central Cancer Treatment Group (NCCTG)

Peer Review Process of Conflicts of Interest

Drs. Jennifer Ligibel of the Dana Farber Cancer Institute, Boston, MA, and Patrick J. Flynn of US Oncology in Minneapolis, MN. Have independently peer-reviewed this enduring material educational activity.

Note: To enlarge the COI form image, please click on it.

Disclosure of Unlabeled Uses

This educational activity may contain discussion of published and/or investigational uses of agents that are not indicated by the US Food and Drug Administration (FDA). For additional information about approved uses, including approved indications, contraindications, and warnings, please refer to the prescribing information for each product or consult the Physicians’ Desk Reference.

The Oncology Learning Center (OLC) does not recommend the use of any agent outside of the FDA labeled indications. The opinions expressed in the educational activity are those of the faculty and do not necessarily represent the views of the OLC. Please refer to the official FDA prescribing information for each product for discussion of approved indicated, contraindications, and warnings.

Acknowledgement of Supporters

Educational Grants
Sincere appreciation is extended to the following companies for their generous support of this educational meeting: Genentech BioOncology, Novartis, Bristol-Myers Squibb, Lilly, Abraxis BioScience, AstraZeneca, Genomic Health, Eisai, sanofi-aventis, Bayer, Onyx, AviaraDx, Abbott

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