ACRIN Breast Committee October 1, 2010 Constance Lehman, M.D., PhD, FACR Professor and Vice Chair of Radiology University of Washington ACRIN Breast Committee

Clinical Breast Imaging Radiologists- –Constance Lehman, M.D. PhD –Hiroyuke Abe, MD –Wendie Berg, M.D. PhD –Christiane Kuhl, MD –Emily Conant, M.D –Laurie Fajardo, M.D –Ellen Mendelson, M.D –Jay Baker, M.D –Chris Comstock, M.D –Sina Meisamy, MD –Janie Lee, MD Other Radiologists with subspecialization in breast applications –Mike Jacobs, M.D –David Mankoff, M.D –Marilyn Roubidoux, M.D. Breast Committee Members

ACRIN Breast Committee Other Disciplines –Nancy Ellerbroek, M.D Radiation Oncology –Tom Julian, M.D Surgical Oncology –Shahla Masood, M.D Pathology –Charlie Shapiro, M.D. Medical Oncology –Isabelle Bedrosian, M.D. Surgical Oncology Physicists –Ed Hendrick, PhD –Nola Hylton, PhD –Martin Yaffe, PhD –Robert Nishikawa, PhD

ACRIN Breast Committee Statisticians/Epidemiologists –Constantine Gatsonis, PhD –Ben Herman, MS –Zheng Zhang, PhD Others –Barbara LeStage, Patient Advocate –Nancy Sauers, Patient Advocate –Judy Johnson, Patient Advocate –Roslynn Marzan, Research Associate –Bernadine Dunning –Maxine Crooks –Darryl L’Heureux –Ashley Fails

ACRIN Breast Committee Historical strength of breast committee –Assessment of diagnostic accuracy of relatively mature technology Digital mammography for screening average risk populations Ultrasound for screening high risk populations MRI for screening contralateral breast/diagnosing EOD DCE MRI to assess response to therapy Future development –Develop and validate new imaging biomarkers to predict and assess response to therapy Advanced MR imaging (MR spectroscopy, MR DWI), Advanced PET applications, optical imaging

ACRIN Breast Committee SPECIFIC AIMS Test new screening strategies based on individualized risk profiles. Assess the use of imaging for the measurement of extent of disease and for monitoring and mid-therapy adaptation of treatment protocols. Reduce the morbidity of breast cancer therapy through non- invasive imaging-guided mechanisms.

ACRIN Breast Committee Aim 1: Targeted surveillance of at-risk populations Protocol Number 4006 – Tomosynthesis: Comparison of Full Field Digital Mammography with Digital Breast Tomosynthesis (T-MIST) Image Acquisition and Projection Combinations in relation to Screening Call-Back Rate PI: Emily Conant, MD

ACRIN Breast Committee Aim 2: Characterization of cancer in order to drive targeted therapy Protocols applying functional imaging methods to determine the anatomic extent of tumor in order to focus therapy ACRIN 6694 ACOSOG collaboration pre op MRI ACRIN DCIS trial—potential collaboration with SWOG

ACRIN Breast Committee Aim 3: Development of imaging-based predictive and prognostic biomarkers of response to targeted treatment extension (MR diffusion, spectroscopy) ISPY2 (6693) EISC FLT study (6688)

ACRIN Breast Committee Concepts approved by ACRIN steering committee –ACRIN Concept 6693: MR Imaging Biomarkers for Assessment of Breast Cancer Response to Neoadjuvant Treatment: A sub-study of the I-SPY 2 TRIAL (Investigation of Serial Studies to Predict Your Therapeutic Response with Imaging And molecular Analysis) PI: Nola Hylton, PhD –ACRIN Concept 6694 – ACOSOG Z1101: Impact of Breast MRI on Selection and Outcome of Breast Cancer Patients Undergoing Breast Conserving Therapy PI: Isabelle Bedrosian, MD, Surgery PI: Chris Comstock, MD, Imaging

ACRIN Breast Committee 3 Active Trials – ACRIN 6683 CAD 1 is complete and was presented at 2009 RSNA. CAD 2 is was presented at this meeting and will be presented at the 2010 RSNA. – ACRIN 6657 ISPY Extension: Contrast Enhanced Breast MRI and MRS for evaluation of Patients undergoing neoadjuvant treatment for Locally Advanced Breast Cancer. PI: Nola Hylton, PhD Target accrual 140- accrual to date 114 – ACRIN 6688 Phase II study of 3’-Deoxy-3’ 18F Flourothymidine (FLT) in Invasive Breast Cancer PI- Lale Kostakoglu, MD David Mankoff, MD PI Target accrual 54- accrual to date 12

ACRIN Breast Committee Manuscripts 6652 Comparison of Softcopy and Hardcopy Reading for Full-Field Digital Mammography. Radiology, 252(1): April Nishikawa R; Acharyya S; Gastonsis C; Pisano E; Cole E; Marques H; D’Orsi C, Farria D; et al Cancer Cases from ACRIN Digital Mammographic Imaging Screening Trial: Radiologist Analysis with use of a Logistic Regression Model. Radiology, 252(2): August Pisano E; Acharyya S; Cole E; Marques H; Yaffe M; Blevins M; Conant E; Hendrick R; et al Comparison of Acquisition Parameters and Breast Does in Digital Mammography and Screen-Film Mammography in the ACRIN DMIST Trial. American Journal of Roentgenology, 194: February Hendrick E, Pisano E; Averbukh A; Moran C; Berns A; Yaffe M; Herman B; Acharyya S; Gatsonis C.American Journal of Roentgenology 6667 Frequency of Malignancy in Probably Benign Lesions Seen on Contrast-Enhanced Breast MRI. Radiology, 255: June Weinstein S, Hanna L, Gatsonis C, Schnall M, Rosen M, Lehman C Reasons Women at Elevated Risk of Breast Cancer Refuse Breast MR Imaging Screening. Radiology, 254(1): January Berg W; Blume J; Adams A; Jong R; Barr R; Lehrer D; et al. Papers Published 7/1/09-6/30/10

ACRIN Breast Committee Abstracts 6652 Title: Comparative Effectiveness and Cost-Effectiveness of Digital Mammography and MRI for Breast Cancer Screening in BRCA1 Gene Mutation Carriers Conference: 2009 Radiological Society of North America Annual Meeting (RSNA) Presenter: Janie Lee, MD 6657 Title: MRI Tumor Volume Predicts Response to Neoadjuvant Chemotherapy: Findings from the ACRIN Rrial 6657 (poster) Conference: 2009 American Society of Clinical Oncology (ASCO) Presenter: Nola Hylton, PhD 6657 Title: Assessing Residual Disease in Breast Cancer Patients Post Neoadjuvant Chemotherapy Prior to Surgery: Findings of the American College of Radiology Imaging Network (ACRIN) Trial 6657 Conference: 2009 Radiological Society of North America Annual Meeting (RSNA) Presenter: Constance Lehman, MD, PhD 6666 Title: Screening Breast Ultrasound as a Supplement to Mammography: Yield of Annual Screening in ACRIN 6666 Conference: 2009 Radiological Society of North America Annual Meeting (RSNA) Presenter: Wendie Berg, MD, PhD, FACR 6666 Title: False Positives Induced by Annual Screening US Added to Mammography: ACRIN 6666 Conference: 2009 Radiological Society of North America Annual Meeting (RSNA) Presenter: Wendie Berg, MD, PhD, FACR 6666 Title: Supplemental Yield and Performance Characteristics of Screening MRI after Combined Ultrasound and Mammography: ACRIN 6666 Conference: 2009 Radiological Society of North America Annual Meeting (RSNA) Presenter: Wendie Berg, MD, PhD, FACR 6683 Title: CAD System Marking of Digital Mammograms of DMIST Cancers Conference: 2009 Radiological Society of North America Annual Meeting (RSNA) Presenter: Elodia Cole Abstracts Published 2009