Brown University, Providence, RI B.A Biochemist Columbia Univ. College of Physicians & Surgeons, NY, NY

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1 BIOGRAPHICAL SKETCH Provide the following information for the Senior/key personnel and other significant contributors in the order listed on Form Page 2. Follow this format for each person. DO NOT EXCEED FOUR PAGES. NAME Alison T. Stopeck era COMMONS USER NAME (credential, e.g., agency login) astopeck POSITION TITLE Associate Professor of Medicine Director, Clinical Breast Cancer Program, AZCC Director, AZ Hemophilia and Thrombosis Center EDUCATION/TRAINING (Begin with baccalaureate or other initial professional education, such as nursing, include postdoctoral training and residency training if applicable.) DEGREE INSTITUTION AND LOCATION MM/YY FIELD OF STUDY (if applicable) Brown University, Providence, RI B.A Biochemist Columbia Univ. College of Physicians & Surgeons, NY, NY M.D Medicine A. PERSONAL STATEMENT. Dr. Stopeck is the Director and Team Leader of the Clinical Breast Cancer Program and the Arizona Hemophilia and Thrombosis Center at the Arizona Cancer Center. She has extensive experience in designing, initiating, and successfully completing clinical trials. She has been the Principle Investigator on multiple phase I, II, and III clinical trials in breast cancer, hemophilia and osteoporosis, including cooperative group, pharmaceutical sponsored, and investigator-initiated trials. She is also on the breast cancer working group of the Southwest Oncology Group (SWOG) and has been a study coordinator on several SWOG sponsored trials including S0108 and S0515. She has successfully filed and obtained IND approval for first in human phase I clinical trials and has been a member of the University of Arizona Institutional Review Board as well as the Arizona Cancer Center s Data Safety and Monitoring Committee. Her laboratory is involved in biomarker discovery including the enumeration and characterization of circulating tumor cells and endothelial cells as well as the use of functional imaging for predicting breast cancer risk and response to antitumor therapies. Selected publications reflect her role as PI in clinical trials that often involve correlative biomarkers performed in her laboratory. The publications attest to her qualifications and experience in designing, implementing, and completing successful clinical trials. B. POSITIONS AND HONORS Medical and Academic Appointments: Medical intern and resident, Columbia-Presbyterian Medical Center Clinical Fellow, Hematology-Oncology, New York Hospital-Cornell Medical Center Research Fellow, Cornell Medical College, Hematology-Oncology, Laboratory of Vascular Biology Instructor in Medicine, Cornell University Medical College Assistant Professor of Medicine, Cornell University Medical College Assistant Professor of Medicine, University of Arizona, Arizona Cancer Center 1997-present Director, Arizona Hemophilia and Thrombosis Center-Tucson 2001-present Director, Breast Cancer Program, Arizona Cancer Center 2002-present Associate Professor of Medicine, University of Arizona, Arizona Cancer Center Awards and Other Professional Activities: Magna Cum Laude Sigma XI Alpha Omega Alpha NIH Physician's Scientist Award, /95 to present: Medical Director, Coagulation Laboratory University Medical Center Associate Editor, American Journal of Medicine Memberships Board Certification American Association for Cancer Research 1988 Internal Medicine

2 American College of Physicians 1990 Hematology American Society of Clinical Oncology 1991 Medical Oncology American Society of Hematology C. SELECTED PEER-REVIEWED PUBLICATIONS (related to clinical trials, biomarkers or breast cancer expertise from 68 peer-reviewed publications): 1. MS Gordon, D Mendelson, R Carr, RA Knight, RA Humerickhouse, M Iannone, Stopeck, AT. A phase I trial of 2 dose schedules of ABT-510, an antiangiogenic, thrombospondin-1-mimetic peptide, in patients with advanced cancer. Cancer. 2008;113(12): CA Thomson, PA Thompson PA, J Wright-Bea, E Nardi, GR Frey, Stopeck, AT. Metabolic syndrome and elevated C-reactive protein in breast cancer survivors on adjuvant hormone therapy. J Womens Health 2009;18(12): Thompson PA, Hsu CH, Green S, Stopeck, AT, Johnson K, Alberts DS, Chow HH. Sulindac and sulindac metabolites in nipple aspirate fluid and effect on drug targets in a phase I trial. Cancer Prev Res. 2010;3: Chalasani P, Downey L, Stopeck AT. Caring for the breast cancer survivor: a guide for primary care physicians. Am J Med 2010;123(6): Stopeck AT, Lipton A, Body JJ, Steger GG, Tonkin K, de Boer R, Lichinitser M, Fujiwara Y, Yardley D, Viniegra M, Fan M, Jiang Q, Braun A, Dansey R, Jun S. Denosumab compared with zoledronic acid for the treatment of bone metastases in patients with advanced breast cancer: a randomized, double-blind study. J Clin Oncol 2010; 28: PMID: Thomson CA, Stopeck AT, Bea JW, Cussler E, Nardi E, Frey G, Thompson PA. Changes in body weight and metabolic indexes in overweight breast cancer survivors enrolled in a randomized trial of low-fat vs. reduced carbohydrate diets. Nutr Cancer Nov;62(8): PMID: Modi S, Stopeck A, Linden HM, Solit DB, Chandarlapaty S, Rosen N, D'Andrea G, Dickler MN, Moynahan ME, Sugarman S, Ma W, Patil S, Norton L, Hannah AL, Hudis C. HSP90 Inhibition is Effective in Breast Cancer: A Phase 2 Trial of Tanespimycin (17AAG) plus Trastuzumab in Patients with HER2-Positive Metastatic Breast Cancer Progressing on Trastuzumab. Clin Cancer Res. 2011;17: PMID: Rugo HS, Stopeck AT, Joy AA, Chan S, Verma S, Lluch A, Liau KF, Kim S, Bycott P, Rosbrook B, Bair AH, Soulieres D. Randomized, Placebo-Controlled, Double-Blind, Phase II Study of Axitinib Plus Docetaxel Versus Docetaxel Plus Placebo in Patients With Metastatic Breast Cancer. J Clin Oncol. 2011; 29: PMID: Greenberg S, Stopeck A, Rugo HS. Systemic treatment of early breast cancer--a biological perspective. J Surg Oncol. 2011;103(6): PMID: D. 10. Gerber DE, Stopeck AT, Wong L, Rosen LS, Thorpe PE, Shan JS, Ibrahim NK. Phase I Safety and Pharmacokinetic Study of Bavituximab, a Chimeric Phosphatidylserine-Targeting Monoclonal Antibody, in Patients with Advanced Solid Tumors. Clin Cancer Res 2011; 17(21): PMID: Rugo HS, Jo Chien A, Franco SX, Stopeck AT, Glencer A, Lahiri S, Arbushites MC, Scott J, Park JW, Hudis C, Nulsen B, Dickler MN. A phase II study of lapatinib and bevacizumab as treatment for HER2- overexpressing metastatic breast cancer. Breast Cancer Res Treat Dec 24 [epub ahead of print] PMID: Brown-Glaberman U, Stopeck AT. Role of denosumab in the management of skeletal complications in patients with bone metastases from solid tumors. Biologics. 2012;6: PMID: Stopeck AT, Brown-Glaberman U, Wong HY, Park BH, Barnato SE, Gradishar WJ, Hudis CA, Rugo HS. The role of targeted therapy and biomarkers in breast cancer treatment. Clin Exp Metastasis Jun 13 [epub ahead of print] PMID: Jha AK, Kupinski MA, Rodríguez JJ, Stephen RM, Stopeck AT. Task based evaluation of segmentation algorithms for diffusion-weighted MRI without using a gold standard. Phys Med boil. 2012; 57(13): PMID: Stopeck A, Rader M, Henry D, Danese M, Halperin M, Cong Z, Qian Y, Dansey R, Chung K. Cost- Effectiveness of Denosumab versus Zoledronic Acid for Prevention of Skeletal-Related Events in Patients with Solid Tumors and Bone Metastases in the United States. J Med Econ Mar 12. PMID:

3 D. RESEARCH SUPPORT Ongoing Federally Funded Research 1R01CA (Stopeck and Thompson, Joint PIs) 7/1/12-04/30/ calendar NIH/NCI $224,414 NSAID Effects on Clinical and Imaging Breast Biomarkers The goal of this project is to investigate the effect of sulindac combined with aromatase inhibitor on breast density measured by MRI. 1RO1CA A1 (Thomson, PI) 7/7/10-6/30/15.60 calendar NIH/NCI $3,276,181 Evaluation of Diinodlymethane Supplementation to Modulate Tamoxifen Efficacy in Breast Cancer Role: Co-Investigator The major goal of this project is to test the efficacy and safety of diindolymethane in women taking tamoxifen as adjuvant therapy for breast cancer. 1R01CA (Chow, PI) 7/1/13-6/30/18.96 calendar NIH/NCI $386,687 Role: Co-Investigator Metformin for Reduction of Obesity-Associated Breast Cancer Risk Aims: The goal of this project is to conduct a Phase II clinical trial of metformin to determine the potential activity of metformin on breast cancer risk reduction. ATHN (Stopeck, PI) 6/1/10-5/31/14.10 calendar Regional Hemophilia Network-Mountain States $32,000 Oregon Health and Science University Subcontract to provide comprehensive care to patients with hemophilia and other bleeding disorders. Centers for Disease Control (Stopeck, PI) 9/30/12-9/29/13.10 calendar Subcontract with University of Colorado $19,868 Public Health Surveillance of the Prevention of Complications of Bleeding and Clotting Disorders The goal of this federal subcontract is to treat and prevent complications in patients with hemophilia through the establishment of specialized Hemophilia Treatment Centers Ongoing Investigator initiated trials Phase II Trial, Pfizer. 6/7/07-10/31/13 A Phase II Study evaluating the safety of sunitinib maleate in combination with weekly paclitaxel followed by doxorubicin and daily oral cyclophosphamide plus G-CSF as neoadjuvant chemotherapy for locally advanced and inflammatory breast cancer and co-investigator Goal: Investigator initiated trial to determine pathologic complete response rate of adding the antiangiogenic TKI, sunitinib, to metronomic chemotherapy in patients with locally advanced breast cancer. Biomarker studies including circulating endothelial cells, endothelial cell precursor cells, and plasma angiogenic factors will be performed in my laboratory for both sites of this trial. Bayer 12/16/10-12/15/12 The Role of Receptor Activator of Nuclear Factor A, B Ligand (RANKL) and Osteoprotegerin (OPG) in Hemophilia Induced Bone Loss

4 Goal: To compare by immunohistochemistry the role of the RANK-RANKL pathway in the jointsof patients with hemophilia versus osteoarthritis and rheumatoid arthritis Peregrine 12/02/10 12/01/13 Phase I Clinical Trial of Weekly Paclitaxel in Combination with Bavituximab in Patients with HER2 Negative Metastatic Breast Cancer Goal: An investigator initiated trial examining angiogenic and circulating biomarkers as well as response rates and PFS of the combination of paclitaxel and bavituximab in patients with HER2 negative metastatic breast cancer. PENDING: Amgen Phase II study of Denosumab in patients at increased risk of breast cancer recurrence Goal: To determine the effects of 6 months of denosumab therapy on contralateral breast density and tissue biomarkers of cancer risk. LOI approved and protocol in final stages of review. Pharmaceutical sponsored clinical trials Merck 12/10/10-12/19/13 A Two-Part, Adaptive, Randomized Trial of Ridaforolimus in Combination with Dalotuzumab Compared to Exemestane or Compared to Ridaforolimus or Dalotuzumab Monotherapy in Estrogen Receptor Positive Breast Cancer Patients Amgen 3/12/09-3/11/14 An Open-Label Study of AMG-386 in Combination with Either Paclitaxel and Trastuzumab or Capecitabine and Lapatinib in Subjects with HER2 Positive Locally Recurrent or Metastatic Breast Cancer Novartis A Randomized multicenter, trial of everolimus plus trastuzumab and vinorelbine in women with HER2 positive locally advanced or metastatic breast cancer previously treated with a taxane and resistant to trastuzumab. Amgen 9/20/10-ongoing A randomized, double-blind, placebo-controlled, multi-center Phase 3 study of denosumab as adjuvant treatment for women with early stage breast cancer at high risk of recurrence (D-CARE) Genentech/Roche 8/6/12-11/1/14 A Two-Cohort, Open-Label, Multicenter Phase II Trial Assessing the Efficacy and Safety of Pertuzumab Given in Combination with Trastuzumab and Vinorelbine in First Line Patients with HER2 Positive Advanced (metastatic or locally advanced) Breast Cancer Bayer 8/6/12-8/5/15 A Phase II/III, Multicenter, Partially Randomized, Open-Label Trial Investigating Safety and Efficacy of On Demand and Prophylactic Treatment with BAY in Severe Hemophilia A

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