Tanya Michelle Prowell, MD

Primary Academic Title

Associate Professor of Oncology

Background

Centers and Institutes

Breast Health Services

Clinical Trial Keywords

breast cancer

Videos

• COVID-19 and Cancer: What Have We Learned?

Recent News Articles and Media Coverage

• FDA To Let Women Try New Breast Cancer Drugs Earlier, Reuters, June 3, 2012

  An Emotional Slap in The Face: The Language of Cancer, Medscape (June 17, 2019)

  Clinical Trials for People with Metastatic Breast Cancer. Komen Real Pink (January 6, 2020)

  What the Coronavirus Crisis Reveals about American Medicine, The New Yorker (May 4, 2020)

Research Interests

Brain metastases, Breast cancer in young women, Decentralized clinical trials, Eligibility criteria, Neoadjuvant therapy for breast cancer, Novel therapies for breast cancer, Triple-negative breast cancer

Selected Publications

• 1. Prowell T, Smith B. Neutropenic Fever. In: Cheng A, Zaas A., eds. The Osler Medical Handbook, First Edition. Philadelphia: Mosby, 2003: 537-544.
  2. Prowell T, Liu M. Asthma. In: Cheng A, Zaas A., eds. The Osler Medical Handbook, First Edition. Philadelphia: Mosby, 2003: 867-880.
  3. Prowell T, Davidson N. What is the role of ovarian ablation in the management of primary and metastatic breast cancer today? The Oncologist 2004; 9(5): 507-517.
  4. Prowell T, Stearns V. Commentary on: “Are breast density and bone mineral density independent risk factors for breast cancer?” (Kerlikowske et al, J Natl Cancer Inst 2005;97:368-374). The North America Menopausal Society (NAMS): First to Know. April 2005. www.menopause.org/news.html
  5. Sheth A, Prowell T, Krishnan J. Asthma. In: Nilsson K, Piccini J., eds. The Osler Medical Handbook, Second Edition. Philadelphia: Saunders Elsevier, 2006: 865-876.
  6. Prowell T, Stearns V, Trock B. Lipophilic statins merit additional study for breast cancer chemoprevention. Journal of Clinical Oncology, 2006; 24(13): 2128-2129.
  7. Prowell T, Stearns V. Disease-free survival was greater with letrozole than tamoxifen in postmenopausal women with early breast cancer. ACP Journal Club, 2006: 145(1): 11.
  8. Bao T, Prowell T, Stearns V. Chemoprevention of breast cancer: Tamoxifen, raloxifene, and beyond. American Journal of Therapeutics, 2006; 13(4): 337-348.
  9. Prowell T, Davidson N. Metastatic breast cancer: Tailored endocrine therapy for premenopausal women. In: Piccart M, Wood W, Hung M-C, Solin L, Cardoso F., eds. Breast Cancer Management and Molecular Medicine: Towards Tailored Approaches. Springer-Verlag, 2006: 445-458.
  10. Prowell T, Armstrong D. Selecting endocrine therapy for breast cancer: What role does HER-2/neu status play? Seminars in Oncology, 2006; 33(6): 681-687.
  11. Prowell T, Stearns V. Extended adjuvant therapy for breast cancer—how much is enough? J Natl Cancer Inst. 2007 99: 1825-1827.
  12. Prowell T, Fackler M, Argani P, Khouri N, Blackford A, Shahverdi K, Wolff A, Davidson N, Sukumar S, Stearns V. A prospective study of adjuvant anastrozole and gene promoter methylation in the contralateral breast of high-risk women. J Clin Oncol 26: 2008 (May 20 suppl; abstr 1514).
  13. Bao T, Shahverdi K, Blackford A, Prowell T, Jeter S, Powers P, Wright L,. Snyder C, Stearns V, Visvanathan K.Quality of life changes in breast cancer patients participating in an anastrozole secondary prevention trial.J Clin Oncol 26: 2008 (May 20 suppl; abstr 1515).
  14. Prowell T, Ibrahim A, Farrell A, Justice R, Sun Mitchell S, Sridhara R, and Pazdur R. FDA Approval Summary: Temsirolimus as Treatment for Advanced Renal Cell Carcinoma. The Oncologist 2010; 15:428-35.
  15. Prowell T, Blackford A, Byrne C, Khouri N, Dowsett M, Folkerd E, Tarpinian K, Powers P, Wright L, Donehower M, Jeter S, Armstrong D, Emens L, Fetting J, Wolff A, Garrett-Mayer E, Skaar T, Davidson N, Stearns V. Changes in breast density and circulating estrogens in postmenopausal women receiving adjuvant anastrozole. Cancer Prev Res 2011; 4:1993-2001.
  16. Higgins M, Prowell T, Blackford A, Byrne C, Khouri N, Slater S, Jeter S, Armstrong D, Davidson N, Emens L, Fetting J, Powers P, Wolff A, Green H, Thibert J, Rae J, Folkerd E, Dowsett M, Blumenthal R, Garber J, Stearns V. A Short-Term Biomarker Modulation Study of Simvastatin in Women at Increased Risk of a New Breast Cancer. Breast Cancer Res Treat 2012; 131: 915-924
  17. Prowell T, Pazdur R. Pathological Complete Response and Accelerated Drug Approval in Early Breast Cancer. N Engl J Med. 2012; 366:2438-41.
  18. Prowell T. Guidance for Industry: Pathologic Complete Response in Neoadjuvant Treatment of High-Risk Early-Stage Breast Cancer: Use as an Endpoint to Support Accelerated Approval; http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM305501.pdf.
  19. Zhang L, Untch M, Mehta K, Costantino J, Wolmark N, Bonnefoi H, Cameron D, Gianni L, Valagussa P, Zujewski J, Justice R, Loibl S, Wickerham L, Bogaerts J, Baselga J, Perou C, Blumenthal G, Blohmer J, Mamounas E, Bergh J, Semiglazov V, Prowell T, Eidtmann H, Paik S, Piccart M, Sridhara R, Fasching P, Swain S, Slaets L, Tang S, Gerber B, Geyer C, Pazdur R, Ditsch N, Rastogi P, Eiermann W, and von MinckwitzG. Meta-analysis Results from the Collaborative Trials in Neoadjuvant Breast Cancer (CTneoBC). Cancer Res 2012;72 (24 Suppl):Abstract P114-20.
  20. Prowell T, Eidtmann H, Paik S, Piccart M, Sridhara R, Fasching P, Swain S, Slaets L, Tang S, Gerber B, Geyer C, Pazdur R, Ditsch N, Rastogi P, Eiermann W, and von Minckwitz G. A Definition of a High-Risk Early-Breast Cancer Population Based on Data from the Collaborative Trials in Neoadjuvant Breast Cancer (CTNeoBC) meta-analysis.  Cancer Res 2013; Abstract P5-17-01.
  21. Prowell T, Eidtmann H, Paik S, Piccart M, Sridhara R, Fasching P, Swain SM, Slaets L, Tang S, Gerber B, Geyer C, Pazdur R, Ditsch N, Rastogi P, Eiermann W, vonMincwitz G. Pathological complete response in breast cancer: CTNeoBC pooled-analysis. The Lancet. Epub ahead of print Feb 14, 2014.

Honors

• FDA Commissioner's Special Achievement Award, US Food & Drug Administration, 8/31/21
• Webby Special Achievement Award, The Webby Awards, 5/19/20
• John and Samuel Bard Award in Medicine and Science, Bard College, 5/1/19
• Merrill Egorin Outstanding Mentor Award, AACR/ASCO - Vail Methods in Clinical Cancer Research Workshop, 8/1/18
• Best Lecture Award, AACR/ASCO - Vail Methods in Clinical Cancer Research Workshop, 8/1/18
• Best Lecture Award, AACR/ASCO - Vail Methods in Clinical Cancer Research Workshop, 8/1/17
• FDA Outstanding Service Award, US Food & Drug Administration, 8/1/15
• Award for Excellence in Communication, Food & Drug Administration, 1/1/14
• Award for Excellence in Communication, Food & Drug Administration, 1/1/12
• FDA Group Recognition Award, 1/1/11
• Award for Excellence in Communication, Food & Drug Administration, 1/1/10
• Pearl M. Stetler Research Fund Award, 1/1/05
• Pearl M. Stetler Research Fund Award, 1/1/04
• Young Investigator Award, American Society of Clinical Oncology, 1/1/04
• Phi Beta Kappa Society, Johns Hopkins University, 1/1/99
• Alpha Omega Alpha Honor Medical Society, Johns Hopkins University School of Medicine, 1/1/99
• Bishop-Jervis Prize (for four years of overall academic excellence), Bard College, 1/1/94
• Summer Intramural Research Training Award, NIH, 1/1/93
• Heinrich Bl√ºcher Scholar (for excellence in the Division of Languages and Literature), Bard College, 1/1/93
• Asher B. Edelman Excellence and Equal Cost Scholarship (full academic scholarship), Bard College, 1/1/90

Lectures & Presentations

• Accelerating the Search for Breast Cancer Therapies for Triple Negative Breast Cancer., Cancer Policy Roundtable, National Coalition for Cancer Survivorship, Washington, DC, 7/29/12
• Access to Data from Clinical Trials: A New Age of Clinical Trial Transparency., American Society of Clinical Oncology (ASCO) Annual Meeting, Chicago, IL, 6/1/14
• Are Anthracyclines Past Their Prime?, Accelerating Anticancer Agent Development and Validation (AAADV) Workshop, Annapolis, MD, 3/30/12
• Challenges in Oncology Drug Development., Presentation to Congressional Staff, FDA, Silver Spring, MD, 3/28/11
• Clinical Trials Module, Accelerating Anticancer Agent Development and Validation (AAADV) Workshop, Metastatic Breast Cancer Network National Conference, Bethesda, MD, 5/18/11
• Clinical Trials Versus Standard of Care., CBS Biocentury TV, Baltimore, MD, 10/29/11
• Clinical Trials with Molecular Selection: Neoadjuvant Trial Design., American Society of Clinical Oncology (ASCO) Annual Meeting, Chicago, IL, 5/30/13
• Compassionate Use of Investigational Agents., Johns Hopkins University School of Medicine Ethics Course, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD, 12/18/13
• Considerations for Neoadjuvant Breast Cancer Trials to Support Accelerated Approval., American Association for Cancer Research (AACR) Annual Meeting, Silver Spring, MD, 3/22/13
• Doxil in Advanced Breast Cancer., FDA Presentation, Oncology Drugs Advisory Committee Meeting, Gaithersburg, MD, 7/15/09
• Draft Guidance on Using Pathologic Complete Response as an Endpoint to Support Accelerated Approval of Drugs to Treat Early-Stage Breast Cancer., CBS Biocentury TV, Silver Spring, MD, 6/28/12
• Drug-Induced Peripheral Neuropathy in Cancer Patients., Accelerating Anticancer Agent Development and Validation (AAADV) Workshop, Silver Spring, MD, 4/11/13
• Emerging Concepts of Drug Safety in Oncology,, iSPY2 Annual Investigators Meeting, Chicago, IL, 6/1/12
• Ethics of Oncology Drug Development., Norris Cotton Cancer Center Grand Rounds, 2/12/14
• Exploiting the Preoperative Setting: Streamlining Drug Development in High-Risk, Early Stage Breast Cancer., Clinical Investigator Seminar Series, Dana Farber Cancer Institute, Baltimore, MD, 1/4/13
• FDA and Cancer: The Inside View., Clinical Investigator Seminar Series, Dana Farber Cancer Institute, Washington, DC, 2/5/12
• FDA History and Regulatory Authority, National Breast Cancer Coalition, Project LEAD Conference, Lansdowne, VA, 11/4/10
• From Drug Activity to Meaningful Clinical Benefit., Accelerating Anticancer Agent Development and Validation (AAADV) Workshop, Bethesda, MD, 5/7/14
• Impact of Phase I Trials on Safety and Optimal Dose for Future Clinical Practice., in Pushing the Limits of Upfront Care and Drug Development: Neoadjuvant Opportunities in Breast Cancer, Chicago, IL, 6/1/13
• Implementation of the Final Guidance on Accelerated Approval in the Neoadjuvant Setting., Breast Oncology Multidisciplinary Seminar, Washington, DC, 11/15/13
• Meet the Professor Session: Breast Cancer., American Society of Clinical Oncology (ASCO) Annual Meeting, Baltimore, MD, 5/9/12
• Neoadjuvant Chemotherapy-Pros and Cons., The Fifth Bi-Annual Johns Hopkins Breast Cancer Conference, Baltimore, MD, 3/27/10
• Oncology Drug Development: A Regulatory Perspective, Clinical Investigator Seminar Series, Dana Farber Cancer Institute, Boston, MA, 3/22/11
• Oncology Drug Development: A Regulatory Perspective., Webinar, Office of Medical Policy, Center for Drug Evaluation and Research, Food & Drug Administration, Baltimore, MD, 6/22/12
• Oncology Drug Development: A Regulatory Perspective., Breast Oncology Seminar Series, Dana Farber Cancer Institute, Boston, MA, 3/5/13
• Oncology Drug Development: A Regulatory Perspective., Massachusetts General Hospital, 3/25/14
• Pathologic Complete Response as an Endpoint to Support Accelerated Approval,, Grand Rounds, Medical Oncology, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Chicago, IL, 6/1/12
• Pathological Complete Response as an Endpoint to Support Accelerated Approval in High-Risk, Early-Stage Breast Cancer., Grand Rounds, Internal Medicine, Johns Hopkins Hospital, New York, NY, 11/8/12
• Pathological Complete Response: Is It the Holy Grail?, Clinical Investigator Seminar Series, Dana Farber Cancer Institute, Boston, MA, 3/7/14
• Pathological Complete Response: Promise, Perils, and the Path Forward., American Association for Cancer Research (AACR) Annual Meeting, Boston, MA, 3/25/14
• Pertuzumab for High-Risk, Early Breast Cancer., Breast Oncology Multidisciplinary Seminar, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD, 11/20/13
• Pitfalls in Oncology Drug Development., Topics in Clinical Medicine course, Johns Hopkins University School of Medicine, Bethesda, MD, 5/16/12
• Pitfalls in Oncology Drug Development., American Association for Cancer Research (AACR) Annual Meeting, Washington, DC, 4/6/13
• Pitfalls in Oncology Drug Development., American Society of Clinical Oncology (ASCO) Pre-Annual Meeting, New Drugs in Oncology Seminar, Bethesda, MD, 5/8/13
• Preoperative Systemic Therapy for Breast Cancer: Considerations for Investigators, Clinicians, and Patients., The Seventh Bi-Annual Johns Hopkins Breast Cancer Conference- A Multidisciplinary Perspective, Dartmouth-Hitchcock Medical Center, Baltimore, MD, 2/18/14
• Regulatory Considerations in Oncology Drug Development., The Sixth Bi-Annual Johns Hopkins Breast Cancer Conference: Controversies in Management-A Multidisciplinary Perspective, Boston, MA, 3/5/12
• Regulatory Considerations in Oncology Drug Development., American Society of Clinical Oncology Leadership Development Program, Washington, DC, 10/25/12
• Strategies to Expedite Oncology Drug Development., Chemotherapy Foundation Symposium, Mt, Silver Spring, MD, 11/7/12
• Successful Oncology Drug Development: Balancing Knowledge, Speed, and Risk., American Association for Cancer Research (AACR) Annual Meeting, San Diego, CA, 4/8/14
• The Promise and Challenges of Pathological Complete Response (pCR) as a Novel Endpoint for Drug Approval in High-Risk, Early-Stage Breast Cancer., CASE Seminar on Drug-Induced Peripheral Neuropathy, Washington, DC, 4/8/13
• Treatment with adjuvant anastrozole decreases cumulative gene methylation in the contralateral breast of women at increased risk for a second breast cancer., ASCO Breast Cancer Symposium; oral abstract presentation (Abstract 1), San Francisco, CA, 9/7/07
• Understanding the FDA Drug Approval Process in Breast Cancer: How It Works and How It Could Work Better., ASCO/FDA Innovations in Breast Cancer Drug Development - Neoadjuvant Breast Cancer Workshop, Boston, MA, 3/6/13
• Understanding the U.S. FDA Guidance on Pathological Complete Response and Accelerated Approval, I-SPY 3 Planning Meeting, American Society of Clinical Oncology (ASCO) Annual Meeting, Chicago, IL, 6/1/13
• Use of Biopsies for Clinical and Regulatory Decision-Making in Late-Stage Drug Development., San Diego, CA, 4/7/14
• Why have we not prevented or cured breast cancer, and what are we going to do about it?, Vision Panel Speaker, Collaborative Summit on Breast Cancer Research, Leesburg, VA, 11/2/07
• Write Your Ticket: Career Options in Medical Oncology--A Session for Fellows and Junior Faculty., ASCO Annual Meeting, Orlando, FL, 6/5/09

Memberships

• American Society of Clinical Oncology