DeniseAYardleyMD

Oncology • Nashville, TN

Senior Investigator, Breast Cancer Research Program; Principal Investigator, Sarah Cannon Research Institute

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Office
335 24th Ave North
Ste 200
Nashville, TN 37203
Phone+1 615-329-7640
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Education & Training

University of Texas Southwestern Medical CenterFellowship, Hematology and Medical Oncology, 1991 - 1994
University of Texas Southwestern Medical CenterResidency, Internal Medicine, 1988 - 1991
Medical College of Georgia at Augusta UniversityClass of 1988

Certifications & Licensure

TN State Medical License 2000 - 2025
TX State Medical License 1989 - 2005

Awards, Honors, & Recognition

Redbook Magazine: Top Breast Cancer Doctors Castle Connolly, 2001

Clinical Trials

Weekly Docetaxel and CMF in the Adjuvant Treatment of Elderly Women With High-Risk Breast Cancer Start of enrollment: 2002 Mar 01
Completed
Phase 3
Doxorubicin HCI Liposome Injection Versus Weekly Docetaxel in Patients First Relapse Metastatic Breast Cancer Start of enrollment: 2001 Feb 01
Completed
Phase 2
Weekly Gemcitabine, Epirubicin, and Docetaxel in Locally Advanced or Inflammatory Breast Cancer Start of enrollment: 2001 Nov 01
Completed
Phase 2
Weekly Gemcitabine and Trastuzumab in the Treatment of Patients With Human Epidermal Growth Factor Receptor 2 (HER2) Positive Metastatic Breast Cancer Start of enrollment: 2001 Jul 01
Completed
Phase 2
Combination Gemcitabine, Carboplatin With or Without Trastuzumab in Patients With Metastatic Breast Cancer Start of enrollment: 2003 Nov 01
Completed
Phase 2
Docetaxel Followed by Doxorubicin Plus Cyclophosphamide for Node Positive or High-Risk Primary Breast Cancer Start of enrollment: 2004 Mar 01
Completed
Phase 2
Docetaxel Plus Imatinib Mesylate in Metastatic Breast Cancer Start of enrollment: 2005 May 01
Completed
Phase 2
Neo-adjuvant Gemcitabine, Epirubicin, ABI-007 (GEA) in Locally Advanced or Inflammatory Breast Cancer Start of enrollment: 2005 Sep 01
Completed
Phase 2
Vinflunine Plus Trastuzumab in Human Epidermal Growth Factor Receptor 2 (HER2neu) Over-Expressing Metastatic Breast Cancer Start of enrollment: 2006 Jan 01
Completed
Phase 2
Trastuzumab and Oxaliplatin in Patients With Metastatic Breast Cancer Start of enrollment: 2006 Feb 01
Completed
Phase 2
Preoperative Bevacizumab and Trastuzumab With ABI-007 and Carboplatin in HER2+ Breast Cancer Start of enrollment: 2006 Oct 01
Completed
Phase 2
Bevacizumab Given With Either Anastrozole or Fulvestrant With Trastuzumab for Postmenopausal Metastatic Breast Cancer Start of enrollment: 2006 Nov 01
Completed
Phase 2
Adjuvant Doxorubicin/Cyclophosphamide and Paclitaxel Plus Sorafenib Breast Cancer Start of enrollment: 2007 May 01
Completed
Not Applicable
Study to Evaluate Exemestane With and Without Entinostat (SNDX-275) in Treatment of Postmenopausal Women With Advanced Breast Cancer Start of enrollment: 2008 Jun 13
Completed
Phase 2
A Randomized Trial of Ixempra Versus Taxol in Adjuvant Therapy of Triple Negative Breast Cancer Start of enrollment: 2008 Dec 01
Completed
Phase 3
Neoadjuvant Ixabepilone/Carboplatin/Trastuzumab in HER2-Positive Locally Advanced Breast Cancer Start of enrollment: 2009 Feb 01
Completed
Phase 2
Phase I/II Trial of Sorafenib Plus Ixabepilone in HER2-Negative Metastatic Breast Cancer Start of enrollment: 2009 Mar 01
Completed
Phase 1, Phase 2
Ixabepilone and Cyclophosphamide as Neoadjuvant Therapy in HER-2 Negative Breast Cancer Start of enrollment: 2009 Apr 01
Completed
Phase 2
Neoadjuvant Sunitinib With Paclitaxel/Carboplatin in Patients With Triple-Negative Breast Cancer Start of enrollment: 2009 Jun 01
Completed
Phase 1, Phase 2
Panitumumab, Gemcitabine and Carboplatin in Triple-Negative Metastatic Breast Cancer Start of enrollment: 2010 Feb 01
Completed
Phase 2
Trial of Paclitaxel/Bevacizumab +/- Everolimus for Patients With HER2-Negative Metastatic Breast Cancer Start of enrollment: 2009 Jul 01
Completed
Phase 2
A Study of NK012 in Patients With Advanced, Metastatic Triple Negative Breast Cancer Start of enrollment: 2009 Feb 01
Completed
Phase 2
Trial of Amrubicin as Treatment for Patients With HER2-Negative Metastatic Breast Cancer Start of enrollment: 2009 Dec 01
Completed
Phase 1, Phase 2
Safety and Efficacy of INCB007839 With Trastuzumab and Vinorelbine in Patients With Metastatic HER2+ Breast Cancer Start of enrollment: 2010 Oct 01
Terminated
Phase 1, Phase 2
Trial of Eribulin in Patients Who Do Not Achieve Pathologic Complete Response (pCR) Following Neoadjuvant Chemotherapy Start of enrollment: 2011 Sep 23
Completed
Phase 2
Trial of Eribulin/Cyclophosphamide or Docetaxel/Cyclophosphamide as Neoadjuvant Therapy in Locally Advanced HER2-Negative Breast Cancer Start of enrollment: 2012 Jun 01
Completed
Phase 2
Characterization of Circulating Tumor Cells (CTC) From Patients With Metastatic Breast Cancer Using the CTC-Endocrine Therapy Index Start of enrollment: 2013 Apr 01
Completed
A Phase II Study of Everolimus in Combination With Exemestane Versus Everolimus Alone Versus Capecitabine in Advance Breast Cancer. Start of enrollment: 2013 Feb 26
Completed
Phase 2
Phase 2 Study of the Monoclonal Antibody MGAH22 (Margetuximab) in Patients With Relapsed or Refractory Advanced Breast Cancer Start of enrollment: 2013 Mar 01
Completed
Phase 2
BKM120 for Patients With PI3K-activated Tumors Start of enrollment: 2013 Mar 29
Completed
Phase 2
T-DM1 vs Paclitaxel/Trastuzumab for Breast (ATEMPT Trial) Start of enrollment: 2013 May 01
Active, not recruiting
Phase 2
Cabazitaxel Plus Lapatinib as Therapy for HER2-Positive Metastatic Breast Cancer Patients With Intracranial Metastases Start of enrollment: 2014 May 01
Terminated
Phase 2
A Study Evaluating Talazoparib (BMN 673), a PARP Inhibitor, in Advanced and/or Metastatic Breast Cancer Patients With BRCA Mutation (EMBRACA Study) Start of enrollment: 2013 Oct 14
Completed
Phase 3
Study of Efficacy and Safety of LEE011 in Postmenopausal Women With Advanced Breast Cancer.(MONALEESA-2) Start of enrollment: 2013 Dec 17
Completed
Phase 3
Study of Glembatumumab Vedotin (CDX-011) in Patients With Metastatic, gpNMB Over-Expressing, Triple Negative Breast Cancer Start of enrollment: 2013 Nov 01
Completed
Phase 2
A Study of Abemaciclib (LY2835219) In Participants With Previously Treated Breast Cancer That Has Spread Start of enrollment: 2014 Jun 10
Completed
Phase 2
Phase 2 Study of Fulvestrant With and Without Entinostat in Postmenopausal Women With ER+ Advanced Breast Cancer Start of enrollment: 2014 Apr 01
Withdrawn
Phase 2
A Study to Assess the Safety and Efficacy of the VEGFR-FGFR-PDGFR Inhibitor, Lucitanib, Given to Patients With Metastatic Breast Cancer Start of enrollment: 2014 Sep 09
Terminated
Phase 2
Trilaciclib (G1T28), a CDK 4/6 Inhibitor, in Combination With Gemcitabine and Carboplatin in Metastatic Triple Negative Breast Cancer (mTNBC) Start of enrollment: 2017 Feb 02
Terminated
Phase 2
ATEMPT 2.0: Adjuvant T-DM1 vs TH Start of enrollment: 2021 Jun 16
Recruiting
Phase 2
Roles: Principal Investigator, Contact
A Single Arm Phase II Study of ADjuvant Endocrine Therapy, Pertuzumab, and Trastuzumab for Patients With Anatomic Stage I Hormone Receptor-positive, HER2-positive Breast Cancer Start of enrollment: 2021 Jan 11
Recruiting
Phase 2
Roles: Principal Investigator, Contact
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Publications & Presentations

PubMed

Axillary Nodal Response to Neoadjuvant T-DM1 Combined with Pertuzumab in a Prospective Phase II Multi-Institution Clinical Trial.
Jin, Q., Spring, L., Wrabel, E., Tayob, N., Viale, G., King, T., Metzger-Filho, O., Weiss, A., Waks, A., Yardley, D., Krop, I.> ;Journal of the American College of Surgeons. 2024 Mar 1
1 citations
Endocrine Therapy Synergizes with SMAC Mimetics to Potentiate Antigen Presentation and Tumor Regression in Hormone Receptor-Positive Breast Cancer.
Francisco Hermida-Prado, Yingtian Xie, Shira Sherman, Zsuzsanna Nagy, Douglas Russo, Tara Akhshi, Zhengtao Chu, Avery Feit, Marco Campisi, Minyue Chen, Agostina Nardon...> ;Cancer Research. 2023 Oct 2
2 citations
Neoadjuvant palbociclib plus either giredestrant or anastrozole in oestrogen receptor-positive, HER2-negative, early breast cancer (coopERA Breast Cancer): an open-lab...
Sara A Hurvitz, Aditya Bardia, Vanesa Quiroga, Yeon Hee Park, Isabel Blancas, José Luis Alonso-Romero, Aleksandr Vasiliev, Hryhoriy Adamchuk, Marcelo Salgado, Denise A...> ;The Lancet. Oncology. 2023 Sep 1
34 citations
Adjuvant paclitaxel and trastuzumab for node-negative, HER2-positive breast cancer: final 10-year analysis of the open-label, single-arm, phase 2 APT trial.
Tolaney, S., Tarantino, P., Graham, N., Tayob, N., Parè, L., Villacampa, G., Dang, C., Yardley, D., Moy, B., Marcom, P., Albain, K., Rugo, H., Ellis, M., Shapira, I., ...> ;The Lancet. Oncology. 2023 Mar 1
16 citations
Rationale and trial design of NATALEE: a Phase III trial of adjuvant ribociclib + endocrine therapyendocrine therapy alone in patients with HR+/HER2- early breast cancer.
Dennis J Slamon, Peter A Fasching, Sara Hurvitz, Stephen Chia, John Crown, Miguel Martín, Carlos H Barrios, Aditya Bardia, Seock-Ah Im, Denise A Yardley, Michael Untch...> ;Therapeutic Advances in Medical Oncology. 2023 Jan 1
Matching-adjusted indirect comparison of PFS and OS comparing ribociclib plus letrozolepalbociclib plus letrozole as first-line treatment of HR+/HER2- advanced breast ...
O'Shaughnessy, J., Fasching, P., Sharma, V., Biswas, C., Thuerigen, A., Pathak, P., Jhaveri, K., Tolaney, S., Yardley, D., Rugo, H.> ;Therapeutic Advances in Medical Oncology. 2023 Jan 1
4 citations
Treatment discontinuation, patient-reported toxicities and quality-of-life by age following trastuzumab emtansine or paclitaxel/trastuzumab (ATEMPT).
Tal Sella, Yue Zheng, Nabihah Tayob, Kathryn J Ruddy, Rachel A Freedman, Chau Dang, Denise Yardley, Steven J Isakoff, Vicente Valero, Michelle DeMeo, Harold J Burstein...> ;NPJ Breast Cancer. 2022 Nov 30
19 citations
Margetuximab Versus Trastuzumab in Patients With Previously Treated HER2-Positive Advanced Breast Cancer (SOPHIA): Final Overall Survival Results From a Randomized Pha...
Hope S Rugo, Seock-Ah Im, Fatima Cardoso, Javier Cortes, Giuseppe Curigliano, Antonino Musolino, Mark D Pegram, Thomas Bachelot, Gail S Wright, Cristina Saura, Santiag...> ;Journal of Clinical Oncology. 2023 Jan 10
66 citations
Long-term efficacy and safety of addition of carboplatin with or without veliparib to standard neoadjuvant chemotherapy in triple-negative breast cancer: 4-year follow...
C E Geyer, W M Sikov, J Huober, H S Rugo, N Wolmark, J O'Shaughnessy, D Maag, M Untch, M Golshan, J Ponce Lorenzo, O Metzger, M Dunbar, W F Symmans, P Rastogi, J H Soh...> ;Annals of Oncology. 2022 Apr 1
8 citations
Cardiac outcomes of subjects on adjuvant trastuzumab emtansine vs paclitaxel in combination with trastuzumab for stage I HER2-positive breast cancer (ATEMPT) study (TB...
Romualdo Barroso-Sousa, Paolo Tarantino, Nabihah Tayob, Chau Dang, Denise A Yardley, Steven J Isakoff, Vicente Valero, Meredith Faggen, Therese Mulvey, Ron Bose, Jiani...> ;NPJ Breast Cancer. 2022 Feb 16
3 citations
Correlation between work productivity loss and EORTC QLQ-C30 and -BR23 domains from the MONALEESA-7 trial of premenopausal women with HR+/HER2- advanced breast cancer.
Debu Tripathy, Tristan Curteis, Sara Hurvitz, Denise Yardley, Fabio Franke, K Govind Babu, Paul Wheatley-Price, Young-Hyuck Im, Radost Pencheva, Lucy A Eddowes, Pierre...> ;Therapeutic Advances in Medical Oncology. 2022 Jan 1
5 citations
A Phase II Study Evaluating Orteronel, an Inhibitor of Androgen Biosynthesis, in Patients With Androgen Receptor (AR)-Expressing Metastatic Breast Cancer (MBC).
Denise A. Yardley, Robyn R. Young, Kerin B. Adelson, Andrea Silber, Jose E. Najera, Davey B. Daniel, N. W. Peacock, L Finney, Susan J. Hoekstra, Mythili Shastry, John ...> ;Clinical Breast Cancer. 2021 Oct 28
25 citations
Safety and impact of dose reductions on efficacy in the randomised MONALEESA-2, -3 and -7 trials in hormone receptor-positive, HER2-negative advanced breast cancer.
Howard A. Burris, Arlene Chan, Aditya Bardia, J. Thaddeus Beck, Joohyuk Sohn, Patrick Neven, Debu Tripathy, Seock-Ah Im, Stephen Chia, Francisco J. Esteva, Lowell L. H...> ;British Journal of Cancer. 2021 Aug 31
8 citations
Next-Generation Sequencing of Patients With Breast Cancer in Community Oncology Clinics
Emma Sturgill, Amanda Misch, Rebecca Lachs, Carissa Jones, Daniel Schlauch, Suzanne F. Jones, Mythili Shastry, Denise A. Yardley, Howard A. Burris, David R. Spigel, Er...> ;JCO Precision Oncology. 2021 Aug 19
36 citations
Phase I/II Trial of Exemestane, Ribociclib, and Everolimus in Women with HR+/HER2- Advanced Breast Cancer after Progression on CDK4/6 Inhibitors (TRINITI-1).
Aditya Bardia, Sara A. Hurvitz, Angela DeMichele, Amy S. Clark, Amelia Zelnak, Denise A. Yardley, Meghan Sri Karuturi, Tara Sanft, Sibel Blau, Lowell L. Hart, Cynthia ...> ;Clinical Cancer Research. 2021 Aug 1
14 citations
Chemotherapy-related amenorrhea (CRA) after adjuvant ado-trastuzumab emtansine (T-DM1) compared to paclitaxel in combination with trastuzumab (TH) (TBCRC033: ATEMPT Tr...
Kathryn J. Ruddy, Yue Zheng, Nabihah Tayob, Jiani Hu, Chau T. Dang, Denise A. Yardley, Steven J. Isakoff, Vicente Valero, Meredith Faggen, Therese M. Mulvey, Ron Bose,...> ;Breast Cancer Research and Treatment. 2021 Jun 12
62 citations
Adjuvant Trastuzumab Emtansine Versus Paclitaxel in Combination With Trastuzumab for Stage I HER2-Positive Breast Cancer (ATEMPT): A Randomized Clinical Trial
Sara M. Tolaney, Nabihah Tayob, Chau T. Dang, Denise A. Yardley, Steven J. Isakoff, Vicente Valero, Meredith Faggen, Therese M. Mulvey, Ron Bose, Jiani Hu, Douglas Wec...> ;Journal of Clinical Oncology. 2021 Jun 2
25 citations
Glembatumumab vedotin for patients with metastatic, gpNMB overexpressing, triple-negative breast cancer (“METRIC”): a randomized multicenter study
Linda T. Vahdat, Peter Schmid, Andres Forero-Torres, Kimberly L. Blackwell, Melinda L. Telli, Michelle E. Melisko, Volker Möbus, Javier Cortes, Alberto J. Montero, Cyn...> ;NPJ Breast Cancer. 2021 May 20
70 citations
Impact of HER2 Heterogeneity on Treatment Response of Early-Stage HER2-Positive Breast Cancer: Phase II Neoadjuvant Clinical Trial of T-DM1 Combined with Pertuzumab.
Otto Metzger Filho, Giuseppe Viale, Shayna Stein, Lorenzo Trippa, Denise A. Yardley, Ingrid A. Mayer, Vandana G Abramson, Carlos L. Arteaga, Laura Spring, Adrienne G. ...> ;Cancer Discovery. 2021 May 3
175 citations
Efficacy of Margetuximab vs Trastuzumab in Patients With Pretreated ERBB2-Positive Advanced Breast Cancer: A Phase 3 Randomized Clinical Trial.
Hope S. Rugo, Seock-Ah Im, Fatima Cardoso, Javier Cortes, Giuseppe Curigliano, Antonino Musolino, Mark D. Pegram, Gail S. Wright, Cristina Saura, Santiago Escrivá-de-R...> ;JAMA Oncology. 2021 Apr 1
5 citations
Baseline characteristics and first-line treatment patterns in patients with HER2-positive metastatic breast cancer in the SystHERs registry
Peter A. Kaufman, Sara A. Hurvitz, Joyce O'Shaughnessy, Ginny Mason, Denise A. Yardley, Adam Brufsky, Hope S. Rugo, Melody A. Cobleigh, Sandra M. Swain, Debu Tripathy,...> ;Breast Cancer Research and Treatment. 2021 Feb 28
66 citations
A Phase II Study of Abemaciclib in Patients with Brain Metastases Secondary to Hormone Receptor-Positive Breast Cancer.
Sara M Tolaney, Solmaz Sahebjam, Emilie Le Rhun, Thomas Bachelot, Peter Kabos, Ahmad Awada, Denise Yardley, Arlene Chan, Pierfranco Conte, Véronique Diéras, Nancy U Li...> ;Clinical Cancer Research. 2020 Oct 15
24 citations
A Randomized Placebo Controlled Phase II Trial Evaluating Exemestane with or without Enzalutamide in Patients with Hormone Receptor-Positive Breast Cancer.
Ian E. Krop, Vandana G. Abramson, Marco Colleoni, Tiffany A. Traina, Frankie A. Holmes, Laura García-Estévez, Lowell L. Hart, Ahmad Awada, Claudio Zamagni, Patrick G. ...> ;Clinical Cancer Research. 2020 Sep 28
2 citations
Real-world survival outcomes of heavily pretreated patients with refractory HR+, HER2−metastatic breast cancer receiving single-agent chemotherapy—a comparison with MO...
Hope S. Rugo, Véronique Diéras, Javier Cortes, Debra A. Patt, Hans Wildiers, Joyce O'Shaughnessy, Esther Zamora, Denise A. Yardley, Gebra Cuyun Carter, Kristin M Sheff...> ;Breast Cancer Research and Treatment. 2020 Aug 12
2 citations
Correction to: A window-of-opportunity trial of the CXCR1/2 inhibitor reparixin in operable HER-2-negative breast cancer.
Lori J. Goldstein, Raymond P. Perez, Denise A. Yardley, Linda K. Han, James M. Reuben, Hui Gao, Susan McCanna, Beth Butler, Pier Adelchi Ruffini, Yi Liu, Roberto R. Ro...> ;Breast Cancer Research. 2020 May 20
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Journal Articles

Efficacy of Margetuximab vs Trastuzumab in Patients with Pretreated ERBB2-Positive Advanced Breast Cancer
Denise A Yardley, William J Gradishar, JAMA Oncology

Press Mentions

OS Advances Gather Steam in Breast CancerNovember 13th, 2022
Sarah Cannon to Present Latest Cancer Research Insights at ASCO®20 Virtual MeetingMay 28th, 2020
Dr. Yardley on the Utility of CDK4/6 Inhibitors in Metastatic HR+ Breast CancerJanuary 15th, 2020
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