Published Manuscripts
Rugo HS, Campbell M, Yau C, et al. Pexidartinib and standard neoadjuvant therapy in the adaptively randomized I-SPY2 trial for early breast cancer. Breast Cancer Res Treat. 2024 Dec 3. doi: 10.1007/s10549-024-07555-9. PMID: 39625569
Albain KS, Yau C, Petricoin EF, et al. Neoadjuvant Trebananib plus Paclitaxel-based Chemotherapy for Stage II/III Breast Cancer in the Adaptively Randomized I-SPY2 Trial—Efficacy and Biomarker Discovery. Clin Cancer Res30:729-740, 2024.
Kyalwazi B, Yau C, Campbell MJ, et al. Race, Gene Expression Signatures, and Clinical Outcomes of Patients With High-Risk Early Breast Cancer. JAMA Network Open6:e2349646, 2023.
Gallagher RI, Wulfkuhle J, Wolf DM, et al. Protein signaling and drug target activation signatures to guide therapy prioritization: Therapeutic resistance and sensitivity in the I-SPY 2 Trial. Cell Rep MedPublished online 2023:101312:, 2023.
Perlmutter J, Brain S, Brown T, et al. Advocate involvement in Clinical Trials: Lessons from the Patient-centric I-SPY2 Breast Cancer Trial. Med Res Arch11 (7.2):, 2023.
Boughey JC, Yu H, Dugan CL, et al. Changes in Surgical Management of the Axilla Over 11 Years – Report on More Than 1500 Breast Cancer Patients Treated with Neoadjuvant Chemotherapy on the Prospective I-SPY2 Trial. Ann Surg Oncol(published online):1-10, 2023.
Mukhtar RA, Chau H, Woriax H, et al. Breast Conservation Surgery and Mastectomy have Similar Locoregional Recurrence Following Neoadjuvant Chemotherapy: Results from 1,462 Patients on the Prospective, Randomized I-SPY2 Trial. Ann Surg(published ahead of print):, 2023.
Yu K, Basu A, Yau C, Wolf DM, Goodarzi H, Bandyopadhyay S, Korkola JE, Hirst GL, Asare S, DeMichele A, Hylton N, Yee D, Esserman L, van ‘t Veer L, Sirota M Computational drug repositioning for the identification of new agents to sensitize drug-resistant breast tumors across treatments and receptor subtypes. Frontiers in Oncol13:1192208, 2023.
Magbanua MGM, Brown-Swigart L, Ahmed Z, et al. Clinical significance and biology of circulating tumor DNA in high-risk early-stage HER2-negative breast cancer receiving neoadjuvant chemotherapy. Cancer Cell:, 2023.
Parker BA, Shatsky RA, Schwab RB, et al. Association of baseline ROR1 and ROR2 gene expression with clinical outcomes in the I-SPY2 neoadjuvant breast cancer trial. Breast Cancer Res Treat199:281–291, 2023.
Chitalia R, Miliotis M, Jahani N, et al. Radiomic tumor phenotypes augment molecular profiling in predicting recurrence free survival after breast neoadjuvant chemotherapy. Communications Med3:46, 2023.
Magbanua MGM, van ‘t Veer L, Clark AS, et al. Outcomes and clinicopathologic characteristics associated with disseminated tumor cells in bone marrow after neoadjuvant chemotherapy in high-risk early stage breast cancer: the I-SPY SURMOUNT study. Breast Cancer Res Treat198:383–390, 2023.
Lang JE, Forero-Torres A, Yee D, et al Safety and efficacy of HSP90 inhibitor ganetespib for neoadjuvant treatment of stage II/III breast cancer. npj Breast Cancer8:128, 2022.
Li W, Le NN, Onishi N, et al Diffusion-Weighted MRI for Predicting Pathologic Complete Response in Neoadjuvant Immunotherapy. Cancers14:4436-4448, 2022.
Osdoit M, Yau C, Symmans WF, et al. Association of Residual Ductal Carcinoma In Situ With Breast Cancer Recurrence in the Neoadjuvant I-SPY2 Trial. JAMA Surgery157:1034–1041, 2022.
Chitalia R, Pati S, Bhalerao M, et al. Expert tumor annotations and radiomics for locally advanced breast cancer in DCE-MRI for ACRIN 6657/I-SPY1. Scientific Data 9:440, 2022.
Wolf DM, Yau C, Wulfkuhle JD, et al. Redefining breast cancer subtypes to guide treatment prioritization and maximize response: Predictive biomarkers across 10 cancer therapies. Cancer Cell40:P609-623.E6, 2022.
Marczyk M, Mrukwa A, Yau C, et al. Treatment Efficacy Score—continuous residual cancer burden-based metric to compare neoadjuvant chemotherapy efficacy between randomized trial arms in breast cancer trials. Annals of Oncology33:814–823, 2022.
Le NN, Li W, Onishi N, et al. Effect of Inter-Reader Variability on Diffusion-Weighted MRI Apparent Diffusion Coefficient Measurements and Prediction of Pathologic Complete Response for Breast Cancer. Tomography8:1208–1220, 2022.
Thakran S, Cohen E, Jahani N, et al. Impact of deformable registration methods for prediction of recurrence free survival response to neoadjuvant chemotherapy in breast cancer: Results from the ISPY 1/ACRIN 6657 trial. Translat Oncol20:101411, 2022.
Nguyen AA-T, Onishi N, Carmona-Bozo J, et al. Post-Processing Bias Field Inhomogeneity Correction for Assessing Background Parenchymal Enhancement on Breast MRI as a Quantitative Marker of Treatment Response. Tomography8:891–904, 2022.
Yau C, Osdoit M, van der Noordaa M, et al. Residual cancer burden after neoadjuvant chemotherapy and long-term survival outcomes in breast cancer: a multicentre pooled analysis of 5161 patients. Lancet Oncol 23:149-160, 2021.
Clark AS, Yau C, Wolf DM, et al. Neoadjuvant T-DM1/pertuzumab and paclitaxel/trastuzumab/pertuzumab for HER2+ breast cancer in the adaptively randomized I-SPY2 trial. Nature Comm 12: 6428, 2021.
Engebraaten O, Yau C, Berg K, et al. RAB5A expression is a predictive biomarker for trastuzumab emtansine in breast cancer. Nature Comm 12: 6427, 2021.
Yee D, Isaacs C, Wolf D, et al. Ganitumab and metformin plus standard neoadjuvant therapy in stage 2/3 breast cancer. Npj Breast Cancer 7: 131, 2021.
Symmans WF, Yau C, Chen YY, et al. Assessment of Residual Cancer Burden and Event-Free Survival in Neoadjuvant Treatment for High-risk Breast Cancer: An Analysis of Data From the I-SPY2 Randomized Clinical Trial. JAMA Onc 7: 1654-1663, 2021.
Onishi N, Li W, Newitt DC, et al. Breast MRI during Neoadjuvant Chemotherapy: Lack of Background Parenchymal Enhancement Suppression and Inferior Treatment Response. Radiology 301: 295–308, 2021.
Gonzalez-Ericsson PI, Wulfkhule JD, Gallagher RI, et al. Tumor-Specific Major Histocompatibility-II Expression Predicts Benefit to Anti–PD-1/L1 Therapy in Patients With HER2-Negative Primary Breast Cancer. Clin Cancer Res 27: 5299-5306, 2021.
Pusztai L, Yau C, Wolf DM, et al. Durvalumab with olaparib and paclitaxel for high-risk HER2-negative stage II/III breast cancer: Results from the adaptively randomized I-SPY2 trial. Cancer Cell 39: 989-998, 2021.
O’Grady N, Gibbs DL, Abdilleh K, et al. PRoBE the cloud toolkit: finding the best biomarkers of drug response within a breast cancer clinical trial. JAMIA Open 4: ooab038, 2021.
Liefaard M, Lips E, Wesseling J, et al. The Way of the Future: Personalizing Treatment Plans Through Technology. ASCO EDUCATIONAL BOOK 41: 12-23, 2021.
Magbanua MJM, Li W, Wolf DM, et al. Circulating tumor DNA and magnetic resonance imaging to predict neoadjuvant chemotherapy response and recurrence risk. NPJ 7:, 2021.
Du L, Yau C, Brown-Swigart L, et al. Predicted sensitivity to endocrine therapy for stage II-III hormone receptor-positive and HER2-negative (HR+/HER2−) breast cancer before chemo-endocrine therapy. Annals of Oncology : , 2021.
Potter DA, Herrera-Ponzanelli CA, Hinojosa D, et al. Recent advances in neoadjuvant therapy for breast cancer. Fac Rev 10:, 2021.
Tan ET, Wilmes LJ, Joe BN, et al. Denoising and Multiple Tissue Compartment Visualization of Multi‐b‐Valued Breast Diffusion MRI. J Mag Res Imaging 53:271–282, 2021.
Li W, Newitt DC, Gibbs J, et al. Predicting breast cancer response to neoadjuvant treatment using multi-feature MRI: results from the I-SPY 2 TRIAL. NPJ Breast Cancer 6:63, 2020.
Magbanua M, Brown-Swigart L, Wu H, et al. Circulating tumor DNA in neoadjuvant-treated breast cancer reflects response and survival. Ann Oncol 32:229-239, 2020.
Basu A, Philip EJ, Dewitt B, et al. The quality of life index: a pilot study integrating treatment efficacy and quality of life in oncology. NPJ Breast Cancer 6:52, 2020.
Wolf DM, Yau C, Wulfkuhle J, et al. Mechanism of action biomarkers predicting response to AKT inhibition in the I-SPY 2 breast cancer trial. NPJ Breast Cancer 6:48, 2020.
I-SPY Trial Consortium. Association of Event-Free and Distant Recurrence–Free Survival With Individual-Level Pathologic Complete Response in Neoadjuvant Treatment of Stages 2 and 3 Breast Cancer. JAMA Oncol 6:1355-1362, 2020.
Arasu VA, Kim P, Li W, et al. Predictive Value of Breast MRI Background Parenchymal Enhancement for Neoadjuvant Treatment Response among HER2− Patients. J Breast Imaging 2:352-360, 2020.
Jones EF, Hathi DK, Freimanis R, et al. Current Landscape of Breast Cancer Imaging and Potential Quantitative Imaging Markers of Response in ER-Positive Breast Cancers Treated with Neoadjuvant Therapy. Cancers 12:1511, 2020.
Li W, Newitt DC, Yun BL, et al. Tumor Sphericity Predicts Response in Neoadjuvant Chemotherapy for Invasive Breast Cancer. Tomogr 6:216-222, 2020.
Nguyen AA-T, Arasu VA, Strand F, et al. Comparison of Segmentation Methods in Assessing Background Parenchymal Enhancement as a Biomarker for Response to Neoadjuvant Therapy. Tomography 6:101–110, 2020.
Onishi N, Li W, Gibbs J, et al. Impact of MRI Protocol Adherence on Prediction of Pathological Complete Response in the I-SPY 2 Neoadjuvant Breast Cancer Trial. Tomography 6:77–85, 2020.
Malyarenko DI, Newitt DC, Amouzandeh G, et al. Retrospective Correction of ADC for Gradient Nonlinearity Errors in Multicenter Breast DWI Trials: ACRIN6698 Multiplatform Feasibility Study. Tomography 6:86-92, 2020.
Nanda R, Liu MC, Yau C, et al. Effect of Pembrolizumab Plus Neoadjuvant Chemotherapy on Pathologic Complete Response in Women With Early-Stage Breast Cancer. JAMA Oncol 6:676-684, 2020.
Chien AJ, Tripathy D, Albain KS, et al. MK-2206 and Standard Neoadjuvant Chemotherapy Improves Response in Patients With Human Epidermal Growth Factor Receptor 2–Positive and/or Hormone Receptor–Negative Breast Cancers in the I-SPY 2 Trial. J Clin Oncol 38:1059-1069, 2020.
Jahani N, Cohen E, Hsieh M-K, et al. Prediction of Treatment Response to Neoadjuvant Chemotherapy for Breast Cancer via Early Changes in Tumor Heterogeneity Captured by DCE-MRI Registration. Scientific Reports 9:12114, 2019.
Piawah S, Hyland C, Umetsu SE, et al. A case report of vanishing bile duct syndrome after exposure to pexidartinib (PLX3397) and paclitaxel. NPJ Breast Cancer 5:17, 2019.
Li W, Newitt DC, Wilmes LJ, et al. Additive value of diffusion-weighted MRI in the I-SPY 2 TRIAL. J Magn Reson Imaging 50:1742-1753, 2019.
Partridge SC, Newitt DC, Chenevert TL, et al. Diffusion-weighted MRI in Multicenter Trials of Breast Cancer. Radiol 291:546–546, 2019.
Newitt DC, Zheng Z, Gibbs JE, et al. Test–retest repeatability and reproducibility of ADC measures by breast DWI: Results from the ACRIN 6698 trial. J Mag Res Imag 49:1617-1628, 2019.
Esserman L, Hylton N, Asare S, et al. I-SPY2: Unlocking the Potential of the Platform Trial. In Z. Antonijevic & R. A. Beckman (Eds.), Platform Trial Designs in Drug Development: Umbrella Trials and Basket Trials (Chapman and Hall/CRC); pp. 3-22, 2018.
Partridge SC, Zhang Z, Newitt DC, et al. Diffusion-weighted MRI Findings Predict Pathologic Response in Neoadjuvant Treatment of Breast Cancer: The ACRIN 6698 Multicenter Trial. Radiol 289:618-627, 2018.
Boughey JC, Alvarado MD, Lancaster RB, et al. Surgical Standards for Management of the Axilla in Breast Cancer Clinical Trials with Pathological Complete Response Endpoint. NPJ Breast Cancer 4:26, 2018.
Wulfkuhle JD, Yau C, Wolf DM, et al. Evaluation of the HER/PI3K/AKT Family Signaling Network as a Predictive Biomarker of Pathologic Complete Response for Patients With Breast Cancer Treated With Neratinib in the I-SPY 2 TRIAL. JCO Precision Oncology 2:1-20, 2018.
Scheel JR, Kim E, Partridge SC, et al. MRI, Clinical Examination, and Mammography for Preoperative Assessment of Residual Disease and Pathologic Complete Response After Neoadjuvant Chemotherapy for Breast Cancer: ACRIN 6657 Trial. Am J Roentgenol 210:1376-1385, 2018.
Drukker K, Li H, Antropova N, et al. Most-enhancing tumor volume by MRI radiomics predicts recurrence-free survival “early on” in neoadjuvant treatment of breast cancer. Cancer Imaging 18:12, 2018.
Olshen A, Wolf D, Jones EF, et al. Features of MRI stromal enhancement with neoadjuvant chemotherapy: a subgroup analysis of the ACRIN 6657/I-SPY TRIAL. J Med Imaging 5:11014, 2018.
Severson TM, Wolf DM, Yau C, et al. The BRCA1 ness signature is associated significantly with response to PARP inhibitor treatment versus control in the I-SPY 2 randomized neoadjuvant setting. Breast Cancer Res 19:99, 2017.
Wolf DM, Yau C, Sanil A, et al. DNA repair deficiency biomarkers and the 70-gene ultra-high risk signature as predictors of veliparib/carboplatin response in the I-SPY 2 breast cancer trial. NPJ Breast Cancer 3:, 2017.
Campbell JI, Yau C, Krass P, et al. Comparison of residual cancer burden, American Joint Committee on Cancer staging and pathologic complete response in breast cancer after neoadjuvant chemotherapy: results from the I-SPY 1 TRIAL (CALGB 150007/150012; ACRIN 6657). Breast Cancer Res Treat 165:181-191, 2017.
Vidula N, Yau C, Li J, et al. Receptor activator of nuclear factor kappa B (RANK) expression in primary breast cancer correlates with recurrence-free survival and development of bone metastases in I-SPY1 (CALGB 150007/150012; ACRIN 6657). Breast Cancer Res Treat 165:129-138, 2017.
Jones EF, Ray KM, Li W, et al. Dedicated Breast Positron Emission Tomography for the Evaluation of Early Response to Neoadjuvant Chemotherapy in Breast Cancer. Clin Breast Cancer 17:e155–e159, 2017.
Bolan PJ, Kim E, Herman BA, et al. MR spectroscopy of breast cancer for assessing early treatment response: Results from the ACRIN 6657 MRS trial. J Mag Res Imaging 46:290-302, 2017.
Li W, Arasu V, Newitt DC, et al. Effect of MR Imaging Contrast Thresholds on Prediction of Neoadjuvant Chemotherapy Response in Breast Cancer Subtypes: A Subgroup Analysis of the ACRIN 6657/I-SPY 1 TRIAL. Tomography 2:378-387, 2016.
Rugo HS, Olopade, OI, DeMichele A, et al. Adaptive randomization of veliparib-carboplatin treatment in breast cancer. New Engl J Med 375:23-34, 2016.
Park JW, Liu MC, Yee D, et al. Adaptive Randomization of Neratinib in Early Breast Cancer. N Engl J Med 375:11-22, 2016.
Hylton NM, Gatsonis CA, Rosen MA, et al. Neoadjuvant Chemotherapy for Breast Cancer: Functional Tumor Volume by MR Imaging Predicts Recurrence-free Survival—Results from the ACRIN 6657/CALGB 150007 I-SPY 1 TRIAL. Radiol 279:44–55, 2016.
Magbanua MJM, Wolf DM, Yau C, et al. Serial expression analysis of breast tumors during neoadjuvant chemotherapy reveals changes in cell cycle and immune pathways associated with recurrence and response. Breast Cancer Res 17:73, 2015.
DeMichele A, Yee D, Berry D, et al. The Neoadjuvant Model Is Still the Future for Drug Development in Breast Cancer. Clinical Cancer Research 21:2911-2915, 2015.
Price ER, Wong J, Mukhtar R, et al. How to use magnetic resonance imaging following neoadjuvant chemotherapy in locally advanced breast cancer. World J Clinical Cases 3:607-613, 2015.
Clark AS, Chen J, Kapoor S, et al. Pretreatment vitamin D level and response to neoadjuvant chemotherapy in women with breast cancer on the I‐SPY trial (CALGB 150007/150015/ACRIN6657). Cancer Medicine 3:693-701, 2014.
Newitt DC, Aliu SO, Witcomb N, et al. Real-Time Measurement of Functional Tumor Volume by MRI to Assess Treatment Response in Breast Cancer Neoadjuvant Clinical Trials: Validation of the Aegis SER Software Platform. Translat Oncol 7:94-100, 2014.
Cureton EL, Yau C, Alvarado MD, et al. Local Recurrence Rates are Low in High-Risk Neoadjuvant Breast Cancer in the I-SPY 1 Trial (CALGB 150007/150012; ACRIN 6657). Ann Surg Oncol 21:2889-2896, 2014.
Alvarez JV, Pan T-C, Ruth J, et al. Par-4 Downregulation Promotes Breast Cancer Recurrence by Preventing Multinucleation following Targeted Therapy. Cancer Cell 24:30-44, 2013.
Mukhtar RA, Yau C, Rosen M, et al. Clinically Meaningful Tumor Reduction Rates Vary by Prechemotherapy MRI Phenotype and Tumor Subtype in the I-SPY 1 TRIAL (CALGB 150007/150012; ACRIN 6657). Ann Surg Oncol 20:3823-3830, 2013.
DeMichele A, Berry DA, Zujewski J, et al. Developing Safety Criteria for Introducing New Agents into Neoadjuvant Trials. Clinical Cancer Research 19:2817-2823, 2013.
Glück S, de Snoo F, Peeters J, et al. Molecular subtyping of early-stage breast cancer identifies a group of patients who do not benefit from neoadjuvant chemotherapy. Breast Cancer Res Treat 139:759-767, 2013.
Yee D, Haddad T, Albain K, et al. Adaptive trials in the neoadjuvant setting: a model to safely tailor care while accelerating drug development [Correspondence]. J. Clin. Oncol. 30:Jun-84, 2012.
Esserman LJ, Barker AD, Woodcock J, et al. A Model for Accelerating Identification and Regulatory Approval of Effective Investigational Agents. Cureus 4:e76, 2012.
Wulfkuhle JD, Berg D, Wolff C, et al. Molecular Analysis of HER2 Signaling in Human Breast Cancer by Functional Protein Pathway Activation Mapping. Clinical Cancer Research 18:6426-6435, 2012.
Esserman LJ, Berry DA, DeMichele A, et al. Pathologic complete response predicts recurrence-free survival more effectively by cancer subset: results from the I-SPY 1 TRIAL–CALGB 150007/150012, ACRIN 6657. J Clin Oncol 30:3242-3249, 2012.
Lips EH, Mukhtar RA, Yau C, et al. Lobular histology and response to neoadjuvant chemotherapy in invasive breast cancer. Breast Cancer Res Treat 136:35-43, 2012.
Hylton NM, Blume JD, Bernreuter WK, et al. Locally Advanced Breast Cancer: MR Imaging for Prediction of Response to Neoadjuvant Chemotherapy—Results from ACRIN 6657/I-SPY TRIAL. Radiology 263:663-672, 2012.
Lin C, Buxton MB, Moore D, et al. Locally advanced breast cancers are more likely to present as Interval Cancers: results from the I-SPY 1 TRIAL (CALGB 150007/150012, ACRIN 6657, InterSPORE Trial). Breast Cancer Res Treat 132:871-879, 2012.
Esserman LJ, Berry DA, Cheang MCU, et al. Chemotherapy response and recurrence-free survival in neoadjuvant breast cancer depends on biomarker profiles: results from the I-SPY 1 TRIAL (CALGB 150007/150012; ACRIN 6657). Breast Cancer Res Treat 132:1049-1062, 2012.
Esserman LJ, Woodcock J. Accelerating identification and regulatory approval of investigational cancer drugs. JAMA 306:2608-2609, 2011.
Perlmutter, J. Advocate Involvement in I-SPY 2. Breast Disease: A Year Book Quarterly 22:21-24, 2011.
Barker AD, Sigman CC, Kelloff GJ, et al. I-SPY 2: an adaptive breast cancer trial design in the setting of neoadjuvant chemotherapy. Clinical Pharmacol & Therapeutics 86:97-100, 2009.