[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT01042379":3,"trial-entities:NCT01042379":951,"trial-summary:NCT01042379":305},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":30,"study_type":43,"primary_purpose":44,"phases":45,"enrollment_info":47,"interventions":50,"primary_outcomes":287,"secondary_outcomes":291,"sex":303,"minimum_age":304,"maximum_age":305,"healthy_volunteers":306,"eligibility_criteria":307,"std_ages":330,"locations":333,"central_contacts":805,"overall_officials":813,"references":817,"see_also_links":938},"NCT01042379","097517","I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer","I-SPY Trial (Investigation of Serial Studies to Predict Your Therapeutic Response With Imaging And moLecular Analysis 2)","RECRUITING","2031-12","2026-05","2026-05-06","2010-03-01","QuantumLeap Healthcare Collaborative","OTHER",true,"The purpose of this study is to further advance the ability to practice personalized medicine by learning which new drug agents are most effective with which types of breast cancer tumors and by learning more about which early indicators of response (tumor analysis prior to surgery via magnetic resonance imaging (MRI) images along with tissue and blood samples) are predictors of treatment success.","I-SPY2 will assess the efficacy of novel drugs in sequence with standard chemotherapy. The goal is identify treatment strategies for subsets on the basis of molecular characteristics (biomarker signatures) of their disease with high estimated pCR rate. As described for previous adaptive trials, novel regimens with sufficiently high activities alone and contribute to treatment strategies that show a high Bayesian predictive probability of being more effective than the dynamic control will graduate from the trial with their corresponding biomarker signature(s). Treatment strategies will be dropped if they show a low probability of improved efficacy with any biomarker signature. New drugs will enter as those that have undergone testing complete their evaluation.",[19,20,21,22,23,24,25,26,27,28,29],"Breast Neoplasms","Breast Cancer","Breast Tumors","Angiosarcoma","TNBC - Triple-Negative Breast Cancer","HER2-positive Breast Cancer","HER2-negative Breast Cancer","Hormone Receptor Positive Tumor","Hormone Receptor Negative Tumor","Early-stage Breast Cancer","Locally Advanced Breast Cancer",[31,32,33,34,35,36,37,38,39,40,41,42],"Neoadjuvant","Breast","Cancer","Neoplasm","Adaptive","pCR","Pathologic Complete Response","Biomarkers signature","MRI Volume","Endocrine Therapy","Chemotherapy","Immunotherapy","INTERVENTIONAL","TREATMENT",[46],"PHASE2",{"count":48,"type":49},5000,"ESTIMATED",[51,58,64,70,75,80,85,91,94,99,102,105,109,112,116,120,124,127,131,136,140,144,150,154,160,165,172,179,186,191,196,204,211,217,222,227,232,237,242,247,252,257,262,267,272,277],{"type":52,"name":53,"description":54,"armGroupLabels":55,"otherNames":56},"DRUG","Standard Therapy","Paclitaxel: 80 mg\u002Fm2 IV during the 12 weekly treatment cycles post randomization; Doxorubicin: 60 mg\u002Fm2 IV after completion of the 12 weekly treatment cycles and prior to surgery for weeks 13-16; Cyclophosphamide: 600 mg\u002Fm2 IV after completion of the 12 weekly treatment cycles and prior to surgery for weeks 13-16",[53],[57],"Paclitaxel (Taxol); Doxorubicin (Adriamycin)",{"type":52,"name":59,"description":60,"armGroupLabels":61,"otherNames":62},"AMG 386 with or without Trastuzumab","Arm is closed.",[59],[63],"AMG 386 (Trebananib); (Trastuzumab) Herceptin",{"type":52,"name":65,"description":60,"armGroupLabels":66,"otherNames":68},"AMG 479 (Ganitumab) plus Metformin",[67],"AMG 479 plus Metformin",[69],"Ganitumab",{"type":52,"name":71,"description":60,"armGroupLabels":72,"otherNames":73},"MK-2206 with or without Trastuzumab",[71],[74],"(Trastuzumab) Herceptin",{"type":52,"name":76,"description":60,"armGroupLabels":77,"otherNames":78},"AMG 386 and Trastuzumab",[59],[79],"AMG 386 (Trebananib); Trastuzumab (Herceptin)",{"type":52,"name":81,"description":60,"armGroupLabels":82,"otherNames":83},"T-DM1 and Pertuzumab",[81],[84],"T-DM1 (Trastuzumab emtansine); Pertuzumab (Perjeta)",{"type":52,"name":86,"description":87,"armGroupLabels":88,"otherNames":89},"Pertuzumab and Trastuzumab","Arm is closed for Accrual.\n\nPertuzumab: 840 mg IV (loading dose) week 1 and 420 mg every 3 weeks (weeks 4, 7, 10) post-randomization; Trastuzumab: 4 mg\u002Fkg (loading dose) week 1 and 2 mg\u002Fkg weekly (weeks 2-12) post-randomization",[86],[90],"Pertuzumab (Perjeta); Trastuzumab (Herceptin)",{"type":52,"name":92,"description":60,"armGroupLabels":93},"Ganetespib",[92],{"type":52,"name":95,"description":60,"armGroupLabels":96,"otherNames":97},"ABT-888",[95],[98],"Veliparib",{"type":52,"name":100,"description":60,"armGroupLabels":101},"Neratinib",[100],{"type":52,"name":103,"description":60,"armGroupLabels":104},"PLX3397",[103],{"type":52,"name":106,"description":60,"armGroupLabels":107},"Pembrolizumab - 4 cycle",[108],"Pembrolizumab 4 cycle",{"type":52,"name":110,"description":60,"armGroupLabels":111},"Talazoparib plus Irinotecan",[110],{"type":52,"name":113,"description":60,"armGroupLabels":114},"Patritumab and Trastuzumab",[115],"Patritumab with or without Trastuzumab",{"type":52,"name":117,"description":60,"armGroupLabels":118},"Pembrolizumab - 8 cycle",[119],"Pembrolizumab 8 cycle",{"type":52,"name":121,"description":122,"armGroupLabels":123},"SGN-LIV1A","Arm is closed. SGN-LIV1A: 2.5 mg\u002Fkg IV cycles 1,4,7,10 Doxorubicin + Cyclophosphamide: Cycles 13-16",[121],{"type":52,"name":125,"description":60,"armGroupLabels":126},"Durvalumab plus Olaparib",[125],{"type":52,"name":128,"description":129,"armGroupLabels":130},"SD-101 + Pembrolizumab","Arm is closed. SD-101: IT injection 2 mg\u002Fml (1 ml for T2 tumors, 2 ml for \\>T3 tumors) weekly x 4, then every 3 weeks x 2 cycles 1,2,3,4,7,10 Pembrolizumab: 200mg IV cycles 1,4,7,10 Paclitaxel: 80 mg\u002Fm2 IV cycles 1-12 Doxorubicin + Cyclophosphamide: Cycles 13-16; Doxorubicin: 60 mg\u002Fm2 IV Every 2 or 3 weeks for 4 cycles; Cyclophosphamide: 600 mg\u002Fm2 IV Every 2 or 3 weeks for 4 cycles",[128],{"type":52,"name":132,"description":133,"armGroupLabels":134},"Tucatinib plus trastuzumab and pertuzumab","Arm is closed. Tucatinib: 300 mg PO BID 12 weeks CLOSED Tucatinib: 250 mg PO BID 12 weeks CLOSED Tucatinib adaptive: 150mg BID days 1-28, 250mg BID days 29-84 Trastuzumab: 4 mg\u002Fkg IV (loading dose) cycle 1; 2 mg\u002Fkg (thereafter) cycles 2-12 Pertuzumab: 840 mg IV (loading dose) cycle 1; 420 mg (thereafter) cycles 4, 7 and 10 Paclitaxel: 80 mg\u002Fm2 IV cycles 1-12 Doxorubicin + Cyclophosphamide: Cycles 13-16; Doxorubicin: 60 mg\u002Fm2 IV Every 2 or 3 weeks for 4 cycles; Cyclophosphamide: 600 mg\u002Fm2 IV Every 2 or 3 weeks for 4 cycles",[135],"Tucatinib",{"type":52,"name":137,"description":138,"armGroupLabels":139},"Cemiplimab","Cemiplimab: 350 mg q3w X 12 weeks IV cycles 1,4,7,10 Paclitaxel: 80 mg\u002Fm2 IV cycles 1-12 Doxorubicin + Cyclophosphamide: Cycles 13-16; Doxorubicin: 60 mg\u002Fm2 IV Every 2 or 3 weeks for 4 cycles; Cyclophosphamide: 600 mg\u002Fm2 IV Every 2 or 3 weeks for 4 cycles",[137],{"type":52,"name":141,"description":142,"armGroupLabels":143},"Cemiplimab plus REGN3767","Arm is closed.\n\nCemiplimab: 350 mg q3w X 12 weeks IV cycles 1,4,7,10 REGN 3767: 1600 mg q3W X 12 weeks IV cycles 1,4,7,10 Paclitaxel: 80 mg\u002Fm2 IV cycles 1-12 Doxorubicin + Cyclophosphamide: Cycles 13-16; Doxorubicin: 60 mg\u002Fm2 IV Every 2 or 3 weeks for 4 cycles; Cyclophosphamide: 600 mg\u002Fm2 IV Every 2 or 3 weeks for 4 cycles",[141],{"type":52,"name":145,"description":146,"armGroupLabels":147,"otherNames":148},"Trilaciclib with or without trastuzumab + pertuzumab","Arm closed for accrual.\n\nTrilaciclib: 240 mg\u002Fm2 IV weekly cycle 1-16 Paclitaxel: 80 mg\u002Fm2 IV cycles 1-12 Doxorubicin + Cyclophosphamide: Cycles 13-16; Doxorubicin: 60 mg\u002Fm2 IV Every 2 or 3 weeks for 4 cycles; Cyclophosphamide: 600 mg\u002Fm2 IV Every 2 or 3 weeks for 4 cycles\n\nFor HER2+:\n\nPertuzumab: 840 mg IV (loading dose) week 1 and 420 mg every 3 weeks (weeks 4, 7, 10) post-randomization Trastuzumab: 4 mg\u002Fkg (loading dose) week 1 and 2 mg\u002Fkg weekly (weeks 2-12) post-randomization",[145],[149],"Trilaciclib (G1T28); Pertuzumab (Perjeta); Trastuzumab (Herceptin)",{"type":52,"name":151,"description":152,"armGroupLabels":153},"SYD985 ([vic-]trastuzumab duocarmazine)","Arm is closed.\n\nSYD985: 1.2 mg\u002Fkg IV (q3w x 12 weeks) cycles 1,4,7,10 Doxorubicin + Cyclophosphamide: Cycles 13-16; Doxorubicin: 60 mg\u002Fm2 IV Every 2 or 3 weeks for 4 cycles; Cyclophosphamide: 600 mg\u002Fm2 IV Every 2 or 3 weeks for 4 cycles",[151],{"type":52,"name":155,"description":156,"armGroupLabels":157,"otherNames":158},"Oral Paclitaxel + Encequidar + Dostarlimab (TSR-042) + Carboplatin with or without trastuzumab","Arm is closed.\n\nFor HER2+ Dostarlimab (TSR-042), 500 mg, IV, q3wks for wk 1, 4, 7, 10 Trastuzumab, 4 mg\u002Fkg cycle 1, then 2 mg\u002Fkg cycles 2-12 q1wk, IV, for wk1-12 Oral paclitaxel, 205 mg\u002Fm2, oral, daily for Three (3) days in a row each week for weeks 1-12 Oral encequidar, 15 mg, oral, daily for Three (3) days in a row each week for weeks 1-12 Carboplatin, AUC 1.5, IV, q1wk from wk1-12 Followed by Doxorubicin: 60 mg\u002Fm2, IV, every 2 or 3 weeks for 4 cycles Cyclophosphamide: 600 mg\u002Fm2, IV, every 2 or 3 weeks for 4 cycle\n\nFor HER2- Dostarlimab (TSR-042), 500 mg, IV, q3wks for wk 1, 4, 7, 10 Oral paclitaxel, 205 mg\u002Fm2, oral, daily for Three (3) days in a row each week for weeks 1-12 Oral encequidar, 15 mg, oral, daily for Three (3) days in a row each week for weeks 1-12 Carboplatin, AUC 1.5, IV, q1wk from wk1-12 Followed by Doxorubicin: 60 mg\u002Fm2, IV, every 2 or 3 weeks for 4 cycles Cyclophosphamide: 600 mg\u002Fm2, IV, every 2 or 3 weeks for 4 cycle",[155],[159],"Oral Paclitaxel + Encequidar (Oraxol); Dostarlimab (TSR-042); Trastuzumab (Herceptin)",{"type":52,"name":161,"description":162,"armGroupLabels":163,"otherNames":164},"Oral Paclitaxel + Encequidar + Dostarlimab (TSR-042) with or without trastuzumab","Arm is closed.\n\nFor HER2+ Dostarlimab (TSR-042), 500 mg, IV, q3wks for wk 1, 4, 7, 10 Trastuzumab, 4 mg\u002Fkg cycle 1, then 2 mg\u002Fkg cycles 2-12 q1wk, IV, for wk1-12 Oral paclitaxel, 205 mg\u002Fm2, oral, daily for Three (3) days in a row each week for weeks 1-12 Oral encequidar, 15 mg, oral, daily for Three (3) days in a row each week for weeks 1-12 Followed by Doxorubicin: 60 mg\u002Fm2, IV, every 2 or 3 weeks for 4 cycles Cyclophosphamide: 600 mg\u002Fm2, IV, every 2 or 3 weeks for 4 cycle\n\nFor HER2- Dostarlimab (TSR-042), 500 mg, IV, q3wks for wk 1, 4, 7, 10 Oral paclitaxel, 205 mg\u002Fm2, oral, daily for Three (3) days in a row each week for weeks 1-12 Oral encequidar, 15 mg, oral, daily for Three (3) days in a row each week for weeks 1-12 Followed by Doxorubicin: 60 mg\u002Fm2, IV, every 2 or 3 weeks for 4 cycles Cyclophosphamide: 600 mg\u002Fm2, IV, every 2 or 3 weeks for 4 cycle",[161],[159],{"type":52,"name":166,"description":167,"armGroupLabels":168,"otherNames":170},"Amcenestrant","Arm is closed.\n\nAmcenestrant (SAR439859), 200mg QD, p.o., for 24 weeks.",[169],"Endocrine Optimization Pilot: Amcenestrant Monotherapy",[171],"SAR439859",{"type":52,"name":173,"description":174,"armGroupLabels":175,"otherNames":177},"Amcenestrant + Abemaciclib","Arm is closed.\n\nAmcenestrant (SAR439859), 200mg QD, p.o., for 24 weeks Abemaciclib (Verzenio), 150mg BID, p.o., for 24 weeks",[176],"Endocrine Optimization Pilot: Amcenestrant + Abemaciclib",[178],"Amcenestrant (SAR439859), Abemaciclib (Verzenio)",{"type":52,"name":180,"description":181,"armGroupLabels":182,"otherNames":184},"Amcenestrant + Letrozole","Arm is closed.\n\nAmcenestrant (SAR439859), 200mg QD, p.o., for 24 weeks Letrozole (Femara), 2.5mg QD, p.o., for 24 weeks",[183],"Endocrine Optimization Pilot: Amcenestrant + Letrozole",[185],"Amcenestrant (SAR439859), Letrozole (Femara)",{"type":52,"name":187,"description":188,"armGroupLabels":189},"ARX788","Arm is closed.\n\nARX788, 1.5 mg\u002Fkg Q3W, IV for 12 weeks",[190],"ARX788 in Block A and followed by SOC in Block B",{"type":52,"name":192,"description":193,"armGroupLabels":194},"ARX788 + Cemiplimab","Arm is closed.\n\nARX788, 1.5 mg\u002Fkg Q3W, IV for 12 weeks Cemiplimab, 350 mg Q3W, IV for 12 weeks",[195],"ARX788 + Cemiplimab in Block A and followed by SOC in Block B",{"type":52,"name":197,"description":198,"armGroupLabels":199,"otherNames":201},"VV1 + Cemiplimab","Arm is closed.\n\nVV1, 3x10\\^9 TCID50 once (day-8), Intra-tumoral injection Cemiplimab, 350 mg Q3W, IV for 12 weeks",[200],"VSV-IFNβ-NIS (VOYAGER V1™; VV1) + Cemiplimab in Block A and followed by SOC in block B",[202,203],"VOYAGER V1™","VSV-IFNβ-NIS",{"type":52,"name":205,"description":206,"armGroupLabels":207,"otherNames":209},"Datopotamab deruxtecan","Arm is closed.\n\nDato-DXd, 6 mg\u002Fkg Q3W, IV for 12 weeks",[208],"Datopotamab Deruxtecan in Block A and followed by SOC in block B",[210],"Dato-DXd",{"type":52,"name":212,"description":213,"armGroupLabels":214,"otherNames":216},"Datopotamab deruxtecan + Durvalumab","Arm is closed.\n\nDato-DXd, 6 mg\u002Fkg Q3W, IV for 12 weeks Durvalumab, 1120 mg Q3W, IV for 12 weeks",[215],"Datopotamab Deruxtecan + Durvalumab in Block A and followed by SOC in block B",[210],{"type":52,"name":218,"description":219,"armGroupLabels":220},"Zanidatamab","Zanidatamab: IV Infusion at a 2-tiered flat dose. 1,800mg (\\\u003C70 kg) and 2400mg (≥70 kg).\n\nNeoadjuvant doing of zanidatamab: The initial dose will be administered on Cycle 1 Day 1, with Cycle 2 Day 1 occurring 14 days thereafter, followed by subsequent dosing every 3 weeks (Q3W) for a total of up to 5 doses in block A, up to 4 doses Block B, up to 5 doses Block C.\n\nAdjuvant dosing of zanidatamab: Administered every 3 weeks (Q3W) for a total of 1 year of HER2 based therapy. The total number of adjuvant weeks will be dependent on the number of weeks of exposure of zanidatamab in Blocks A, B, and C.",[221],"Zanidatamab for Block ABC",{"type":52,"name":223,"description":224,"armGroupLabels":225},"Lasofoxifene","Arm is closed.\n\nLasofoxifene: 5.0 mg QD, p.o., for 24 weeks",[226],"Endocrine Optimization Pilot: Lasofoxifene",{"type":52,"name":228,"description":229,"armGroupLabels":230},"Z-endoxifen","Arm is closed.\n\nZ-endoxifen: 10 mg QD, p.o., for 24 weeks",[231],"Endocrine Optimization Pilot: (Z)-Endoxifen",{"type":52,"name":233,"description":234,"armGroupLabels":235},"ARV-471","Arm is closed.\n\nARV-471: 200 mg QD, p.o, for 24 weeks.",[236],"Endocrine Optimization Pilot: ARV-471",{"type":52,"name":238,"description":239,"armGroupLabels":240},"ARV-471 + Letrozole","Arm is closed.\n\nARV-471: 200 mg QD, p.o, for 24 weeks Letrozole: 2.5 mg QD, p.o, for 24 weeks",[241],"Endocrine Optimization Pilot: ARV-471 + Letrozole",{"type":52,"name":243,"description":244,"armGroupLabels":245},"ARV-471 + Abemaciclib","Arm is closed.\n\nARV-471: 200 mg QD, p.o, for 24 weeks Abemaciclib: 150 mg BID, p.o, for 24 weeks",[246],"Endocrine Optimization Pilot: ARV-471 + Abemaciclib",{"type":52,"name":248,"description":249,"armGroupLabels":250},"Endoxifen + Abemaciclib","Z-endoxifen: 80 mg QD, p.o., for 24 weeks Abemaciclib: 150 mg BID, p.o, for 20 weeks",[251],"Endocrine Optimization Pilot: (Z)-Endoxifen + Abemaciclib",{"type":52,"name":253,"description":254,"armGroupLabels":255},"Rilvegostomig + TDXd","Arm closed to accrual\n\nRilvegostomig: 750mg IV Q3W for 12 weeks TDXd: 5.4 mg\u002Fkg IV Q3W for 12 weeks",[256],"Rilvegostomig + TDXd in Block A and followed by SOC in Block B",{"type":52,"name":258,"description":259,"armGroupLabels":260},"Dan222 + Niraparib","Arm is closed.\n\nDAN222: 8mg\u002Fm2 IV QW for 12 weeks Niraparib: 200mg QD p.p., 12 weeks",[261],"DAN222 + Niraparib in Block A and followed by SOC in Block B",{"type":52,"name":263,"description":264,"armGroupLabels":265},"Sarilumab + Cemiplimab + Paclitaxel","Arm is closed to accrual.\n\nSarilumab: 200mg Subcutaneous injection Q2W for 12 weeks Cemiplimab: 350mg IV Q3W for 12 weeks Paclitaxel: 80 mg\u002Fm2 IV QW for 12 weeks",[266],"Sarilumab + Cemiplimab + Paclitaxel in Block B followed by SOC Block C",{"type":52,"name":268,"description":269,"armGroupLabels":270},"GSK 5733584","Arm is open for accrual.\n\nRoute: Intravenous infusion Dosage Form: 4.8 mg\u002Fkg intravenous Q3W for injection. Will receive a max of 12 weeks.",[271],"GSK 5733584 in Block A and followed by SOC in Block B",{"type":52,"name":273,"description":274,"armGroupLabels":275},"GSK 5733584 + Dostarlimab","Arm is open for accrual.\n\nGSK 5733584 Route: Intravenous Infusion Dosage Form: 4.8 mg\u002Fkg intravenous Q3W for injection x 12 weeks max.\n\nDostarlimab Route: Intravenous Infusion Dosage Form: 500 mg fixed dose intravenous Q3W for infusion x 12 weeks max.",[276],"GSK 5733584 + Dostarlimab in Block A and followed by SOC in Block B",{"type":52,"name":278,"description":279,"armGroupLabels":280,"otherNames":282},"Ivonescimab (20mg\u002Fkg Q3W)","Strengths to be used in trial:\n\n1. 20 mg\u002Fkg IV Q3W monotherapy\n2. 20 mg\u002Fkg IV Q3W with paclitaxel\n3. 20 mg\u002Fkg IV Q3W with carboplatin and paclitaxel.\n\nStandard Regimen:\n\n20 mg\u002Fkg IV Q3W. Patients in Block A will receive a minimum of 6 weeks a maximum of 12 weeks of Ivonescimab monotherapy in Block A. Patients that have completed Block A, may receive ivonescimab plus paclitaxel or ivonescimab plus paclitaxel plus carboplatin in Block B (depending on subtype).",[281],"Ivonescimab in Blocks A and B",[283,284,285,286],"AK112","SMT112","PD-1 \u002F VEGF bispecific antibody","依达方® (Yiwoxi Dankang Zhusheye)",[288],{"measure":289,"timeFrame":290},"Determine whether adding experimental agents to standard neoadjuvant medications increases the probability of pathologic complete response (pCR) over standard neoadjuvant chemotherapy for each biomarker signature established at trial entry.","Post surgery based on upto 36-week treatment",[292,295,298,301],{"measure":293,"timeFrame":294},"Establishing predictive and prognostic indices based on qualification and exploratory markers to predict pCR and residual cancer burden (RCB).","Blood and Tissue Collection: Baseline, Post-Randomization, Pre-AC, Pre- and Post-Surgery",{"measure":296,"timeFrame":297},"To determine three- and five-year relapse-free survival (RFS) and OS among the treatment arms.","Three- and Five-Year Post-surgery Follow-up",{"measure":299,"timeFrame":300},"To determine incidence of adverse events (AEs), serious adverse events (SAEs), and laboratory abnormalities of each investigational agent tested.","Post-Randomization, Pre-AC, Pre-Surgery, Post-Surgery upto One Year during follow-up",{"measure":39,"timeFrame":302},"Four time points during the on-study phase: Baseline, Post-randomization, Pre-AC treatment and Pre-Surgery","ALL","18 Years",null,false,{"inclusion":308,"exclusion":325,"raw_text":329},[309,310,311,312,313,314,315,316,317,318,319,320,321,322,323,324],"Histologically confirmed invasive cancer of the breast","Clinically or radiologically measureable disease in the breast after diagnostic biopsy, defined as longest diameter greater than or equal to 25 mm (2.5cm)","No prior cytotoxic regimens are allowed for this malignancy. Patients may not have had prior chemotherapy or prior radiation therapy to the ipsilateral breast for this malignancy. Prior bis-phosphonate therapy is allowed","Age ≥18 years","ECOG performance status 0-1","Willing to undergo core biopsy of the primary breast lesion to assess baseline biomarkers","Non-pregnant and non-lactating","No ferromagnetic prostheses. Patients who have metallic surgical implants that are not compatible with an MRI machine are not eligible.","Ability to understand and willingness to sign a written informed consent (I-SPY TRIAL Screening Consent)","Eligible tumors must meet one of the following criteria: Stage II or III, or T4, any N, M0, including clinical or pathologic inflammatory cancer or Regional Stage IV, where supraclavicular lymph nodes are the only sites metastasis","Any tumor ER\u002FPgR status, any HER-2\u002Fneu status as measured by local hospital pathology laboratory and meets any tumor assay profile described in protocol section 4.1.2F","Normal organ and marrow function: Leukocytes ≥ 3000\u002FμL, Absolute neutrophil count ≥ 1500\u002FμL, Platelets ≥ 100,000\u002FμL, Total bilirubin within normal institutional limits, unless patient has Gilbert's disease, for which bilirubin must be ≤ 2.0 x ULN, AST(SGOT)\u002FALT (SGPT) ≤ 1.5 x institutional ULN, creatinine \\\u003C 1.5 x institutional ULN","No uncontrolled or severe cardiac disease. Baseline ejection fraction (by nuclear imaging or echocardiography) must by ≥ 50%","No clinical or imaging evidence of distant metastases by PA and Lateral CXR, Radionuclide Bone scan, and LFTs including total bilirubin, ALT, AST, and alkaline phosphatase","Tumor assay profile must include on of the following: MammaPrint High, any ER status, any HER2 status, or MammaPrint Low, ER negative (\\\u003C5%), any HER2 status, or MammaPrint Low, ER positive, HER2\u002Fneu positive by any one of the three methods used (IHC, FISH, TargetPrint™)","Ability to understand and willingness to sign a written informed consent document (I-SPY 2 TRIAL Consent #2)",[326,327,328],"Use of any other investigational agents within 30 days of starting study treatment","History of allergic reactions attributed to compounds of similar chemical or biologic composition to the study agent or accompanying supportive medications.","Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements","Inclusion Criteria:\n\n* Histologically confirmed invasive cancer of the breast\n* Clinically or radiologically measureable disease in the breast after diagnostic biopsy, defined as longest diameter greater than or equal to 25 mm (2.5cm)\n* No prior cytotoxic regimens are allowed for this malignancy. Patients may not have had prior chemotherapy or prior radiation therapy to the ipsilateral breast for this malignancy. Prior bis-phosphonate therapy is allowed\n* Age ≥18 years\n* ECOG performance status 0-1\n* Willing to undergo core biopsy of the primary breast lesion to assess baseline biomarkers\n* Non-pregnant and non-lactating\n* No ferromagnetic prostheses. Patients who have metallic surgical implants that are not compatible with an MRI machine are not eligible.\n* Ability to understand and willingness to sign a written informed consent (I-SPY TRIAL Screening Consent)\n* Eligible tumors must meet one of the following criteria: Stage II or III, or T4, any N, M0, including clinical or pathologic inflammatory cancer or Regional Stage IV, where supraclavicular lymph nodes are the only sites metastasis\n* Any tumor ER\u002FPgR status, any HER-2\u002Fneu status as measured by local hospital pathology laboratory and meets any tumor assay profile described in protocol section 4.1.2F\n* Normal organ and marrow function: Leukocytes ≥ 3000\u002FμL, Absolute neutrophil count ≥ 1500\u002FμL, Platelets ≥ 100,000\u002FμL, Total bilirubin within normal institutional limits, unless patient has Gilbert's disease, for which bilirubin must be ≤ 2.0 x ULN, AST(SGOT)\u002FALT (SGPT) ≤ 1.5 x institutional ULN, creatinine \\\u003C 1.5 x institutional ULN\n* No uncontrolled or severe cardiac disease. Baseline ejection fraction (by nuclear imaging or echocardiography) must by ≥ 50%\n* No clinical or imaging evidence of distant metastases by PA and Lateral CXR, Radionuclide Bone scan, and LFTs including total bilirubin, ALT, AST, and alkaline phosphatase\n* Tumor assay profile must include on of the following: MammaPrint High, any ER status, any HER2 status, or MammaPrint Low, ER negative (\\\u003C5%), any HER2 status, or MammaPrint Low, ER positive, HER2\u002Fneu positive by any one of the three methods used (IHC, FISH, TargetPrint™)\n* Ability to understand and willingness to sign a written informed consent document (I-SPY 2 TRIAL Consent #2)\n\nExclusion Criteria:\n\n* Use of any other investigational agents within 30 days of starting study treatment\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to the study agent or accompanying supportive medications.\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements",[331,332],"ADULT","OLDER_ADULT",[334,347,362,370,381,393,407,421,431,445,461,480,495,506,512,523,536,548,556,567,580,591,601,614,625,637,644,655,665,680,693,703,720,733,740,751,759,767,774,785,793,801],{"facility":335,"status":8,"city":336,"state":337,"zip":338,"country":339,"contacts":340,"geoPoint":344},"University of Alabama at Birmingham","Birmingham","Alabama","35294","United States",[341],{"name":342,"role":343},"Erica Stringer-Reasor, MD","PRINCIPAL_INVESTIGATOR",{"lat":345,"lon":346},33.52066,-86.80249,{"facility":348,"status":349,"city":350,"state":351,"zip":352,"country":339,"contacts":353,"geoPoint":359},"Mayo Clinic - Scottsdale","NOT_YET_RECRUITING","Scottsdale","Arizona","85259",[354,357],{"role":355,"phone":356},"CONTACT","507-538-7623",{"name":358,"role":343},"Donald Northfelt, MD",{"lat":360,"lon":361},33.50921,-111.89903,{"facility":363,"status":364,"city":365,"state":351,"zip":366,"country":339,"geoPoint":367},"University of Arizona","ACTIVE_NOT_RECRUITING","Tucson","85724",{"lat":368,"lon":369},32.22174,-110.92648,{"facility":371,"status":8,"city":372,"state":373,"zip":374,"country":339,"contacts":375,"geoPoint":378},"University of California - Davis, Comprehensive Cancer Center","Davis","California","95817",[376],{"name":377,"role":343},"Mili Arora, MD",{"lat":379,"lon":380},38.54491,-121.74052,{"facility":382,"status":8,"city":383,"state":373,"zip":384,"country":339,"contacts":385,"geoPoint":390},"City of Hope","Duarte","91010",[386,388],{"role":355,"phone":387},"800-826-4673",{"name":389,"role":343},"Hope Rugo, MD",{"lat":391,"lon":392},34.13945,-117.97729,{"facility":394,"status":8,"city":395,"state":373,"zip":396,"country":339,"contacts":397,"geoPoint":404},"University of California San Diego","La Jolla","92093-0698",[398,400,402],{"role":355,"phone":399},"858-822-6194",{"role":355,"phone":399,"email":401},"CancerCTO@ucsd.edu",{"name":403,"role":343},"Anne Wallace, MD",{"lat":405,"lon":406},32.84727,-117.2742,{"facility":408,"status":8,"city":409,"state":373,"zip":410,"country":339,"contacts":411,"geoPoint":418},"University of Southern California","Los Angeles","90033",[412,416],{"name":413,"role":355,"phone":414,"email":415},"Kristy Watkins, RN","323-865-0452","Watkins_K@ccnt.usc.edu",{"name":417,"role":343},"Evanthia Roussos Torres, MD",{"lat":419,"lon":420},34.05223,-118.24368,{"facility":422,"status":8,"city":423,"state":373,"zip":424,"country":339,"contacts":425,"geoPoint":428},"HOAG Memorial Hospital Presbyterian","Newport Beach","92663",[426],{"name":427,"role":343},"Chaitali Nangia, MD",{"lat":429,"lon":430},33.61891,-117.92895,{"facility":432,"status":8,"city":433,"state":373,"zip":434,"country":339,"contacts":435,"geoPoint":442},"University of California San Francisco (UCSF)","San Francisco","94115",[436,440],{"name":437,"role":355,"phone":438,"email":439},"Clinical Research Coordinator","415-443-4296","ispycrc@ucsf.edu",{"name":441,"role":343},"Amy Jo Chien, MD",{"lat":443,"lon":444},37.77493,-122.41942,{"facility":446,"status":8,"city":447,"state":448,"zip":449,"country":339,"contacts":450,"geoPoint":458},"University of Colorado Cancer Center","Aurora","Colorado","80045",[451,453,456],{"role":355,"phone":452},"720-848-1622",{"name":454,"role":455},"Anthony Elias, MD","SUB_INVESTIGATOR",{"name":457,"role":343},"Virgnia Borges, MD",{"lat":459,"lon":460},39.72943,-104.83192,{"facility":462,"status":8,"city":463,"state":464,"zip":465,"country":339,"contacts":466,"geoPoint":477},"Yale Cancer Center","New Haven","Connecticut","06510",[467,471,473,475],{"name":468,"role":355,"phone":469,"email":470},"Trisha Burello, MS","203-737-2848","trisha.burrello@yale.edu",{"name":472,"role":455},"Tara Snaft, MD",{"name":474,"role":455},"Lajos Pusztai, MD",{"name":476,"role":343},"Mariya Rozenblit, MD",{"lat":478,"lon":479},41.30815,-72.92816,{"facility":481,"status":8,"city":482,"state":483,"zip":484,"country":339,"contacts":485,"geoPoint":492},"Georgetown University Medical Center","Washington D.C.","District of Columbia","20007",[486,490],{"name":487,"role":355,"phone":488,"email":489},"Minetta Liu, MD","202-444-3677","Liumc@georgetown.edu",{"name":491,"role":343},"Claudine Isaacs, MD",{"lat":493,"lon":494},38.89511,-77.03637,{"facility":496,"status":8,"city":497,"state":498,"zip":499,"country":339,"contacts":500,"geoPoint":503},"H. Lee Moffitt Cancer Center and Research Institute","Tampa","Florida","33612",[501],{"name":502,"role":343},"Hyo Heather Han, MD",{"lat":504,"lon":505},27.94752,-82.45843,{"facility":507,"status":8,"city":497,"state":498,"zip":499,"country":339,"contacts":508,"geoPoint":511},"Moffitt Cancer Center",[509],{"name":510,"role":343},"Heather Han, MD",{"lat":504,"lon":505},{"facility":513,"status":8,"city":514,"state":515,"zip":516,"country":339,"contacts":517,"geoPoint":520},"Winship Cancer Institute of Emory University","Atlanta","Georgia","30322",[518],{"name":519,"role":343},"Kevin Kalinsky, MD",{"lat":521,"lon":522},33.749,-84.38798,{"facility":524,"status":8,"city":525,"state":526,"zip":527,"country":339,"contacts":528,"geoPoint":533},"University of Chicago","Chicago","Illinois","60453",[529,531],{"role":355,"phone":530},"773-834-2756",{"name":532,"role":343},"Rita Nanda, MD",{"lat":534,"lon":535},41.85003,-87.65005,{"facility":537,"status":8,"city":538,"state":526,"zip":539,"country":339,"contacts":540,"geoPoint":545},"Loyola University","Maywood","60153",[541,543],{"role":355,"phone":542},"708-327-3102",{"name":544,"role":343},"Kathy S Albain, MD",{"lat":546,"lon":547},41.8792,-87.84312,{"facility":549,"status":364,"city":550,"state":551,"zip":552,"country":339,"geoPoint":553},"University of Kansas","Westwood","Kansas","66205",{"lat":554,"lon":555},39.04056,-94.6169,{"facility":557,"status":8,"city":558,"state":559,"zip":560,"country":339,"contacts":561,"geoPoint":564},"Herbert-Herman Cancer Center, Sparrow Hospital","Lansing","Michigan","48912",[562],{"name":563,"role":343},"Brittani Thomas, DO",{"lat":565,"lon":566},42.73253,-84.55553,{"facility":568,"status":8,"city":569,"state":570,"zip":571,"country":339,"contacts":572,"geoPoint":577},"University of Minnesota","Minneapolis","Minnesota","55455",[573,575],{"role":355,"phone":574},"612-626-8487",{"name":576,"role":343},"Douglas Yee, MD",{"lat":578,"lon":579},44.97997,-93.26384,{"facility":581,"status":8,"city":582,"state":570,"zip":583,"country":339,"contacts":584,"geoPoint":588},"Mayo Clinic","Rochester","55905",[585,586],{"role":355,"phone":356},{"name":587,"role":343},"Judy C Boughey, MD",{"lat":589,"lon":590},44.02163,-92.4699,{"facility":592,"status":8,"city":593,"state":570,"zip":594,"country":339,"contacts":595,"geoPoint":598},"Metro Minnesota Community Oncology Research Consortium, Hennepin County Medical Center","Saint Louis Park","55416",[596],{"name":597,"role":343},"Satya Bommakanti, MD",{"lat":599,"lon":600},44.9483,-93.34801,{"facility":602,"status":8,"city":603,"state":604,"zip":605,"country":339,"contacts":606,"geoPoint":611},"Rutgers Cancer Institute of New Jersey","New Brunswick","New Jersey","08903",[607,609],{"role":355,"phone":608},"732-235-7356",{"name":610,"role":343},"Coral Omene, MD, PhD",{"lat":612,"lon":613},40.48622,-74.45182,{"facility":615,"status":8,"city":616,"state":617,"zip":618,"country":339,"contacts":619,"geoPoint":622},"Roswell Park Cancer Institute","Buffalo","New York","14263",[620],{"name":621,"role":343},"Ellis Levine, MD",{"lat":623,"lon":624},42.88645,-78.87837,{"facility":626,"status":8,"city":617,"state":617,"zip":627,"country":339,"contacts":628,"geoPoint":634},"Laura and Isaac Perlmutter Cancer Center \u002F NYU Langone Health","10016",[629,632],{"name":630,"role":355,"email":631},"Yannis Karamitas","Yannis.Karamitas@nyulangone.org",{"name":633,"role":343},"Nancy Chan, MD",{"lat":635,"lon":636},40.71427,-74.00597,{"facility":638,"status":8,"city":617,"state":617,"zip":639,"country":339,"contacts":640,"geoPoint":643},"Columbia University Medical Center","10032",[641],{"name":642,"role":343},"Meghana Trivedi, MD",{"lat":635,"lon":636},{"facility":645,"status":8,"city":582,"state":617,"zip":646,"country":339,"contacts":647,"geoPoint":652},"University of Rochester Wilmot Cancer Institute","14642",[648,650],{"role":355,"email":649},"WCICTOResearch@urmc.rochester.edu",{"name":651,"role":343},"Carla Folksm, MD",{"lat":653,"lon":654},43.15478,-77.61556,{"facility":656,"status":8,"city":657,"state":617,"zip":658,"country":339,"contacts":659,"geoPoint":662},"Montefiore Medical Center","The Bronx","10467",[660],{"name":661,"role":343},"Jesus D Anampa",{"lat":663,"lon":664},40.84985,-73.86641,{"facility":666,"status":8,"city":667,"state":668,"zip":669,"country":339,"contacts":670,"geoPoint":677},"Wake Forest Baptist Comprehensive Cancer Center","Winston-Salem","North Carolina","27157",[671,675],{"name":672,"role":355,"phone":673,"email":674},"Angela Howell, MD","336-716-5440","anhowell@wakehealth.edu",{"name":676,"role":343},"Marissa Howard-McNatt, MD",{"lat":678,"lon":679},36.09986,-80.24422,{"facility":681,"status":8,"city":682,"state":683,"zip":684,"country":339,"contacts":685,"geoPoint":690},"Cleveland Clinic","Cleveland","Ohio","44106",[686,688],{"role":355,"phone":687},"800-233-2273",{"name":689,"role":343},"Julie Lang, MD",{"lat":691,"lon":692},41.4995,-81.69541,{"facility":694,"status":8,"city":695,"state":683,"zip":696,"country":339,"contacts":697,"geoPoint":700},"The Ohio State University, Stefanie Spielman Comprehensive Breast Center","Columbus","43212",[698],{"name":699,"role":343},"Nicole Williams, MD",{"lat":701,"lon":702},39.96118,-82.99879,{"facility":704,"status":8,"city":705,"state":706,"zip":707,"country":339,"contacts":708,"geoPoint":717},"Oregon Health & Science Institute (OHSU)","Portland","Oregon","97239",[709,713,715],{"name":710,"role":355,"phone":711,"email":712},"Brienna Palm","503-494-4438","palmb@ohsu.edu",{"role":355,"phone":714},"503-494-8573",{"name":716,"role":343},"Alexandra Zimmer, MD",{"lat":718,"lon":719},45.52345,-122.67621,{"facility":721,"status":8,"city":722,"state":723,"zip":724,"country":339,"contacts":725,"geoPoint":730},"University of Pennsylvania (U Penn)","Philadelphia","Pennsylvania","19104",[726,728],{"role":355,"phone":727},"215-614-1850",{"name":729,"role":343},"Amy Clark, MD",{"lat":731,"lon":732},39.95238,-75.16362,{"facility":734,"status":364,"city":735,"state":723,"zip":736,"country":339,"geoPoint":737},"University Pittsburgh Medical Center","Pittsburgh","15213",{"lat":738,"lon":739},40.44062,-79.99589,{"facility":741,"status":8,"city":742,"state":743,"zip":744,"country":339,"contacts":745,"geoPoint":748},"Sanford Clinical Research","Sioux Falls","South Dakota","57104",[746],{"name":747,"role":343},"Amy Sanford, MD",{"lat":749,"lon":750},43.54369,-96.72796,{"facility":752,"status":364,"city":753,"state":754,"zip":755,"country":339,"geoPoint":756},"Vanderbilt University Medical Center","Nashville","Tennessee","27204",{"lat":757,"lon":758},36.16589,-86.78444,{"facility":760,"status":364,"city":761,"state":762,"zip":763,"country":339,"geoPoint":764},"University of Texas, Southwestern Medical Center","Dallas","Texas","75390-9155",{"lat":765,"lon":766},32.78306,-96.80667,{"facility":768,"status":364,"city":769,"state":762,"zip":770,"country":339,"geoPoint":771},"University of Texas, M.D. Anderson Cancer Center","Houston","77230-1439",{"lat":772,"lon":773},29.76328,-95.36327,{"facility":775,"status":8,"city":776,"state":777,"zip":778,"country":339,"contacts":779,"geoPoint":782},"Huntsman Cancer Institute, University of Utah","Salt Lake City","Utah","84112",[780],{"name":781,"role":343},"Christos Vaklavas, MD",{"lat":783,"lon":784},40.76078,-111.89105,{"facility":786,"status":364,"city":787,"state":788,"zip":789,"country":339,"geoPoint":790},"Inova Health System","Falls Church","Virginia","22042",{"lat":791,"lon":792},38.88233,-77.17109,{"facility":794,"status":364,"city":795,"state":796,"zip":797,"country":339,"geoPoint":798},"Swedish Cancer Institute","Seattle","Washington","98104",{"lat":799,"lon":800},47.60621,-122.33207,{"facility":802,"status":364,"city":795,"state":796,"zip":803,"country":339,"geoPoint":804},"University of Washington","98115",{"lat":799,"lon":800},[806,810],{"name":807,"role":355,"phone":808,"email":809},"Won Chang","(855) 866-0505","w.chang@quantumleaphealth.org",{"name":811,"role":355,"email":812},"Heather Prisant","h.prisant@qlhc.org",[814],{"name":815,"affiliation":816,"role":343},"Laura Esserman, MD, MBA","University of California, San Francisco",[818,822,825,829,832,835,838,842,845,848,851,854,857,860,863,866,869,872,875,878,881,884,887,890,893,896,899,902,905,908,911,914,917,920,923,926,929,932,935],{"pmid":819,"type":820,"citation":821},"19440188","BACKGROUND","Barker AD, Sigman CC, Kelloff GJ, Hylton NM, Berry DA, Esserman LJ. I-SPY 2: an adaptive breast cancer trial design in the setting of neoadjuvant chemotherapy. Clin Pharmacol Ther. 2009 Jul;86(1):97-100. doi: 10.1038\u002Fclpt.2009.68. Epub 2009 May 13.",{"pmid":823,"type":820,"citation":824},"22187281","Esserman LJ, Woodcock J. Accelerating identification and regulatory approval of investigational cancer drugs. JAMA. 2011 Dec 21;306(23):2608-9. doi: 10.1001\u002Fjama.2011.1837. No abstract available.",{"pmid":826,"type":827,"citation":828},"22649152","RESULT","Esserman LJ, Berry DA, DeMichele A, Carey L, Davis SE, Buxton M, Hudis C, Gray JW, Perou C, Yau C, Livasy C, Krontiras H, Montgomery L, Tripathy D, Lehman C, Liu MC, Olopade OI, Rugo HS, Carpenter JT, Dressler L, Chhieng D, Singh B, Mies C, Rabban J, Chen YY, Giri D, van 't Veer L, Hylton N. Pathologic complete response predicts recurrence-free survival more effectively by cancer subset: results from the I-SPY 1 TRIAL--CALGB 150007\u002F150012, ACRIN 6657. J Clin Oncol. 2012 Sep 10;30(26):3242-9. doi: 10.1200\u002FJCO.2011.39.2779. Epub 2012 May 29.",{"pmid":830,"type":827,"citation":831},"22623692","Hylton NM, Blume JD, Bernreuter WK, Pisano ED, Rosen MA, Morris EA, Weatherall PT, Lehman CD, Newstead GM, Polin S, Marques HS, Esserman LJ, Schnall MD; ACRIN 6657 Trial Team and I-SPY 1 TRIAL Investigators. Locally advanced breast cancer: MR imaging for prediction of response to neoadjuvant chemotherapy--results from ACRIN 6657\u002FI-SPY TRIAL. Radiology. 2012 Jun;263(3):663-72. doi: 10.1148\u002Fradiol.12110748.",{"pmid":833,"type":827,"citation":834},"21796368","Lin C, Buxton MB, Moore D, Krontiras H, Carey L, DeMichele A, Montgomery L, Tripathy D, Lehman C, Liu M, Olapade O, Yau C, Berry D, Esserman LJ; I-SPY TRIAL Investigators. Locally advanced breast cancers are more likely to present as Interval Cancers: results from the I-SPY 1 TRIAL (CALGB 150007\u002F150012, ACRIN 6657, InterSPORE Trial). Breast Cancer Res Treat. 2012 Apr;132(3):871-9. doi: 10.1007\u002Fs10549-011-1670-4. Epub 2011 Jul 28.",{"pmid":836,"type":827,"citation":837},"22198468","Esserman LJ, Berry DA, Cheang MC, Yau C, Perou CM, Carey L, DeMichele A, Gray JW, Conway-Dorsey K, Lenburg ME, Buxton MB, Davis SE, van't Veer LJ, Hudis C, Chin K, Wolf D, Krontiras H, Montgomery L, Tripathy D, Lehman C, Liu MC, Olopade OI, Rugo HS, Carpenter JT, Livasy C, Dressler L, Chhieng D, Singh B, Mies C, Rabban J, Chen YY, Giri D, Au A, Hylton N; I-SPY 1 TRIAL Investigators. Chemotherapy response and recurrence-free survival in neoadjuvant breast cancer depends on biomarker profiles: results from the I-SPY 1 TRIAL (CALGB 150007\u002F150012; ACRIN 6657). Breast Cancer Res Treat. 2012 Apr;132(3):1049-62. doi: 10.1007\u002Fs10549-011-1895-2. Epub 2011 Dec 25.",{"pmid":839,"type":840,"citation":841},"42619946","DERIVED","Magbanua MJM, Wolf DM, Yau C, Manon NA, Sayaman RW, Brown Swigart L, Hirst G, Li W, Isaacs C, Shatsky R, Clark AS, Zimmer A, Mukhtar R, Delson AL, Perlmutter J, Pohlmann PR, Hylton NM, Nanda R, Yee D, Symmans WF, Esserman LJ, Rugo HS, DeMichele A, van 't Veer LJ. Circulating tumor DNA concentration at diagnosis is a modifiable prognostic factor for distant metastatic recurrence in patients with high-risk breast cancer receiving neoadjuvant therapy. medRxiv [Preprint]. 2026 Jul 29:2026.07.28.26358343. doi: 10.64898\u002F2026.07.28.26358343.",{"pmid":843,"type":840,"citation":844},"42545411","Tseng J, Dimitroff K, Sauder CAM, Chien AJ, Ahmed KA, Allen LF, Arciero CA, Burke EE, Chandler JM, Jordan JE, Golshan M, Gutnik LA, Jaskowiak NT, Hewitt KC, Howard-McNatt M, Ito F, Kang IM, Kesmodel SB, Kuerer HM, Lee MC, Moran MC, Postlewait LM, Prionas ND, Rao R, Reyna CR, Schwer A, Taunk NK, Tchou J, Wallace AM, Li TJ, Perlmutter J, DeMichele AM, Yee D, Hylton NM, Veer LJV, Rugo HS, Symmans WF, Shatsky RA, Isaacs CJD, Yau C, Esserman LJ, Boughey JC, Mukhtar RA. Surgical Management of Young Women with High-Risk Breast Cancer Receiving Neoadjuvant Systemic Therapy on the I-SPY2 Trial. Ann Surg Oncol. 2026 Aug 3. doi: 10.1245\u002Fs10434-026-20153-x. Online ahead of print.",{"pmid":846,"type":840,"citation":847},"42530945","Isaacs C, Nanda R, Yau C, Chien AJ, Hershman DL, Stringer-Reasor EM, Wallace AM, Thomas A, Vaklavas C, Clark AS, Kennedy LC, Sanford A, Boughey JC, Albain KS, Pusztai L, Kalinsky KM, Beckwith H, Williams NO, Han HS, Falkson C, Arora M, Elias AD, Pohlmann PR, Rozenblit M, Marshall N, Chen YY, Trivedi MS, McGuinness JE, Howard FM, Chen N, Khoury K, Lancaster RB, Yeung KT, Douglas E, Wei M, Mainor C, LeStage B, Delson AL, Asare AL, Brown-Swigart L, Hirst GL, Matthews JB, Perlmutter J, Symmans WF, Yee D, Hylton NM, van 't Veer LJ, Rugo HS, DeMichele AM, Berry DA, Esserman LJ. Cemiplimab and Fianlimab With Neoadjuvant Chemotherapy in Early-Stage High-Risk ERBB2-Negative Breast Cancer: The I-SPY2 Randomized Clinical Trial. JAMA Oncol. 2026 Jul 30. doi: 10.1001\u002Fjamaoncol.2026.2576. Online ahead of print.",{"pmid":849,"type":840,"citation":850},"41879562","Teng X, Ma J, Zhang J, Zhao M, Meng X, Yin Y, Xiao H, Lai Q, Zhang X, Jiang Y, Cai J. Longitudinal DCE MRI Vascular Textures: Radiologic and Biologic Insights for pCR Prediction in HER2-Negative Breast Cancer. Radiol Artif Intell. 2026 May;8(3):e250734. doi: 10.1148\u002Fryai.250734.",{"pmid":852,"type":840,"citation":853},"40777112","Hensley M, Lengfeld J, Stoesz S, Edwards M, Pass F, Hirst GL, Brown-Swigart L, van 't Veer L, Esserman LJ, Beckwith H, Yee D. Detection of serum HER2 in patients treated with neratinib or trastuzumab: analysis of the I-SPY Trial. Front Oncol. 2025 Jul 24;15:1605120. doi: 10.3389\u002Ffonc.2025.1605120. eCollection 2025.",{"pmid":855,"type":840,"citation":856},"40679371","Gilad M, Partridge SC, Iima M, Md RR, Freiman M. Radiomics-based Machine Learning Prediction of Neoadjuvant Chemotherapy Response in Breast Cancer Using Physiologically Decomposed Diffusion-weighted MRI. Radiol Imaging Cancer. 2025 Jul;7(4):e240312. doi: 10.1148\u002Frycan.240312.",{"pmid":858,"type":840,"citation":859},"40639409","Jing B, Wang J. A two-stage dual-task learning strategy for early prediction of pathological complete response to neoadjuvant chemotherapy for breast cancer using dynamic contrast-enhanced magnetic resonance images. Phys Med Biol. 2025 Jul 18;70(14):145030. doi: 10.1088\u002F1361-6560\u002Fadee73.",{"pmid":861,"type":840,"citation":862},"40551254","Leon-Ferre RA, Dimitroff K, Yau C, Giridhar KV, Mukhtar R, Hirst G, Hylton N, Perlmutter J, DeMichele A, Yee D, van 't Veer L, Rugo H, Symmans WF, Goetz MP, Esserman L, Boughey JC. Combined prognostic impact of initial clinical stage and residual cancer burden after neoadjuvant systemic therapy in triple-negative and HER2-positive breast cancer: an analysis of the I-SPY2 randomized clinical trial. Breast Cancer Res. 2025 Jun 23;27(1):115. doi: 10.1186\u002Fs13058-025-02070-1.",{"pmid":864,"type":840,"citation":865},"40526879","Wolf DM, Yau C, Campbell M, Glas A, Barcaru A, Mittempergher L, Kuilman M, Brown-Swigart L, Hirst G, Basu A, Magbanua M, Sayaman R, Huppert L, Delson A; I-SPY2 Investigators; Symmans WF, Borowsky A, Pohlmann P, Rugo H, Clark A, Yee D, DeMichele A, Perlmutter J, Petricoin EF, Chien J, Stringer-Reasor E, Shatsky R, Liu M, Han H, Soliman H, Isaacs C, Nanda R, Hylton N, Pusztai L, Esserman L, van 't Veer L. Immune Subtyping Identifies Patients With Hormone Receptor-Positive Early-Stage Breast Cancer Who Respond to Neoadjuvant Immunotherapy (IO): Results From Five IO Arms of the I-SPY2 Trial. JCO Precis Oncol. 2025 Jun;9:e2400776. doi: 10.1200\u002FPO-24-00776. 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