[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100136130":3},{"organization":4,"armGroups":7,"interventions":202,"overallOfficials":394,"centralContacts":399,"locations":408,"responsibleParty":965,"collaborators":238,"id":967,"slug":968,"hasResults":969,"nctId":970,"briefTitle":971,"officialTitle":972,"acronym":973,"eligibilityCriteria":974,"healthyVolunteers":969,"sex":975,"minAge":976,"maxAge":238,"enrollmentInfo":977,"targetDuration":238,"studyType":980,"phases":981,"briefSummary":983,"conditions":984,"keywords":996,"overallStatus":411,"whyStopped":238,"lastUpdateSubmitDate":1009,"lastUpdatePostDateStruct":1010,"startDateStruct":1013,"completionDateStruct":1015,"leadSponsor":1017,"locationsCount":1018},{"fullName":5,"class":6},"QuantumLeap Healthcare Collaborative","OTHER",[8,14,21,25,29,33,38,42,46,50,54,58,62,66,70,74,78,82,86,91,95,99,103,107,111,115,119,123,128,133,137,141,145,150,155,159,163,167,171,176,180,184,188,193,197],{"label":9,"type":10,"description":11,"interventionNames":12},"Standard Therapy","ACTIVE_COMPARATOR","Paclitaxel, Herceptin followed by Doxorubicin and Cyclophosphamide treatment depending on HR\u002FHER-2 status.",[13],"Drug: Standard Therapy",{"label":15,"type":16,"description":17,"interventionNames":18},"AMG 386 with or without Trastuzumab","EXPERIMENTAL","Arm is closed.",[19,20],"Drug: AMG 386 with or without Trastuzumab","Drug: AMG 386 and Trastuzumab",{"label":22,"type":6,"description":17,"interventionNames":23},"AMG 479 plus Metformin",[24],"Drug: AMG 479 (Ganitumab) plus Metformin",{"label":26,"type":16,"description":17,"interventionNames":27},"MK-2206 with or without Trastuzumab",[28],"Drug: MK-2206 with or without Trastuzumab",{"label":30,"type":16,"description":17,"interventionNames":31},"T-DM1 and Pertuzumab",[32],"Drug: T-DM1 and Pertuzumab",{"label":34,"type":10,"description":35,"interventionNames":36},"Pertuzumab and Trastuzumab","Arm is closed. Novel Control Investigational Agent.",[37],"Drug: Pertuzumab and Trastuzumab",{"label":39,"type":16,"description":17,"interventionNames":40},"Ganetespib",[41],"Drug: Ganetespib",{"label":43,"type":6,"description":17,"interventionNames":44},"ABT-888",[45],"Drug: ABT-888",{"label":47,"type":6,"description":17,"interventionNames":48},"Neratinib",[49],"Drug: Neratinib",{"label":51,"type":16,"description":17,"interventionNames":52},"PLX3397",[53],"Drug: PLX3397",{"label":55,"type":16,"description":17,"interventionNames":56},"Pembrolizumab 4 cycle",[57],"Drug: Pembrolizumab - 4 cycle",{"label":59,"type":16,"description":17,"interventionNames":60},"Talazoparib plus Irinotecan",[61],"Drug: Talazoparib plus Irinotecan",{"label":63,"type":16,"description":17,"interventionNames":64},"Patritumab with or without Trastuzumab",[65],"Drug: Patritumab and Trastuzumab",{"label":67,"type":16,"description":17,"interventionNames":68},"Pembrolizumab 8 cycle",[69],"Drug: Pembrolizumab - 8 cycle",{"label":71,"type":16,"description":17,"interventionNames":72},"SGN-LIV1A",[73],"Drug: SGN-LIV1A",{"label":75,"type":16,"description":17,"interventionNames":76},"Durvalumab plus Olaparib",[77],"Drug: Durvalumab plus Olaparib",{"label":79,"type":16,"description":17,"interventionNames":80},"SD-101 + Pembrolizumab",[81],"Drug: SD-101 + Pembrolizumab",{"label":83,"type":16,"description":17,"interventionNames":84},"Tucatinib",[85],"Drug: Tucatinib plus trastuzumab and pertuzumab",{"label":87,"type":16,"description":88,"interventionNames":89},"Cemiplimab","Arm is closed. Novel Investigational Agent.",[90],"Drug: Cemiplimab",{"label":92,"type":16,"description":88,"interventionNames":93},"Cemiplimab plus REGN3767",[94],"Drug: Cemiplimab plus REGN3767",{"label":96,"type":16,"description":88,"interventionNames":97},"Trilaciclib with or without trastuzumab + pertuzumab",[98],"Drug: Trilaciclib with or without trastuzumab + pertuzumab",{"label":100,"type":16,"description":88,"interventionNames":101},"SYD985 ([vic-]trastuzumab duocarmazine)",[102],"Drug: SYD985 ([vic-]trastuzumab duocarmazine)",{"label":104,"type":16,"description":88,"interventionNames":105},"Oral Paclitaxel + Encequidar + Dostarlimab (TSR-042) + Carboplatin with or without trastuzumab",[106],"Drug: Oral Paclitaxel + Encequidar + Dostarlimab (TSR-042) + Carboplatin with or without trastuzumab",{"label":108,"type":16,"description":88,"interventionNames":109},"Oral Paclitaxel + Encequidar + Dostarlimab (TSR-042) with or without trastuzumab",[110],"Drug: Oral Paclitaxel + Encequidar + Dostarlimab (TSR-042) with or without trastuzumab",{"label":112,"type":16,"description":88,"interventionNames":113},"Endocrine Optimization Pilot: Amcenestrant Monotherapy",[114],"Drug: Amcenestrant",{"label":116,"type":16,"description":88,"interventionNames":117},"Endocrine Optimization Pilot: Amcenestrant + Abemaciclib",[118],"Drug: Amcenestrant + Abemaciclib",{"label":120,"type":16,"description":88,"interventionNames":121},"Endocrine Optimization Pilot: Amcenestrant + Letrozole",[122],"Drug: Amcenestrant + Letrozole",{"label":124,"type":16,"description":125,"interventionNames":126},"ARX788 in Block A and followed by SOC in Block B","Arm is closed for accrual for accrual. Novel investigational Agent followed by SOC.",[127],"Drug: ARX788",{"label":129,"type":16,"description":130,"interventionNames":131},"ARX788 + Cemiplimab in Block A and followed by SOC in Block B","Arm is closed for accrual. Novel investigational Agent followed by SOC.",[132],"Drug: ARX788 + Cemiplimab",{"label":134,"type":16,"description":130,"interventionNames":135},"VSV-IFNβ-NIS (VOYAGER V1™; VV1) + Cemiplimab in Block A and followed by SOC in block B",[136],"Drug: VV1 + Cemiplimab",{"label":138,"type":16,"description":130,"interventionNames":139},"Datopotamab Deruxtecan in Block A and followed by SOC in block B",[140],"Drug: Datopotamab deruxtecan",{"label":142,"type":16,"description":130,"interventionNames":143},"Datopotamab Deruxtecan + Durvalumab in Block A and followed by SOC in block B",[144],"Drug: Datopotamab deruxtecan + Durvalumab",{"label":146,"type":16,"description":147,"interventionNames":148},"Zanidatamab for Block ABC","Arm open for accrual. Novel investigational Agent.",[149],"Drug: Zanidatamab",{"label":151,"type":16,"description":152,"interventionNames":153},"Endocrine Optimization Pilot: Lasofoxifene","Arm is closed for accrual. Novel investigational Agent.",[154],"Drug: Lasofoxifene",{"label":156,"type":16,"description":152,"interventionNames":157},"Endocrine Optimization Pilot: (Z)-Endoxifen",[158],"Drug: Z-endoxifen",{"label":160,"type":16,"description":152,"interventionNames":161},"Endocrine Optimization Pilot: ARV-471",[162],"Drug: ARV-471",{"label":164,"type":16,"description":152,"interventionNames":165},"Endocrine Optimization Pilot: ARV-471 + Letrozole",[166],"Drug: ARV-471 + Letrozole",{"label":168,"type":16,"description":152,"interventionNames":169},"Endocrine Optimization Pilot: ARV-471 + Abemaciclib",[170],"Drug: ARV-471 + Abemaciclib",{"label":172,"type":16,"description":173,"interventionNames":174},"Endocrine Optimization Pilot: (Z)-Endoxifen + Abemaciclib","Arm is closed for accrual. Enrollment completed. Novel investigational Agent.",[175],"Drug: Endoxifen + Abemaciclib",{"label":177,"type":16,"description":152,"interventionNames":178},"Rilvegostomig + TDXd in Block A and followed by SOC in Block B",[179],"Drug: Rilvegostomig + TDXd",{"label":181,"type":16,"description":152,"interventionNames":182},"DAN222 + Niraparib in Block A and followed by SOC in Block B",[183],"Drug: Dan222 + Niraparib",{"label":185,"type":16,"description":152,"interventionNames":186},"Sarilumab + Cemiplimab + Paclitaxel in Block B followed by SOC Block C",[187],"Drug: Sarilumab + Cemiplimab + Paclitaxel",{"label":189,"type":16,"description":190,"interventionNames":191},"GSK 5733584 in Block A and followed by SOC in Block B","Arm is open for accrual. Novel Investigational Agent.",[192],"Drug: GSK 5733584",{"label":194,"type":16,"description":190,"interventionNames":195},"GSK 5733584 + Dostarlimab in Block A and followed by SOC in Block B",[196],"Drug: GSK 5733584 + Dostarlimab",{"label":198,"type":16,"description":199,"interventionNames":200},"Ivonescimab in Blocks A and B","Open for accrual. Novel Investigational Agent.",[201],"Drug: Ivonescimab (20mg\u002Fkg Q3W)",[203,209,213,218,222,227,231,236,239,243,245,247,250,252,255,258,261,263,266,270,273,276,281,284,289,293,299,305,311,315,319,326,332,337,341,345,349,353,357,361,365,369,373,377,381,385],{"type":204,"name":9,"description":205,"armGroupLabels":206,"otherNames":207},"DRUG","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",[9],[208],"Paclitaxel (Taxol); Doxorubicin (Adriamycin)",{"type":204,"name":15,"description":17,"armGroupLabels":210,"otherNames":211},[15],[212],"AMG 386 (Trebananib); (Trastuzumab) Herceptin",{"type":204,"name":214,"description":17,"armGroupLabels":215,"otherNames":216},"AMG 479 (Ganitumab) plus Metformin",[22],[217],"Ganitumab",{"type":204,"name":26,"description":17,"armGroupLabels":219,"otherNames":220},[26],[221],"(Trastuzumab) Herceptin",{"type":204,"name":223,"description":17,"armGroupLabels":224,"otherNames":225},"AMG 386 and Trastuzumab",[15],[226],"AMG 386 (Trebananib); Trastuzumab (Herceptin)",{"type":204,"name":30,"description":17,"armGroupLabels":228,"otherNames":229},[30],[230],"T-DM1 (Trastuzumab emtansine); Pertuzumab (Perjeta)",{"type":204,"name":34,"description":232,"armGroupLabels":233,"otherNames":234},"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",[34],[235],"Pertuzumab (Perjeta); Trastuzumab (Herceptin)",{"type":204,"name":39,"description":17,"armGroupLabels":237,"otherNames":238},[39],null,{"type":204,"name":43,"description":17,"armGroupLabels":240,"otherNames":241},[43],[242],"Veliparib",{"type":204,"name":47,"description":17,"armGroupLabels":244,"otherNames":238},[47],{"type":204,"name":51,"description":17,"armGroupLabels":246,"otherNames":238},[51],{"type":204,"name":248,"description":17,"armGroupLabels":249,"otherNames":238},"Pembrolizumab - 4 cycle",[55],{"type":204,"name":59,"description":17,"armGroupLabels":251,"otherNames":238},[59],{"type":204,"name":253,"description":17,"armGroupLabels":254,"otherNames":238},"Patritumab and Trastuzumab",[63],{"type":204,"name":256,"description":17,"armGroupLabels":257,"otherNames":238},"Pembrolizumab - 8 cycle",[67],{"type":204,"name":71,"description":259,"armGroupLabels":260,"otherNames":238},"Arm is closed. SGN-LIV1A: 2.5 mg\u002Fkg IV cycles 1,4,7,10 Doxorubicin + Cyclophosphamide: Cycles 13-16",[71],{"type":204,"name":75,"description":17,"armGroupLabels":262,"otherNames":238},[75],{"type":204,"name":79,"description":264,"armGroupLabels":265,"otherNames":238},"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",[79],{"type":204,"name":267,"description":268,"armGroupLabels":269,"otherNames":238},"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",[83],{"type":204,"name":87,"description":271,"armGroupLabels":272,"otherNames":238},"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",[87],{"type":204,"name":92,"description":274,"armGroupLabels":275,"otherNames":238},"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",[92],{"type":204,"name":96,"description":277,"armGroupLabels":278,"otherNames":279},"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",[96],[280],"Trilaciclib (G1T28); Pertuzumab (Perjeta); Trastuzumab (Herceptin)",{"type":204,"name":100,"description":282,"armGroupLabels":283,"otherNames":238},"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",[100],{"type":204,"name":104,"description":285,"armGroupLabels":286,"otherNames":287},"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",[104],[288],"Oral Paclitaxel + Encequidar (Oraxol); Dostarlimab (TSR-042); Trastuzumab (Herceptin)",{"type":204,"name":108,"description":290,"armGroupLabels":291,"otherNames":292},"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",[108],[288],{"type":204,"name":294,"description":295,"armGroupLabels":296,"otherNames":297},"Amcenestrant","Arm is closed.\n\nAmcenestrant (SAR439859), 200mg QD, p.o., for 24 weeks.",[112],[298],"SAR439859",{"type":204,"name":300,"description":301,"armGroupLabels":302,"otherNames":303},"Amcenestrant + Abemaciclib","Arm is closed.\n\nAmcenestrant (SAR439859), 200mg QD, p.o., for 24 weeks Abemaciclib (Verzenio), 150mg BID, p.o., for 24 weeks",[116],[304],"Amcenestrant (SAR439859), Abemaciclib (Verzenio)",{"type":204,"name":306,"description":307,"armGroupLabels":308,"otherNames":309},"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",[120],[310],"Amcenestrant (SAR439859), Letrozole (Femara)",{"type":204,"name":312,"description":313,"armGroupLabels":314,"otherNames":238},"ARX788","Arm is closed.\n\nARX788, 1.5 mg\u002Fkg Q3W, IV for 12 weeks",[124],{"type":204,"name":316,"description":317,"armGroupLabels":318,"otherNames":238},"ARX788 + Cemiplimab","Arm is closed.\n\nARX788, 1.5 mg\u002Fkg Q3W, IV for 12 weeks Cemiplimab, 350 mg Q3W, IV for 12 weeks",[129],{"type":204,"name":320,"description":321,"armGroupLabels":322,"otherNames":323},"VV1 + Cemiplimab","Arm is closed.\n\nVV1, 3x10\\^9 TCID50 once (day-8), Intra-tumoral injection Cemiplimab, 350 mg Q3W, IV for 12 weeks",[134],[324,325],"VOYAGER V1™","VSV-IFNβ-NIS",{"type":204,"name":327,"description":328,"armGroupLabels":329,"otherNames":330},"Datopotamab deruxtecan","Arm is closed.\n\nDato-DXd, 6 mg\u002Fkg Q3W, IV for 12 weeks",[138],[331],"Dato-DXd",{"type":204,"name":333,"description":334,"armGroupLabels":335,"otherNames":336},"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",[142],[331],{"type":204,"name":338,"description":339,"armGroupLabels":340,"otherNames":238},"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.",[146],{"type":204,"name":342,"description":343,"armGroupLabels":344,"otherNames":238},"Lasofoxifene","Arm is closed.\n\nLasofoxifene: 5.0 mg QD, p.o., for 24 weeks",[151],{"type":204,"name":346,"description":347,"armGroupLabels":348,"otherNames":238},"Z-endoxifen","Arm is closed.\n\nZ-endoxifen: 10 mg QD, p.o., for 24 weeks",[156],{"type":204,"name":350,"description":351,"armGroupLabels":352,"otherNames":238},"ARV-471","Arm is closed.\n\nARV-471: 200 mg QD, p.o, for 24 weeks.",[160],{"type":204,"name":354,"description":355,"armGroupLabels":356,"otherNames":238},"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",[164],{"type":204,"name":358,"description":359,"armGroupLabels":360,"otherNames":238},"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",[168],{"type":204,"name":362,"description":363,"armGroupLabels":364,"otherNames":238},"Endoxifen + Abemaciclib","Z-endoxifen: 80 mg QD, p.o., for 24 weeks Abemaciclib: 150 mg BID, p.o, for 20 weeks",[172],{"type":204,"name":366,"description":367,"armGroupLabels":368,"otherNames":238},"Rilvegostomig + TDXd","Arm closed to accrual\n\nRilvegostomig: 750mg IV Q3W for 12 weeks TDXd: 5.4 mg\u002Fkg IV Q3W for 12 weeks",[177],{"type":204,"name":370,"description":371,"armGroupLabels":372,"otherNames":238},"Dan222 + Niraparib","Arm is closed.\n\nDAN222: 8mg\u002Fm2 IV QW for 12 weeks Niraparib: 200mg QD p.p., 12 weeks",[181],{"type":204,"name":374,"description":375,"armGroupLabels":376,"otherNames":238},"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",[185],{"type":204,"name":378,"description":379,"armGroupLabels":380,"otherNames":238},"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.",[189],{"type":204,"name":382,"description":383,"armGroupLabels":384,"otherNames":238},"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.",[194],{"type":204,"name":386,"description":387,"armGroupLabels":388,"otherNames":389},"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).",[198],[390,391,392,393],"AK112","SMT112","PD-1 \u002F VEGF bispecific antibody","依达方® (Yiwoxi Dankang Zhusheye)",[395],{"name":396,"affiliation":397,"role":398},"Laura Esserman, MD, MBA","University of California, San Francisco","PRINCIPAL_INVESTIGATOR",[400,405],{"name":401,"role":402,"phone":403,"phoneExt":238,"email":404},"Won Chang","CONTACT","(855) 866-0505","w.chang@quantumleaphealth.org",{"name":406,"role":402,"phone":238,"phoneExt":238,"email":407},"Heather Prisant","h.prisant@qlhc.org",[409,426,442,452,465,479,495,511,523,539,557,578,595,608,616,629,644,658,668,681,696,709,721,736,749,763,772,785,797,814,829,841,860,875,884,897,907,917,926,939,949,959],{"facility":410,"status":411,"city":412,"state":413,"zip":414,"country":415,"countryCode":416,"cosmosGeoPoint":417,"geoPoint":422,"contacts":423},"University of Alabama at Birmingham","RECRUITING","Birmingham","Alabama","35294","United States","US",{"type":418,"coordinates":419},"Point",[420,421],-86.80249,33.52066,{"lat":421,"lon":420},[424],{"name":425,"role":398,"phone":238,"phoneExt":238,"email":238},"Erica Stringer-Reasor, MD",{"facility":427,"status":428,"city":429,"state":430,"zip":431,"country":415,"countryCode":416,"cosmosGeoPoint":432,"geoPoint":436,"contacts":437},"Mayo Clinic - Scottsdale","NOT_YET_RECRUITING","Scottsdale","Arizona","85259",{"type":418,"coordinates":433},[434,435],-111.89903,33.50921,{"lat":435,"lon":434},[438,440],{"name":238,"role":402,"phone":439,"phoneExt":238,"email":238},"507-538-7623",{"name":441,"role":398,"phone":238,"phoneExt":238,"email":238},"Donald Northfelt, MD",{"facility":443,"status":444,"city":445,"state":430,"zip":446,"country":415,"countryCode":416,"cosmosGeoPoint":447,"geoPoint":451,"contacts":238},"University of 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Coordinator","415-443-4296","ispycrc@ucsf.edu",{"name":538,"role":398,"phone":238,"phoneExt":238,"email":238},"Amy Jo Chien, MD",{"facility":540,"status":411,"city":541,"state":542,"zip":543,"country":415,"countryCode":416,"cosmosGeoPoint":544,"geoPoint":548,"contacts":549},"University of Colorado Cancer Center","Aurora","Colorado","80045",{"type":418,"coordinates":545},[546,547],-104.83192,39.72943,{"lat":547,"lon":546},[550,552,555],{"name":238,"role":402,"phone":551,"phoneExt":238,"email":238},"720-848-1622",{"name":553,"role":554,"phone":238,"phoneExt":238,"email":238},"Anthony Elias, MD","SUB_INVESTIGATOR",{"name":556,"role":398,"phone":238,"phoneExt":238,"email":238},"Virgnia Borges, MD",{"facility":558,"status":411,"city":559,"state":560,"zip":561,"country":415,"countryCode":416,"cosmosGeoPoint":562,"geoPoint":566,"contacts":567},"Yale Cancer Center","New Haven","Connecticut","06510",{"type":418,"coordinates":563},[564,565],-72.92816,41.30815,{"lat":565,"lon":564},[568,572,574,576],{"name":569,"role":402,"phone":570,"phoneExt":238,"email":571},"Trisha Burello, MS","203-737-2848","trisha.burrello@yale.edu",{"name":573,"role":554,"phone":238,"phoneExt":238,"email":238},"Tara Snaft, MD",{"name":575,"role":554,"phone":238,"phoneExt":238,"email":238},"Lajos Pusztai, MD",{"name":577,"role":398,"phone":238,"phoneExt":238,"email":238},"Mariya Rozenblit, MD",{"facility":579,"status":411,"city":580,"state":581,"zip":582,"country":415,"countryCode":416,"cosmosGeoPoint":583,"geoPoint":587,"contacts":588},"Georgetown University Medical Center","Washington D.C.","District of Columbia","20007",{"type":418,"coordinates":584},[585,586],-77.03637,38.89511,{"lat":586,"lon":585},[589,593],{"name":590,"role":402,"phone":591,"phoneExt":238,"email":592},"Minetta Liu, MD","202-444-3677","Liumc@georgetown.edu",{"name":594,"role":398,"phone":238,"phoneExt":238,"email":238},"Claudine Isaacs, MD",{"facility":596,"status":411,"city":597,"state":598,"zip":599,"country":415,"countryCode":416,"cosmosGeoPoint":600,"geoPoint":604,"contacts":605},"H. Lee Moffitt Cancer Center and Research Institute","Tampa","Florida","33612",{"type":418,"coordinates":601},[602,603],-82.45843,27.94752,{"lat":603,"lon":602},[606],{"name":607,"role":398,"phone":238,"phoneExt":238,"email":238},"Hyo Heather Han, MD",{"facility":609,"status":411,"city":597,"state":598,"zip":599,"country":415,"countryCode":416,"cosmosGeoPoint":610,"geoPoint":612,"contacts":613},"Moffitt Cancer Center",{"type":418,"coordinates":611},[602,603],{"lat":603,"lon":602},[614],{"name":615,"role":398,"phone":238,"phoneExt":238,"email":238},"Heather Han, MD",{"facility":617,"status":411,"city":618,"state":619,"zip":620,"country":415,"countryCode":416,"cosmosGeoPoint":621,"geoPoint":625,"contacts":626},"Winship Cancer Institute of Emory University","Atlanta","Georgia","30322",{"type":418,"coordinates":622},[623,624],-84.38798,33.749,{"lat":624,"lon":623},[627],{"name":628,"role":398,"phone":238,"phoneExt":238,"email":238},"Kevin Kalinsky, 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Minnesota","Minneapolis","Minnesota","55455",{"type":418,"coordinates":687},[688,689],-93.26384,44.97997,{"lat":689,"lon":688},[692,694],{"name":238,"role":402,"phone":693,"phoneExt":238,"email":238},"612-626-8487",{"name":695,"role":398,"phone":238,"phoneExt":238,"email":238},"Douglas Yee, MD",{"facility":697,"status":411,"city":698,"state":684,"zip":699,"country":415,"countryCode":416,"cosmosGeoPoint":700,"geoPoint":704,"contacts":705},"Mayo Clinic","Rochester","55905",{"type":418,"coordinates":701},[702,703],-92.4699,44.02163,{"lat":703,"lon":702},[706,707],{"name":238,"role":402,"phone":439,"phoneExt":238,"email":238},{"name":708,"role":398,"phone":238,"phoneExt":238,"email":238},"Judy C Boughey, MD",{"facility":710,"status":411,"city":711,"state":684,"zip":712,"country":415,"countryCode":416,"cosmosGeoPoint":713,"geoPoint":717,"contacts":718},"Metro Minnesota Community Oncology Research Consortium, Hennepin County Medical Center","Saint Louis Park","55416",{"type":418,"coordinates":714},[715,716],-93.34801,44.9483,{"lat":716,"lon":715},[719],{"name":720,"role":398,"phone":238,"phoneExt":238,"email":238},"Satya Bommakanti, MD",{"facility":722,"status":411,"city":723,"state":724,"zip":725,"country":415,"countryCode":416,"cosmosGeoPoint":726,"geoPoint":730,"contacts":731},"Rutgers Cancer Institute of New Jersey","New Brunswick","New Jersey","08903",{"type":418,"coordinates":727},[728,729],-74.45182,40.48622,{"lat":729,"lon":728},[732,734],{"name":238,"role":402,"phone":733,"phoneExt":238,"email":238},"732-235-7356",{"name":735,"role":398,"phone":238,"phoneExt":238,"email":238},"Coral Omene, MD, PhD",{"facility":737,"status":411,"city":738,"state":739,"zip":740,"country":415,"countryCode":416,"cosmosGeoPoint":741,"geoPoint":745,"contacts":746},"Roswell Park Cancer Institute","Buffalo","New York","14263",{"type":418,"coordinates":742},[743,744],-78.87837,42.88645,{"lat":744,"lon":743},[747],{"name":748,"role":398,"phone":238,"phoneExt":238,"email":238},"Ellis Levine, MD",{"facility":750,"status":411,"city":739,"state":739,"zip":751,"country":415,"countryCode":416,"cosmosGeoPoint":752,"geoPoint":756,"contacts":757},"Laura and Isaac Perlmutter Cancer Center \u002F NYU Langone Health","10016",{"type":418,"coordinates":753},[754,755],-74.00597,40.71427,{"lat":755,"lon":754},[758,761],{"name":759,"role":402,"phone":238,"phoneExt":238,"email":760},"Yannis Karamitas","Yannis.Karamitas@nyulangone.org",{"name":762,"role":398,"phone":238,"phoneExt":238,"email":238},"Nancy Chan, MD",{"facility":764,"status":411,"city":739,"state":739,"zip":765,"country":415,"countryCode":416,"cosmosGeoPoint":766,"geoPoint":768,"contacts":769},"Columbia University Medical Center","10032",{"type":418,"coordinates":767},[754,755],{"lat":755,"lon":754},[770],{"name":771,"role":398,"phone":238,"phoneExt":238,"email":238},"Meghana Trivedi, MD",{"facility":773,"status":411,"city":698,"state":739,"zip":774,"country":415,"countryCode":416,"cosmosGeoPoint":775,"geoPoint":779,"contacts":780},"University of Rochester Wilmot Cancer Institute","14642",{"type":418,"coordinates":776},[777,778],-77.61556,43.15478,{"lat":778,"lon":777},[781,783],{"name":238,"role":402,"phone":238,"phoneExt":238,"email":782},"WCICTOResearch@urmc.rochester.edu",{"name":784,"role":398,"phone":238,"phoneExt":238,"email":238},"Carla Folksm, MD",{"facility":786,"status":411,"city":787,"state":739,"zip":788,"country":415,"countryCode":416,"cosmosGeoPoint":789,"geoPoint":793,"contacts":794},"Montefiore Medical Center","The Bronx","10467",{"type":418,"coordinates":790},[791,792],-73.86641,40.84985,{"lat":792,"lon":791},[795],{"name":796,"role":398,"phone":238,"phoneExt":238,"email":238},"Jesus D 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Center","Houston","77230-1439",{"type":418,"coordinates":922},[923,924],-95.36327,29.76328,{"lat":924,"lon":923},{"facility":927,"status":411,"city":928,"state":929,"zip":930,"country":415,"countryCode":416,"cosmosGeoPoint":931,"geoPoint":935,"contacts":936},"Huntsman Cancer Institute, University of Utah","Salt Lake City","Utah","84112",{"type":418,"coordinates":932},[933,934],-111.89105,40.76078,{"lat":934,"lon":933},[937],{"name":938,"role":398,"phone":238,"phoneExt":238,"email":238},"Christos Vaklavas, MD",{"facility":940,"status":444,"city":941,"state":942,"zip":943,"country":415,"countryCode":416,"cosmosGeoPoint":944,"geoPoint":948,"contacts":238},"Inova Health System","Falls Church","Virginia","22042",{"type":418,"coordinates":945},[946,947],-77.17109,38.88233,{"lat":947,"lon":946},{"facility":950,"status":444,"city":951,"state":952,"zip":953,"country":415,"countryCode":416,"cosmosGeoPoint":954,"geoPoint":958,"contacts":238},"Swedish Cancer 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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","ALL","18 Years",{"count":978,"type":979},5000,"ESTIMATED","INTERVENTIONAL",[982],"PHASE2","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.",[985,986,987,988,989,990,991,992,993,994,995],"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",[997,998,999,1000,1001,1002,1003,1004,1005,1006,1007,1008],"Neoadjuvant","Breast","Cancer","Neoplasm","Adaptive","pCR","Pathologic Complete Response","Biomarkers signature","MRI Volume","Endocrine Therapy","Chemotherapy","Immunotherapy","2026-05-04",{"date":1011,"type":1012},"2026-05-06","ACTUAL",{"date":1014,"type":1012},"2010-03-01",{"date":1016,"type":979},"2031-12",{"name":5,"class":6},42]