2025
Outcomes with trastuzumab deruxtecan by biomarker status, line of treatment and prior receipt of sacituzumab govitecan in a large real-world database of patients with metastatic breast cancer
Tarantino P, Lee D, Foldi J, Soulos P, Gross C, Grinda T, Winer E, Lin N, Krop I, Tolaney S, Lustberg M, Sammons S. Outcomes with trastuzumab deruxtecan by biomarker status, line of treatment and prior receipt of sacituzumab govitecan in a large real-world database of patients with metastatic breast cancer. ESMO Open 2025, 10: 105330. PMID: 40532362, PMCID: PMC12212133, DOI: 10.1016/j.esmoop.2025.105330.Peer-Reviewed Original ResearchMetastatic breast cancerHER2-positive diseaseTriple-negative diseaseT-DXdHER2-positiveOverall survivalTrastuzumab deruxtecanSacituzumab govitecanBreast cancerHR-positive/HER2-negative metastatic breast cancerHuman epidermal growth factor receptor 2 (HER2)-positiveElectronic health record-derived databaseHER2-negative metastatic breast cancerClinical trialsAssociated with inferior outcomesHormone receptorsTreat metastatic breast cancerHR-positive/HER2-negativeMedian prior linesProgression-free survivalKaplan-Meier methodDatabase of patientsLines of treatmentAntibody-drug conjugatesHER2-negativeSafety overview and management of inavolisib alone and in combination therapies in PIK3CA-mutated, HR-positive, HER2-negative advanced breast cancer (GO39374)
Gambardella V, Accordino M, Bedard P, Cervantes A, Hamilton E, Italiano A, Kalinsky K, Krop I, Oliveira M, Saura C, Schmid P, Turner N, Varga A, Fernandez-Saranillo A, Jin Y, Royer-Joo S, Peters U, Shankar N, Schutzman J, Juric D, Jhaveri K. Safety overview and management of inavolisib alone and in combination therapies in PIK3CA-mutated, HR-positive, HER2-negative advanced breast cancer (GO39374). ESMO Open 2025, 10: 105303. PMID: 40513140, PMCID: PMC12205636, DOI: 10.1016/j.esmoop.2025.105303.Peer-Reviewed Original ResearchHER2-negative advanced breast cancerAdvanced breast cancerAdverse eventsCombination therapyPIK3CA-mutationsBreast cancerHormone receptor (HR)-positiveDiscontinued study treatmentBreast cancer therapyLong-term toleranceDose reductions/interruptionsAny-gradeData cutoffDose modificationTolerability profileHR-positiveProgressive diseaseStudy treatmentMetformin treatmentCancer therapyNo treatmentPatientsRisk factorsTherapyHyperglycemiaCirculating tumor DNA and late recurrence in high-risk, hormone receptor-positive, HER2-negative breast cancer: An updated analysis of the CHiRP study.
Yoo T, Heiling H, Santos K, Lipsyc-Sharf M, De Bruin E, Patel A, Kirkner G, Hughes M, Partridge A, Krop I, Howarth K, Winer E, Tolaney S, Tayob N, Lin N, Parsons H. Circulating tumor DNA and late recurrence in high-risk, hormone receptor-positive, HER2-negative breast cancer: An updated analysis of the CHiRP study. Journal Of Clinical Oncology 2025, 43: 3055-3055. DOI: 10.1200/jco.2025.43.16_suppl.3055.Peer-Reviewed Original ResearchHR+/HER2- breast cancerNegative predictive valueAdjuvant settingBreast cancerFollow-upCtDNA testingDistant recurrenceClinical outcomesPlasma samplesHER2-negative breast cancerEarly-stage breast cancerRoutine surveillance imagingHormone receptor-positiveStage III diseaseYrs of follow-upMedian follow-upCirculating tumor DNALack of clinical recurrenceRisk of recurrenceFollow-up periodFollow-up visitMedian lead timeImpact clinical outcomesGuideline-concordant careCtDNA-negativeQuantifying the clinical impact of tissue reflex testing for liquid biopsy ESR1 mutation–negative cases with low ctDNA tumor fraction (TF) in HR(+)HER2(-) breast cancer.
Du J, Quintanilha J, Huang R, Heilmann A, Kahn A, Rozenblit M, Chiang A, Pusztai L, Krop I, Winer E, Graf R, Mills J, Gasco Hernandez A, Levy M, Lustberg M. Quantifying the clinical impact of tissue reflex testing for liquid biopsy ESR1 mutation–negative cases with low ctDNA tumor fraction (TF) in HR(+)HER2(-) breast cancer. Journal Of Clinical Oncology 2025, 43: 1065-1065. DOI: 10.1200/jco.2025.43.16_suppl.1065.Peer-Reviewed Original ResearchMetastatic breast cancerComprehensive genomic profilingPositive percent agreementClinicogenomic databaseTumor fractionCtDNA sheddingBC patientsReflex testBreast cancerFirst-line standard of careResistance to estrogen deprivationTissue comprehensive genomic profilingMetastatic breast cancer patientsFalse negative rateFoundationOne Liquid CDxFirst-line standardMutation-negative casesCohort of patientsStandard of careESR1 mutationsTumor genotypeEstrogen deprivationFirst-lineAromatase inhibitorsClinical impactPhase I/Ib study of inavolisib (INAVO) alone and in combination with endocrine therapy ± palbociclib (PALBO) in patients (pts) with PIK3CA-mutated, hormone receptor–positive, HER2-negative locally advanced/metastatic breast cancer (HR+, HER2– LA/mBC): Analysis of hyperglycemia (HG) in prediabetic/obese pts.
Oliveira M, Accordino M, Cervantes A, Gambardella V, Hamilton E, Italiano A, Jhaveri K, Juric D, Kalinsky K, Krop I, Saura C, Schmid P, Turner N, Varga A, Jin Y, Lim S, Royer-Joo S, Shankar N, Schutzman J, Bedard P. Phase I/Ib study of inavolisib (INAVO) alone and in combination with endocrine therapy ± palbociclib (PALBO) in patients (pts) with PIK3CA-mutated, hormone receptor–positive, HER2-negative locally advanced/metastatic breast cancer (HR+, HER2– LA/mBC): Analysis of hyperglycemia (HG) in prediabetic/obese pts. Journal Of Clinical Oncology 2025, 43: 1004-1004. DOI: 10.1200/jco.2025.43.16_suppl.1004.Peer-Reviewed Original ResearchPhase I/Ib studyAdverse eventsPI3K inhibitorsDose interruptionStarting doseLocally advanced/metastatic breast cancerMedian time to onsetRisk factorsMedian time to improvementMedian starting doseHormone receptor-positiveAdvanced/metastatic breast cancerEffects of PI3K inhibitorsTime to improvementOn-target side effectsClinical cut-offTime to onsetBaseline risk factorsYears of ageCut-offDose intensityLaboratory glucose valuesReceptor-positiveAdvanced BCPIK3CA mutationsLong-term outcomes of patients with HER2-positive invasive lobular carcinoma in the ALTTO trial (BIG 2-06/NCCTG N063D [Alliance]).
Nader Marta G, Ameye L, Viale G, Martins-Branco D, Paesmans M, Aftimos P, Desmedt C, Choudhury A, Wolff A, Krop I, Piccart-Gebhart M, de Azambuja E. Long-term outcomes of patients with HER2-positive invasive lobular carcinoma in the ALTTO trial (BIG 2-06/NCCTG N063D [Alliance]). Journal Of Clinical Oncology 2025, 43: 542-542. DOI: 10.1200/jco.2025.43.16_suppl.542.Peer-Reviewed Original ResearchTime to distant recurrenceInvasive lobular carcinomaNo special typeDisease-free survivalCentral nervous system recurrenceCentral pathology reviewTrastuzumab-containing armsCentral nervous systemOutcomes of patientsLong-term outcomesOverall survivalHistological subtypesALTTO trialPathology reviewLobular carcinomaBreast cancerHistological subtype of breast cancerLong-term outcomes of patientsIncidence of CNS metastasesRandomized phase III trialSubtypes of breast cancerProportion of invasive lobular carcinomasLocal pathologyHormone receptor-positivePattern of relapseComparative analysis of PIK3CA mutation detection methods in the first-in-human phase 1/1b study of inavolisib.
Hilz S, Accordino M, Bedard P, Cervantes A, Gambardella V, Hamilton E, Italiano A, Jhaveri K, Juric D, Kalinsky K, Krop I, Oliveira M, Saura Manich C, Schmid P, Aimi J, Royer-Joo S, Schutzman J, Hutchinson K. Comparative analysis of PIK3CA mutation detection methods in the first-in-human phase 1/1b study of inavolisib. Journal Of Clinical Oncology 2025, 43: e13058-e13058. DOI: 10.1200/jco.2025.43.16_suppl.e13058.Peer-Reviewed Original ResearchMetastatic breast cancerHER2- metastatic breast cancerCtDNA testingNGS assaysTumor tissuesDetection concordanceTesting of tumor tissueFoundationOne Liquid CDxPIK3CA mutation testingFresh tumor tissueTissue-based testingBlood-based testOncogenic amino acid substitutionsBlood-based assayCatalytic subunit of PI3KSubunit of PI3KFoundation MedicineMutation detection methodsPIK3CA-mutationsTherapy regimenCtDNA sheddingAlpha catalytic subunitNG-TestReflex testAmino acid substitutionsTrial in progress: ENCORE—Multicenter prospective registry of sequential antibody drug conjugates (ADCs) in HER2 negative metastatic breast cancer (MBC) (TBCRC-067).
Huppert L, Ellisen L, Anders C, Isaacs C, Santa-Maria C, Anampa J, DeMichele A, Balic M, Specht J, Lustberg M, Wolff A, Krop I, Rugo H. Trial in progress: ENCORE—Multicenter prospective registry of sequential antibody drug conjugates (ADCs) in HER2 negative metastatic breast cancer (MBC) (TBCRC-067). Journal Of Clinical Oncology 2025, 43: tps1137-tps1137. DOI: 10.1200/jco.2025.43.16_suppl.tps1137.Peer-Reviewed Original ResearchMetastatic breast cancerReal-world overall survivalProgression free survivalHER2-negative metastatic breast cancerMetastatic triple negative breast cancerStandard of careAntibody-drug conjugatesDisease control rateDuration of responseOverall survivalBreast cancerPatient-reported outcomesFree survivalHER2 negative metastatic breast cancerTreatment strategiesHormone receptor-positive/HER2-negativeNegative metastatic breast cancerTriple negative breast cancerEffective new treatment strategyPhase III clinical trialsRegistry study of patientsKaplan-Meier methodNegative breast cancerIII clinical trialsNew treatment strategiesA randomized phase 2 study of neratinib with or without fulvestrant for patients with HER2-positive, estrogen receptor-positive metastatic breast cancer
Morganti S, Chu X, Ballinger T, Unni N, Sinclair S, Wesolowski R, Pereslete A, Lange P, Tayob N, Lin N, Leone J, Krop I, Tolaney S, Parsons H. A randomized phase 2 study of neratinib with or without fulvestrant for patients with HER2-positive, estrogen receptor-positive metastatic breast cancer. Clinical Breast Cancer 2025 PMID: 40484776, DOI: 10.1016/j.clbc.2025.05.009.Peer-Reviewed Original ResearchProgression-free survivalCirculating tumor DNAMetastatic breast cancerOverall survivalEstrogen receptorBreast cancerClearance of circulating tumor DNAHER2-positive metastatic breast cancerAssociated with progression-free survivalEstrogen receptor-positive metastatic breast cancerGrade 3 adverse eventsMedian progression-free survivalRandomized phase 2 studyIdentification of predictive biomarkersPhase 2 clinical trialCombination of neratinibDuration of responseOverall response rateER signaling pathwayCtDNA dynamicsMedian OSHER2-positiveER-positiveOpen-labelSlow accrual314P Outcomes with trastuzumab deruxtecan (T-DXd) for metastatic breast cancer (MBC) according to BRCA and PD-L1 status
Tarantino P, Lee D, Foldi J, Soulos P, Gross C, Grinda T, Winer E, Lin N, Krop I, Tolaney S, Sammons S, Lustberg M. 314P Outcomes with trastuzumab deruxtecan (T-DXd) for metastatic breast cancer (MBC) according to BRCA and PD-L1 status. ESMO Open 2025, 10: 104886. DOI: 10.1016/j.esmoop.2025.104886.Peer-Reviewed Original Research322P Human epidermal growth factor receptor 2 (HER2)-directed therapies administered after trastuzumab deruxtecan (T-DXd) remain effective in patients (pts) with metastatic breast cancer (mBC): Exploratory analysis from DESTINY-Breast02 and -03
Fasching P, Bianchini G, Ciruelos E, Cortés J, Curigliano G, Gligorov J, Harbeck N, Hurvitz S, Im S, Iwata H, Pasteiner W, Nakatani S, Lu W, Liang Z, Egorov A, Krop I. 322P Human epidermal growth factor receptor 2 (HER2)-directed therapies administered after trastuzumab deruxtecan (T-DXd) remain effective in patients (pts) with metastatic breast cancer (mBC): Exploratory analysis from DESTINY-Breast02 and -03. ESMO Open 2025, 10: 104894. DOI: 10.1016/j.esmoop.2025.104894.Peer-Reviewed Original ResearchMultiplex Spatial Proteomic Analysis of HER2–Positive Breast Tumors Reveals Unique Molecular and Immunologic Features Associated With Treatment Response
Hennessy M, Cimino-Mathews A, Carter J, Kachergus J, Ma Y, Leal J, Solnes L, Denbow R, Abramson V, Carey L, Rimawi M, Specht J, Storniolo A, Valero V, Vaklavas C, Winer E, Krop I, Wolff A, Wahl R, Perez E, Huang C, Stearns V, Thompson E, Connolly R. Multiplex Spatial Proteomic Analysis of HER2–Positive Breast Tumors Reveals Unique Molecular and Immunologic Features Associated With Treatment Response. JCO Precision Oncology 2025, 9: e2400546. PMID: 40179327, PMCID: PMC11968088, DOI: 10.1200/po-24-00546.Peer-Reviewed Original ResearchConceptsPrediction of pathological complete responseHER2-positive breast cancerBreast cancerAbundant tumorHematoxylin and eosin and immunohistochemistryClinical trialsEstrogen receptor (ER)-negativeStromal tumor-infiltrating lymphocytesHuman epidermal growth factor 2 (HER2)-positive breast cancerPathological complete responseTumor-infiltrating lymphocytesEpidermal growth factor receptor signalingImmune cell activationDigital spatial profilingImmune-based biomarkersGeoMx Digital Spatial ProfilerNanoString GeoMx Digital Spatial ProfilingGrowth factor receptor signalingBaseline Ki67Baseline tumorsComplete responseER-negativeBasal-likeTumor biopsiesImmunological featuresA composite 18F-FDG PET/CT and HER2 tissue-based biomarker to predict response to neoadjuvant pertuzumab and trastuzumab in HER2-positive breast cancer (TBCRC026)
Hennessy M, Cimino-Mathews A, Carter J, Kachergus J, Ma Y, Leal J, Solnes L, Abramson V, Carey L, Rimawi M, Specht J, Storniolo A, Vaklavas C, Krop I, Winer E, Denbow R, Valero V, Wolff A, Wahl R, Huang C, Stearns V, Thompson E, Connolly R. A composite 18F-FDG PET/CT and HER2 tissue-based biomarker to predict response to neoadjuvant pertuzumab and trastuzumab in HER2-positive breast cancer (TBCRC026). The Breast 2025, 81: 104432. PMID: 40049115, PMCID: PMC11928837, DOI: 10.1016/j.breast.2025.104432.Peer-Reviewed Original ResearchTissue-based biomarkersBreast cancerHER2-positive breast cancerHER2 3+Negative predictive valueEarly metabolic changesNeoadjuvant pertuzumabScore cut-offNeoadjuvant therapyIntrinsic subtypesSULmaxC1D15PET/CTDays post-initiationHER2 proteinYouden indexComposite biomarkerDe-intensificationHER2Post-initiationPredictive valueBiomarker performanceC-statisticImaging biomarkersMetabolic changesCorrection: PIK3CAH1047R- and Her2-initiated mammary tumors escape PI3K dependency by compensatory activation of MEK-ERK signaling
Cheng H, Liu P, Ohlson C, Xu E, Symonds L, Isabella A, Muller W, Lin N, Krop I, Roberts T, Winer E, Arteaga C, Zhao J. Correction: PIK3CAH1047R- and Her2-initiated mammary tumors escape PI3K dependency by compensatory activation of MEK-ERK signaling. Oncogene 2025, 44: 478-479. PMID: 39890968, DOI: 10.1038/s41388-025-03281-8.Peer-Reviewed Original Research
2024
Final analysis of the ALTTO trial: adjuvant trastuzumab in sequence or in combination with lapatinib in patients with HER2-positive early breast cancer [BIG 2-06/NCCTG N063D (Alliance)]
de Azambuja E, Piccart-Gebhart M, Fielding S, Townend J, Hillman D, Colleoni M, Roylance R, Kelly C, Lombard J, El-Abed S, Choudhury A, Korde L, Vicente M, Chumsri S, Rodeheffer R, Ellard S, Wolff A, Holtschmidt J, Lang I, Untch M, Boyle F, Xu B, Werutsky G, Tujakowski J, Huang C, Baruch N, Bliss J, Ferro A, Gralow J, Kim S, Kroep J, Krop I, Kuemmel S, McConnell R, Moscetti L, Knop A, van Duijnhoven F, Gomez H, Cameron D, Di Cosimo S, Gelber R, Moreno-Aspitia A. Final analysis of the ALTTO trial: adjuvant trastuzumab in sequence or in combination with lapatinib in patients with HER2-positive early breast cancer [BIG 2-06/NCCTG N063D (Alliance)]. ESMO Open 2024, 9: 103938. PMID: 39418883, PMCID: PMC11532431, DOI: 10.1016/j.esmoop.2024.103938.Peer-Reviewed Original ResearchDisease-free survivalHER2-positive early breast cancerEarly breast cancerOverall survivalALTTO trialBreast cancerFollow-upMetastatic HER2-positive breast cancerDual anti-HER2 blockadeAnti-human epidermal growth factor receptor 2HER2-positive breast cancerEpidermal growth factor receptor 2Lapatinib to trastuzumabAnti-HER2 therapyAnti-HER2 blockadeTreatment groupsOutcomes of patientsAdjuvant trastuzumabOpen-labelAdjuvant chemotherapyPrimary endpointSecondary endpointsEfficacy analysisMulticenter studyAnti-HER2Phase I/Ib Trial of Inavolisib Plus Palbociclib and Endocrine Therapy for PIK3CA-Mutated, Hormone Receptor–Positive, Human Epidermal Growth Factor Receptor 2–Negative Advanced or Metastatic Breast Cancer
Jhaveri K, Accordino M, Bedard P, Cervantes A, Gambardella V, Hamilton E, Italiano A, Kalinsky K, Krop I, Oliveira M, Schmid P, Saura C, Turner N, Varga A, Cheeti S, Hilz S, Hutchinson K, Jin Y, Royer-Joo S, Peters U, Shankar N, Schutzman J, Juric D. Phase I/Ib Trial of Inavolisib Plus Palbociclib and Endocrine Therapy for PIK3CA-Mutated, Hormone Receptor–Positive, Human Epidermal Growth Factor Receptor 2–Negative Advanced or Metastatic Breast Cancer. Journal Of Clinical Oncology 2024, 42: 3947-3956. PMID: 39236276, PMCID: PMC11575912, DOI: 10.1200/jco.24.00110.Peer-Reviewed Original ResearchTreatment-related adverse eventsDrug-drug interactionsPreliminary antitumor activityEndocrine therapyStudy treatmentHuman epidermal growth factor receptor 2-negativeBreast cancerTreatment-related adverse event ratesLack of drug-drug interactionsConfirmed objective response rateLocally advanced/metastatic breast cancerCirculating tumor DNA analysisEffect of study treatmentPK drug-drug interactionsAntitumor activityObjective response ratePhase I/Ib studyHormone receptor-positiveProgression-free survivalAdvanced/metastatic breast cancerTumor DNA analysisBiomarkers of responseMetastatic breast cancerYears of ageReceptor-positiveA pooled analysis of trastuzumab deruxtecan in patients with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer with brain metastases
André F, Cortés J, Curigliano G, Modi S, Li W, Park Y, Chung W, Kim S, Yamashita T, Pedrini J, Im S, Tseng L, Harbeck N, Krop I, Nakatani S, Tecson K, Ashfaque S, Egorov A, Hurvitz S. A pooled analysis of trastuzumab deruxtecan in patients with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer with brain metastases. Annals Of Oncology 2024, 35: 1169-1180. PMID: 39241960, DOI: 10.1016/j.annonc.2024.08.2347.Peer-Reviewed Original ResearchHER2-positive metastatic breast cancerBlinded independent central reviewMetastatic breast cancerBrain metastasesT-DXdOverall survivalCNS-PFSTrastuzumab deruxtecanBreast cancerCentral nervous system progression-free survivalIntracranial responsePooled analysisIntracranial objective response rateSafety of trastuzumab deruxtecanSystemic progression-free survivalObjective response rateORR of patientsProgression-free survivalDuration of responseFood and Drug Administration criteriaIndependent central reviewUS Food and Drug Administration criteriaCompare treatmentsExploratory pooled analysisBM statusNeratinib and ado-trastuzumab emtansine for pretreated and untreated human epidermal growth factor receptor 2 (HER2)-positive breast cancer brain metastases: Translational Breast Cancer Research Consortium trial 022 ☆
Freedman R, Heiling H, Li T, Trapani D, Tayob N, Smith K, Davis R, Pereslete A, DeMeo M, Cotter C, Chen W, Parsons H, Santa-Maria C, Van Poznak C, Moy B, Brufsky A, Melisko M, O’Sullivan C, Ashai N, Rauf Y, Nangia J, Burns R, Savoie J, Wolff A, Winer E, Rimawi M, Krop I, Lin N. Neratinib and ado-trastuzumab emtansine for pretreated and untreated human epidermal growth factor receptor 2 (HER2)-positive breast cancer brain metastases: Translational Breast Cancer Research Consortium trial 022 ☆. Annals Of Oncology 2024, 35: 993-1002. PMID: 38977064, DOI: 10.1016/j.annonc.2024.07.245.Peer-Reviewed Original ResearchHER2-positive breast cancer brain metastasesBreast cancer brain metastasesT-DM1Ado-trastuzumab emtansineCentral nervous systemOverall survivalCNS objective response rateEfficacy of neratinibT-DM1 exposureObjective response rateCancer brain metastasesPhase II studyMedian OSRANO-BMBrain MetastasesSlow accrualIntracranial activityII studyPrimary endpointPreclinical dataCohort 4Response assessmentTreatment optionsNeratinibPatientsAdjuvant Trastuzumab Emtansine Versus Paclitaxel Plus Trastuzumab for Stage I Human Epidermal Growth Factor Receptor 2–Positive Breast Cancer: 5-Year Results and Correlative Analyses From ATEMPT
Tarantino P, Tayob N, Villacampa G, Dang C, Yardley D, Isakoff S, Valero V, Faggen M, Mulvey T, Bose R, Weckstein D, Wolff A, Reeder-Hayes K, Rugo H, Ramaswamy B, Zuckerman D, Hart L, Gadi V, Constantine M, Cheng K, Garrett A, Marcom P, Albain K, DeFusco P, Tung N, Ardman B, Nanda R, Jankowitz R, Rimawi M, Abramson V, Pohlmann P, Van Poznak C, Forero-Torres A, Liu M, Ruddy K, Waks A, DeMeo M, Burstein H, Partridge A, Dell'Orto P, Russo L, Krause E, Newhouse D, Kurt B, Mittendorf E, Schneider B, Prat A, Winer E, Krop I, Tolaney S, Investigators T, Barroso-Sousa R, Curigliano G, DiLullo M, Hui W, Kirkup C, Viale G, Zheng Y. Adjuvant Trastuzumab Emtansine Versus Paclitaxel Plus Trastuzumab for Stage I Human Epidermal Growth Factor Receptor 2–Positive Breast Cancer: 5-Year Results and Correlative Analyses From ATEMPT. Journal Of Clinical Oncology 2024, 42: 3652-3665. PMID: 38935923, PMCID: PMC11527383, DOI: 10.1200/jco.23.02170.Peer-Reviewed Original ResearchInvasive disease-free survivalRecurrence-free intervalAdjuvant T-DM1T-DM1Long-term outcomesBreast cancerStage I HER2-positive breast cancerInvasive disease-free survival eventsLong-term outcomes of patientsBreast cancer-specific survivalHER2-positive breast cancerAdjuvant trastuzumab emtansinePredictors of thrombocytopeniaRisk scoreT-DM1 armCancer-specific survivalHormone receptor statusHigh-risk tumorsDisease-free survivalMedian follow-upClinically relevant toxicitiesRisk of recurrenceOutcomes of patientsHER2 immunohistochemical scoresTH armPhase Ib dose-escalation trial of taselisib (GDC-0032) in combination with HER2-directed therapies in patients with advanced HER2+ breast cancer
Grinshpun A, Ren S, Graham N, DeMeo M, Wrabel E, Carter J, Tayob N, Pereslete A, Hamilton E, Juric D, Mayer E, Tolaney S, Krop I, Metzger O. Phase Ib dose-escalation trial of taselisib (GDC-0032) in combination with HER2-directed therapies in patients with advanced HER2+ breast cancer. ESMO Open 2024, 9: 103465. PMID: 38833970, PMCID: PMC11179085, DOI: 10.1016/j.esmoop.2024.103465.Peer-Reviewed Original ResearchProgression-free survivalMaximal tolerated doseHER2+ breast cancerAdverse eventsBreast cancerT-DM1Cohort AHuman epidermal growth factor receptor 2-positiveEpidermal growth factor receptor 2-positiveHER2+) breast cancerMedian progression-free survivalAll-grade adverse eventsAssociated with significant toxicityCirculating tumor DNA analysisDevelopment of acquired resistanceHER2-directed regimensHER2-directed therapyAnti-HER2 therapyHER2-targeted therapyPhase Ib studyTumor DNA analysisPI3KDose escalationImprove disease controlOral inhibitor
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