2021
Phase II Single-Arm Study to Assess Trastuzumab and Vinorelbine in Advanced Breast Cancer Patients With HER2-Negative Tumors and HER2-Positive Circulating Tumor Cells
Parsons HA, Macrae ER, Guo H, Li T, Barry WT, Tayob N, Wulf GM, Isakoff SJ, Krop IE. Phase II Single-Arm Study to Assess Trastuzumab and Vinorelbine in Advanced Breast Cancer Patients With HER2-Negative Tumors and HER2-Positive Circulating Tumor Cells. JCO Precision Oncology 2021, 5: 896-903. PMID: 34994617, PMCID: PMC9848583, DOI: 10.1200/po.20.00461.Peer-Reviewed Original ResearchConceptsMetastatic breast cancerHER2-positive CTCsHER2-negative metastatic breast cancerObjective response rateBreast cancerHER2-Positive Circulating Tumor CellsHER2-positive metastatic breast cancerResponse rateMedian progression-free survivalPhase II single-arm studyProgressive metastatic breast cancerHER2-negative breast cancerAdvanced breast cancer patientsHuman epidermal growth factor receptor 2Epidermal growth factor receptor 2Tumor cellsHER2-positive diseasePrior chemotherapy regimenTumor tissue testingClinical benefit ratePrimary end pointPhase II trialProgression-free survivalGrowth factor receptor 2HER2-negative tumors
2020
Phase II trial of carboplatin and bevacizumab in patients with breast cancer brain metastases
Leone JP, Emblem KE, Weitz M, Gelman RS, Schneider BP, Freedman RA, Younger J, Pinho MC, Sorensen AG, Gerstner ER, Harris G, Krop IE, Morganstern D, Sohl J, Hu J, Kasparian E, Winer EP, Lin NU. Phase II trial of carboplatin and bevacizumab in patients with breast cancer brain metastases. Breast Cancer Research 2020, 22: 131. PMID: 33256829, PMCID: PMC7706261, DOI: 10.1186/s13058-020-01372-w.Peer-Reviewed Original ResearchMeSH KeywordsAdultAntineoplastic Combined Chemotherapy ProtocolsBevacizumabBrainBrain NeoplasmsBreastBreast NeoplasmsCarboplatinFemaleGenotyping TechniquesHumansKaplan-Meier EstimateMagnetic Resonance ImagingMiddle AgedPolymorphism, Single NucleotideProgression-Free SurvivalTrastuzumabVascular Endothelial Growth Factor AConceptsProgression-free survivalBreast cancer brain metastasesEarly MRI changesCancer brain metastasesBrain metastasesOverall survivalMRI changesBreast cancerEastern Cooperative Oncology Group performance statusDay 1Cycle 1 day 1Cycle 1 day 8Median progression-free survivalWorse progression-free survivalRegimen warrants further investigationDurable objective responsesECOG PS 1Efficacy of bevacizumabHER2-positive diseaseProgressive brain metastasesResultsThirty-eight patientsMedian overall survivalObjective response ratePhase II trialContrast-enhanced brain MRI
2019
HER2-Enriched Subtype and ERBB2 Expression in HER2-Positive Breast Cancer Treated with Dual HER2 Blockade
Prat A, Pascual T, De Angelis C, Gutierrez C, Llombart-Cussac A, Wang T, Cortés J, Rexer B, Paré L, Forero A, Wolff AC, Morales S, Adamo B, Brasó-Maristany F, Vidal M, Veeraraghavan J, Krop I, Galván P, Pavlick AC, Bermejo B, Izquierdo M, Rodrik-Outmezguine V, Reis-Filho JS, Hilsenbeck SG, Oliveira M, Dieci MV, Griguolo G, Fasani R, Nuciforo P, Parker JS, Conte P, Schiff R, Guarneri V, Osborne CK, Rimawi MF. HER2-Enriched Subtype and ERBB2 Expression in HER2-Positive Breast Cancer Treated with Dual HER2 Blockade. Journal Of The National Cancer Institute 2019, 112: 46-54. PMID: 31037288, PMCID: PMC7850037, DOI: 10.1093/jnci/djz042.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntibodies, Monoclonal, HumanizedAntineoplastic AgentsAntineoplastic Combined Chemotherapy ProtocolsBiomarkers, TumorBreast NeoplasmsClinical Trials, Phase II as TopicClinical Trials, Phase III as TopicFemaleGene ExpressionHumansLapatinibMiddle AgedMolecular Targeted TherapyNeoadjuvant TherapyNeoplasm StagingPrognosisReceptor, ErbB-2Reproducibility of ResultsSurvival AnalysisTreatment OutcomeConceptsHER2-positive breast cancerProgression-free survivalOverall response rateHER2-positive diseasePathological complete responseOverall survivalBreast cancerEarly diseaseAdvanced HER2-positive diseaseLonger progression-free survivalHigher overall response rateDual HER2 blockadeLonger overall survivalHER2-positive tumorsHER2 blockadeNeoadjuvant lapatinibNeoadjuvant trastuzumabAdvanced diseaseComplete responsePrimary outcomeClinical trialsIntrinsic subtypesIdentifies tumorsAdvanced settingERBB2 mRNALocal–regional recurrence in women with small node-negative, HER2-positive breast cancer: results from a prospective multi-institutional study (the APT trial)
Bellon JR, Guo H, Barry WT, Dang CT, Yardley DA, Moy B, Marcom PK, Albain KS, Rugo HS, Ellis M, Wolff AC, Carey LA, Overmoyer BA, Partridge AH, Hudis CA, Krop I, Burstein HJ, Winer EP, Tolaney SM. Local–regional recurrence in women with small node-negative, HER2-positive breast cancer: results from a prospective multi-institutional study (the APT trial). Breast Cancer Research And Treatment 2019, 176: 303-310. PMID: 31004299, DOI: 10.1007/s10549-019-05238-4.Peer-Reviewed Original ResearchConceptsHER2-positive breast cancerLocal-regional recurrenceDisease-free survivalEffective anti-HER2 therapyLRR-free survivalAnti-HER2 therapyBreast-conserving surgeryBreast cancerRadiation therapySystemic therapyHormone receptor-positive tumorsProspective multi-institutional studyHER2-negative diseaseHER2-positive diseaseNegative axillary nodesEffective systemic therapyProspective multicenter trialEarly-stage patientsKaplan-Meier methodReceptor-positive tumorsHER2-positive tumorsMulti-institutional studyFuture investigational effortsAdjuvant trastuzumabProtocol therapy
2016
Role of Patient and Disease Factors in Adjuvant Systemic Therapy Decision Making for Early-Stage, Operable Breast Cancer: American Society of Clinical Oncology Endorsement of Cancer Care Ontario Guideline Recommendations
Henry NL, Somerfield MR, Abramson VG, Allison KH, Anders CK, Chingos DT, Hurria A, Openshaw TH, Krop IE. Role of Patient and Disease Factors in Adjuvant Systemic Therapy Decision Making for Early-Stage, Operable Breast Cancer: American Society of Clinical Oncology Endorsement of Cancer Care Ontario Guideline Recommendations. Journal Of Clinical Oncology 2016, 34: 2303-2311. PMID: 27001586, DOI: 10.1200/jco.2015.65.8609.Peer-Reviewed Original ResearchConceptsOncotype DX recurrence scoreDX recurrence scoreDistant relapse riskNode-negative tumorsRisk stratification toolRecurrence scoreEstrogen receptorRole of patientsASCO panelAdjuvant therapyStratification toolRelapse riskBreast cancerDisease factorsHuman epidermal growth factor receptor 2 (HER2) statusEpidermal growth factor receptor 2 statusSmall node-negative tumorsLymph node-negative tumorsEarly-stage breast cancerAdjuvant therapy recommendationsClinical Oncology EndorsementHER2-positive diseaseLymphovascular invasion positivityMicrometastatic nodal diseaseSystemic therapy decisions
2015
Molecular Heterogeneity and Response to Neoadjuvant Human Epidermal Growth Factor Receptor 2 Targeting in CALGB 40601, a Randomized Phase III Trial of Paclitaxel Plus Trastuzumab With or Without Lapatinib
Carey LA, Berry DA, Cirrincione CT, Barry WT, Pitcher BN, Harris LN, Ollila DW, Krop IE, Henry NL, Weckstein DJ, Anders CK, Singh B, Hoadley KA, Iglesia M, Cheang MC, Perou CM, Winer EP, Hudis CA. Molecular Heterogeneity and Response to Neoadjuvant Human Epidermal Growth Factor Receptor 2 Targeting in CALGB 40601, a Randomized Phase III Trial of Paclitaxel Plus Trastuzumab With or Without Lapatinib. Journal Of Clinical Oncology 2015, 34: 542-549. PMID: 26527775, PMCID: PMC4980567, DOI: 10.1200/jco.2015.62.1268.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsCarcinomaEstrogen Receptor alphaFemaleGene ExpressionHumansImmunoglobulin GLapatinibMiddle AgedNeoadjuvant TherapyNeoplasm, ResidualPaclitaxelQuinazolinesReceptor, ErbB-2Receptors, EstrogenReceptors, ProgesteroneRNA, MessengerTrastuzumabTreatment OutcomeTumor MicroenvironmentTumor Suppressor Protein p53Young AdultConceptsPathologic complete response rateCALGB 40601Dual therapyIntrinsic subtypesHormone receptor-negative diseaseRandomized phase III trialHuman epidermal growth factor receptor 2End pointHER2-positive breast cancerEpidermal growth factor receptor 2Correlative end pointsDual HER2 blockadeHER2-positive diseaseComplete response ratePrimary end pointPhase III trialsProgression-free survivalReceptor-negative diseaseAddition of lapatinibGrowth factor receptor 2Immune cell signaturesFactor receptor 2Gene expression-based assaysMolecular featuresDual HER2