2021
Adjuvant Trastuzumab Emtansine Versus Paclitaxel in Combination With Trastuzumab for Stage I HER2-Positive Breast Cancer (ATEMPT): A Randomized Clinical Trial
Tolaney SM, Tayob N, Dang C, Yardley DA, Isakoff SJ, Valero V, Faggen M, Mulvey T, Bose R, Hu J, Weckstein D, Wolff AC, Reeder-Hayes K, Rugo HS, Ramaswamy B, Zuckerman D, Hart L, Gadi VK, Constantine M, Cheng K, Briccetti F, Schneider B, Garrett AM, Marcom K, Albain K, DeFusco P, Tung N, Ardman B, Nanda R, Jankowitz RC, Rimawi M, Abramson V, Pohlmann PR, Van Poznak C, Forero-Torres A, Liu M, Ruddy K, Zheng Y, Rosenberg SM, Gelber RD, Trippa L, Barry W, DeMeo M, Burstein H, Partridge A, Winer EP, Krop I. Adjuvant Trastuzumab Emtansine Versus Paclitaxel in Combination With Trastuzumab for Stage I HER2-Positive Breast Cancer (ATEMPT): A Randomized Clinical Trial. Journal Of Clinical Oncology 2021, 39: 2375-2385. PMID: 34077270, DOI: 10.1200/jco.20.03398.Peer-Reviewed Original ResearchConceptsInvasive disease-free survivalT-DM1Breast cancerStage IStage I HER2-positive breast cancerHER2-positive breast cancerHuman epidermal growth factor receptorAdjuvant T-DM1Co-primary objectivesDisease-free survivalPatient-reported outcomesEpidermal growth factor receptorGrowth factor receptorProtocol therapyAnalysis populationTrastuzumab emtansineClinical trialsRelevant toxicityPatientsFactor receptorLess toxicityWeeksTrastuzumabCancerPaclitaxelGenomic Characterization of de novo Metastatic Breast Cancer
Garrido-Castro AC, Spurr LF, Hughes ME, Li YY, Cherniack AD, Kumari P, Lloyd MR, Bychkovsky B, Barroso-Sousa R, Di Lascio S, Jain E, Files J, Mohammed-Abreu A, Krevalin M, MacKichan C, Barry WT, Guo H, Xia D, Cerami E, Rollins BJ, MacConaill LE, Lindeman NI, Krop IE, Johnson BE, Wagle N, Winer EP, Dillon DA, Lin NU. Genomic Characterization of de novo Metastatic Breast Cancer. Clinical Cancer Research 2021, 27: 1105-1118. PMID: 33293374, PMCID: PMC7887078, DOI: 10.1158/1078-0432.ccr-20-1720.Peer-Reviewed Original ResearchConceptsMetastatic breast cancerPrimary tumorOverall survivalBreast cancerDe novo metastatic breast cancerNovo metastatic breast cancerDifferential therapeutic sensitivityBetter OSPoor OSShorter OSInitial diagnosisHigh TMBMetastatic tumorsDnMBCCurrent treatmentMutational burdenTreatment selectionMetastatic driversStage IMultiple comparison adjustmentTherapeutic sensitivityTumorsPatientsCancerIntrinsic resistance
2020
Survival, Pathologic Response, and Genomics in CALGB 40601 (Alliance), a Neoadjuvant Phase III Trial of Paclitaxel-Trastuzumab With or Without Lapatinib in HER2-Positive Breast Cancer.
Fernandez-Martinez A, Krop IE, Hillman DW, Polley MY, Parker JS, Huebner L, Hoadley KA, Shepherd J, Tolaney S, Henry NL, Dang C, Harris L, Berry D, Hahn O, Hudis C, Winer E, Partridge A, Perou CM, Carey LA. Survival, Pathologic Response, and Genomics in CALGB 40601 (Alliance), a Neoadjuvant Phase III Trial of Paclitaxel-Trastuzumab With or Without Lapatinib in HER2-Positive Breast Cancer. Journal Of Clinical Oncology 2020, 38: 4184-4193. PMID: 33095682, PMCID: PMC7723687, DOI: 10.1200/jco.20.01276.Peer-Reviewed Original ResearchConceptsPathologic complete responseRelapse-free survivalHuman epidermal growth factor receptor 2HER2-positive breast cancerBetter relapse-free survivalOverall survivalCALGB 40601Breast cancerImmune signaturesGene expression signaturesDe-escalation treatment strategiesPrediction of pCREnd pointEpidermal growth factor receptor 2Shorter relapse-free survivalPrimary end pointResidual disease groupSecondary end pointsUntreated stage IIGood prognostic factorGrowth factor receptor 2Phase III trialsExpression signaturesFactor receptor 2OS benefit
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 therapyGenomic alterations in breast cancer: level of evidence for actionability according to ESMO Scale for Clinical Actionability of molecular Targets (ESCAT)
Condorelli R, Mosele F, Verret B, Bachelot T, Bedard P, Cortes J, Hyman D, Juric D, Krop I, Bieche I, Saura C, Sotiriou C, Cardoso F, Loibl S, Andre F, Turner N. Genomic alterations in breast cancer: level of evidence for actionability according to ESMO Scale for Clinical Actionability of molecular Targets (ESCAT). Annals Of Oncology 2019, 30: 365-373. PMID: 30715161, DOI: 10.1093/annonc/mdz036.Peer-Reviewed Original ResearchConceptsLevel of evidenceBreast cancerESMO ScaleClinical actionabilityGenomic alterationsMicrosatellite instabilityLarge randomized trialsMolecular targetsBRCA 1/2 mutationsGermline BRCA1/2 mutationsESR1 mutationsPreclinical evidenceNTRK fusionsRandomized trialsPIK3CA mutationsERBB2 mutationsBRCA1/2 mutationsRecurrent genomic alterationsMDM2 amplificationERBB2 amplificationClinical practiceDriver alterationsPTEN lossTumor genomic landscapeAntitumor activityTBCRC026: Phase II Trial Correlating Standardized Uptake Value With Pathologic Complete Response to Pertuzumab and Trastuzumab in Breast Cancer
Connolly RM, Leal JP, Solnes L, Huang CY, Carpenter A, Gaffney K, Abramson V, Carey LA, Liu MC, Rimawi M, Specht J, Storniolo AM, Valero V, Vaklavas C, Krop IE, Winer EP, Camp M, Miller RS, Wolff AC, Cimino-Mathews A, Park BH, Wahl RL, Stearns V. TBCRC026: Phase II Trial Correlating Standardized Uptake Value With Pathologic Complete Response to Pertuzumab and Trastuzumab in Breast Cancer. Journal Of Clinical Oncology 2019, 37: jco.2018.78.7986. PMID: 30721110, PMCID: PMC6424139, DOI: 10.1200/jco.2018.78.7986.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsChemotherapy, AdjuvantFemaleFluorodeoxyglucose F18HumansMiddle AgedNeoadjuvant TherapyNeoplasm StagingPredictive Value of TestsRadiopharmaceuticalsReceptor, ErbB-2Receptors, EstrogenSingle Photon Emission Computed Tomography Computed TomographyTime FactorsTrastuzumabTreatment OutcomeUnited StatesConceptsPathologic complete responseHER2-positive breast cancerPositron emission tomography/Emission tomography/Standardized uptake valueBreast cancerComplete responseTomography/Uptake valueTumor maximum standardized uptake valueOne-sided type IHuman epidermal growth factor receptor 2Stage II/IIIEpidermal growth factor receptor 2Maximum standardized uptake valueCycles of PTGrowth factor receptor 2Median percent reductionPositive breast cancerLean body massFactor receptor 2Significant differencesEvaluable patientsNeoadjuvant pertuzumabPT initiation
2018
4th ESO–ESMO International Consensus Guidelines for Advanced Breast Cancer (ABC 4) † † These guidelines were developed by the European School of Oncology (ESO) and the European Society for Medical Oncology (ESMO).
Cardoso F, Senkus E, Costa A, Papadopoulos E, Aapro M, André F, Harbeck N, Lopez B, Barrios CH, Bergh J, Biganzoli L, Boers-Doets CB, Cardoso MJ, Carey LA, Cortés J, Curigliano G, Diéras V, Saghir N, Eniu A, Fallowfield L, Francis PA, Gelmon K, Johnston SRD, Kaufman B, Koppikar S, Krop IE, Mayer M, Nakigudde G, Offersen BV, Ohno S, Pagani O, Paluch-Shimon S, Penault-Llorca F, Prat A, Rugo HS, Sledge GW, Spence D, Thomssen C, Vorobiof DA, Xu B, Norton L, Winer EP. 4th ESO–ESMO International Consensus Guidelines for Advanced Breast Cancer (ABC 4) † † These guidelines were developed by the European School of Oncology (ESO) and the European Society for Medical Oncology (ESMO). Annals Of Oncology 2018, 29: 1634-1657. PMID: 30032243, PMCID: PMC7360146, DOI: 10.1093/annonc/mdy192.Peer-Reviewed Original ResearchMeSH KeywordsBiomarkers, TumorBiopsy, Large-Core NeedleBreastBreast NeoplasmsChemoradiotherapy, AdjuvantClinical Trials as TopicConsensus Development Conferences as TopicEuropeEvidence-Based MedicineFemaleHumansIntegrative MedicineMastectomyMedical OncologyNeoadjuvant TherapyNeoplasm StagingSocieties, MedicalTreatment Outcome
2017
Use of Biomarkers to Guide Decisions on Adjuvant Systemic Therapy for Women With Early-Stage Invasive Breast Cancer: American Society of Clinical Oncology Clinical Practice Focused Update Guideline Summary
Krop I, Ismaila N, Stearns V. Use of Biomarkers to Guide Decisions on Adjuvant Systemic Therapy for Women With Early-Stage Invasive Breast Cancer: American Society of Clinical Oncology Clinical Practice Focused Update Guideline Summary. JCO Oncology Practice 2017, 13: jop.2017.024646. PMID: 28696818, DOI: 10.1200/jop.2017.024646.Peer-Reviewed Original ResearchMeSH KeywordsBiomarkersBreast NeoplasmsChemotherapy, AdjuvantFemaleGuidelines as TopicHumansNeoplasm StagingUnited States
2016
Pictilisib for oestrogen receptor-positive, aromatase inhibitor-resistant, advanced or metastatic breast cancer (FERGI): a randomised, double-blind, placebo-controlled, phase 2 trial
Krop IE, Mayer IA, Ganju V, Dickler M, Johnston S, Morales S, Yardley DA, Melichar B, Forero-Torres A, Lee SC, de Boer R, Petrakova K, Vallentin S, Perez EA, Piccart M, Ellis M, Winer E, Gendreau S, Derynck M, Lackner M, Levy G, Qiu J, He J, Schmid P. Pictilisib for oestrogen receptor-positive, aromatase inhibitor-resistant, advanced or metastatic breast cancer (FERGI): a randomised, double-blind, placebo-controlled, phase 2 trial. The Lancet Oncology 2016, 17: 811-821. PMID: 27155741, PMCID: PMC5524539, DOI: 10.1016/s1470-2045(16)00106-6.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overBiomarkers, TumorBreast NeoplasmsDouble-Blind MethodDrug Resistance, NeoplasmEstradiolEstrogen Receptor AntagonistsFemaleFollow-Up StudiesFulvestrantHumansMiddle AgedNeoplasm Recurrence, LocalNeoplasm StagingPrognosisReceptor, ErbB-2Receptors, EstrogenSalvage TherapySurvival RateConceptsProgression-free survivalSerious adverse eventsTreatment-related serious adverse eventsWorse adverse eventsPlacebo groupAdverse eventsNon-measurable diseaseAromatase inhibitor treatmentPIK3CA mutationsBreast cancerDay 1Grade 3Inhibitor treatmentDay 15Cycle 1Median progression-free survivalHER2-negative breast cancerEndocrine-resistant breast cancerPIK3CA-mutated tumorsPhase 2 studyPhase 2 trialMetastatic breast cancerWeeks of treatmentAromatase inhibitor resistanceF Hoffmann-La RocheRole 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 decisionsCardiac Outcomes of Patients Receiving Adjuvant Weekly Paclitaxel and Trastuzumab for Node-Negative, ERBB2-Positive Breast Cancer
Dang C, Guo H, Najita J, Yardley D, Marcom K, Albain K, Rugo H, Miller K, Ellis M, Shapira I, Wolff AC, Carey LA, Moy B, Groarke J, Moslehi J, Krop I, Burstein HJ, Hudis C, Winer EP, Tolaney SM. Cardiac Outcomes of Patients Receiving Adjuvant Weekly Paclitaxel and Trastuzumab for Node-Negative, ERBB2-Positive Breast Cancer. JAMA Oncology 2016, 2: 1-8. PMID: 26539793, PMCID: PMC5654518, DOI: 10.1001/jamaoncol.2015.3709.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsBiomarkers, TumorBreast NeoplasmsChemotherapy, AdjuvantDisease-Free SurvivalDrug Administration ScheduleFemaleHumansMiddle AgedNeoplasm StagingPaclitaxelReceptor, ErbB-2Risk AssessmentRisk FactorsStroke VolumeTime FactorsTrastuzumabTreatment OutcomeUnited StatesVentricular Dysfunction, LeftVentricular Function, LeftYoung AdultConceptsErbB2-positive breast cancerAsymptomatic LVEF declineCardiac toxic effectsLVEF declineBreast cancerPatients LVEFGrade 3Early-stage human epidermal growth factor receptor 2Asymptomatic left ventricular ejection fraction declineLeft ventricular ejection fraction declineVentricular ejection fraction declineHuman epidermal growth factor receptor 2Epidermal growth factor receptor 2Adjuvant weekly paclitaxelCardiac safety dataEjection fraction declineMedian patient ageVentricular systolic dysfunctionTrastuzumab-based treatmentWeeks of chemotherapyGrowth factor receptor 2Positive breast cancerLife-saving therapyFactor receptor 2Single-group study
2015
Trastuzumab Emtansine (T-DM1) in Patients With HER2-Positive Metastatic Breast Cancer Previously Treated With Chemotherapy and 2 or More HER2-Targeted Agents
Yardley DA, Krop IE, LoRusso PM, Mayer M, Barnett B, Yoo B, Perez EA. Trastuzumab Emtansine (T-DM1) in Patients With HER2-Positive Metastatic Breast Cancer Previously Treated With Chemotherapy and 2 or More HER2-Targeted Agents. The Cancer Journal 2015, 21: 357-364. PMID: 26389758, DOI: 10.1097/ppo.0000000000000144.Peer-Reviewed Original ResearchMeSH KeywordsAdo-Trastuzumab EmtansineAdultAgedAntibodies, Monoclonal, HumanizedAntineoplastic AgentsAntineoplastic Combined Chemotherapy ProtocolsBiomarkers, TumorBreast NeoplasmsBreast Neoplasms, MaleComorbidityFemaleHumansMaleMaytansineMiddle AgedMolecular Targeted TherapyNeoplasm MetastasisNeoplasm Recurrence, LocalNeoplasm StagingReceptor, ErbB-2RetreatmentTrastuzumabTreatment OutcomeConceptsMetastatic breast cancerObjective response rateAdvanced breast cancerBreast cancerT-DM1Measurable diseaseAdverse eventsTrastuzumab emtansineGrade 3Investigator-assessed objective response rateHER2-positive metastatic breast cancerResponse ratePositive metastatic breast cancerHuman epidermal growth factor receptor 2Epidermal growth factor receptor 2Grade adverse eventsNew safety signalsPhase III studyGrowth factor receptor 2Significant cardiovascular diseaseVentricular ejection fractionPlatelet count decreaseSimilar patient populationsRoutine clinical practiceFactor receptor 2Chemotherapy-related amenorrhea after adjuvant paclitaxel–trastuzumab (APT trial)
Ruddy KJ, Guo H, Barry W, Dang CT, Yardley DA, Moy B, Marcom PK, Albain KS, Rugo HS, Ellis MJ, Shapira I, Wolff AC, Carey LA, Overmoyer BA, Hudis C, Krop IE, Burstein HJ, Winer EP, Partridge AH, Tolaney SM. Chemotherapy-related amenorrhea after adjuvant paclitaxel–trastuzumab (APT trial). Breast Cancer Research And Treatment 2015, 151: 589-596. PMID: 25981899, PMCID: PMC5057177, DOI: 10.1007/s10549-015-3426-z.Peer-Reviewed Original ResearchConceptsChemotherapy-related amenorrheaChemotherapy initiationMenopausal symptomsBreast cancerAdjuvant breast cancer therapyEarly-stage breast cancerNode-negative HER2Weeks of paclitaxelStage breast cancerLast menstrual periodBreast cancer therapyAdjuvant paclitaxelAmenorrhea ratesAPT trialEligible patientsEvaluable populationPremenopausal womenAdjuvant studiesTrastuzumab monotherapyMedian timeMenstrual periodCancer regimensAmenorrheaTrastuzumabMonthsFeasibility and Cardiac Safety of Trastuzumab Emtansine After Anthracycline-Based Chemotherapy As (neo)Adjuvant Therapy for Human Epidermal Growth Factor Receptor 2–Positive Early-Stage Breast Cancer
Krop IE, Suter TM, Dang CT, Dirix L, Romieu G, Zamagni C, Citron ML, Campone M, Xu N, Smitt M, Gianni L. Feasibility and Cardiac Safety of Trastuzumab Emtansine After Anthracycline-Based Chemotherapy As (neo)Adjuvant Therapy for Human Epidermal Growth Factor Receptor 2–Positive Early-Stage Breast Cancer. Journal Of Clinical Oncology 2015, 33: 1136-1142. PMID: 25713436, PMCID: PMC5657012, DOI: 10.1200/jco.2014.58.7782.Peer-Reviewed Original ResearchMeSH KeywordsAdolescentAdultAgedAnthracyclinesAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsChemotherapy, AdjuvantCombined Modality TherapyCyclophosphamideDoxorubicinDrug Administration ScheduleEpirubicinFeasibility StudiesFluorouracilHeadacheHeart FailureHumansMaytansineMiddle AgedNauseaNeoplasm StagingReceptor, ErbB-2TrastuzumabTreatment OutcomeYoung AdultConceptsEarly-stage breast cancerHER2-positive early-stage breast cancerHuman epidermal growth factor receptorT-DM1Breast cancerEpidermal growth factor receptorGrowth factor receptorCardiac eventsCardiac safetyTrastuzumab emtansineSymptomatic congestive heart failureAsymptomatic LVEF declineCytotoxic agent DM1Planned radiation doseAnthracycline-based chemotherapyCoprimary end pointsPhase III trialsCongestive heart failureFactor receptorMetastatic breast cancerVentricular ejection fractionT-DM1 treatmentStage breast cancerLVEF declineAdverse events
2014
ESO-ESMO 2nd international consensus guidelines for advanced breast cancer (ABC2)
Cardoso F, Costa A, Norton L, Senkus E, Aapro M, André F, Barrios C, Bergh J, Biganzoli L, Blackwell K, Cardoso M, Cufer T, Saghir N, Fallowfield L, Fenech D, Francis P, Gelmon K, Giordano S, Gligorov J, Goldhirsch A, Harbeck N, Houssami N, Hudis C, Kaufman B, Krop I, Kyriakides S, Lin U, Mayer M, Merjaver S, Nordström E, Pagani O, Partridge A, Penault-Llorca F, Piccart M, Rugo H, Sledge G, Thomssen C, Veer L, Vorobiof D, Vrieling C, West N, Xu B, Winer E. ESO-ESMO 2nd international consensus guidelines for advanced breast cancer (ABC2). The Breast 2014, 23: 489-502. PMID: 25244983, DOI: 10.1016/j.breast.2014.08.009.Peer-Reviewed Original Research
2013
Neoadjuvant bevacizumab: surgical complications of mastectomy with and without reconstruction
Kansal KJ, Dominici LS, Tolaney SM, Isakoff SJ, Smith BL, Jiang W, Brock JE, Winer EP, Krop IE, Golshan M. Neoadjuvant bevacizumab: surgical complications of mastectomy with and without reconstruction. Breast Cancer Research And Treatment 2013, 141: 255-259. PMID: 24026859, DOI: 10.1007/s10549-013-2682-z.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAngiogenesis InhibitorsAntibodies, Monoclonal, HumanizedAntineoplastic AgentsAntineoplastic Combined Chemotherapy ProtocolsBevacizumabBreast NeoplasmsFemaleHumansMammaplastyMastectomyMiddle AgedNeoadjuvant TherapyNeoplasm StagingPostoperative ComplicationsTreatment OutcomeYoung AdultConceptsSurgical complicationsAC/TPostoperative complicationsComplication rateCohort 2Cohort 1Breast cancerExact testImmediate expander/implant reconstructionHER2-negative breast cancerExpander/implant reconstructionOperable breast cancerOverall complication rateRate of complicationsThird of patientsCohort of patientsSame healthcare systemSingle-arm trialFisher's exact testUse of BevTerms of demographicsNeoadjuvant bevacizumabNeoadjuvant therapyImplant reconstructionMastectomyClinicopathological Features Among Patients With Advanced Human Epidermal Growth Factor–2-Positive Breast Cancer With Prolonged Clinical Benefit to First-Line Trastuzumab-Based Therapy: A Retrospective Cohort Study
Vaz-Luis I, Seah D, Olson EM, Wagle N, Metzger-Filho O, Sohl J, Litsas G, Burstein HJ, Krop IE, Winer EP, Lin NU. Clinicopathological Features Among Patients With Advanced Human Epidermal Growth Factor–2-Positive Breast Cancer With Prolonged Clinical Benefit to First-Line Trastuzumab-Based Therapy: A Retrospective Cohort Study. Clinical Breast Cancer 2013, 13: 254-263. PMID: 23829891, PMCID: PMC4084778, DOI: 10.1016/j.clbc.2013.02.010.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAntineoplastic Agents, HormonalBreast NeoplasmsCarcinoma, Ductal, BreastCarcinoma, LobularChemotherapy, AdjuvantFemaleFollow-Up StudiesHumansMiddle AgedNeoplasm MetastasisNeoplasm Recurrence, LocalNeoplasm StagingPractice Patterns, Physicians'PrognosisReceptor, ErbB-2Receptors, EstrogenReceptors, ProgesteroneRetrospective StudiesSurvival RateTamoxifenYoung AdultConceptsTrastuzumab-based therapyFirst-line trastuzumab-based therapyAdvanced HER2-positive breast cancerHER2-positive breast cancerAdjuvant trastuzumabBreast cancerClinicopathological featuresClinical benefitC-statisticHuman epidermal growth factor-2-positive breast cancerTreatment durationPredictive valueHormone receptor-positive tumorsLong-term clinical benefitPrevious adjuvant trastuzumabTreatment duration groupsRetrospective cohort studyDisease-free intervalHormone receptor positivityReceptor-positive tumorsDuration of treatmentMagnitude of benefitLow predictive valueLogistic regression modelsDifferent logistic regression modelsA phase II study of bevacizumab in combination with vinorelbine and trastuzumab in HER2-positive metastatic breast cancer
Lin NU, Seah DS, Gelman R, Desantis S, Mayer EL, Isakoff S, DiPiro P, Krop IE, Come SE, Weckstein D, Winer EP, Burstein HJ. A phase II study of bevacizumab in combination with vinorelbine and trastuzumab in HER2-positive metastatic breast cancer. Breast Cancer Research And Treatment 2013, 139: 403-410. PMID: 23645007, DOI: 10.1007/s10549-013-2551-9.Peer-Reviewed Original ResearchConceptsMetastatic breast cancerGrade 3/4 non-hematologic toxicitiesHER2-positive metastatic breast cancerNon-hematologic toxicitiesTreatment-related toxicityBreast cancerCommon treatment-related toxicitiesFirst-line patientsProtocol-based therapySecond-line cohortSecond-line patientsSecond-line settingPhase II studyProportion of patientsCombination of vinorelbineCo-primary endpointsEligible patientsFebrile neutropeniaMedian PFSII studyMedian durationObjective responsePrior linesUnacceptable toxicityMedian agePreclinical and Clinical Studies of Gamma Secretase Inhibitors with Docetaxel on Human Breast Tumors
Schott AF, Landis MD, Dontu G, Griffith KA, Layman RM, Krop I, Paskett LA, Wong H, Dobrolecki LE, Lewis MT, Froehlich AM, Paranilam J, Hayes DF, Wicha MS, Chang JC. Preclinical and Clinical Studies of Gamma Secretase Inhibitors with Docetaxel on Human Breast Tumors. Clinical Cancer Research 2013, 19: 1512-1524. PMID: 23340294, PMCID: PMC3602220, DOI: 10.1158/1078-0432.ccr-11-3326.Peer-Reviewed Original ResearchConceptsBreast cancer stem cellsGamma-secretase inhibitorsAdvanced breast cancerClinical trialsBreast cancerSecretase inhibitorsMaximum-tolerated doseEfficacy of docetaxelSerial tumor biopsiesNotch pathwayTumors of patientsDoses of MKConcurrent clinical trialsHuman breast tumorsNotch pathway inhibitorsCancer stem cellsManageable toxicityTumorgraft modelsDocetaxel treatmentBCSC markersSerial biopsiesConventional therapyPreclinical dataClinical studiesExperimental therapies