2023
Patritumab Deruxtecan (HER3-DXd), a Human Epidermal Growth Factor Receptor 3–Directed Antibody-Drug Conjugate, in Patients With Previously Treated Human Epidermal Growth Factor Receptor 3–Expressing Metastatic Breast Cancer: A Multicenter, Phase I/II Trial
Krop I, Masuda N, Mukohara T, Takahashi S, Nakayama T, Inoue K, Iwata H, Yamamoto Y, Alvarez R, Toyama T, Takahashi M, Osaki A, Saji S, Sagara Y, O'Shaughnessy J, Ohwada S, Koyama K, Inoue T, Li L, Patel P, Mostillo J, Tanaka Y, Sternberg D, Sellami D, Yonemori K. Patritumab Deruxtecan (HER3-DXd), a Human Epidermal Growth Factor Receptor 3–Directed Antibody-Drug Conjugate, in Patients With Previously Treated Human Epidermal Growth Factor Receptor 3–Expressing Metastatic Breast Cancer: A Multicenter, Phase I/II Trial. Journal Of Clinical Oncology 2023, 41: 5550-5560. PMID: 37801674, PMCID: PMC10730028, DOI: 10.1200/jco.23.00882.Peer-Reviewed Original ResearchConceptsTreatment-emergent adverse eventsHuman epidermal growth factor receptor 3Epidermal growth factor receptor 3Metastatic breast cancerGrowth factor receptor 3Breast cancerReceptor 3Dose expansionPrevious therapyClinical subtypesCommon treatment-emergent adverse eventsPhase I/II trialHER2-positive breast cancerTriple-negative breast cancerDose-escalation partDose-expansion partManageable safety profileAdvanced breast cancerEpidermal growth factor receptorAntibody-drug conjugatesGrowth factor receptorAdvanced diseaseHematologic toxicityII trialObjective response
2022
Circulating Tumor DNA and Late Recurrence in High-Risk Hormone Receptor–Positive, Human Epidermal Growth Factor Receptor 2–Negative Breast Cancer
Lipsyc-Sharf M, de Bruin EC, Santos K, McEwen R, Stetson D, Patel A, Kirkner GJ, Hughes ME, Tolaney SM, Partridge AH, Krop IE, Knape C, Feger U, Marsico G, Howarth K, Winer EP, Lin NU, Parsons HA. Circulating Tumor DNA and Late Recurrence in High-Risk Hormone Receptor–Positive, Human Epidermal Growth Factor Receptor 2–Negative Breast Cancer. Journal Of Clinical Oncology 2022, 40: 2408-2419. PMID: 35658506, PMCID: PMC9467679, DOI: 10.1200/jco.22.00908.Peer-Reviewed Original ResearchConceptsMinimal residual diseaseWhole-exome sequencingClinical recurrenceMetastatic recurrenceBreast cancerEarly-stage hormone receptor-positive breast cancerHormone receptor-positive breast cancerTumor tissueHigh-risk stage IIReceptor-positive breast cancerTumor DNAHuman epidermal growth factor receptorDistant metastatic recurrenceHormone receptor positiveMRD-positive patientsPlasma samplesTime of consentPrimary tumor tissuesSufficient tumor tissueEpidermal growth factor receptorAdjuvant settingGrowth factor receptorLocal recurrenceClinical outcomesDistant metastasisClinical outcomes with alpelisib (ALP) plus fulvestrant (FUL) after prior treatment (tx) with FUL in patients (pts) with advanced breast cancer (ABC): A real-world (RW) analysis.
O'Shaughnessy J, Woeckel A, Pistilli B, Hegg R, Vahdat L, Vuina D, ZVK P, Smith T, Kim J, Krop I. Clinical outcomes with alpelisib (ALP) plus fulvestrant (FUL) after prior treatment (tx) with FUL in patients (pts) with advanced breast cancer (ABC): A real-world (RW) analysis. Journal Of Clinical Oncology 2022, 40: 1055-1055. DOI: 10.1200/jco.2022.40.16_suppl.1055.Peer-Reviewed Original ResearchAdvanced breast cancerEndocrine-based therapyPIK3CA mutationsMetastatic settingClinical outcomesCyclin-dependent kinase 4/6 inhibitorsDe-identified electronic health record dataHuman epidermal growth factor receptorImmediate prior therapyLines of therapyProgression-free survivalProgression/deathElectronic health record dataDate of deathHealth record dataEpidermal growth factor receptorReal-world analysisGrowth factor receptorNCCN guidelinesPrior chemotherapyPrior therapyMedian durationMedian timeSubsequent therapyClinical benefitA prospective trial of treatment de-escalation following neoadjuvant paclitaxel/trastuzumab/pertuzumab in HER2-positive breast cancer
Waks AG, Desai NV, Li T, Poorvu PD, Partridge AH, Sinclair N, Spring LM, Faggen M, Constantine M, Metzger O, Alberti J, Deane J, Rosenberg SM, Frank E, Tolaney SM, Krop IE, Tung NM, Tayob N, King TA, Mittendorf EA, Winer EP. A prospective trial of treatment de-escalation following neoadjuvant paclitaxel/trastuzumab/pertuzumab in HER2-positive breast cancer. Npj Breast Cancer 2022, 8: 63. PMID: 35538105, PMCID: PMC9091255, DOI: 10.1038/s41523-022-00429-7.Peer-Reviewed Original ResearchPathologic complete responseProspective trialBreast cancerSingle-arm prospective trialHER2-positive breast cancerHuman epidermal growth factor receptorAdjuvant treatment plansDose of THPEarly-stage HER2Incomplete clinical responsePrimary feasibility endpointTrastuzumab/pertuzumabMajority of patientsOngoing prospective trialsStage II tumorsLong-term efficacyBreast cancer recurrenceEpidermal growth factor receptorAdjuvant chemotherapyFeasibility endpointsGrowth factor receptorNeoadjuvant regimenAdjuvant therapyDoublet therapyPrimary endpoint175P Alpelisib (ALP) + endocrine therapy (ET) in patients (pts) with PIK3CA-mutated, hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2–) advanced breast cancer (ABC): Subgroup analyses from the BYLieve study
Cardoso F, Juric D, Lerebours F, Krop I, Borrego M, Neven P, Park Y, Yardley D, Jhaveri K, Arce C, Gu E, Akdere M, Rugo H. 175P Alpelisib (ALP) + endocrine therapy (ET) in patients (pts) with PIK3CA-mutated, hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2–) advanced breast cancer (ABC): Subgroup analyses from the BYLieve study. Annals Of Oncology 2022, 33: s206-s207. DOI: 10.1016/j.annonc.2022.03.194.Peer-Reviewed Original Research
2021
Trastuzumab Emtansine Plus Pertuzumab Versus Taxane Plus Trastuzumab Plus Pertuzumab After Anthracycline for High-Risk Human Epidermal Growth Factor Receptor 2–Positive Early Breast Cancer: The Phase III KAITLIN Study
Krop IE, Im SA, Barrios C, Bonnefoi H, Gralow J, Toi M, Ellis PA, Gianni L, Swain SM, Im YH, De Laurentiis M, Nowecki Z, Huang CS, Fehrenbacher L, Ito Y, Shah J, Boulet T, Liu H, Macharia H, Trask P, Song C, Winer EP, Harbeck N. Trastuzumab Emtansine Plus Pertuzumab Versus Taxane Plus Trastuzumab Plus Pertuzumab After Anthracycline for High-Risk Human Epidermal Growth Factor Receptor 2–Positive Early Breast Cancer: The Phase III KAITLIN Study. Journal Of Clinical Oncology 2021, 40: 438-448. PMID: 34890214, PMCID: PMC8824393, DOI: 10.1200/jco.21.00896.Peer-Reviewed Original ResearchConceptsInvasive disease-free survivalOverall populationTrastuzumab emtansineHigh-risk human epidermal growth factor receptorHuman epidermal growth factor receptor 2End pointEpidermal growth factor receptor 2Early breast cancer treatmentHuman epidermal growth factor receptorAnthracycline-based chemotherapyCoprimary end pointsPrimary end pointDisease-free survivalSerious adverse eventsEarly breast cancerGlobal health statusGrowth factor receptor 2Treatment completion ratesStandard of careBreast cancer treatmentFactor receptor 2Epidermal growth factor receptorGrowth factor receptorEndocrine therapyAdverse eventsCirculating tumor cell number and endocrine therapy index in ER positive metastatic breast cancer patients
Paoletti C, Regan MM, Niman SM, Dolce EM, Darga EP, Liu MC, Marcom PK, Hart LL, Smith JW, Tedesco KL, Amir E, Krop IE, DeMichele AM, Goodwin PJ, Block M, Aung K, Brown ME, McCormack RT, Hayes DF. Circulating tumor cell number and endocrine therapy index in ER positive metastatic breast cancer patients. Npj Breast Cancer 2021, 7: 77. PMID: 34117261, PMCID: PMC8196036, DOI: 10.1038/s41523-021-00281-1.Peer-Reviewed Original ResearchMetastatic breast cancerProgression-free survivalER-positive metastatic breast cancerHER2-negative metastatic breast cancerWorse progression-free survivalWhole bloodTherapy indexExact testPositive metastatic breast cancer patientsMedian progression-free survivalMetastatic breast cancer patientsHuman epidermal growth factor receptorMulti-institutional clinical trialsGroup of patientsBreast cancer patientsSerial time pointsFisher's exact testTumor cell numberEpidermal growth factor receptorElevated CTCsGrowth factor receptorPrimary endpointClinical outcomesCancer patientsClinical trialsAdjuvant 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 toxicityWeeksTrastuzumabCancerPaclitaxel
2020
A Phase II Study of Pembrolizumab in Combination With Palliative Radiotherapy for Hormone Receptor-positive Metastatic Breast Cancer
Barroso-Sousa R, Krop IE, Trippa L, Tan-Wasielewski Z, Li T, Osmani W, Andrews C, Dillon D, Richardson ET, Pastorello RG, Winer EP, Mittendorf EA, Bellon JR, Schoenfeld JD, Tolaney SM. A Phase II Study of Pembrolizumab in Combination With Palliative Radiotherapy for Hormone Receptor-positive Metastatic Breast Cancer. Clinical Breast Cancer 2020, 20: 238-245. PMID: 32113750, DOI: 10.1016/j.clbc.2020.01.012.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntibodies, Monoclonal, HumanizedAntineoplastic Agents, ImmunologicalBiomarkers, TumorBreastBreast NeoplasmsCarcinoma, Ductal, BreastChemoradiotherapyDrug Administration ScheduleFemaleHumansInfusions, IntravenousMiddle AgedPalliative CareProgrammed Cell Death 1 ReceptorProgression-Free SurvivalReceptor, ErbB-2Receptors, EstrogenReceptors, ProgesteroneResponse Evaluation Criteria in Solid TumorsConceptsMetastatic breast cancerHormone receptor-positive metastatic breast cancerProgression-free survivalRadiation therapyObjective responseOverall survivalBreast cancerResponse rateMedian progression-free survivalCause adverse eventsGrade 3 eventsMedian prior linesMedian overall survivalObjective response ratePalliative radiation therapyPhase II studyTumor-infiltrating lymphocytesLymph node lesionsOverall response rateEpidermal growth factor receptorEligible patientsExploratory endpointsGrowth factor receptorPalliative radiotherapyPrimary endpoint
2018
Recommendations on Disease Management for Patients With Advanced Human Epidermal Growth Factor Receptor 2–Positive Breast Cancer and Brain Metastases: ASCO Clinical Practice Guideline Update
Ramakrishna N, Temin S, Chandarlapaty S, Crews JR, Davidson NE, Esteva FJ, Giordano SH, Kirshner JJ, Krop IE, Levinson J, Modi S, Patt DA, Perlmutter J, Winer EP, Lin NU. Recommendations on Disease Management for Patients With Advanced Human Epidermal Growth Factor Receptor 2–Positive Breast Cancer and Brain Metastases: ASCO Clinical Practice Guideline Update. Journal Of Clinical Oncology 2018, 36: jco.2018.79.271. PMID: 29939840, DOI: 10.1200/jco.2018.79.2713.Peer-Reviewed Original ResearchConceptsHuman epidermal growth factor receptorAdvanced breast cancerBrain metastasesBreast cancerEpidermal growth factor receptorGrowth factor receptorSystemic therapyLocal therapyAdvanced human epidermal growth factor receptorASCO Clinical Practice Guideline UpdateHER2-positive advanced breast cancerClinical Practice Guideline UpdateAppropriate local therapyBest supportive careWhole brain radiotherapyProgression-free survivalSize of metastasesFactor receptorExpert panelPresence of symptomsRoutine magnetic resonanceOutcomes of interestStrong quality evidenceMagnetic resonance imagingAdvocacy experts
2017
A phase II study of eribulin mesylate in combination with trastuzumab and pertuzumab in patients (pts) with human epidermal growth factor receptor 2-positive (HER2+) metastatic breast cancer (MBC).
Luis I, Guo H, Barry W, Krop I, Wagle N, Lowe A, Gore D, Andrews C, Osmani W, Isakoff S, Tung N, Winer E, Lin N, Freedman R. A phase II study of eribulin mesylate in combination with trastuzumab and pertuzumab in patients (pts) with human epidermal growth factor receptor 2-positive (HER2+) metastatic breast cancer (MBC). Journal Of Clinical Oncology 2017, 35: 1034-1034. DOI: 10.1200/jco.2017.35.15_suppl.1034.Peer-Reviewed Original ResearchMetastatic breast cancerOverall response ratePhase II studyStable diseasePertuzumab exposureAdverse eventsII studyCohort AHuman epidermal growth factor receptorActivity of eribulinDose of eribulinFrequent grade 3First-line settingMost adverse eventsAnti-HER2 therapyCorrelative studiesEpidermal growth factor receptorCell-free DNAGrowth factor receptorHematologic toxicityCohort studyOverall survivalPartial responseCohort BSingle center
2015
Phase II Study of Lapatinib in Combination With Trastuzumab in Patients With Human Epidermal Growth Factor Receptor 2–Positive Metastatic Breast Cancer: Clinical Outcomes and Predictive Value of Early [18F]Fluorodeoxyglucose Positron Emission Tomography Imaging (TBCRC 003)
Lin NU, Guo H, Yap JT, Mayer IA, Falkson CI, Hobday TJ, Dees EC, Richardson AL, Nanda R, Rimawi MF, Ryabin N, Najita JS, Barry WT, Arteaga CL, Wolff AC, Krop IE, Winer EP, Van den Abbeele AD. Phase II Study of Lapatinib in Combination With Trastuzumab in Patients With Human Epidermal Growth Factor Receptor 2–Positive Metastatic Breast Cancer: Clinical Outcomes and Predictive Value of Early [18F]Fluorodeoxyglucose Positron Emission Tomography Imaging (TBCRC 003). Journal Of Clinical Oncology 2015, 33: 2623-2631. PMID: 26169615, PMCID: PMC4534525, DOI: 10.1200/jco.2014.60.0353.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsCohort StudiesFemaleFluorodeoxyglucose F18HumansLapatinibMiddle AgedNeoplasm MetastasisPositron-Emission TomographyQuinazolinesReceptor, ErbB-2TrastuzumabTreatment OutcomeConceptsMetastatic breast cancerHuman epidermal growth factor receptorClinical benefit rateEpidermal growth factor receptorObjective response rateProgression-free survivalGrowth factor receptorClinical outcomesWeek 1Cohort 2Benefit rateCohort 1Breast cancerFactor receptorPredictive valueResponse rateConfirmed objective response rateMedian progression-free survivalEnd pointPhase II studyPrimary end pointSecondary end pointsSelection of patientsToxicity of chemotherapyPET/CTFeasibility 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
A phase II study of eribulin mesylate in combination with trastuzumab and pertuzumab in patients (pts) with metastatic, human epidermal growth factor receptor 2-positive breast cancer.
Freedman R, Luis I, Barry W, Krop I, Wagle N, Lowe A, Galler S, Sohl J, Isakoff S, Tung N, Winer E, Lin N. A phase II study of eribulin mesylate in combination with trastuzumab and pertuzumab in patients (pts) with metastatic, human epidermal growth factor receptor 2-positive breast cancer. Journal Of Clinical Oncology 2014, 32: tps668-tps668. DOI: 10.1200/jco.2014.32.15_suppl.tps668.Peer-Reviewed Original ResearchSystemic Therapy for Patients With Advanced Human Epidermal Growth Factor Receptor 2–Positive Breast Cancer: American Society of Clinical Oncology Clinical Practice Guideline
Giordano SH, Temin S, Kirshner JJ, Chandarlapaty S, Crews JR, Davidson NE, Esteva FJ, Gonzalez-Angulo AM, Krop I, Levinson J, Lin NU, Modi S, Patt DA, Perez EA, Perlmutter J, Ramakrishna N, Winer EP. Systemic Therapy for Patients With Advanced Human Epidermal Growth Factor Receptor 2–Positive Breast Cancer: American Society of Clinical Oncology Clinical Practice Guideline. Journal Of Clinical Oncology 2014, 32: 2078-2099. PMID: 24799465, PMCID: PMC6076031, DOI: 10.1200/jco.2013.54.0948.Peer-Reviewed Original ResearchMeSH KeywordsAdo-Trastuzumab EmtansineAnastrozoleAntibodies, Monoclonal, HumanizedAntineoplastic Agents, HormonalAntineoplastic Combined Chemotherapy ProtocolsBiomarkers, TumorBreast NeoplasmsClinical Trials as TopicComorbidityDocetaxelDrug Administration ScheduleEvidence-Based MedicineFemaleHealth Status DisparitiesHealthcare DisparitiesHumansLapatinibLetrozoleMaytansineMolecular Targeted TherapyNitrilesQuinazolinesReceptor, ErbB-2Receptors, EstrogenReceptors, ProgesteroneSocieties, MedicalTaxoidsTrastuzumabTreatment OutcomeTriazolesUnited StatesConceptsAdvanced breast cancerHuman epidermal growth factor receptorSecond-line treatmentProgression-free survivalFirst-line treatmentBreast cancerPFS benefitT-DM1Epidermal growth factor receptorEndocrine therapyGrowth factor receptorSystemic therapyEstrogen receptor-positive/progesterone receptor-positive breast cancerAdvanced human epidermal growth factor receptorHER2-positive advanced breast cancerProgesterone receptor-positive breast cancerClinical Oncology Clinical Practice GuidelineClinical congestive heart failureStandard first-line therapyPositive advanced breast cancerLeft ventricular ejection fractionOncology Clinical Practice GuidelineReceptor-positive breast cancerThird-line settingFirst-line therapyRecommendations on Disease Management for Patients With Advanced Human Epidermal Growth Factor Receptor 2–Positive Breast Cancer and Brain Metastases: American Society of Clinical Oncology Clinical Practice Guideline
Ramakrishna N, Temin S, Chandarlapaty S, Crews JR, Davidson NE, Esteva FJ, Giordano SH, Gonzalez-Angulo AM, Kirshner JJ, Krop I, Levinson J, Modi S, Patt DA, Perez EA, Perlmutter J, Winer EP, Lin NU. Recommendations on Disease Management for Patients With Advanced Human Epidermal Growth Factor Receptor 2–Positive Breast Cancer and Brain Metastases: American Society of Clinical Oncology Clinical Practice Guideline. Journal Of Clinical Oncology 2014, 32: 2100-2108. PMID: 24799487, PMCID: PMC6366342, DOI: 10.1200/jco.2013.54.0955.Peer-Reviewed Original ResearchMeSH KeywordsAntineoplastic Combined Chemotherapy ProtocolsBiomarkers, TumorBrain NeoplasmsBreast NeoplasmsComorbidityConsensusCranial IrradiationDisease ManagementEvidence-Based MedicineFemaleHealth Status DisparitiesHealthcare DisparitiesHumansRadiosurgeryReceptor, ErbB-2Societies, MedicalTreatment OutcomeUnited StatesConceptsMagnetic resonance imagingHuman epidermal growth factor receptorAdvanced breast cancerBrain metastasesBreast cancerEpidermal growth factor receptorGrowth factor receptorSystemic therapyLocal therapyAdvanced human epidermal growth factor receptorHER2-positive advanced breast cancerClinical Oncology Clinical Practice GuidelineExpert consensus-based recommendationsOncology Clinical Practice GuidelineConsensus-based processRoutine magnetic resonance imagingAppropriate local therapyBest supportive careWhole brain radiotherapySize of metastasesFactor receptorClinical practice guidelinesPresence of symptomsConsensus-based recommendationsAmerican Society
2012
Trastuzumab Emtansine (T-DM1) for the Treatment of HER2-Positive Cancer with a Focus on Breast Cancer
Rugo H, Krop I, Chu Y. Trastuzumab Emtansine (T-DM1) for the Treatment of HER2-Positive Cancer with a Focus on Breast Cancer. Cancer Drug Discovery And Development 2012, 179-210. DOI: 10.1007/978-1-4614-5456-4_11.Peer-Reviewed Original ResearchBreast cancerHER2 overexpressionHuman epidermal growth factor receptor type 2Epidermal growth factor receptor type 2Factor receptor type 2Important histopathologic featureHER2-positive cancersReceptor type 2Epidermal growth factor receptorHuman solid tumorsProgression of tumorsGrowth factor receptorHistopathologic featuresPoor prognosisOncologic unitsTrastuzumab emtansinePancreatic cancerHER receptorsSolid tumorsType 2Malignant transformationCancerTyrosine kinase familyFactor receptorSubsequent activationA population pharmacokinetic/pharmacodynamic model of thrombocytopenia characterizing the effect of trastuzumab emtansine (T-DM1) on platelet counts in patients with HER2-positive metastatic breast cancer
Bender BC, Schaedeli-Stark F, Koch R, Joshi A, Chu YW, Rugo H, Krop IE, Girish S, Friberg LE, Gupta M. A population pharmacokinetic/pharmacodynamic model of thrombocytopenia characterizing the effect of trastuzumab emtansine (T-DM1) on platelet counts in patients with HER2-positive metastatic breast cancer. Cancer Chemotherapy And Pharmacology 2012, 70: 591-601. PMID: 22886072, DOI: 10.1007/s00280-012-1934-7.Peer-Reviewed Original ResearchConceptsT-DM1 3.6Incidence of gradePK/PD modelBaseline characteristicsPlatelet countT-DM1Semimechanistic PK/PD modelHER2-positive metastatic breast cancerPharmacodynamic modelPD modelHuman epidermal growth factor receptorGrade 3 thrombocytopeniaPatient baseline characteristicsPhase II studyDose-limiting toxicityMetastatic breast cancerPatient's platelet countSingle-agent studiesPD parametersEpidermal growth factor receptorAntibody-drug conjugatesGrowth factor receptorDose delaysFirst doseII study
2010
Advances in Targeting Src in the Treatment of Breast Cancer and Other Solid Malignancies
Mayer EL, Krop IE. Advances in Targeting Src in the Treatment of Breast Cancer and Other Solid Malignancies. Clinical Cancer Research 2010, 16: 3526-3532. PMID: 20634194, DOI: 10.1158/1078-0432.ccr-09-1834.Peer-Reviewed Original ResearchConceptsMultiple solid tumor typesVascular endothelial growth factor receptorEndothelial growth factor receptorEarly phase trialsSolid tumor typesMultiple human malignanciesTargeting SrcEndocrine therapyGrowth factor receptorCombination regimensOngoing trialsFuture trialsSolid malignanciesProstate cancerBreast cancerEstrogen receptorPreclinical studiesAntitumor effectsTumor typesAngiogenesis inhibitorsCell-signaling pathwaysInhibitor dasatinibInvestigation of combinationsHuman malignanciesModest activity