2013
Beyond Trastuzumab and Lapatinib: New Options for HER2-Positive Breast Cancer
Zardavas D, Cameron D, Krop I, Piccart M. Beyond Trastuzumab and Lapatinib: New Options for HER2-Positive Breast Cancer. American Society Of Clinical Oncology Educational Book 2013, e2-e11. DOI: 10.14694/edbook_am.2013.33.e2.Peer-Reviewed Original ResearchHER2-positive breast cancerDual HER2 blockadeAntibody-drug conjugatesHER2 blockadeMetastatic settingBreast cancerAdjuvant settingTrastuzumab-DM1Clinical trialsSmall molecule inhibitorsClinical practiceMonoclonal antibodiesAnti-HER2 resistanceAnti-HER2 agentsLarge randomized trialsEfficacy of trastuzumabSubset of patientsAdvanced clinical testingHER2-targeted agentsNew treatment optionsAggressive biologic behaviorDrug conjugatesMajor clinical issueImproved treatment outcomesMolecule inhibitorsBeyond trastuzumab and lapatinib: new options for HER2-positive breast cancer .
Zardavas D, Cameron D, Krop I, Piccart M. Beyond trastuzumab and lapatinib: new options for HER2-positive breast cancer . American Society Of Clinical Oncology Educational Book 2013, 33: e2-e11. PMID: 23714441, DOI: 10.1200/edbook_am.2013.33.e2.Peer-Reviewed Original ResearchMeSH KeywordsAnimalsAntibodies, Monoclonal, HumanizedAntineoplastic AgentsBreast NeoplasmsChemotherapy, AdjuvantDrug Resistance, NeoplasmFemaleHumansLapatinibMolecular Targeted TherapyNeoadjuvant TherapyProtein Kinase InhibitorsQuinazolinesReceptor, ErbB-2Signal TransductionTrastuzumabTreatment OutcomeConceptsHER2-positive breast cancerDual HER2 blockadeAntibody-drug conjugatesHER2 blockadeBreast cancerMetastatic settingClinical trialsAnti-HER2 resistanceAnti-HER2 agentsLarge randomized trialsHER2-targeted agentsNew treatment optionsAggressive biologic behaviorMajor clinical issueImproved treatment outcomesNew therapeutic avenuesDevelopment of agentsAdjuvant settingNeoadjuvant settingAdvanced diseaseTrastuzumab-DM1Randomized trialsTreatment optionsBiologic rationaleHER2 inhibition
2011
A semi-physiologic population pharmacokinetic/pharmacodynamic (PK/PD) model of thrombocytopenia (TCP) characterizing the effect of trastuzumab-DM1 (T-DM1) on platelet counts in patients with HER2-positive MBC.
Bender B, Schaedeli Stark F, Joshi A, Chu Y, Rugo H, Krop I, Girish S, Gupta M. A semi-physiologic population pharmacokinetic/pharmacodynamic (PK/PD) model of thrombocytopenia (TCP) characterizing the effect of trastuzumab-DM1 (T-DM1) on platelet counts in patients with HER2-positive MBC. Journal Of Clinical Oncology 2011, 29: 605-605. DOI: 10.1200/jco.2011.29.15_suppl.605.Peer-Reviewed Original Research
2010
Phase II Study of the Antibody Drug Conjugate Trastuzumab-DM1 for the Treatment of Human Epidermal Growth Factor Receptor 2 (HER2) –Positive Breast Cancer After Prior HER2-Directed Therapy
Burris HA, Rugo HS, Vukelja SJ, Vogel CL, Borson RA, Limentani S, Tan-Chiu E, Krop IE, Michaelson RA, Girish S, Amler L, Zheng M, Chu YW, Klencke B, O'Shaughnessy JA. Phase II Study of the Antibody Drug Conjugate Trastuzumab-DM1 for the Treatment of Human Epidermal Growth Factor Receptor 2 (HER2) –Positive Breast Cancer After Prior HER2-Directed Therapy. Journal Of Clinical Oncology 2010, 29: 398-405. PMID: 21172893, DOI: 10.1200/jco.2010.29.5865.Peer-Reviewed Original ResearchMeSH KeywordsAdo-Trastuzumab EmtansineAdultAgedAged, 80 and overAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic AgentsBreast NeoplasmsDisease-Free SurvivalFemaleHumansImmunotoxinsKaplan-Meier EstimateMaytansineMiddle AgedReceptor, ErbB-2RNA, MessengerTime FactorsTrastuzumabTreatment OutcomeUnited StatesConceptsHER2-positive metastatic breast cancerMetastatic breast cancerPhase II studyTrastuzumab-DM1II studyAdverse eventsResponse rateBreast cancerHER2 levelsMedian progression-free survival timeSingle-arm phase II studyRobust single-agent activityProgression-free survival timeHuman epidermal growth factor receptor 2Epidermal growth factor receptor 2Human epidermal growth factor receptorHER2-directed therapiesMaximum-tolerated doseMost adverse eventsObjective response ratePhase II doseGrowth factor receptor 2Single-agent activityHER2-positive tumorsReverse transcriptase-polymerase chain reactionQuantitative assessment of diagnostic markers and correlations with efficacy in two phase II studies of trastuzumab-DM1 (T-DM1) for patients (pts) with metastatic breast cancer (MBC) who had progressed on prior HER2-directed therapy.
LoRusso P, Krop I, Burris H, Vukelja S, Miller K, Zheng M, Chu Y, Lu M, Amler L, Rugo H. Quantitative assessment of diagnostic markers and correlations with efficacy in two phase II studies of trastuzumab-DM1 (T-DM1) for patients (pts) with metastatic breast cancer (MBC) who had progressed on prior HER2-directed therapy. Journal Of Clinical Oncology 2010, 28: 1016-1016. DOI: 10.1200/jco.2010.28.15_suppl.1016.Peer-Reviewed Original ResearchPhase I Study of Trastuzumab-DM1, an HER2 Antibody-Drug Conjugate, Given Every 3 Weeks to Patients With HER2-Positive Metastatic Breast Cancer
Krop IE, Beeram M, Modi S, Jones SF, Holden SN, Yu W, Girish S, Tibbitts J, Yi JH, Sliwkowski MX, Jacobson F, Lutzker SG, Burris HA. Phase I Study of Trastuzumab-DM1, an HER2 Antibody-Drug Conjugate, Given Every 3 Weeks to Patients With HER2-Positive Metastatic Breast Cancer. Journal Of Clinical Oncology 2010, 28: 2698-2704. PMID: 20421541, DOI: 10.1200/jco.2009.26.2071.Peer-Reviewed Original ResearchMeSH KeywordsAdo-Trastuzumab EmtansineAdultAgedAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedBiopsy, NeedleBone NeoplasmsBreast NeoplasmsDose-Response Relationship, DrugDrug Administration ScheduleFemaleFollow-Up StudiesHalf-LifeHumansImmunoconjugatesImmunohistochemistryLiver NeoplasmsLung NeoplasmsMaximum Tolerated DoseMaytansineMiddle AgedNeoplasm StagingPatient SelectionReceptor, ErbB-2Risk AssessmentSurvival AnalysisThrombocytopeniaTrastuzumabTreatment OutcomeConceptsMaximum-tolerated doseAdvanced HER2-positive breast cancerHER2-positive breast cancerTrastuzumab-DM1Breast cancerAdverse eventsCommon drug-related adverse eventsHER2-positive metastatic breast cancerDrug-related adverse eventsHER2 antibody-drug conjugatesClinical benefit rateConfirmed response rateSubstantial clinical activityTrastuzumab-based therapyMetastatic breast cancerHER2-positive cellsAntibody-drug conjugatesMeasurable diseaseNeuropathy eventsElevated transaminasesCardiac effectsDose modificationMetastatic diseaseObjective responseReversible toxicity
2009
Quantitative assessment of HER2 status and correlation with efficacy for patients (pts) with metastatic breast cancer (MBC) in a phase II study of trastuzumab-DM1 (T-DM1)
Krop I, Burris H, Rugo H, O'Shaughnessy J, Vogel C, Amler L, Strauss A, Wong E, Klencke B, Pippen J. Quantitative assessment of HER2 status and correlation with efficacy for patients (pts) with metastatic breast cancer (MBC) in a phase II study of trastuzumab-DM1 (T-DM1). Journal Of Clinical Oncology 2009, 27: 1003-1003. DOI: 10.1200/jco.2009.27.15_suppl.1003.Peer-Reviewed Original ResearchMetastatic breast cancerEnzyme-linked immunosorbent assayPhase II studyPartial responseTrastuzumab-DM1II studyQRT-PCRGood responseSingle-arm studyT-DM1 therapyCentral laboratory testingAdditional diagnostic markerReal-time polymerase chain reactionQuantitative real-time polymerase chain reactionAnti-microtubule agentsMedian 4.4Metastatic settingCorrelation of responseHER2 statusPolymerase chain reactionBreast cancerECD levelsMedian levelsResponse ratePT serumA phase I study of weekly dosing of trastuzumab-DM1 (T-DM1) in patients with advanced HER2+ breast cancer.
Krop I, Mita M, Burris H, Birkner M, Girish S, Tibbitts J, Holden S, Lutzker S, Modi S. A phase I study of weekly dosing of trastuzumab-DM1 (T-DM1) in patients with advanced HER2+ breast cancer. Cancer Research 2009, 69: 3136. DOI: 10.1158/0008-5472.sabcs-3136.Peer-Reviewed Original ResearchTrastuzumab-DM1Advanced HER2Antibody-drug conjugatesBreast cancerChemotherapy regimenCycle 1 day 1HER2 antibody-drug conjugatesFirst antibody-drug conjugatePhase IActivity of trastuzumabGrade 4 thrombocytopeniaReversible transaminase elevationT-DM1 exposureDose-escalation studyPhase II trialMeasurable diseaseQ3W dosingTransaminase elevationEscalation studyII trialPartial responseWeekly dosingCardiac toxicityTumor responseClinical trials
2008
A phase I study of weekly dosing of trastuzumab-DM1 (T-DM1) in patients (pts) with advanced HER2+ breast cancer (BC)
Holden S, Beeram M, Krop I, Burris H, Birkner M, Girish S, Tibbitts J, Lutzker S, Modi S. A phase I study of weekly dosing of trastuzumab-DM1 (T-DM1) in patients (pts) with advanced HER2+ breast cancer (BC). Journal Of Clinical Oncology 2008, 26: 1029-1029. DOI: 10.1200/jco.2008.26.15_suppl.1029.Peer-Reviewed Original ResearchA phase I study of trastuzumab-DM1 (T-DM1), a first-in-class HER2 antibody-drug conjugate (ADC), in patients (pts) with advanced HER2+ breast cancer (BC)
Beeram M, Burris H, Modi S, Birkner M, Girish S, Tibbitts J, Holden S, Lutzker S, Krop I. A phase I study of trastuzumab-DM1 (T-DM1), a first-in-class HER2 antibody-drug conjugate (ADC), in patients (pts) with advanced HER2+ breast cancer (BC). Journal Of Clinical Oncology 2008, 26: 1028-1028. DOI: 10.1200/jco.2008.26.15_suppl.1028.Peer-Reviewed Original Research
2007
2118 POSTER A phase I study of trastuzumab-DM1, a first-in-class HER2 antibody-drug conjugate, in patients with HER2+ metastatic breast cancer
Krop I, Beeram M, Modi S, Rabbee N, Girish S, Tibbitts J, Holden S, Lutzker S, Burris H. 2118 POSTER A phase I study of trastuzumab-DM1, a first-in-class HER2 antibody-drug conjugate, in patients with HER2+ metastatic breast cancer. European Journal Of Cancer Supplements 2007, 5: 219. DOI: 10.1016/s1359-6349(07)70880-7.Peer-Reviewed Original Research