2020
A Randomized Placebo Controlled Phase II Trial Evaluating Exemestane with or without Enzalutamide in Patients with Hormone Receptor–Positive Breast Cancer
Krop I, Abramson V, Colleoni M, Traina T, Holmes F, Garcia-Estevez L, Hart L, Awada A, Zamagni C, Morris PG, Schwartzberg L, Chan S, Gucalp A, Biganzoli L, Steinberg J, Sica L, Trudeau M, Markova D, Tarazi J, Zhu Z, O'Brien T, Kelly C, Winer E, Yardley D. A Randomized Placebo Controlled Phase II Trial Evaluating Exemestane with or without Enzalutamide in Patients with Hormone Receptor–Positive Breast Cancer. Clinical Cancer Research 2020, 26: 6149-6157. PMID: 32988969, DOI: 10.1158/1078-0432.ccr-20-1693.Peer-Reviewed Original ResearchConceptsProgression-free survivalHormone receptor-positive breast cancerReceptor-positive breast cancerPhase II trialEndocrine therapyBreast cancerII trialAR mRNACohort 1Higher AR mRNA levelsLower ESR1 mRNA levelsET-naïve patientsGrade adverse eventsPrior endocrine therapyMetastatic breast cancerAndrogen receptor inhibitorMRNA levelsAR mRNA levelsESR1 mRNA levelsEnzalutamide armITT populationTreat populationAdvanced diseasePrimary endpointAdverse events
2016
Phase 1b/2a study of trastuzumab emtansine (T-DM1), paclitaxel, and pertuzumab in HER2-positive metastatic breast cancer
Krop IE, Modi S, LoRusso PM, Pegram M, Guardino E, Althaus B, Lu D, Strasak A, Elias A. Phase 1b/2a study of trastuzumab emtansine (T-DM1), paclitaxel, and pertuzumab in HER2-positive metastatic breast cancer. Breast Cancer Research 2016, 18: 34. PMID: 26979312, PMCID: PMC4791863, DOI: 10.1186/s13058-016-0691-7.Peer-Reviewed Original ResearchConceptsClinical benefit ratePhase 1b/2a studyObjective response rateT-DM1Adverse eventsPaclitaxel dosesPeripheral neuropathyBreast cancerHER2-positive advanced breast cancerHER2-positive metastatic breast cancerPhase 2aPhase 1bGrade adverse eventsT-DM1 3.6Advanced breast cancerMetastatic breast cancerDose-escalation approachPre-clinical studiesAnti-tumor activityConclusionsThis regimenExperienced gradeMeasurable diseasePaclitaxel 80Prior therapyResultsThe MTD
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 2
2014
Trastuzumab Emtansine in Human Epidermal Growth Factor Receptor 2–Positive Metastatic Breast Cancer: An Integrated Safety Analysis
Diéras V, Harbeck N, Budd GT, Greenson JK, Guardino AE, Samant M, Chernyukhin N, Smitt MC, Krop IE. Trastuzumab Emtansine in Human Epidermal Growth Factor Receptor 2–Positive Metastatic Breast Cancer: An Integrated Safety Analysis. Journal Of Clinical Oncology 2014, 32: 2750-2757. PMID: 25024070, DOI: 10.1200/jco.2013.54.4999.Peer-Reviewed Original ResearchConceptsMetastatic breast cancerHER2-positive metastatic breast cancerHuman epidermal growth factor receptor 2Adverse eventsDrug discontinuationSafety profileT-DM1Trastuzumab emtansineBreast cancerGrade 3Dose reductionEpidermal growth factor receptor 2Human epidermal growth factor receptorCommon grade 3Grade adverse eventsRandomized phase IISelect adverse eventsBreast cancer settingGreater adverse eventsGrowth factor receptor 2Single-arm studyT-DM1 treatmentFavorable safety profileFactor receptor 2Epidermal growth factor receptor