2021
Pharmacokinetic (PK) analyses in CSF and plasma from TBCRC049, an ongoing trial to assess the safety and efficacy of the combination of tucatinib, trastuzumab and capecitabine for the treatment of leptomeningeal metastasis (LM) in HER2 positive breast cancer.
Stringer-Reasor E, O'Brien B, Topletz-Erickson A, White J, Lobbous M, Riley K, Childress J, LaMaster K, Melisko M, Morikawa A, De Groot J, Krop I, Valero V, Rimawi M, Wolff A, Tripathy D, Lin N, Murthy R. Pharmacokinetic (PK) analyses in CSF and plasma from TBCRC049, an ongoing trial to assess the safety and efficacy of the combination of tucatinib, trastuzumab and capecitabine for the treatment of leptomeningeal metastasis (LM) in HER2 positive breast cancer. Journal Of Clinical Oncology 2021, 39: 1044-1044. DOI: 10.1200/jco.2021.39.15_suppl.1044.Peer-Reviewed Original ResearchLeptomeningeal metastasesBrain metastasesBreast cancerPharmacokinetic analysisPhase 2 single-arm studyHER2-positive breast cancerCombination of tucatinibNew brain metastasesSingle-arm studyPositive breast cancerTyrosine kinase inhibitorsHigh interindividual variabilityMetastatic HER2Accrual goalEligible patientsMetastatic settingPrimary endpointOverall survivalOmmaya reservoirOngoing trialsPlasma concentrationsCapecitabinePatientsDay 1PK samples
2019
A phase II study of pembrolizumab in combination with palliative radiotherapy (RT) for hormone receptor-positive (HR+) metastatic breast cancer (MBC).
Barroso-Sousa R, Krop I, Trippa L, Tan-Wasielewski Z, Li T, Osmani W, Andrews C, Dillon D, Richardson E, Winer E, Mittendorf E, Schoenfeld J, Tolaney S. A phase II study of pembrolizumab in combination with palliative radiotherapy (RT) for hormone receptor-positive (HR+) metastatic breast cancer (MBC). Journal Of Clinical Oncology 2019, 37: 1047-1047. DOI: 10.1200/jco.2019.37.15_suppl.1047.Peer-Reviewed Original ResearchMetastatic breast cancerNeutrophil/lymphocyte ratioObjective response rateProgression-free survivalTumor-infiltrating lymphocytesPalliative radiotherapyAdverse eventsHormone receptor-positive metastatic breast cancerPhase II single-arm studyMedian progression-free survivalCause adverse eventsDistant tumor responsesECOG PS 1Prior cytotoxic therapyImmune checkpoint inhibitorsPD-L1 expressionPD-L1 statusPhase II studySingle-arm studyTotal RT doseUnexpected adverse eventsECOG PSEligible ptsRECIST v1.1Measurable lesions
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
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 serum