2013
A phase I study of neoadjuvant chemotherapy (NCT) with the gamma secretase (GS) inhibitor RO4929097 in combination with paclitaxel (P) and carboplatin (C) in women with triple-negative breast cancer (TNBC).
Mrozek E, Wesolowski R, Lustberg M, Layman R, Ling Y, Schaaf L, Phelps M, Ivy S, Grever M, Shapiro C. A phase I study of neoadjuvant chemotherapy (NCT) with the gamma secretase (GS) inhibitor RO4929097 in combination with paclitaxel (P) and carboplatin (C) in women with triple-negative breast cancer (TNBC). Journal Of Clinical Oncology 2013, 31: 1043-1043. DOI: 10.1200/jco.2013.31.15_suppl.1043.Peer-Reviewed Original ResearchTriple-negative breast cancerMaximum-tolerated doseNon-hematologic toxicitiesNeoadjuvant chemotherapyAUC 5G4 neutropeniaDay 1Gamma secretase inhibitor RO4929097Cycles of NACGrade 4 thrombocytopeniaComplete pathologic responseTreatment-related toxicityMinimal residual cancerMinimal residual diseaseLC-MS/MS assaysAUC 6G3 anemiaG3 fatigueG3 neutropeniaG3 thrombocytopeniaG4 thrombocytopeniaStarting dosePathologic responseResidual cancerOral inhibitor
2010
Severe and Prolonged Lymphopenia Observed In Patients Treated with Bendamustine and Erlotinib for Metastatic Triple Negative Breast Cancer
Layman R, Ruppert A, Lynn M, Mrozek E, Ramaswamy B, Lustberg M, Susan O, Carothers S, Kraut E, Shapiro C. Severe and Prolonged Lymphopenia Observed In Patients Treated with Bendamustine and Erlotinib for Metastatic Triple Negative Breast Cancer. Blood 2010, 116: 1739. DOI: 10.1182/blood.v116.21.1739.1739.Peer-Reviewed Original ResearchTriple-negative breast cancerPneumocystis carinii pneumoniaDose level 2Metastatic triple-negative breast cancerNational Comprehensive Cancer NetworkDose level 1Serious adverse eventsNegative breast cancerStudy therapyProlonged lymphopeniaOpportunistic infectionsCombination therapyBreast cancerPhase I/II trialAdequate bone marrow functionEpidermal growth factor receptor expressionDepressed CD4 countGrade 3 infectionNon-hematologic toxicitiesOverall hematologic toxicityECOG performance statusGrowth factor receptor expressionWhole brain radiationAbsolute neutrophil countGrowth factor support