2012
A phase I/IB dose-escalation study of BEZ235 in combination with trastuzumab in patients with PI3-kinase or PTEN altered HER2+ metastatic breast cancer.
Krop I, Saura C, Rodon Ahnert J, Becerra C, Britten C, Isakoff S, Demanse D, Hackl W, Quadt C, Silva A, Burris H, Abu-Khalaf M, Baselga J. A phase I/IB dose-escalation study of BEZ235 in combination with trastuzumab in patients with PI3-kinase or PTEN altered HER2+ metastatic breast cancer. Journal Of Clinical Oncology 2012, 30: 508-508. DOI: 10.1200/jco.2012.30.15_suppl.508.Peer-Reviewed Original ResearchMetastatic breast cancerPI3K pathway alterationsBreast cancerG3 nauseaResistant HER2Disease stabilizationPathway alterationsPI3K/AKT/mTOR pathwayAcceptable safety profileDose-escalation studyAdvanced solid tumorsAKT/mTOR pathwayBreast cancer modelLogistic regression modelsPI3K pathwayG3 fatigueObserved DLTsBrain metastasesPartial responseSkin rashAdverse eventsLiver metastasesDose escalationSafety profileDose levels
2011
P1-06-23: Changes in Gene Expression after One Dose of Trastuzumab (T) in HER2+ Breast Cancer Cell Lines Predict Novel Pathways of Response in HER2 Positive Early Stage Breast Cancer.
Sprecher E, Lezon-Geyda K, Sarkar S, Bossuyt V, Narayaan M, Kumar A, Krop I, Winer E, Tuck D, Kleinstein S, Harris L. P1-06-23: Changes in Gene Expression after One Dose of Trastuzumab (T) in HER2+ Breast Cancer Cell Lines Predict Novel Pathways of Response in HER2 Positive Early Stage Breast Cancer. Cancer Research 2011, 71: p1-06-23-p1-06-23. DOI: 10.1158/0008-5472.sabcs11-p1-06-23.Peer-Reviewed Original ResearchPathologic complete responseBreast cancer patientsBreast cancer cell linesSensitive cell linesCancer cell linesCancer patientsSingle doseBreast cancerHER2-positive early-stage breast cancerPositive early-stage breast cancerCell linesBreast tumorsEarly breast cancer patientsEarly-stage breast cancerDose of trastuzumabEarly-stage HER2Early breast cancerResistant breast tumorsStage breast cancerTumor core biopsiesPathway analysisMechanism of actionResistant HER2RECIST criteriaClinical response
2007
A phase I study of trastuzumab-MCC-DM1 (T-DM1), a first-in-class HER2 antibody-drug conjugate (ADC), in patients (pts) with HER2+ metastatic breast cancer (BC)
Beeram M, Krop I, Modi S, Tolcher A, Rabbee N, Girish S, Tibbitts J, Holden S, Lutzker S, Burris H. A phase I study of trastuzumab-MCC-DM1 (T-DM1), a first-in-class HER2 antibody-drug conjugate (ADC), in patients (pts) with HER2+ metastatic breast cancer (BC). Journal Of Clinical Oncology 2007, 25: 1042-1042. DOI: 10.1200/jco.2007.25.18_suppl.1042.Peer-Reviewed Original ResearchAntibody-drug conjugatesMetastatic breast cancerAdverse eventsT-DM1Breast cancerDose levelsHER2 antibody-drug conjugatesFirst antibody-drug conjugatePhase IOngoing partial responsePrincipal adverse eventsReversible transaminase elevationT-DM1 pharmacokineticsObjective tumor responseHuman phase IDose-dependent decreasePotent anti-tumor agentAntigen-specific monoclonal antibodiesAnti-tumor agentsCancer ptsQ3 weeksResistant HER2Transaminase elevationHepatic transaminasesPartial response