2021
A phase I/Ib study evaluating GDC-0077 (inavolisib) + palbociclib (palbo) + fulvestrant in patients (pts) with PIK3CA-mutant (mut), hormone receptor-positive/HER2-negative metastatic breast cancer (HR+/HER2- mBC)
Schmid P, Bedard P, Jhaveri K, Cervantes A, Gambardella V, Hamilton E, Italiano A, Kalinsky K, Krop I, Oliveira M, Saura C, Turner N, Varga A, Hutchinson K, Lei G, Royer-Joo S, Thomas P, JL S, Juric D. A phase I/Ib study evaluating GDC-0077 (inavolisib) + palbociclib (palbo) + fulvestrant in patients (pts) with PIK3CA-mutant (mut), hormone receptor-positive/HER2-negative metastatic breast cancer (HR+/HER2- mBC). Senologie - Zeitschrift Für Mammadiagnostik Und -therapie 2021, 18: e36-e37. DOI: 10.1055/s-0041-1730220.Peer-Reviewed Original Research
2020
PI3K pathway biomarkers and clinical response in a phase I/Ib study of GDC-0077 in hormone receptor-positive/HER2-negative breast cancer (HR+/HER2– BC)
Gambardella V, Cervantes A, Bedard P, Hamilton E, Italiano A, Jhaveri K, Juric D, Kalinsky K, Krop I, Oliveira M, Saura C, Schmid P, Turner N, Varga A, Liu B, Chen J, Aimi J, Royer-Joo S, Schutzman J, Hutchinson K. PI3K pathway biomarkers and clinical response in a phase I/Ib study of GDC-0077 in hormone receptor-positive/HER2-negative breast cancer (HR+/HER2– BC). Annals Of Oncology 2020, 31: s381-s382. DOI: 10.1016/j.annonc.2020.08.438.Peer-Reviewed Original Research
2019
First‐in‐human, phase I study of PF‐06647263, an anti‐EFNA4 calicheamicin antibody–drug conjugate, in patients with advanced solid tumors
Garrido‐Laguna I, Krop I, Burris HA, Hamilton E, Braiteh F, Weise AM, Abu‐Khalaf M, Werner TL, Pirie‐Shepherd S, Zopf CJ, Lakshminarayanan M, Holland JS, Baffa R, Hong DS. First‐in‐human, phase I study of PF‐06647263, an anti‐EFNA4 calicheamicin antibody–drug conjugate, in patients with advanced solid tumors. International Journal Of Cancer 2019, 145: 1798-1808. PMID: 30680712, PMCID: PMC6875752, DOI: 10.1002/ijc.32154.Peer-Reviewed Original ResearchConceptsTriple-negative breast cancerAdvanced solid tumorsTumor responseSolid tumorsMetastatic triple-negative breast cancerPhase IPhase 2 doseAntitumor activityHuman xenograft tumor modelsAvailable standard therapiesDose-related mannerLimited antitumor activityXenograft tumor modelCommon AEsStable diseaseManageable safetyPartial responsePotent antitumor activityStandard therapyToxicity probability interval methodOvarian cancerBreast cancerPatientsRP2DTumor model
2017
264P Progression-free survival (PFS) and site of first progression in HER2+ metastatic breast cancer (MBC) patients (pts) with (w) or without (w/o) brain metastases: A pooled analysis of tucatinib phase I studies
Moulder S, Hamilton E, Ferrario C, Conlin A, Krop I, Chamberlain M, Gray T, Borges V. 264P Progression-free survival (PFS) and site of first progression in HER2+ metastatic breast cancer (MBC) patients (pts) with (w) or without (w/o) brain metastases: A pooled analysis of tucatinib phase I studies. Annals Of Oncology 2017, 28: v85. DOI: 10.1093/annonc/mdx365.027.Peer-Reviewed Original Research
2009
A 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 ResearchA 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