2019
343P Phase I dose escalation study of a selective androgen receptor modulator RAD140 in estrogen receptor positive (ER+), HER2 negative (HER2-) breast cancer (BC)
Hamilton E, Vidula N, Ma C, LoRusso P, Bagley R, Yu Z, Annett M, Weitzman A, Conlan M, Weise A. 343P Phase I dose escalation study of a selective androgen receptor modulator RAD140 in estrogen receptor positive (ER+), HER2 negative (HER2-) breast cancer (BC). Annals Of Oncology 2019, 30: v123. DOI: 10.1093/annonc/mdz242.038.Peer-Reviewed Original ResearchProstate-specific antigenSelective AR modulatorsALT/ASTBreast cancerMetastatic BCRadius HealthAndrogen receptorHER2-negative breast cancerSerum prostate-specific antigenAR agonist activityGenentech/RocheWeight/appetiteAntitumor activityFrequent adverse eventsAcceptable safety profileKey eligibility criteriaMetastatic breast cancerPhase 1 studyHormone-binding globulinAndrogen-responsive tissuesDrug-related deathsNegative breast cancerBristol-Myers SquibbFlatiron HealthStable disease
2012
MDV3100-08: A phase I open-label, dose-escalation study evaluating the safety, tolerability, and pharmacokinetics of MDV3100 in women with incurable breast cancer.
Elias A, Richer J, LoRusso P, Peterson A, Steinberg J, Mordenti J, Lopez C, Hudis C, Traina T. MDV3100-08: A phase I open-label, dose-escalation study evaluating the safety, tolerability, and pharmacokinetics of MDV3100 in women with incurable breast cancer. Journal Of Clinical Oncology 2012, 30: tps668-tps668. DOI: 10.1200/jco.2012.30.15_suppl.tps668.Peer-Reviewed Original ResearchPhase 2 doseIncurable breast cancerBreast cancerAndrogen receptorDay 1PK samplesDay 8Dose-escalation stageOverall survival benefitDose-escalation studyPhase 1 studyAR nuclear translocationInhibition of androgenPotential therapeutic strategyPK samplingAdverse eventsDaily dosingSurvival benefitAR expressionHistologic subtypeDiscontinuation criteriaPreclinical activityProstate cancerTumor assessmentMDV3100