2023
Phase II trial of pembrolizumab in patients with brain metastases.
Brastianos P, Kim A, Giobbie-Hurder A, Lee E, Lin N, Overmoyer B, Wen P, Nayak L, Cohen J, Dietrich J, Heist R, Krop I, Lawrence D, Mayer E, Winer E, Shih H, Oh K, Cahill D, Gerstner E, Sullivan R. Phase II trial of pembrolizumab in patients with brain metastases. Journal Of Clinical Oncology 2023, 41: 2006-2006. DOI: 10.1200/jco.2023.41.16_suppl.2006.Peer-Reviewed Original ResearchBrain metastasesPrimary endpointBenefit rateEvaluable patientsLung cancerBreast cancerTherapeutic strategiesSingle-arm phase 2 clinical trialNon-small cell lung cancerHormone receptor-positive diseaseSmall cell lung cancerPhase 2 clinical trialGrade 4 toxicityLogical therapeutic strategyRECIST 1.1 criteriaMedian overall survivalPD-1 blockadePD-1 inhibitorsPrimary efficacy endpointReceptor-positive diseasePhase II trialImmune-based strategiesTriple-negative subtypeCell lung cancerT cell cytotoxicity
2017
SANDPIPER: Phase III study of the PI3-kinase (PI3K) inhibitor taselisib (GDC-0032) plus fulvestrant in patients (pts) with estrogen receptor (ER)-positive, HER2-negative locally advanced or metastatic breast cancer (BC) enriched for pts with PIK3CA- mutant tumors.
Baselga J, Cortés J, DeLaurentiis M, Dent S, Diéras V, Harbeck N, Hsu J, Jin H, Schimmoller F, Wilson T, Im Y, Jacot W, Krop I, Verma S. SANDPIPER: Phase III study of the PI3-kinase (PI3K) inhibitor taselisib (GDC-0032) plus fulvestrant in patients (pts) with estrogen receptor (ER)-positive, HER2-negative locally advanced or metastatic breast cancer (BC) enriched for pts with PIK3CA- mutant tumors. Journal Of Clinical Oncology 2017, 35: tps1119-tps1119. DOI: 10.1200/jco.2017.35.15_suppl.tps1119.Peer-Reviewed Original ResearchPIK3CA-mutant tumorsMetastatic breast cancerBreast cancerPIK3CA mutationsInvestigator-assessed progression-free survivalHER2-negative breast tumorsClinical benefit rateObjective response ratePrimary efficacy endpointProgression-free survivalPatient-reported outcomesAromatase inhibitor treatmentSelective PI3K inhibitorFrequent genomic alterationsProliferation of tumorsBC cell linesPIK3CA mutant breast cancersPI3K inhibitorsEfficacy endpointObjective responseOverall survivalPartial responseVisceral diseaseDisease recurrenceEndocrine sensitivity