2018
Phase III study of taselisib (GDC-0032) + fulvestrant (FULV) v FULV in patients (pts) with estrogen receptor (ER)-positive, PIK3CA -mutant (MUT), locally advanced or metastatic breast cancer (MBC): Primary analysis from SANDPIPER.
Baselga J, Dent S, Cortés J, Im Y, Diéras V, Harbeck N, Krop I, Verma S, Wilson T, Jin H, Wang L, Schimmoller F, Hsu J, He J, DeLaurentiis M, Drullinsky P, Jacot W. Phase III study of taselisib (GDC-0032) + fulvestrant (FULV) v FULV in patients (pts) with estrogen receptor (ER)-positive, PIK3CA -mutant (MUT), locally advanced or metastatic breast cancer (MBC): Primary analysis from SANDPIPER. Journal Of Clinical Oncology 2018, 36: lba1006-lba1006. DOI: 10.1200/jco.2018.36.18_suppl.lba1006.Peer-Reviewed Original ResearchInvestigator-assessed progression-free survivalMetastatic breast cancerClinical benefit rateObjective response rateOverall survivalBlinded independent central reviewProgression-free survivalIndependent central reviewDose of treatmentSelective PI3K inhibitorBC cell linesPI3K inhibitorsTreat populationPrimary endpointSecondary endpointsAdverse eventsObjective responsePartial responseVisceral diseaseDisease recurrenceEndocrine sensitivityCentral reviewSafety profileAromatase inhibitorsBenefit rate
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
2009
Comparison of the Cellsearch Profile Kit (CPK) with the Standard Cellsearch Epithelial Kit (CEK) Demonstrates the CPK Produces Higher Circulating Tumor Cell (CTC) Yields and Is Better Suited for Use in Obtaining CTC's for Molecular Characterization.
Flores L, Kindelberger D, Ligon A, Cappeletti M, Fiorentino M, Loda M, Cibas E, Janne P, Krop I. Comparison of the Cellsearch Profile Kit (CPK) with the Standard Cellsearch Epithelial Kit (CEK) Demonstrates the CPK Produces Higher Circulating Tumor Cell (CTC) Yields and Is Better Suited for Use in Obtaining CTC's for Molecular Characterization. Cancer Research 2009, 69: 3003-3003. DOI: 10.1158/0008-5472.sabcs-09-3003.Peer-Reviewed Original ResearchML of bloodTumor cellsBreast cancerCytospin slidesLow intrapatient variabilityHER2 gene copy numberMetastatic breast cancerPeripheral blood samplesBC cell linesMedian cell countTumor cell yieldMean total numberMetastatic tumor cellsPrimary cancerCD45 stainingPredictive biomarkersMechanisms of resistanceHealthy controlsIntrapatient variabilityMetastatic cancerCTC yieldPharmacodynamic studiesSolid cancersCytokeratin stainingBlood samples