2020
A Randomized Placebo Controlled Phase II Trial Evaluating Exemestane with or without Enzalutamide in Patients with Hormone Receptor–Positive Breast Cancer
Krop I, Abramson V, Colleoni M, Traina T, Holmes F, Garcia-Estevez L, Hart L, Awada A, Zamagni C, Morris PG, Schwartzberg L, Chan S, Gucalp A, Biganzoli L, Steinberg J, Sica L, Trudeau M, Markova D, Tarazi J, Zhu Z, O'Brien T, Kelly C, Winer E, Yardley D. A Randomized Placebo Controlled Phase II Trial Evaluating Exemestane with or without Enzalutamide in Patients with Hormone Receptor–Positive Breast Cancer. Clinical Cancer Research 2020, 26: 6149-6157. PMID: 32988969, DOI: 10.1158/1078-0432.ccr-20-1693.Peer-Reviewed Original ResearchConceptsProgression-free survivalHormone receptor-positive breast cancerReceptor-positive breast cancerPhase II trialEndocrine therapyBreast cancerII trialAR mRNACohort 1Higher AR mRNA levelsLower ESR1 mRNA levelsET-naïve patientsGrade adverse eventsPrior endocrine therapyMetastatic breast cancerAndrogen receptor inhibitorMRNA levelsAR mRNA levelsESR1 mRNA levelsEnzalutamide armITT populationTreat populationAdvanced diseasePrimary endpointAdverse events
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