A Phase II Randomized Study of Neoadjuvant Letrozole Plus Alpelisib for Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Breast Cancer (NEO-ORB)
Mayer IA, Prat A, Egle D, Blau S, Fidalgo JAP, Gnant M, Fasching PA, Colleoni M, Wolff AC, Winer EP, Singer CF, Hurvitz S, Estévez LG, van Dam PA, Kümmel S, Mundhenke C, Holmes F, Babbar N, Charbonnier L, Diaz-Padilla I, Vogl FD, Sellami D, Arteaga CL. A Phase II Randomized Study of Neoadjuvant Letrozole Plus Alpelisib for Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Breast Cancer (NEO-ORB). Clinical Cancer Research 2019, 25: 2975-2987. PMID: 30723140, PMCID: PMC6522303, DOI: 10.1158/1078-0432.ccr-18-3160.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsBiomarkers, TumorBreast NeoplasmsCell ProliferationClass I Phosphatidylinositol 3-KinasesFemaleHigh-Throughput Nucleotide SequencingHumansLetrozoleMiddle AgedMutationNeoadjuvant TherapyReceptor, ErbB-2Receptors, EstrogenReceptors, ProgesteroneSignal TransductionThiazolesTreatment OutcomeConceptsObjective response rateMetastatic breast cancerBreast cancerResponse rateLetrozole treatmentPathologic complete response ratePhase II Randomized StudyHuman epidermal growth factor receptor 2Epidermal growth factor receptor 2Human epidermal growth factor receptorComplete response rateHormone receptor positiveMaculo-papular rashProgression-free survivalGrowth factor receptor 2Early breast cancerPhase I studiesWild-type cohortsFactor receptor 2Epidermal growth factor receptorCombination of alpelisibGrowth factor receptorNeoadjuvant letrozoleNeoadjuvant settingPrimary endpoint