2021
Saci-IO HR+: Randomized phase II trial of sacituzumab govitecan (SG) +/- pembrolizumab in PD-L1+ hormone receptor-positive (HR+) / HER2- metastatic breast cancer (MBC).
Garrido-Castro A, Keenan T, Li T, Lange P, Callahan C, Guerriero J, Tayob N, Anderson L, Stover D, Gogineni K, Carey L, Nanda R, Winer E, Mittendorf E, Tolaney S. Saci-IO HR+: Randomized phase II trial of sacituzumab govitecan (SG) +/- pembrolizumab in PD-L1+ hormone receptor-positive (HR+) / HER2- metastatic breast cancer (MBC). Journal Of Clinical Oncology 2021, 39: tps1102-tps1102. DOI: 10.1200/jco.2021.39.15_suppl.tps1102.Peer-Reviewed Original ResearchProgression-free survivalImmune checkpoint inhibitorsMedian progression-free survivalRandomized phase II trialCombined positive scorePhase II trialSacituzumab govitecanII trialPD-L1Anti-PD-1/L1 antibodyPD-1/L1 inhibitorsHER2- metastatic breast cancerAntibody-dependent cellular cytotoxicityT cell effector functionPrior hormonal therapyPD-L1 expressionAntitumor immune responseChronic antigen stimulationHealth-related qualityKey eligibility criteriaRegulatory T cellsT cell dysfunctionCell effector functionsOne-sided alphaImmune cell receptorsSaci-IO TNBC: Randomized phase II trial of sacituzumab govitecan (SG) +/- pembrolizumab in PD-L1– metastatic triple-negative breast cancer (mTNBC).
Garrido-Castro A, Keenan T, Li T, Lange P, Callahan C, Guerriero J, Tayob N, Anderson L, Yam C, Daniel B, Carey L, Nanda R, Winer E, Mittendorf E, Tolaney S. Saci-IO TNBC: Randomized phase II trial of sacituzumab govitecan (SG) +/- pembrolizumab in PD-L1– metastatic triple-negative breast cancer (mTNBC). Journal Of Clinical Oncology 2021, 39: tps1106-tps1106. DOI: 10.1200/jco.2021.39.15_suppl.tps1106.Peer-Reviewed Original ResearchMetastatic triple-negative breast cancerProgression-free survivalImmune checkpoint inhibitorsMedian progression-free survivalRandomized phase II trialPhase II trialSacituzumab govitecanPD-L1II trialImmune cellsBreast cancerAnti-PD-1/L1 antibodyPD-1/L1 inhibitorsAntibody-dependent cellular cytotoxicityT cell effector functionTriple-negative breast cancerPrior systemic therapyPD-L1 expressionAntitumor immune responseChronic antigen stimulationHealth-related qualityKey eligibility criteriaRegulatory T cellsT cell dysfunctionCell effector functions
2019
Olaparib and α-specific PI3K inhibitor alpelisib for patients with epithelial ovarian cancer: a dose-escalation and dose-expansion phase 1b trial
Konstantinopoulos PA, Barry WT, Birrer M, Westin SN, Cadoo KA, Shapiro GI, Mayer EL, O'Cearbhaill RE, Coleman RL, Kochupurakkal B, Whalen C, Curtis J, Farooq S, Luo W, Eismann J, Buss MK, Aghajanian C, Mills GB, Palakurthi S, Kirschmeier P, Liu J, Cantley LC, Kaufmann SH, Swisher EM, D'Andrea AD, Winer E, Wulf GM, Matulonis UA. Olaparib and α-specific PI3K inhibitor alpelisib for patients with epithelial ovarian cancer: a dose-escalation and dose-expansion phase 1b trial. The Lancet Oncology 2019, 20: 570-580. PMID: 30880072, PMCID: PMC7025391, DOI: 10.1016/s1470-2045(18)30905-7.Peer-Reviewed Original ResearchMeSH KeywordsAgedAntineoplastic Combined Chemotherapy ProtocolsCarcinoma, Ovarian EpithelialDose-Response Relationship, DrugDrug-Related Side Effects and Adverse ReactionsFemaleGenome, HumanHumansMaximum Tolerated DoseMiddle AgedMutationOvarian NeoplasmsPhosphoinositide-3 Kinase InhibitorsPhthalazinesPiperazinesPoly(ADP-ribose) Polymerase InhibitorsThiazolesTreatment OutcomeConceptsEpithelial ovarian cancerPhase 2 dosePI3K inhibitor alpelisibPrimary peritoneal cancerPhase 1b trialRecurrent breast cancerGermline BRCA mutationsOvarian cancerBreast cancerDose levelsPeritoneal cancerBRCA mutationsFallopian tubeCommon treatment-related grade 3High-grade serous histologyTreatment-related grade 3Breast Cancer Research FoundationDecreased neutrophil countDose-escalation cohortsDose-expansion cohortsTreatment-related deathsTriple negative histologyResponse Evaluation CriteriaSolid Tumors 1.1Key eligibility criteria
2012
HALT MBC: HER2 suppression with the addition of lapatinib to trastuzumab in HER2-positive metastatic breast cancer (LPT112515).
Lin N, Danso M, David A, Muscato J, Rayson D, Houck W, Ellis C, DeSilvio M, Garofalo A, Nagarwala Y, Winer E. HALT MBC: HER2 suppression with the addition of lapatinib to trastuzumab in HER2-positive metastatic breast cancer (LPT112515). Journal Of Clinical Oncology 2012, 30: tps658-tps658. DOI: 10.1200/jco.2012.30.15_suppl.tps658.Peer-Reviewed Original ResearchHER2-positive metastatic BCSecond-line treatmentMetastatic BCOverall survivalHigher pathologic complete response rateHER2-positive metastatic breast cancerBreast cancer preclinical modelsPathologic complete response rateClinical benefit rateDual HER2 blockadeStable brain metastasesComplete response rateCombination of trastuzumabHormone receptor statusPhase III studyAddition of lapatinibKey eligibility criteriaMetastatic breast cancerLine of treatmentChemotherapy discontinuationHER2 blockadeITT populationMedian PFSStable diseaseBrain metastases