2018
Phase II Study of Taselisib (GDC-0032) in Combination with Fulvestrant in Patients with HER2-Negative, Hormone Receptor–Positive Advanced Breast Cancer
Dickler MN, Saura C, Richards DA, Krop IE, Cervantes A, Bedard PL, Patel MR, Pusztai L, Oliveira M, Cardenas AK, Cui N, Wilson TR, Stout TJ, Wei MC, Hsu JY, Baselga J. Phase II Study of Taselisib (GDC-0032) in Combination with Fulvestrant in Patients with HER2-Negative, Hormone Receptor–Positive Advanced Breast Cancer. Clinical Cancer Research 2018, 24: 4380-4387. PMID: 29793946, PMCID: PMC6139036, DOI: 10.1158/1078-0432.ccr-18-0613.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsClass I Phosphatidylinositol 3-KinasesDisease-Free SurvivalDrug-Related Side Effects and Adverse ReactionsFemaleFulvestrantHumansImidazolesMiddle AgedMutationOxazepinesReceptor, ErbB-2Receptors, EstrogenConceptsAdverse eventsClinical activityBreast cancerMutation statusOpen-label phase II studyHR-positive breast cancerHigher objective response rateConfirmatory phase III trialNCI CTCAE v4.0Median treatment durationObjective response ratePhase II studySerious adverse eventsNew safety signalsPhase III trialsPositive breast cancerClin Cancer ResIntramuscular fulvestrantMeasurable diseaseRECIST v1.1II studyIII trialsPostmenopausal womenUnacceptable toxicityTumor response
2015
Changes in the amino acid sequence of the recombinant human factor VIIa analog, vatreptacog alfa, are associated with clinical immunogenicity
Mahlangu J, Weldingh K, Lentz S, Kaicker S, Karim F, Matsushita T, Recht M, Tomczak W, Windyga J, Ehrenforth S, Knobe K, Investigators F, Weltermann A, de Paula E, Cerqueira M, Zupancic‐Salek S, Katsarou O, Economou M, Nemes L, Boda Z, Santagostino E, Tagariello G, Hanabusa H, Fukutake K, Shima M, Serban M, Elezovic I, Savic A, Shen M, Chuansumrit A, Angchaisuksiri P, Kavakli K, Sasmaz I, Madan B, Giangrande P, Kempton C, Young G, Quon D, Ameri A, Kuriakose P, Obzut D, Wang M, Ortiz I. Changes in the amino acid sequence of the recombinant human factor VIIa analog, vatreptacog alfa, are associated with clinical immunogenicity. Journal Of Thrombosis And Haemostasis 2015, 13: 1989-1998. PMID: 26362483, DOI: 10.1111/jth.13141.Peer-Reviewed Original ResearchMeSH KeywordsAmino Acid SequenceAmino Acid SubstitutionAntibody SpecificityAntigen-Antibody ReactionsCross ReactionsEpitopesFactor VIIaHemophilia AHemorrhageHLA-D AntigensHumansImmunoglobulin GIsoantibodiesNeutralization TestsProtein Structure, TertiaryRecombinant ProteinsStructure-Activity RelationshipConceptsRecombinant human factor VIIaAnti-drug antibodiesVatreptacog alfaPhase III trialsIII trialsHemophilia patientsDevelopment of anti-drug antibodiesClinical immunogenicityAnti-drug antibody developmentImmunoglobulin G subtypeConfirmatory phase III trialTreatment of bleedingProlonged elimination phaseFollow-up evaluationHuman factor VIIaCross-reactive antibodiesEpitope mappingPost Hoc AnalysisB patientsDouble-blindG subtypesAcute bleedingHemophilia AFactor VIIaPK profilesPalbociclib
Mangini N, Wesolowski R, Ramaswamy B, Lustberg M, Berger M. Palbociclib. Annals Of Pharmacotherapy 2015, 49: 1252-1260. PMID: 26324355, PMCID: PMC7331461, DOI: 10.1177/1060028015602273.Peer-Reviewed Original ResearchMeSH KeywordsAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsClinical Trials, Phase I as TopicClinical Trials, Phase II as TopicClinical Trials, Phase III as TopicCyclin-Dependent KinasesDisease-Free SurvivalEstradiolFemaleFulvestrantHumansLetrozoleNeoplasms, Hormone-DependentNitrilesPiperazinesPyridinesRandomized Controlled Trials as TopicReceptor, ErbB-2TriazolesUnited StatesConceptsProgression-free survivalAdvanced breast cancerInvestigator-assessed median progression-free survivalMedian progression-free survivalPhase III trialsBreast cancerEndocrine therapyIII trialsOncology abstractsHER2-negative advanced breast cancerHuman epidermal growth factor receptor 2Epidermal growth factor receptor 2Negative advanced breast cancerConfirmatory phase III trialClinical Oncology abstractsMedical Oncology abstractsPALOMA-3 trialFirst-line settingPhase II trialGrowth factor receptor 2Drug Administration approvalFactor receptor 2Life-threatening diseaseCyclin-dependent kinase 4Novel small molecule inhibitor
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