2024
Phase II study of MEK inhibitor trametinib alone and in combination with AKT inhibitor GSK2141795/uprosertib in patients with metastatic triple negative breast cancer
Prasath V, Boutrid H, Wesolowski R, Abdel-Rasoul M, Timmers C, Lustberg M, Layman R, Macrae E, Mrozek E, Shapiro C, Glover K, Vater M, Budd G, Harris L, Isaacs C, Dees C, Perou C, Johnson G, Poklepovic A, Chen H, Villalona-Calero M, Carson W, Stover D, Ramaswamy B. Phase II study of MEK inhibitor trametinib alone and in combination with AKT inhibitor GSK2141795/uprosertib in patients with metastatic triple negative breast cancer. Breast Cancer Research And Treatment 2024, 1-11. PMID: 39644403, DOI: 10.1007/s10549-024-07551-z.Peer-Reviewed Original ResearchMetastatic triple negative breast cancerProgression-free survivalCirculating tumor DNATriple negative breast cancerTrametinib monotherapyNegative breast cancerStable diseasePartial responseBreast cancerCirculating tumor DNA clearanceMedian progression-free survivalClinical benefit rateMEK inhibitor trametinibPhase II studyBiomarkers of responseTreated with chemotherapyPotential early biomarkersInhibitor trametinibOpen-labelOverall survivalConclusionIn patientsDevelopment of resistanceObjective responseTumor DNABenefit rateAn Open-Label Study of Subcutaneous CpG Oligodeoxynucleotide (PF03512676) in Combination with Trastuzumab in Patients with Metastatic HER2+ Breast Cancer
Quiroga D, Wesolowski R, Zelinskas S, Pinette A, Benner B, Schwarz E, Savardekar H, Johnson C, Stiff A, Yu L, Macrae E, Lustberg M, Mrozek E, Ramaswamy B, Carson W. An Open-Label Study of Subcutaneous CpG Oligodeoxynucleotide (PF03512676) in Combination with Trastuzumab in Patients with Metastatic HER2+ Breast Cancer. Cancer Control 2024, 31: 10732748241250189. PMID: 38797949, PMCID: PMC11129578, DOI: 10.1177/10732748241250189.Peer-Reviewed Original ResearchConceptsMetastatic HER2+ breast cancerHER2+ breast cancerStable diseaseBreast cancerCpG-ODNTrastuzumab treatmentTreated patientsHuman epidermal growth factor receptor 2 (HER2)-positiveToll-like receptor 9 agonistHER2-positive breast cancerWeek 2Immune profile changesPeripheral blood mononuclear cellsAdvanced/metastatic breast cancerVEGF-D levelsOpen-label phaseNK cell populationEfficacy of current treatmentsOpen-label studyAggressive breast cancerBlood mononuclear cellsCompared to baselineMedian PFSMetastatic HER2Monocytic MDSCs
2014
A Phase II study of bevacizumab in combination with trastuzumab and docetaxel in HER2 positive metastatic breast cancer
Zhao M, Pan X, Layman R, Lustberg M, Mrozek E, Macrae E, Wesolowski R, Carothers S, Puhalla S, Shapiro C, Ramaswamy B. A Phase II study of bevacizumab in combination with trastuzumab and docetaxel in HER2 positive metastatic breast cancer. Investigational New Drugs 2014, 32: 1285-1294. PMID: 24894652, PMCID: PMC4303337, DOI: 10.1007/s10637-014-0122-5.Peer-Reviewed Original ResearchConceptsProgression-free survivalLeft ventricular ejection fractionClinical benefit rateHER2-positive MBCObjective response rateComplete responsePartial responseBreast cancerStable diseaseFree survivalGrade 3HER2-positive metastatic breast cancerResponse rateAdditional overall survival benefitsMedian progression-free survivalMetastatic breast cancer patientsPositive metastatic breast cancerVascular epithelial growth factorCommon grade 3Cycles of bevacizumabGrade 2 hypertensionMethods Eligible patientsPrior chemotherapy regimensCombination of bevacizumabHand-foot syndrome
2013
A first-in-human phase I trial of AR-12, a PDK-1 inhibitor, in patients with advanced solid tumors.
Mateo J, De Bono J, Ramanathan R, Lustberg M, Zivi A, Basset D, Ng M, Young A, Garrett M, Decordova S, Raynaud F, Yap T, Zukiwski A, Proniuk S, Shapiro C. A first-in-human phase I trial of AR-12, a PDK-1 inhibitor, in patients with advanced solid tumors. Journal Of Clinical Oncology 2013, 31: 2608-2608. DOI: 10.1200/jco.2013.31.15_suppl.2608.Peer-Reviewed Original ResearchPlatelet-rich plasmaAdvanced solid tumorsAR-12PK variabilitySafety dataFood effectSolid tumorsHuman phase I trialAdequate organ functionECOG PS 0Phase II doseDose-escalation studyPhase I trialDrug-related eventsHuman clinical trialsHigh PK variabilityCOX-2 inhibitory activityMechanism of actionBID cohortQD cohortStable diseaseStudy drugPS 0I trialSingle dose
2011
Phase II Trial of Neoadjuvant Exemestane in Combination With Celecoxib in Postmenopausal Women Who Have Breast Cancer
Lustberg M, Povoski S, Zhao W, Ziegler R, Sugimoto Y, Ruppert A, Lehman A, Shiels D, Mrozek E, Ramaswamy B, Layman R, Brueggemeier R, Shapiro C. Phase II Trial of Neoadjuvant Exemestane in Combination With Celecoxib in Postmenopausal Women Who Have Breast Cancer. Clinical Breast Cancer 2011, 11: 221-227. PMID: 21729671, PMCID: PMC3440773, DOI: 10.1016/j.clbc.2011.03.022.Peer-Reviewed Original ResearchMeSH KeywordsAgedAged, 80 and overAndrostadienesAntineoplastic AgentsBreast NeoplasmsCarcinoma, LobularCelecoxibCyclooxygenase 2Cyclooxygenase 2 InhibitorsDrug Therapy, CombinationFemaleFollow-Up StudiesHumansImmunoenzyme TechniquesLymphatic MetastasisMiddle AgedNeoadjuvant TherapyNeoplasm InvasivenessNeoplasm Recurrence, LocalNeoplasm StagingPostmenopausePyrazolesReceptor, ErbB-2Receptors, EstrogenReceptors, ProgesteroneSulfonamidesSurvival RateTreatment OutcomeConceptsPathological complete responsePhase II trialEstrogen receptorKi-67Neoadjuvant exemestaneII trialPostmenopausal womenCOX-2Breast cancerDefinitive breast cancer surgeryCOX-2 inhibitor celecoxibSerious cardiac eventsAnti-tumor responseBreast cancer surgeryAddition of celecoxibCOX-2 expressionMajority of womenStable diseaseCardiac eventsPartial responseComplete responseCancer surgeryCore biopsyAromatase inhibitorsHER-2