2018
Phase II study of ruxolitinib, a selective JAK1/2 inhibitor, in patients with metastatic triple-negative breast cancer
Stover DG, Gil Del Alcazar CR, Brock J, Guo H, Overmoyer B, Balko J, Xu Q, Bardia A, Tolaney SM, Gelman R, Lloyd M, Wang Y, Xu Y, Michor F, Wang V, Winer EP, Polyak K, Lin NU. Phase II study of ruxolitinib, a selective JAK1/2 inhibitor, in patients with metastatic triple-negative breast cancer. Npj Breast Cancer 2018, 4: 10. PMID: 29761158, PMCID: PMC5935675, DOI: 10.1038/s41523-018-0060-z.Peer-Reviewed Original ResearchMetastatic triple-negative breast cancerTriple-negative breast cancerPhase II studyBreast cancerII studyObjective responseNon-randomized phase II studyIL-6/JAK2/STAT3Efficacy of ruxolitinibInfrequent grade 3Refractory patient populationPrimary efficacy endpointMetastatic breast cancerInflammatory breast cancerSelective JAK1/2 inhibitorArchival tumor tissueJAK2/STAT3Central immunohistochemistryCommon toxicitiesRECIST 1.1Efficacy endpointPrimary endpointProtocol therapyJAK1/2 inhibitorPatient population
2014
Extended Therapy With Letrozole and Ovarian Suppression in Premenopausal Patients With Breast Cancer After Tamoxifen
Ruddy KJ, DeSantis SD, Barry W, Guo H, Block CC, Borges V, Winer EP, Partridge AH. Extended Therapy With Letrozole and Ovarian Suppression in Premenopausal Patients With Breast Cancer After Tamoxifen. Clinical Breast Cancer 2014, 14: 413-416. PMID: 24970714, DOI: 10.1016/j.clbc.2014.04.007.Peer-Reviewed Original ResearchMeSH KeywordsAntineoplastic Agents, HormonalAntineoplastic Combined Chemotherapy ProtocolsAromatase InhibitorsBreast NeoplasmsChemotherapy, AdjuvantFeasibility StudiesFemaleFollow-Up StudiesGonadotropin-Releasing HormoneHumansLetrozoleMiddle AgedNeoplasm GradingNeoplasm StagingNitrilesOvariectomyPremenopausePrognosisSurvival RateTamoxifenTriazolesConceptsPremenopausal womenAdjuvant tamoxifenEndocrine therapyExtended therapyAromatase inhibitorsBreast cancerStandard adjuvant endocrine therapyGonadotropin-releasing hormone agonistSingle-arm clinical trialPhase II single-arm clinical trialsEarly study closureYears of tamoxifenAdjuvant endocrine therapySubstantial side effectsProtocol-directed therapyCommon toxicitiesLengthier coursesPremenopausal patientsOvarian suppressionPoor accrualPostmenopausal patientsVaginal drynessHormone agonistStudy closureBone loss
2011
PD09-05: SU2C Phase Ib Study of pan-PI3K Inhibitor BKM120 Plus Aromatase Inhibitor Letrozole in ER+/HER2− Metastatic Breast Cancer (MBC).
Mayer I, Balko J, Kuba M, Sanders M, Yap J, Li Y, Winer E, Arteaga C. PD09-05: SU2C Phase Ib Study of pan-PI3K Inhibitor BKM120 Plus Aromatase Inhibitor Letrozole in ER+/HER2− Metastatic Breast Cancer (MBC). Cancer Research 2011, 71: pd09-05-pd09-05. DOI: 10.1158/0008-5472.sabcs11-pd09-05.Peer-Reviewed Original ResearchPan-PI3K inhibitor BKM120Metastatic breast cancerFDG-PET imagingAromatase inhibitorsBreast cancerSafe side effect profilePhase Ib clinical trialAlternative administration schedulesDiagnostic tumor biopsiesGrade 3 transaminitisMost common toxicitiesPI3K-targeted therapiesSafety/tolerabilityPhase Ib studyMetastatic bone diseaseSide effect profileMonths of initiationPost-menopausal patientsWeeks of treatmentPI3K pathway inhibitionMost breast cancersAromatase inhibitor letrozoleProgression of diseasePI3K/AktCommon toxicities
1998
Oral 5-FU analogues in the treatment of breast cancer.
Bunnell CA, Winer EP. Oral 5-FU analogues in the treatment of breast cancer. Oncology 1998, 12: 39-43. PMID: 9830624.Peer-Reviewed Original ResearchConceptsPhase II trialBreast cancer patientsBreast cancerII trialCancer patientsResponse rateOpen-label phase II trialRandomized phase II studyCombination of UFTHand-foot syndromePartial response ratePhase II studyTreatment-related toxicityAdvanced breast cancerMetastatic breast cancerOverall response rateTreatment of patientsPreliminary response dataAnthracycline useCommon toxicitiesSalvage therapyMetastatic settingII studyTherapeutic armamentariumGrade 3
1995
Randomized comparison of vinorelbine and melphalan in anthracycline-refractory advanced breast cancer.
Jones S, Winer E, Vogel C, Laufman L, Hutchins L, O'Rourke M, Lembersky B, Budman D, Bigley J, Hohneker J. Randomized comparison of vinorelbine and melphalan in anthracycline-refractory advanced breast cancer. Journal Of Clinical Oncology 1995, 13: 2567-74. PMID: 7595708, DOI: 10.1200/jco.1995.13.10.2567.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAntibiotics, AntineoplasticAntineoplastic AgentsBreast NeoplasmsDisease ProgressionDrug Administration ScheduleDrug Resistance, NeoplasmFemaleHematologic DiseasesHumansInjections, IntravenousMelphalanMiddle AgedProportional Hazards ModelsProspective StudiesQuality of LifeSurvival RateVinblastineVinorelbineConceptsQuality of lifeAdvanced breast cancerCancer-related symptomsTreatment failureBreast cancerALK patientsSurvival rateStabilization of diseaseEfficacy end pointTumor response ratePopulation of patientsMedian survival rateCommon toxicitiesProspective multicenterObjective responseSeptic deathSurvival benefitRandomized comparisonPatient populationPatientsIntergroup differencesTreatment centersResponse rateEnd pointVinorelbine tartrate