2023
A randomized phase II study of metronomic cyclophosphamide and methotrexate (CM) with or without bevacizumab in patients with advanced breast cancer
Mayer E, Tayob N, Ren S, Savoie J, Spigel D, Burris H, Ryan P, Harris L, Winer E, Burstein H. A randomized phase II study of metronomic cyclophosphamide and methotrexate (CM) with or without bevacizumab in patients with advanced breast cancer. Breast Cancer Research And Treatment 2023, 204: 123-132. PMID: 38019444, DOI: 10.1007/s10549-023-07167-9.Peer-Reviewed Original ResearchObjective response rateProgression-free survivalAdvanced breast cancerPhase II studyMetastatic breast cancerOverall survivalArm ABreast cancerArm BII studyMetronomic chemotherapyRandomized phase II studyGrade adverse eventsMetronomic oral cyclophosphamideOral metronomic chemotherapyMedian overall survivalStandard-dose chemotherapyFurther clinical evaluationMetronomic cyclophosphamideOral cyclophosphamideArm B.Primary endpointSecondary endpointsAdverse eventsDose chemotherapy
2021
Local Therapy Outcomes and Toxicity From the ATEMPT Trial (TBCRC 033), a Phase II Randomized Trial of Adjuvant T-DM1 vs. TH in Women With Stage I HER2 Positive Breast Cancer
Bellon J, Tayob N, Burstein H, Partridge A, Demeo M, Tralins J, Yang D, Dang C, Isakoff S, Yardley D, Valero V, Winer E, Krop I, Tolaney S. Local Therapy Outcomes and Toxicity From the ATEMPT Trial (TBCRC 033), a Phase II Randomized Trial of Adjuvant T-DM1 vs. TH in Women With Stage I HER2 Positive Breast Cancer. International Journal Of Radiation Oncology • Biology • Physics 2021, 111: s34. DOI: 10.1016/j.ijrobp.2021.07.103.Peer-Reviewed Original ResearchT-DM1 armBreast conserving surgeryPartial breast irradiationT-DM1Radiation therapyBreast cancerLocal recurrenceSkin toxicityGrade 2 acute skin toxicityProspective randomized phase II studyGrade 3 skin toxicityHormone receptor-positive diseaseRandomized phase II studyPhase II Randomized TrialAdjuvant T-DM1Conclusions Radiation therapyGrade 2 pneumonitisGrade 3 pneumonitisIpsilateral rib fracturesPhase II studyReceptor-positive diseaseWeeks of therapyAcute skin toxicityAnti-HER2 therapyNodal radiation therapy
2019
TBCRC 030: A randomized phase II study of preoperative cisplatin versus paclitaxel in TNBC—Evaluating the homologous recombination deficiency (HRD) biomarker.
Mayer E, Abramson V, Jankowitz R, Falkson C, Marcom P, Traina T, Carey L, Rimawi M, Specht J, Miller K, Stearns V, Perou C, Richardson A, Tung N, Barry W, Tan-Wasielewski Z, Timms K, Hartman A, Wolff A, Winer E. TBCRC 030: A randomized phase II study of preoperative cisplatin versus paclitaxel in TNBC—Evaluating the homologous recombination deficiency (HRD) biomarker. Journal Of Clinical Oncology 2019, 37: 507-507. DOI: 10.1200/jco.2019.37.15_suppl.507.Peer-Reviewed Original ResearchPhase II studyII studyPreoperative chemotherapyHRD scoreRandomized phase II studyOne-sided type I errorCo-primary objectivesNew safety signalsSimilar response ratesHomologous recombination deficiency biomarkersPreoperative cisplatinTNBC cohortPathologic responseRCB 0Evaluable specimensPredictive biomarkersAlternative chemotherapySpecific chemotherapySafety signalsArm CCT armChemotherapyStage IResponse rateBaseline tissue
2018
Palbociclib after CDK and endocrine therapy (PACE): A randomized phase II study of fulvestrant, palbociclib, and avelumab for endocrine pre-treated ER+/HER2- metastatic breast cancer.
Mayer E, Wander S, Regan M, DeMichele A, Forero-Torres A, Rimawi M, Ma C, Cristofanilli M, Anders C, Bartlett C, Winer E, Burstein H. Palbociclib after CDK and endocrine therapy (PACE): A randomized phase II study of fulvestrant, palbociclib, and avelumab for endocrine pre-treated ER+/HER2- metastatic breast cancer. Journal Of Clinical Oncology 2018, 36: tps1104-tps1104. DOI: 10.1200/jco.2018.36.15_suppl.tps1104.Peer-Reviewed Original Research
2017
Phase I dose escalation study of the PI3kinase pathway inhibitor BKM120 and the oral poly (ADP ribose) polymerase (PARP) inhibitor olaparib for the treatment of high-grade serous ovarian and breast cancer
Matulonis U, Wulf G, Barry W, Birrer M, Westin S, Farooq S, Bell-McGuinn K, Obermayer E, Whalen C, Spagnoletti T, Luo W, Liu H, Hok R, Aghajanian C, Solit D, Mills G, Taylor B, Won H, Berger M, Palakurthi S, Liu J, Cantley L, Winer E. Phase I dose escalation study of the PI3kinase pathway inhibitor BKM120 and the oral poly (ADP ribose) polymerase (PARP) inhibitor olaparib for the treatment of high-grade serous ovarian and breast cancer. Annals Of Oncology 2017, 28: 512-518. PMID: 27993796, PMCID: PMC5834157, DOI: 10.1093/annonc/mdw672.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAminopyridinesBRCA1 ProteinBRCA2 ProteinBreast NeoplasmsDose-Response Relationship, DrugFemaleGerm-Line MutationHumansMiddle AgedMorpholinesNeoplasm GradingNeoplasm Recurrence, LocalOvarian NeoplasmsPhosphoinositide-3 Kinase InhibitorsPhthalazinesPiperazinesPoly(ADP-ribose) Polymerase InhibitorsPoly(ADP-ribose) PolymerasesConceptsGermline BRCA mutationsOvarian cancerStudy treatmentPARP inhibitorsRandomized phase II studyDose-expansion cohortsPhase II studyPhase I trialDose-escalation designWild-type patientsBiomarkers of responsePARP inhibitor combinationsCombination of BKM120Polymerase inhibitor olaparibPoly (ADP-ribose) polymerase (PARP) inhibitor olaparibPI3K inhibitorsAdditional DLTsOlaparib 300Preclinical synergyRecurrent breastEscalation studyII studyI trialClinical benefitBRCA mutations
2011
Randomized phase II study of lapatinib plus capecitabine or lapatinib plus topotecan for patients with HER2-positive breast cancer brain metastases
Lin NU, Eierman W, Greil R, Campone M, Kaufman B, Steplewski K, Lane SR, Zembryki D, Rubin SD, Winer EP. Randomized phase II study of lapatinib plus capecitabine or lapatinib plus topotecan for patients with HER2-positive breast cancer brain metastases. Journal Of Neuro-Oncology 2011, 105: 613-620. PMID: 21706359, DOI: 10.1007/s11060-011-0629-y.Peer-Reviewed Original ResearchConceptsHER2-positive breast cancerProgressive brain metastasesObjective response rateBrain metastasesTopotecan armBreast cancerHER2-positive breast cancer brain metastasesCentral nervous system progressionBreast cancer brain metastasesRandomized phase II studyCombination of lapatinibPhase II studyCancer brain metastasesEfficacy of lapatinibStandard radiation therapyLack of efficacyNon-CNS lesionsExcess toxicityCapecitabine armRefractory settingCranial radiotherapyPrimary endpointSteroid requirementsII studyObjective response
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