2020
TBCRC 048: Phase II Study of Olaparib for Metastatic Breast Cancer and Mutations in Homologous Recombination-Related Genes.
Tung NM, Robson ME, Ventz S, Santa-Maria CA, Nanda R, Marcom PK, Shah PD, Ballinger TJ, Yang ES, Vinayak S, Melisko M, Brufsky A, DeMeo M, Jenkins C, Domchek S, D'Andrea A, Lin NU, Hughes ME, Carey LA, Wagle N, Wulf GM, Krop IE, Wolff AC, Winer EP, Garber JE. TBCRC 048: Phase II Study of Olaparib for Metastatic Breast Cancer and Mutations in Homologous Recombination-Related Genes. Journal Of Clinical Oncology 2020, 38: 4274-4282. PMID: 33119476, DOI: 10.1200/jco.20.02151.Peer-Reviewed Original ResearchConceptsMetastatic breast cancerObjective response rateProgression-free survivalPoly (ADP-ribose) polymerase (PARP) inhibitorsPhase II studyBreast cancerMutation carriersII studyMedian progression-free survivalNegative metastatic breast cancerHuman epidermal growth factor receptor 2Epidermal growth factor receptor 2Clinical benefit rateHER2-negative diseasePlatinum-refractory diseaseGrowth factor receptor 2Population of patientsFactor receptor 2Homologous recombination-related genesConfirmed responsesEligible patientsMeasurable diseaseSecondary endpointsChemotherapy regimensPrimary endpoint
2019
Ribociclib Plus Trastuzumab in Advanced HER2-Positive Breast Cancer: Results of a Phase 1b/2 Trial
Goel S, Pernas S, Tan-Wasielewski Z, Barry WT, Bardia A, Rees R, Andrews C, Tahara RK, Trippa L, Mayer EL, Winer EP, Spring LM, Tolaney SM. Ribociclib Plus Trastuzumab in Advanced HER2-Positive Breast Cancer: Results of a Phase 1b/2 Trial. Clinical Breast Cancer 2019, 19: 399-404. PMID: 31235441, DOI: 10.1016/j.clbc.2019.05.010.Peer-Reviewed Original ResearchConceptsHER2-positive breast cancerAdvanced HER2-positive breast cancerProgression-free survivalBreast cancerAdverse eventsObjective responseGrade 3 adverse eventsGrade 4/5 adverse eventsHormone receptor-positive diseaseMedian progression-free survivalAnti-HER2 combinationClinical benefit rateHER2-negative diseasePhase 1b/2 studyPhase 1b/2 trialPrior therapy linesReceptor-positive diseaseAnti-HER2 therapyNew safety concernsCyclin-dependent kinase 4Stable diseaseExpansion cohortMetastatic settingPrior linesQTc prolongationLocal–regional recurrence in women with small node-negative, HER2-positive breast cancer: results from a prospective multi-institutional study (the APT trial)
Bellon JR, Guo H, Barry WT, Dang CT, Yardley DA, Moy B, Marcom PK, Albain KS, Rugo HS, Ellis M, Wolff AC, Carey LA, Overmoyer BA, Partridge AH, Hudis CA, Krop I, Burstein HJ, Winer EP, Tolaney SM. Local–regional recurrence in women with small node-negative, HER2-positive breast cancer: results from a prospective multi-institutional study (the APT trial). Breast Cancer Research And Treatment 2019, 176: 303-310. PMID: 31004299, DOI: 10.1007/s10549-019-05238-4.Peer-Reviewed Original ResearchConceptsHER2-positive breast cancerLocal-regional recurrenceDisease-free survivalEffective anti-HER2 therapyLRR-free survivalAnti-HER2 therapyBreast-conserving surgeryBreast cancerRadiation therapySystemic therapyHormone receptor-positive tumorsProspective multi-institutional studyHER2-negative diseaseHER2-positive diseaseNegative axillary nodesEffective systemic therapyProspective multicenter trialEarly-stage patientsKaplan-Meier methodReceptor-positive tumorsHER2-positive tumorsMulti-institutional studyFuture investigational effortsAdjuvant trastuzumabProtocol therapy
2018
Mixed Invasive Ductal and Lobular Carcinoma of the Breast: Prognosis and the Importance of Histologic Grade
Metzger‐Filho O, Ferreira AR, Jeselsohn R, Barry WT, Dillon DA, Brock JE, Vaz‐Luis I, Hughes ME, Winer EP, Lin NU. Mixed Invasive Ductal and Lobular Carcinoma of the Breast: Prognosis and the Importance of Histologic Grade. The Oncologist 2018, 24: e441-e449. PMID: 30518616, PMCID: PMC6656459, DOI: 10.1634/theoncologist.2018-0363.Peer-Reviewed Original ResearchConceptsInvasive lobular carcinomaDisease-free survivalHistologic gradeLobular carcinomaPostmenopausal womenSystemic therapyBetter prognosisAromatase inhibitorsPrognostic powerDisease-free survival advantageEarly-stage breast cancerFavorable disease-free survivalCox proportional hazards modelAdjuvant aromatase inhibitorsBaseline clinicopathologic characteristicsDetailed clinical databaseHER2-negative diseaseRetrospective cohort studyImportant prognostic factorKaplan-Meier methodProportional hazards modelIntermediate histologic gradeDistinct disease subtypesCohort studyOverall prognosis
2015
Variation in type of adjuvant chemotherapy received among patients with stage I breast cancer: A multi‐institutional study
Vaz-Luis I, Hughes ME, Cronin AM, Rugo HS, Edge SB, Moy B, Theriault RL, Hassett MJ, Winer EP, Lin NU. Variation in type of adjuvant chemotherapy received among patients with stage I breast cancer: A multi‐institutional study. Cancer 2015, 121: 1937-1948. PMID: 25757412, PMCID: PMC4457605, DOI: 10.1002/cncr.29310.Peer-Reviewed Original ResearchConceptsStage I breast cancerI breast cancerHuman epidermal growth factor receptor 2Breast cancerAdjuvant chemotherapyIntensive regimensNational Comprehensive Cancer Network centersEpidermal growth factor receptor 2Choice of regimenHER2-negative diseaseHER2-positive diseaseCombination of docetaxelPercentage of patientsProspective cohort studyType of chemotherapyGrowth factor receptor 2Time of diagnosisAmerican Joint CommitteeMultivariable logistic regressionFactor receptor 2Multi-institutional studyCommon regimensChemotherapy regimensIntensive chemotherapyCohort study
2014
Outcomes by Tumor Subtype and Treatment Pattern in Women With Small, Node-Negative Breast Cancer: A Multi-Institutional Study
Vaz-Luis I, Ottesen RA, Hughes ME, Mamet R, Burstein HJ, Edge SB, Gonzalez-Angulo AM, Moy B, Rugo HS, Theriault RL, Weeks JC, Winer EP, Lin NU. Outcomes by Tumor Subtype and Treatment Pattern in Women With Small, Node-Negative Breast Cancer: A Multi-Institutional Study. Journal Of Clinical Oncology 2014, 32: 2142-2150. PMID: 24888816, PMCID: PMC4076026, DOI: 10.1200/jco.2013.53.1608.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsBiomarkers, TumorBreast NeoplasmsChemotherapy, AdjuvantDisease-Free SurvivalFemaleFollow-Up StudiesHumansMastectomy, SegmentalMiddle AgedNeoplasm StagingPrognosisProspective StudiesReceptor, ErbB-2Receptors, EstrogenReceptors, ProgesteroneTrastuzumabTreatment OutcomeTriple Negative Breast NeoplasmsUnited StatesConceptsDistant relapse-free survivalBN0M0 breast cancerHER2-negative tumorsBreast cancerT1a tumorsCohort studyT1b tumorsSurvival outcomesHR-positive/HER2-negative tumorsTumor subtypesNational Comprehensive Cancer Network databaseHuman epidermal growth factor receptor 2 (HER2) statusEpidermal growth factor receptor 2 statusHER2-negative breast cancerNode-negative breast cancerHormone receptorsConsideration of chemotherapyHER2-negative diseasePercent of patientsReceipt of chemotherapyNonrandomized cohort studyProspective cohort studyRelapse-free survivalRate of recurrenceMulti-institutional study