2024
TBCRC 048 (olaparib expanded) expansion cohorts: Phase 2 study of olaparib monotherapy in patients (pts) with metastatic breast cancer (MBC) with germline (g) mutations in PALB2 or somatic (s) mutations in BRCA1 or BRCA2.
Tung N, Robson M, Nanda R, Li T, Vinayak S, Shah P, Khoury K, Kimmick G, Santa-Maria C, Brufsky A, DeMeo M, Vieira J, Carey L, Wulf G, Domchek S, Krop I, Wolff A, Winer E, Garber J. TBCRC 048 (olaparib expanded) expansion cohorts: Phase 2 study of olaparib monotherapy in patients (pts) with metastatic breast cancer (MBC) with germline (g) mutations in PALB2 or somatic (s) mutations in BRCA1 or BRCA2. Journal Of Clinical Oncology 2024, 42: 1021-1021. DOI: 10.1200/jco.2024.42.16_suppl.1021.Peer-Reviewed Original ResearchProgression-free survivalDuration of responseMetastatic breast cancerClinical benefit rateTriple-negative breast cancerMedian duration of responseMedian progression-free survivalMutant allele frequencyExpansion cohortHER2-negativeHER2-positiveCohort 2aNon-respondersBreast cancerEarly due to slow enrollmentMetastatic chemotherapy regimensResponse to olaparibPhase 2 studyPhase II trialKaplan-Meier methodPredictors of responseCohort of womenWilcoxon rank sum testRank sum testBRCA1mOutcomes with trastuzumab deruxtecan (T-DXd) by HER2 status and line of treatment in a large real-world database of patients with metastatic breast cancer.
Tarantino P, Lee D, Foldi J, Soulos P, Gross C, Grinda T, Winer E, Lin N, Krop I, Tolaney S, Lustberg M, Sammons S. Outcomes with trastuzumab deruxtecan (T-DXd) by HER2 status and line of treatment in a large real-world database of patients with metastatic breast cancer. Journal Of Clinical Oncology 2024, 42: 1077-1077. DOI: 10.1200/jco.2024.42.16_suppl.1077.Peer-Reviewed Original ResearchReal-world progression-free survivalLines of therapyMetastatic breast cancerMedian real-world progression-free survivalT-DXdHER2+Overall survivalHER2-lowHER2- patientsBreast cancerHER2- metastatic breast cancerTreat metastatic breast cancerProgression-free survivalKaplan-Meier methodLines of treatmentDatabase of patientsRetrospective observational studyClinical trial settingHER2 casesIHC 0Trastuzumab deruxtecanHR statusHER2 statusTriple-negativeMedian age
2023
Correlation of SUV on Early Interim PET with Recurrence-Free Survival and Overall Survival in Primary Operable HER2-Positive Breast Cancer (the TBCRC026 Trial)
Hennessy M, Leal J, Huang C, Solnes L, Denbow R, Abramson V, Carey L, Liu M, Rimawi M, Specht J, Storniolo A, Valero V, Vaklavas C, Winer E, Krop I, Wolff A, Cimino-Mathews A, Wahl R, Stearns V, Connolly R. Correlation of SUV on Early Interim PET with Recurrence-Free Survival and Overall Survival in Primary Operable HER2-Positive Breast Cancer (the TBCRC026 Trial). Journal Of Nuclear Medicine 2023, 64: jnumed.123.265853. PMID: 37652539, DOI: 10.2967/jnumed.123.265853.Peer-Reviewed Original ResearchConceptsF-FDG PET/CTHER2-positive breast cancerRecurrence-free survivalPET/CTPathologic complete responseOverall survivalBreast cancerOperable HER2-positive breast cancerHuman epidermal growth factor receptor 2Epidermal growth factor receptor 2Growth factor receptor 2Kaplan-Meier methodStatistical significanceLean body massFactor receptor 2Imaging-based biomarkersCorrelation of SUVHER2 therapyNeoadjuvant trastuzumabNeoadjuvant therapyAdjuvant therapyComplete responsePhysician's discretionOS outcomesCox regression
2022
Expanding the Staging Criteria for T1-2N0 Hormone-Receptor Positive Breast Cancer Patients Enrolled in TAILORx
Kantor O, Burstein HJ, King TA, Shak S, Russell CA, Giuliano AE, Hortobagyi GN, Winer EP, Korde LA, Sparano JA, Mittendorf EA. Expanding the Staging Criteria for T1-2N0 Hormone-Receptor Positive Breast Cancer Patients Enrolled in TAILORx. Annals Of Surgical Oncology 2022, 29: 8016-8023. PMID: 35900648, DOI: 10.1245/s10434-022-12225-5.Peer-Reviewed Original ResearchConceptsRecurrence-free intervalBreast cancer patientsRecurrence scoreTAILORx trialEndocrine therapyCancer patientsHormone receptor-positive breast cancer patientsBackgroundThe American Joint CommitteePositive breast cancer patientsCurrent AJCC staging systemHuman epidermal growth factor receptorBreast Recurrence ScoreKaplan-Meier methodAmerican Joint CommitteeAJCC staging systemEpidermal growth factor receptorGrowth factor receptorMedian followT1-2N0T3 diseasePrognostic stagingStaging systemStaging criteriaBreast cancerResultsThe studyOverall Survival with Ribociclib plus Letrozole in Advanced Breast Cancer
Hortobagyi GN, Stemmer SM, Burris HA, Yap YS, Sonke GS, Hart L, Campone M, Petrakova K, Winer EP, Janni W, Conte P, Cameron DA, André F, Arteaga CL, Zarate JP, Chakravartty A, Taran T, Le Gac F, Serra P, O'Shaughnessy J. Overall Survival with Ribociclib plus Letrozole in Advanced Breast Cancer. New England Journal Of Medicine 2022, 386: 942-950. PMID: 35263519, DOI: 10.1056/nejmoa2114663.Peer-Reviewed Original ResearchConceptsAdvanced breast cancerSignificant overall survival benefitMedian overall survivalOverall survival benefitProgression-free survivalOverall survivalBreast cancerSurvival benefitHER2-negative advanced breast cancerKey secondary end pointProtocol-specified final analysisLonger progression-free survivalHuman epidermal growth factor receptor 2Epidermal growth factor receptor 2Negative advanced breast cancerStratified log-rank testFirst-line ribociclibSecondary end pointsFirst-line therapyNew safety signalsPhase 3 trialGrowth factor receptor 2Kaplan-Meier methodLog-rank testFactor receptor 2CALGB 40603 (Alliance): Long-Term Outcomes and Genomic Correlates of Response and Survival After Neoadjuvant Chemotherapy With or Without Carboplatin and Bevacizumab in Triple-Negative Breast Cancer
Shepherd JH, Ballman K, Polley MC, Campbell JD, Fan C, Selitsky S, Fernandez-Martinez A, Parker JS, Hoadley KA, Hu Z, Li Y, Soloway MG, Spears PA, Singh B, Tolaney SM, Somlo G, Port ER, Ma C, Kuzma C, Mamounas E, Golshan M, Bellon JR, Collyar D, Hahn OM, Hudis CA, Winer EP, Partridge A, Hyslop T, Carey LA, Perou CM, Sikov WM. CALGB 40603 (Alliance): Long-Term Outcomes and Genomic Correlates of Response and Survival After Neoadjuvant Chemotherapy With or Without Carboplatin and Bevacizumab in Triple-Negative Breast Cancer. Journal Of Clinical Oncology 2022, 40: 1323-1334. PMID: 35044810, PMCID: PMC9015203, DOI: 10.1200/jco.21.01506.Peer-Reviewed Original ResearchConceptsLong-term outcomesEvent-free survivalTriple-negative breast cancerResidual cancer burdenResidual diseaseImmune activationBreast cancerPathologic complete response rateRandomized phase II trialEnd pointSuperior long-term outcomesCox proportional hazards modelComplete response rateSecondary end pointsPhase II trialPretreatment tumor biopsiesKaplan-Meier methodOverall survival rateTumor-infiltrating lymphocytesLog-rank testPretreatment tumor samplesMinimal residual diseaseProportional hazards modelWeekly paclitaxelII trial
2019
Local–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
2017
Using ePrognosis to estimate 2-year all-cause mortality in older women with breast cancer: Cancer and Leukemia Group B (CALGB) 49907 and 369901 (Alliance A151503)
Kimmick GG, Major B, Clapp J, Sloan J, Pitcher B, Ballman K, Barginear M, Freedman RA, Artz A, Klepin HD, Lafky JM, Hopkins J, Winer E, Hudis C, Muss H, Cohen H, Jatoi A, Hurria A, Mandelblatt J. Using ePrognosis to estimate 2-year all-cause mortality in older women with breast cancer: Cancer and Leukemia Group B (CALGB) 49907 and 369901 (Alliance A151503). Breast Cancer Research And Treatment 2017, 163: 391-398. PMID: 28283904, PMCID: PMC5508575, DOI: 10.1007/s10549-017-4188-6.Peer-Reviewed Original ResearchConceptsMortality rateBreast cancerNon-cancer mortality risksOlder breast cancer patientsStage I-IIA diseaseTwo-year mortality rateAdjuvant therapy decisionsResultsPatients' mean ageCooperative group studiesKaplan-Meier methodOverall survival estimatesBreast cancer patientsAvailable clinical informationCommunity-dwelling eldersObserved mortality rateBreast Cancer StudyAdjuvant therapyCause mortalityMost patientsOlder patientsBetter prognosisWorse prognosisPoor prognosisTrial populationMean age
2013
TBCRC 018: Phase II study of iniparib plus chemotherapy to treat triple-negative breast cancer (TNBC) central nervous system (CNS) metastases (mets).
Anders C, Deal A, Abramson V, Liu M, Storniolo A, Carpenter J, Puhalla S, Nanda R, Melhem-Bertrandt A, Lin N, Marcom P, Van Poznak C, Stearns V, Melisko M, Smith J, Karginova O, Winer E, Perou C, Wolff A, Carey L. TBCRC 018: Phase II study of iniparib plus chemotherapy to treat triple-negative breast cancer (TNBC) central nervous system (CNS) metastases (mets). Journal Of Clinical Oncology 2013, 31: 515-515. DOI: 10.1200/jco.2013.31.15_suppl.515.Peer-Reviewed Original ResearchQuality of lifeBlood-brain barrierResponse rateCommon grade 3/4 adverse eventsCentral nervous system metastasesGrade 3/4 adverse eventsClinical benefit rateNervous system metastasesPhase II studyTumor response rateKaplan-Meier methodWhole brain RTHalf of womenBetter response rateSmall molecule anti-cancer agentTopoisomerase I inhibitorAdvanced TNBCCorrelative endpointsEligible ptsGermline BRCA1/2Measurable lesionsMedian TTPRadiation-naïveAnti-cancer agentsPrimary endpoint