2021
Phase II trial of veliparib and temozolomide in metastatic breast cancer patients with and without BRCA1/2 mutations
Xu J, Keenan TE, Overmoyer B, Tung NM, Gelman RS, Habin K, Garber JE, Ellisen LW, Winer EP, Goss PE, Yeap BY, Chabner BA, Isakoff SJ. Phase II trial of veliparib and temozolomide in metastatic breast cancer patients with and without BRCA1/2 mutations. Breast Cancer Research And Treatment 2021, 189: 641-651. PMID: 34417675, DOI: 10.1007/s10549-021-06292-7.Peer-Reviewed Original ResearchConceptsObjective response rateClinical benefit rateProgression-free survivalMedian progression-free survivalMetastatic breast cancer patientsPhase II trialMetastatic breast cancerBreast cancer patientsBRCA1/2 carriersBreast cancerExpansion cohortII trialPrimary endpointPrimary cohortCancer patientsBenefit rateBRCA1/2 mutationsDay 1Longer median progression-free survivalSingle-arm phase II trialCommon grade 3Doses of veliparibPlatinum-naïve patientsPrior platinum therapyBRCA mutation carriers
2020
Clinical Significance of Circulating Tumor Cells in Hormone Receptor–positive Metastatic Breast Cancer Patients who Received Letrozole with or Without Bevacizumab
Magbanua MJM, Savenkov O, Asmus EJ, Ballman KV, Scott JH, Park JW, Dickler M, Partridge A, Carey LA, Winer EP, Rugo HS. Clinical Significance of Circulating Tumor Cells in Hormone Receptor–positive Metastatic Breast Cancer Patients who Received Letrozole with or Without Bevacizumab. Clinical Cancer Research 2020, 26: 4911-4920. PMID: 32586939, PMCID: PMC7501177, DOI: 10.1158/1078-0432.ccr-20-1329.Peer-Reviewed Original ResearchConceptsProgression-free survivalCTC-positive patientsHormone receptor-positive metastatic breast cancer patientsMetastatic breast cancer patientsAddition of bevacizumabBreast cancer patientsOverall survivalCancer patientsPredictive valueMean survival time analysisMedian progression-free survivalWorse progression-free survivalAssociation of CTCsCTC-negative patientsFirst-line settingRisk of progressionCox regression modelPotential predictive valueML of bloodAdditional time pointsCirculating Tumor CellsLetrozole armOS benefitPFS benefitMultivariable analysisSerial Analysis of Circulating Tumor Cells in Metastatic Breast Cancer Receiving First-Line Chemotherapy
Magbanua MJM, Hendrix LH, Hyslop T, Barry WT, Winer EP, Hudis C, Toppmeyer D, Carey LA, Partridge AH, Pierga JY, Fehm T, Vidal-Martínez J, Mavroudis D, Garcia-Saenz JA, Stebbing J, Gazzaniga P, Manso L, Zamarchi R, Antelo ML, De Mattos-Arruda L, Generali D, Caldas C, Munzone E, Dirix L, Delson AL, Burstein HJ, Qadir M, Ma C, Scott JH, Bidard FC, Park JW, Rugo HS. Serial Analysis of Circulating Tumor Cells in Metastatic Breast Cancer Receiving First-Line Chemotherapy. Journal Of The National Cancer Institute 2020, 113: 443-452. PMID: 32770247, PMCID: PMC8023821, DOI: 10.1093/jnci/djaa113.Peer-Reviewed Original ResearchConceptsProgression-free survivalFirst-line chemotherapyOverall survivalBaseline CTCsCTC statusPrognostic groupsInferior progression-free survivalMetastatic breast cancer patientsFuture prospective clinical trialsNovel prognostic groupsMetastatic breast cancerProspective clinical trialsRisk stratification strategiesBreast cancer patientsCourse of treatmentMore effective treatmentsUndetectable CTCsMBC patientsHazard ratioPoor outcomePrognostic significanceCox regressionCancer patientsClinical trialsCTC measurementTBCRC 048: A phase II study of olaparib monotherapy in metastatic breast cancer patients with germline or somatic mutations in DNA damage response (DDR) pathway genes (Olaparib Expanded).
Tung N, Robson M, Ventz S, Santa-Maria C, Marcom P, Nanda R, Shah P, Ballinger T, Yang E, Melisko M, Brufsky A, Vinayak S, Demeo M, Jenkins C, Domchek S, Wulf G, Krop I, Wolff A, Winer E, Garber J. TBCRC 048: A phase II study of olaparib monotherapy in metastatic breast cancer patients with germline or somatic mutations in DNA damage response (DDR) pathway genes (Olaparib Expanded). Journal Of Clinical Oncology 2020, 38: 1002-1002. DOI: 10.1200/jco.2020.38.15_suppl.1002.Peer-Reviewed Original ResearchReversion and non-reversion mechanisms of resistance to PARP inhibitor or platinum chemotherapy in BRCA1/2-mutant metastatic breast cancer
Waks AG, Cohen O, Kochupurakkal B, Kim D, Dunn CE, Buendia J, Wander S, Helvie K, Lloyd MR, Marini L, Hughes ME, Freeman SS, Ivy SP, Geradts J, Isakoff S, LoRusso P, Adalsteinsson VA, Tolaney SM, Matulonis U, Krop IE, D’Andrea A, Winer EP, Lin NU, Shapiro GI, Wagle N. Reversion and non-reversion mechanisms of resistance to PARP inhibitor or platinum chemotherapy in BRCA1/2-mutant metastatic breast cancer. Annals Of Oncology 2020, 31: 590-598. PMID: 32245699, PMCID: PMC7946408, DOI: 10.1016/j.annonc.2020.02.008.Peer-Reviewed Original ResearchConceptsMetastatic breast cancerPlatinum chemotherapyDNA-damaging therapyMechanisms of resistanceBreast cancerMetastatic breast cancer patientsBreast cancer patientsTumor DNA sequencingNovel sequence alterationsWhole-exome sequencingDNA-damaging therapiesTreatment failureCancer patientsFunctional statusDisease progressionTumor biopsiesClinical cohortImmunohistochemical stainingSubsequent linesBRCA1/2 mutationsTherapeutic benefitPatientsUseful biomarkerFunctional assessmentTumor sections
2019
Clinical significance of circulating tumor cells (CTCs) in hormone receptor-positive (HR+) metastatic breast cancer (MBC) patients (pts) receiving letrozole (Let) or Let plus bevacizumab (Bev): CALGB 40503 (Alliance).
Magbanua M, Oleksandr Savenkov O, Asmus E, Ballman K, Scott J, Park J, Dickler M, Partridge A, Carey L, Winer E, Rugo H. Clinical significance of circulating tumor cells (CTCs) in hormone receptor-positive (HR+) metastatic breast cancer (MBC) patients (pts) receiving letrozole (Let) or Let plus bevacizumab (Bev): CALGB 40503 (Alliance). Journal Of Clinical Oncology 2019, 37: 1049-1049. DOI: 10.1200/jco.2019.37.15_suppl.1049.Peer-Reviewed Original ResearchProgression-free survivalOverall survivalCTC statusHormone receptor-positive metastatic breast cancer patientsPredictive valueLonger median progression-free survivalImproved progression-free survivalMedian progression-free survivalMetastatic breast cancer patientsWorse progression-free survivalAddition of BevFirst-line therapyCox regression analysisEarly breast cancerInitiation of treatmentBreast cancer patientsPotential predictive valueML of bloodMetastatic diseaseMultivariable analysisCancer patientsClinical significanceBreast cancerUS FDATumor cells
2016
Cabozantinib for metastatic breast carcinoma: results of a phase II placebo-controlled randomized discontinuation study
Tolaney SM, Nechushtan H, Ron IG, Schöffski P, Awada A, Yasenchak CA, Laird AD, O’Keeffe B, Shapiro GI, Winer EP. Cabozantinib for metastatic breast carcinoma: results of a phase II placebo-controlled randomized discontinuation study. Breast Cancer Research And Treatment 2016, 160: 305-312. PMID: 27714541, PMCID: PMC5065609, DOI: 10.1007/s10549-016-4001-y.Peer-Reviewed Original ResearchConceptsObjective response rateProgression-free survivalOverall survivalStable diseaseMBC patientsWeek 12Common grade 3/4 adverse eventsOverall median progression-free survivalGrade 3/4 adverse eventsMedian progression-free survivalSolid Tumors version 1.0Metastatic breast cancer patientsOral tyrosine kinase inhibitorResultsForty-five patientsDisease control rateMedian overall survivalPalmar-plantar erythrodysesthesiaResponse Evaluation CriteriaMetastatic breast carcinomaBreast cancer patientsTyrosine kinase inhibitorsCabozantinib monotherapyDiscontinuation studyPrimary endpointRespiratory failureA genome-wide association study (GWAS) of progression-free survival (PFS) in metastatic breast cancer (MBC) patients treated with letrozole (L) with or without bevacizumab (B) in CALGB 40503.
Innocenti F, Owzar K, Jiang C, Sibley A, Mulkey F, Carey L, Tripathy D, Schneider B, Barry W, Winer E, Hudis C, McLeod H, Dickler M. A genome-wide association study (GWAS) of progression-free survival (PFS) in metastatic breast cancer (MBC) patients treated with letrozole (L) with or without bevacizumab (B) in CALGB 40503. Journal Of Clinical Oncology 2016, 34: 538-538. DOI: 10.1200/jco.2016.34.15_suppl.538.Peer-Reviewed Original ResearchWide association studyProgression-free survivalAssociation studiesMetastatic breast cancer patientsBreast cancer patientsCancer patientsPatterns of utilization of imaging and tumor markers (TM) among metastatic breast cancer (MBC) patients (pts).
Di Meglio A, Lin N, Freedman R, Barry W, Winer E, Vaz Luis I. Patterns of utilization of imaging and tumor markers (TM) among metastatic breast cancer (MBC) patients (pts). Journal Of Clinical Oncology 2016, 34: e18224-e18224. DOI: 10.1200/jco.2016.34.15_suppl.e18224.Peer-Reviewed Original ResearchTumor markersMetastatic breast cancer patientsBreast cancer patientsPatterns of utilizationCancer patientsPatients
2015
Whole exome sequencing (WES) in HER2+ metastatic breast cancer (MBC) patients (pts) with extraordinary responses to trastuzumab (T).
Luis I, Oh C, Wang Z, Dipiro P, Macrae E, Painter C, Kryukov G, Krop I, Winer E, Lin N, Wagle N. Whole exome sequencing (WES) in HER2+ metastatic breast cancer (MBC) patients (pts) with extraordinary responses to trastuzumab (T). Journal Of Clinical Oncology 2015, 33: 611-611. DOI: 10.1200/jco.2015.33.15_suppl.611.Peer-Reviewed Original ResearchWhole-exome sequencingMetastatic breast cancer patientsBreast cancer patientsCancer patientsExome sequencingExtraordinary responsePatientsTrastuzumabHER2
2004
HER-2 Testing and Trastuzumab Therapy for Metastatic Breast Cancer: A Cost-Effectiveness Analysis
Elkin EB, Weinstein MC, Winer EP, Kuntz KM, Schnitt SJ, Weeks JC. HER-2 Testing and Trastuzumab Therapy for Metastatic Breast Cancer: A Cost-Effectiveness Analysis. Journal Of Clinical Oncology 2004, 22: 854-863. PMID: 14990641, DOI: 10.1200/jco.2004.04.158.Peer-Reviewed Original ResearchMeSH KeywordsAgedAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedBreast NeoplasmsCohort StudiesCost SavingsCost-Benefit AnalysisDecision Support TechniquesDose-Response Relationship, DrugDrug Administration ScheduleDrug CostsFemaleGenes, erbB-2Genetic TestingHealth Care CostsHumansMarkov ChainsNeoplasm InvasivenessNeoplasm MetastasisNeoplasm StagingQuality of LifeSurvival RateTrastuzumabTreatment OutcomeConceptsIncremental cost-effectiveness ratioMetastatic breast cancer patientsBreast cancer patientsTrastuzumab therapyCancer patientsFavourable incremental cost-effectiveness ratioTest characteristicsMetastatic breast cancerCost-effectiveness ratioEffectiveness of treatmentPositive test resultsNegative test resultsPositive resultsCost-effectiveness analysisTreatment strategiesBreast cancerHypothetical cohortTreatment candidatesHercepTest resultsPatientsClinical practiceFISH confirmationProtein overexpressionLifetime costsHercepTest
1999
Safety and efficacy of using a single agent or a phase II agent before instituting standard combination chemotherapy in previously untreated metastatic breast cancer patients: report of a randomized study--Cancer and Leukemia Group B 8642.
Costanza M, Weiss R, Henderson I, Norton L, Berry D, Cirrincione C, Winer E, Wood W, Frei III E, McIntyre O, Schilsky R. Safety and efficacy of using a single agent or a phase II agent before instituting standard combination chemotherapy in previously untreated metastatic breast cancer patients: report of a randomized study--Cancer and Leukemia Group B 8642. Journal Of Clinical Oncology 1999, 17: 1397-406. PMID: 10334524, DOI: 10.1200/jco.1999.17.5.1397.Peer-Reviewed Original ResearchMeSH KeywordsAdenineAdultAgedAminoglycosidesAnalysis of VarianceAnti-Bacterial AgentsAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsCarboplatinCyclophosphamideDoxorubicinFemaleFluorouracilFollow-Up StudiesHumansImidesIsoquinolinesMelphalanMiddle AgedNaphthalimidesNeoplasm StagingOrganophosphonatesProspective StudiesSurvival AnalysisTrimetrexateConceptsPhase II agentMetastatic breast cancer patientsStandard combination chemotherapyMetastatic breast cancerBreast cancer patientsSingle agentResponse rateCombination chemotherapyCancer patientsBreast cancerUntreated metastatic breast cancer patientsMeasurable metastatic breast cancerRandomized phase III trialPhase III trialsDuration of responseSingle-agent drugsTreatment of patientsCumulative response rateSuggestion of benefitLow response rateImmediate chemotherapyIII trialsMetastatic diseaseVisceral diseaseRandomized study