2020
53. TUCATINIB VS PLACEBO ADDED TO TRASTUZUMAB AND CAPECITABINE FOR PATIENTS WITH PREVIOUSLY TREATED HER2+ METASTATIC BREAST CANCER (MBC) WITH BRAIN METASTASES (BM) (HER2CLIMB)
Lin N, Murthy R, Anders C, Borges V, Hurvitz S, Loi S, Abramson V, Bedard P, Oliveira M, Zelnack A, DiGiovanna M, Bachelot T, Chien A, O’Regan R, Wardley A, Mueller V, Carey L, McGoldrick S, An X, Winer E. 53. TUCATINIB VS PLACEBO ADDED TO TRASTUZUMAB AND CAPECITABINE FOR PATIENTS WITH PREVIOUSLY TREATED HER2+ METASTATIC BREAST CANCER (MBC) WITH BRAIN METASTASES (BM) (HER2CLIMB). Neuro-Oncology Advances 2020, 2: ii11-ii11. PMCID: PMC7401403, DOI: 10.1093/noajnl/vdaa073.041.Peer-Reviewed Original ResearchMetastatic breast cancerBrain metastasesCNS-PFSSecond progressionControl armEfficacy analysisBrain progressionExploratory efficacy analysesMedian CNS-PFSBaseline brain MRIMedian OSOverall deathRECIST 1.1Study therapyMedian timeInvestigator's evaluationIC diseaseLocal treatmentBreast cancerBrain MRIReduced riskCapecitabineTrastuzumabTucatinibHER2Intracranial Efficacy and Survival With Tucatinib Plus Trastuzumab and Capecitabine for Previously Treated HER2-Positive Breast Cancer With Brain Metastases in the HER2CLIMB Trial
Lin NU, Borges V, Anders C, Murthy RK, Paplomata E, Hamilton E, Hurvitz S, Loi S, Okines A, Abramson V, Bedard PL, Oliveira M, Mueller V, Zelnak A, DiGiovanna MP, Bachelot T, Chien AJ, O’Regan R, Wardley A, Conlin A, Cameron D, Carey L, Curigliano G, Gelmon K, Loibl S, Mayor J, McGoldrick S, An X, Winer EP. Intracranial Efficacy and Survival With Tucatinib Plus Trastuzumab and Capecitabine for Previously Treated HER2-Positive Breast Cancer With Brain Metastases in the HER2CLIMB Trial. Journal Of Clinical Oncology 2020, 38: 2610-2619. PMID: 32468955, PMCID: PMC7403000, DOI: 10.1200/jco.20.00775.Peer-Reviewed Original ResearchConceptsHER2-positive breast cancerBrain metastasesProgression-free survivalRisk of deathBreast cancerOverall survivalControl armCNS-PFSIntracranial efficacyIntracranial progressionBaseline brain magnetic resonance imagingHuman epidermal growth factor receptor 2Intracranial objective response rateEpidermal growth factor receptor 2Brain magnetic resonance imagingMedian CNS-PFSRECIST 1.1 criteriaMedian overall survivalObjective response rateGrowth factor receptor 2Positive breast cancerFactor receptor 2Magnetic resonance imagingHER2CLIMB trialImproved antitumor activityTucatinib versus placebo added to trastuzumab and capecitabine for patients with previously treated HER2+ metastatic breast cancer with brain metastases (HER2CLIMB).
Lin N, Murthy R, Anders C, Borges V, Hurvitz S, Loi S, Abramson V, Bedard P, Oliveira M, Zelnak A, DiGiovanna M, Bachelot T, Chien A, O'Regan R, Wardley A, Müller V, Carey L, McGoldrick S, An G, Winer E. Tucatinib versus placebo added to trastuzumab and capecitabine for patients with previously treated HER2+ metastatic breast cancer with brain metastases (HER2CLIMB). Journal Of Clinical Oncology 2020, 38: 1005-1005. DOI: 10.1200/jco.2020.38.15_suppl.1005.Peer-Reviewed Original ResearchMetastatic breast cancerProgression-free survivalObjective response rateBrain metastasesOverall survivalCNS-PFSControl armSecond progressionEfficacy analysisBrain progressionLocal treatmentBreast cancerProlongation of PFSMedian progression-free survivalExploratory efficacy analysesMedian CNS-PFSMedian overall survivalBaseline brain MRIHER2 kinase inhibitorDeath overallRECIST 1.1Study therapyFree survivalInvestigator's evaluationIC disease
2019
Randomized phase II trial of exercise, metformin, or both on metabolic biomarkers in colorectal and breast cancer survivors
Meyerhardt JA, Irwin ML, Jones LW, Zhang S, Campbell N, Brown JC, Pollak M, Sorrentino A, Cartmel B, Harrigan M, Tolaney SM, Winer E, Ng K, Abrams T, Fuchs CS, Sanft T, Douglas PS, Hu F, Ligibel JA. Randomized phase II trial of exercise, metformin, or both on metabolic biomarkers in colorectal and breast cancer survivors. JNCI Cancer Spectrum 2019, 4: pkz096. PMID: 32090192, PMCID: PMC7025659, DOI: 10.1093/jncics/pkz096.Peer-Reviewed Original ResearchBreast cancer survivorsPhase II trialCancer survivorsControl armII trialInsulin levelsRandomized phase II trialInsulin-like growth factor-1Insulin-like growth factorHomeostatic model assessmentCombination of exerciseSignificant weight lossGrowth factor-1Combination armMetformin useSecondary outcomesStandard therapyPrimary outcomeIntervention armInsulin resistanceDisease outcomeModality interventionsAnthropometric measurementsMetabolic markersMetabolic biomarkers
2008
Cardiac Safety Analysis of Doxorubicin and Cyclophosphamide Followed by Paclitaxel With or Without Trastuzumab in the North Central Cancer Treatment Group N9831 Adjuvant Breast Cancer Trial
Perez EA, Suman VJ, Davidson NE, Sledge GW, Kaufman PA, Hudis CA, Martino S, Gralow JR, Dakhil SR, Ingle JN, Winer EP, Gelmon KA, Gersh BJ, Jaffe AS, Rodeheffer RJ. Cardiac Safety Analysis of Doxorubicin and Cyclophosphamide Followed by Paclitaxel With or Without Trastuzumab in the North Central Cancer Treatment Group N9831 Adjuvant Breast Cancer Trial. Journal Of Clinical Oncology 2008, 26: 1231-1238. PMID: 18250349, PMCID: PMC4048960, DOI: 10.1200/jco.2007.13.5467.Peer-Reviewed Original ResearchMeSH KeywordsAdolescentAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsCyclophosphamideDose-Response Relationship, DrugDoxorubicinFemaleFluorouracilHeartHeart FailureHumansPrognosisReceptor, ErbB-2Risk FactorsSurvival RateTamoxifenTrastuzumabVentricular Dysfunction, LeftConceptsLeft ventricular ejection fractionAdjuvant breast cancer trialsBreast cancer trialsCardiac eventsLVEF decreaseCumulative incidenceArm BCancer trialsHER2-positive operable breast cancerPotential cardiac risk factorsOlder ageTrastuzumab-containing armsCardiac risk factorsOperable breast cancerVentricular ejection fractionAntihypertensive medicationsTrastuzumab discontinuationWeekly paclitaxelCardiac medicationsEjection fractionAntihypertensive agentsCardiac dysfunctionCardiac safetyCardiac functionControl arm