2017
A randomized, double-blinded, controlled study of tucatinib (ONT-380) vs. placebo in combination with capecitabine (C) and trastuzumab (Tz) in patients with pretreated HER2+ unresectable locally advanced or metastatic breast carcinoma (mBC) (HER2CLIMB).
Anders C, Murthy R, Hamilton E, Borges V, Cameron D, Carey L, Müller V, Curigliano G, Gelmon K, Hortobagyi G, Krop I, Loibl S, Pivot X, Pegram M, Slamon D, Hurvitz S, Tsai M, Winer E. A randomized, double-blinded, controlled study of tucatinib (ONT-380) vs. placebo in combination with capecitabine (C) and trastuzumab (Tz) in patients with pretreated HER2+ unresectable locally advanced or metastatic breast carcinoma (mBC) (HER2CLIMB). Journal Of Clinical Oncology 2017, 35: tps1107-tps1107. DOI: 10.1200/jco.2017.35.15_suppl.tps1107.Peer-Reviewed Original ResearchProgression-free survivalMetastatic breast carcinomaBrain metsIndependent data monitoring committeeClinical benefit ratePhase 1b studyDuration of responseIndependent central reviewPrimary study objectiveData monitoring committeeCNS progressionEGFR agentsPo bidBrain metastasesAdult patientsObjective responseOverall survivalCentral reviewStudy treatmentT-DM1CNS therapyTrastuzumab emtansineBenefit rateSelective small molecule inhibitorsBreast carcinoma
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 failure
2003
Central nervous system metastases in women who receive trastuzumab‐based therapy for metastatic breast carcinoma
Bendell JC, Domchek SM, Burstein HJ, Harris L, Younger J, Kuter I, Bunnell C, Rue M, Gelman R, Winer E. Central nervous system metastases in women who receive trastuzumab‐based therapy for metastatic breast carcinoma. Cancer 2003, 97: 2972-2977. PMID: 12784331, DOI: 10.1002/cncr.11436.Peer-Reviewed Original ResearchConceptsPercent of patientsMetastatic breast carcinomaTrastuzumab-based therapyCentral nervous system metastasesCentral nervous system diseaseNervous system metastasesCNS diseaseNervous system diseasesBreast carcinomaBrain metastasesCNS metastasesLeptomeningeal involvementSystem diseasesDisease sitesMore brain metastasesParenchymal brain metastasesProgressive CNS diseaseFirst-line therapyTime of diagnosisMedian survival periodBlood-brain barrierNew treatment strategiesStable diseaseMetastatic diseasePharmacy records
2001
Liposome‐encapsulated doxorubicin compared with conventional doxorubicin in a randomized multicenter trial as first‐line therapy of metastatic breast carcinoma
Harris L, Batist G, Belt R, Rovira D, Navari R, Azarnia N, Welles L, Winer E, Group T. Liposome‐encapsulated doxorubicin compared with conventional doxorubicin in a randomized multicenter trial as first‐line therapy of metastatic breast carcinoma. Cancer 2001, 94: 25-36. PMID: 11815957, DOI: 10.1002/cncr.10201.Peer-Reviewed Original ResearchConceptsLeft ventricular ejection fractionMetastatic breast carcinomaClinical congestive heart failureTLC DConventional doxorubicinBreast carcinomaTreatment groupsResponse rateMedian cumulative doxorubicin doseProgesterone receptor-positive patientsWorld Health Organization criteriaCumulative doxorubicin doseOnset of cardiotoxicityPrimary safety endpointReceptor-positive patientsPrimary efficacy endpointRandomized multicenter trialFirst-line therapyFirst-line treatmentPalmar-plantar erythrodysesthesiaCongestive heart failureRelevant prognostic factorsVentricular ejection fractionOverall response rateComparable antitumor activity