2018
Phase II study of ruxolitinib, a selective JAK1/2 inhibitor, in patients with metastatic triple-negative breast cancer
Stover DG, Gil Del Alcazar CR, Brock J, Guo H, Overmoyer B, Balko J, Xu Q, Bardia A, Tolaney SM, Gelman R, Lloyd M, Wang Y, Xu Y, Michor F, Wang V, Winer EP, Polyak K, Lin NU. Phase II study of ruxolitinib, a selective JAK1/2 inhibitor, in patients with metastatic triple-negative breast cancer. Npj Breast Cancer 2018, 4: 10. PMID: 29761158, PMCID: PMC5935675, DOI: 10.1038/s41523-018-0060-z.Peer-Reviewed Original ResearchMetastatic triple-negative breast cancerTriple-negative breast cancerPhase II studyBreast cancerII studyObjective responseNon-randomized phase II studyIL-6/JAK2/STAT3Efficacy of ruxolitinibInfrequent grade 3Refractory patient populationPrimary efficacy endpointMetastatic breast cancerInflammatory breast cancerSelective JAK1/2 inhibitorArchival tumor tissueJAK2/STAT3Central immunohistochemistryCommon toxicitiesRECIST 1.1Efficacy endpointPrimary endpointProtocol therapyJAK1/2 inhibitorPatient population
2011
OT1-02-02: HALT MBC: HER2 Suppression with the Addition of Lapatinib to Trastuzumab in HER2−Positive Metastatic Breast Cancer (LPT112515).
Lin N, Danso M, David A, Muscato J, Ellis C, DeSilvio M, Garofalo A, Nagarwala Y, Winer E. OT1-02-02: HALT MBC: HER2 Suppression with the Addition of Lapatinib to Trastuzumab in HER2−Positive Metastatic Breast Cancer (LPT112515). Cancer Research 2011, 71: ot1-02-02-ot1-02-02. DOI: 10.1158/0008-5472.sabcs11-ot1-02-02.Peer-Reviewed Original ResearchSecond-line treatmentAddition of lapatinibOverall survivalHigher pathological complete response rateBreast cancer preclinical modelsPathological complete response rateClinical benefit rateDual HER2 blockadeStable brain metastasesComplete response rateHormone receptor statusPhase III studyMetastatic breast cancerLine of treatmentAnti-tumor activityHER2 blockadeMedian PFSStable diseaseBrain metastasesEfficacy endpointMaintenance therapyPreoperative treatmentAdverse eventsHazard ratioIII study