2017
Updated results from MONALEESA-2, a phase 3 trial of first-line ribociclib + letrozole in hormone receptor-positive (HR+), HER2-negative (HER2–), advanced breast cancer (ABC).
Hortobagyi G, Stemmer S, Burris H, Yap Y, Sonke G, Paluch-Shimon S, Campone M, Petrakova K, Blackwell K, Winer E, Janni W, Verma S, Conte P, Arteaga C, Cameron D, Xuan F, Miller M, Germa C, Hirawat S, O'Shaughnessy J. Updated results from MONALEESA-2, a phase 3 trial of first-line ribociclib + letrozole in hormone receptor-positive (HR+), HER2-negative (HER2–), advanced breast cancer (ABC). Journal Of Clinical Oncology 2017, 35: 1038-1038. DOI: 10.1200/jco.2017.35.15_suppl.1038.Peer-Reviewed Original ResearchAdvanced breast cancerProgression-free survivalMONALEESA-2Treatment benefitInterim analysisHER2- ABCLET armEndocrine therapyPostmenopausal womenGrade 3/4 laboratory abnormalitiesFirst-line ribociclibElevated alanine aminotransferasePhase 3 trialSecond interim analysisFirst-line treatmentFirst interim analysisET resistancePFS ratesPrimary endpointPrior therapySecondary endpointsLaboratory abnormalitiesMedian durationOverall survivalPFS events
2014
A randomized phase 2 trial comparing efficacy of the combination of the PARP inhibitor olaparib and the antiangiogenic cediranib against olaparib alone in recurrent platinum-sensitive ovarian cancer.
Liu J, Barry W, Birrer M, Lee J, Buckanovich R, Fleming G, Rimel B, Buss M, Nattam S, Hurteau J, Luo W, Quy P, Obermayer E, Whalen C, Lee H, Winer E, Kohn E, Ivy S, Matulonis U. A randomized phase 2 trial comparing efficacy of the combination of the PARP inhibitor olaparib and the antiangiogenic cediranib against olaparib alone in recurrent platinum-sensitive ovarian cancer. Journal Of Clinical Oncology 2014, 32: lba5500-lba5500. DOI: 10.1200/jco.2014.32.18_suppl.lba5500.Peer-Reviewed Original ResearchProgression-free survivalPartial responseComplete responseHazard ratioOvarian cancerRecurrent platinum-sensitive ovarian cancerMedian progression-free survivalPrior anti-angiogenic therapyPARP inhibitorsPlatinum-sensitive ovarian cancerRandomized phase 2 trialOpen-label studyRecurrent ovarian cancerPhase 2 trialPhase 1 studyExploratory subgroup analysisAnti-angiogenic therapyCombination of cediranibPARP inhibitor olaparibMeasurable diseaseRECIST 1.1Radiographic progressionPFS eventsPS 0Oral combination
2013
Human epidermal growth factor receptor 2 (HER2) suppression with the addition of lapatinib to trastuzumab in HER2-positive metastatic breast cancer (HALT: LPT112515).
Lin N, Danso M, David A, Muscato J, Rayson D, Houck W, Ellis C, DeSilvio M, Garofalo A, Levin J, Winer E. Human epidermal growth factor receptor 2 (HER2) suppression with the addition of lapatinib to trastuzumab in HER2-positive metastatic breast cancer (HALT: LPT112515). Journal Of Clinical Oncology 2013, 31: tps664-tps664. DOI: 10.1200/jco.2013.31.15_suppl.tps664.Peer-Reviewed Original ResearchProgression-free survivalMetastatic breast cancerBreast cancerOverall survivalMetastatic BCPFS eventsStage II/III breast cancerHigher pathologic complete response rateHER2-positive metastatic breast cancerMedian progression-free survivalPathologic complete response rateLonger progression-free survivalAssociated hazard ratiosClinical benefit rateDual HER2 blockadeStable brain metastasesComplete response rateSecond-line treatmentHormone receptor statusPhase III studyAddition of lapatinibLine of treatmentChemotherapy discontinuationEligible patientsHER2 blockade