2016
Randomized phase II trial of fulvestrant alone or in combination with bortezomib in hormone receptor-positive metastatic breast cancer resistant to aromatase inhibitors: a New York Cancer Consortium trial
Adelson K, Ramaswamy B, Sparano JA, Christos PJ, Wright JJ, Raptis G, Han G, Villalona-Calero M, Ma CX, Hershman D, Baar J, Klein P, Cigler T, Budd GT, Novik Y, Tan AR, Tannenbaum S, Goel A, Levine E, Shapiro CL, Andreopoulou E, Naughton M, Kalinsky K, Waxman S, Germain D. Randomized phase II trial of fulvestrant alone or in combination with bortezomib in hormone receptor-positive metastatic breast cancer resistant to aromatase inhibitors: a New York Cancer Consortium trial. Npj Breast Cancer 2016, 2: 16037. PMID: 28721390, PMCID: PMC5515340, DOI: 10.1038/npjbcancer.2016.37.Peer-Reviewed Original ResearchProgression-free survivalSelective estrogen receptor downregulatorsMetastatic breast cancerER-positive metastatic breast cancerMedian progression-free survivalArm ABreast cancerArm BHormone receptor-positive metastatic breast cancerRandomized phase II trialPhase II trialEstrogen receptor downregulatorsProteasome inhibitor bortezomibPFS ratesII trialConsortium TrialHazard ratioPostmenopausal womenPreclinical modelsInhibitor bortezomibBortezomibCancerProteasome inhibitorsAdditional evaluationTrials
2011
OT3-01-01: Randomized Phase II Study of Fulvestrant Versus Fulvestrant Plus Bortezomib in Postmenopausal Women with Estrogen Receptor (ER) Positive, Aromatase-Inhibitor (AI) Resistant Metastatic Breast Cancer (MBC): New York Cancer Consortium Trial P8457.
Adelson K, Raptis G, Sparano J, Germain D. OT3-01-01: Randomized Phase II Study of Fulvestrant Versus Fulvestrant Plus Bortezomib in Postmenopausal Women with Estrogen Receptor (ER) Positive, Aromatase-Inhibitor (AI) Resistant Metastatic Breast Cancer (MBC): New York Cancer Consortium Trial P8457. Cancer Research 2011, 71: ot3-01-01-ot3-01-01. DOI: 10.1158/0008-5472.sabcs11-ot3-01-01.Peer-Reviewed Original ResearchMedian progression-free survivalMetastatic breast cancerProgression-free survivalAI therapyPostmenopausal womenMetastatic diseaseAI-resistant metastatic breast cancerResistant metastatic breast cancerAdjuvant AI therapyAI-resistant diseaseClinical benefit ratePrior chemotherapy regimenPhase II studyAdverse event ratesAddition of bortezomibHuman breast cancer cell linesEstrogen-receptor positiveRandomized phase II designsBreast cancer cell linesPhase II designUnfolded protein responseChemotherapy regimenEligible patientsMeasurable diseasePrior chemotherapy