2019
Updated results from MONALEESA-2, a phase III trial of first-line ribociclib plus letrozole versus placebo plus letrozole in hormone receptor-positive, HER2-negative advanced breast cancer
Hortobagyi GN, Stemmer SM, Burris HA, Yap YS, Sonke GS, Paluch-Shimon S, Campone M, Petrakova K, Blackwell KL, Winer EP, Janni W, Verma S, Conte P, Arteaga CL, Cameron DA, Mondal S, Su F, Miller M, Elmeliegy M, Germa C, O’Shaughnessy J. Updated results from MONALEESA-2, a phase III trial of first-line ribociclib plus letrozole versus placebo plus letrozole in hormone receptor-positive, HER2-negative advanced breast cancer. Annals Of Oncology 2019, 30: 1842. PMID: 31407010, PMCID: PMC6927326, DOI: 10.1093/annonc/mdz215.Peer-Reviewed Original Research
2018
A phase Ib study of pictilisib (GDC-0941) in combination with paclitaxel, with and without bevacizumab or trastuzumab, and with letrozole in advanced breast cancer
Schöffski P, Cresta S, Mayer IA, Wildiers H, Damian S, Gendreau S, Rooney I, Morrissey KM, Spoerke JM, Ng VW, Singel SM, Winer E. A phase Ib study of pictilisib (GDC-0941) in combination with paclitaxel, with and without bevacizumab or trastuzumab, and with letrozole in advanced breast cancer. Breast Cancer Research 2018, 20: 109. PMID: 30185228, PMCID: PMC6125885, DOI: 10.1186/s13058-018-1015-x.Peer-Reviewed Original ResearchConceptsDose-limiting toxicityPhase Ib studyMetastatic breast cancerAdverse eventsBreast cancerIb studyResultsSixty-nine patientsAntitumor activityManageable safety profileAdvanced breast cancerSerious adverse eventsPreliminary antitumor activityDrug-drug interactionsEvaluation of safetySecondary endpointsPartial responseComplete responseDose escalationRandomized studySafety profilePatientsBevacizumabTrastuzumabPictilisibLetrozole
2016
LBA1_PR breast cancer, locally advanced and metastatic First-line ribociclib + letrozole for postmenopausal women with 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, Blackwell K, André F, Winer E, Janni W, Verma S, Conte P, Arteaga C, Cameron D, Xuan F, Souami F, Miller M, Germa C, O'Shaughnessy J. LBA1_PR breast cancer, locally advanced and metastatic First-line ribociclib + letrozole for postmenopausal women with hormone receptor-positive (HR+), HER2-negative (HER2–), advanced breast cancer (ABC). Annals Of Oncology 2016, 27: vi553. DOI: 10.1093/annonc/mdw435.03.Peer-Reviewed Original ResearchIdentifying risk factors for toxicity in patients (Pts) with hormone-receptor positive (HR+) advanced breast cancer treated with bevacizumab plus letrozole: A CALGB 40503 (Alliance) correlative study.
Li D, Dickler M, McCall L, Hahn O, Hudis C, Cohen H, Muss H, Ballman K, Winer E, Tripathy D, Schneider B, Cirrincione C, Barry W, Hurria A. Identifying risk factors for toxicity in patients (Pts) with hormone-receptor positive (HR+) advanced breast cancer treated with bevacizumab plus letrozole: A CALGB 40503 (Alliance) correlative study. Journal Of Clinical Oncology 2016, 34: 10047-10047. DOI: 10.1200/jco.2016.34.15_suppl.10047.Peer-Reviewed Original ResearchA randomized trial (MA.17R) of extending adjuvant letrozole for 5 years after completing an initial 5 years of aromatase inhibitor therapy alone or preceded by tamoxifen in postmenopausal women with early-stage breast cancer.
Goss P, Ingle J, Pritchard K, Muss H, Gralow J, Gelmon K, Whelan T, Strasser-Weippl K, Rubin S, Sturtz K, Wolff A, Winer E, Hudis C, Stopeck A, Beck J, Kaur J, Whelan K, Tu D, Parulekar W. A randomized trial (MA.17R) of extending adjuvant letrozole for 5 years after completing an initial 5 years of aromatase inhibitor therapy alone or preceded by tamoxifen in postmenopausal women with early-stage breast cancer. Journal Of Clinical Oncology 2016, 34: lba1-lba1. DOI: 10.1200/jco.2016.34.15_suppl.lba1.Peer-Reviewed Original Research
2015
Relative Effectiveness of Letrozole Compared With Tamoxifen for Patients With Lobular Carcinoma in the BIG 1-98 Trial
Metzger Filho O, Giobbie-Hurder A, Mallon E, Gusterson B, Viale G, Winer EP, Thürlimann B, Gelber RD, Colleoni M, Ejlertsen B, Debled M, Price KN, Regan MM, Coates AS, Goldhirsch A. Relative Effectiveness of Letrozole Compared With Tamoxifen for Patients With Lobular Carcinoma in the BIG 1-98 Trial. Journal Of Clinical Oncology 2015, 33: 2772-2779. PMID: 26215945, PMCID: PMC4550691, DOI: 10.1200/jco.2015.60.8133.Peer-Reviewed Original ResearchMeSH KeywordsAdultAntineoplastic Agents, HormonalAntineoplastic Combined Chemotherapy ProtocolsAromatase InhibitorsBiomarkers, TumorBreast NeoplasmsCarcinoma, Ductal, BreastCarcinoma, LobularChemotherapy, AdjuvantDisease-Free SurvivalFemaleHumansKi-67 AntigenLetrozoleMiddle AgedNitrilesReceptor, ErbB-2TamoxifenTreatment OutcomeTriazolesConceptsInvasive ductal carcinomaInvasive lobular carcinomaDisease-free survivalLobular carcinomaDFS eventsDuctal carcinomaLA subtypeBreast International Group (BIG) 1Early-stage invasive ductal carcinomaClassic invasive lobular carcinomaHER2-negative invasive ductal carcinomaKi-67 labeling indexLow proliferative activityMagnitude of benefitAdjuvant letrozoleMedian followBIG 1ILC subsetsMultivariable modelCox modelGroup 1LetrozoleCarcinomaLabeling indexPatients
2003
Clinical differences among the aromatase inhibitors.
Ligibel JA, Winer EP. Clinical differences among the aromatase inhibitors. Clinical Cancer Research 2003, 9: 473s-9s. PMID: 12538503.Peer-Reviewed Original ResearchConceptsAromatase inhibitorsAdjuvant settingLarge phase III trialsThird-generation aromatase inhibitorsFirst-line settingSecond-line therapyDisease-free survivalPhase III trialsMetastatic breast cancerMegesterol acetateATAC trialIII trialsMetastatic diseaseClinical differencesNonsteroidal agentsClinical significanceBreast cancerAromatase activityAnastrozoleLetrozoleStudy designTamoxifenTrialsExemestaneInhibitors