2020
A Randomized Placebo Controlled Phase II Trial Evaluating Exemestane with or without Enzalutamide in Patients with Hormone Receptor–Positive Breast Cancer
Krop I, Abramson V, Colleoni M, Traina T, Holmes F, Garcia-Estevez L, Hart L, Awada A, Zamagni C, Morris PG, Schwartzberg L, Chan S, Gucalp A, Biganzoli L, Steinberg J, Sica L, Trudeau M, Markova D, Tarazi J, Zhu Z, O'Brien T, Kelly C, Winer E, Yardley D. A Randomized Placebo Controlled Phase II Trial Evaluating Exemestane with or without Enzalutamide in Patients with Hormone Receptor–Positive Breast Cancer. Clinical Cancer Research 2020, 26: 6149-6157. PMID: 32988969, DOI: 10.1158/1078-0432.ccr-20-1693.Peer-Reviewed Original ResearchConceptsProgression-free survivalHormone receptor-positive breast cancerReceptor-positive breast cancerPhase II trialEndocrine therapyBreast cancerII trialAR mRNACohort 1Higher AR mRNA levelsLower ESR1 mRNA levelsET-naïve patientsGrade adverse eventsPrior endocrine therapyMetastatic breast cancerAndrogen receptor inhibitorMRNA levelsAR mRNA levelsESR1 mRNA levelsEnzalutamide armITT populationTreat populationAdvanced diseasePrimary endpointAdverse events
2018
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 2018, 29: 1541-1547. PMID: 29718092, DOI: 10.1093/annonc/mdy155.Peer-Reviewed Original ResearchMeSH KeywordsAgedAminopyridinesAntineoplastic Combined Chemotherapy ProtocolsBiomarkers, TumorBreast NeoplasmsDouble-Blind MethodFemaleFollow-Up StudiesHumansLetrozoleLiver NeoplasmsLung NeoplasmsLymphatic MetastasisNeoplasm Recurrence, LocalPrognosisPurinesReceptor, ErbB-2Receptors, EstrogenReceptors, ProgesteroneSurvival RateConceptsProgression-free survivalFirst-line ribociclibOverall response rateMONALEESA-2 studySecondary end pointsAdvanced breast cancerBreast cancerEnd pointOverall survivalHER2-negative advanced breast cancerKey secondary end pointMedian progression-free survivalHuman epidermal growth factor receptorExploratory biomarker analysisExploratory end pointsImproved efficacy outcomesManageable toxicity profilePrimary end pointSecond interim analysisMetastatic breast cancerPhase III trialsESR1 mRNA levelsEpidermal growth factor receptorTP53 mutation statusBiomarker analysis