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
Tailoring Adjuvant Endocrine Therapy for Premenopausal Breast Cancer
Francis PA, Pagani O, Fleming GF, Walley BA, Colleoni M, Láng I, Gómez HL, Tondini C, Ciruelos E, Burstein HJ, Bonnefoi HR, Bellet M, Martino S, Geyer CE, Goetz MP, Stearns V, Pinotti G, Puglisi F, Spazzapan S, Climent MA, Pavesi L, Ruhstaller T, Davidson NE, Coleman R, Debled M, Buchholz S, Ingle JN, Winer EP, Maibach R, Rabaglio-Poretti M, Ruepp B, Di Leo A, Coates AS, Gelber RD, Goldhirsch A, Regan MM. Tailoring Adjuvant Endocrine Therapy for Premenopausal Breast Cancer. New England Journal Of Medicine 2018, 379: 122-137. PMID: 29863451, PMCID: PMC6193457, DOI: 10.1056/nejmoa1803164.Peer-Reviewed Original ResearchConceptsTamoxifen plus ovarian suppressionTamoxifen-alone groupOvarian suppressionPremenopausal womenBreast cancerAdverse eventsOverall survivalDisease-free survival ratesOvarian Function TrialYears of tamoxifenAdjuvant endocrine therapyHigher adverse eventsReceipt of chemotherapyPremenopausal breast cancerLow recurrence rateAromatase inhibitor exemestaneUse of exemestaneSuppression groupExemestane TrialDistant recurrenceEndocrine therapyRecurrence rateGrade 3ExemestaneTamoxifen
2017
Ki67 Proliferation Index as a Tool for Chemotherapy Decisions During and After Neoadjuvant Aromatase Inhibitor Treatment of Breast Cancer: Results From the American College of Surgeons Oncology Group Z1031 Trial (Alliance)
Ellis MJ, Suman VJ, Hoog J, Goncalves R, Sanati S, Creighton CJ, DeSchryver K, Crouch E, Brink A, Watson M, Luo J, Tao Y, Barnes M, Dowsett M, Budd GT, Winer E, Silverman P, Esserman L, Carey L, X. C, Unzeitig G, Pluard T, Whitworth P, Babiera G, Guenther JM, Dayao Z, Ota D, Leitch M, Olson JA, Allred DC, Hunt K. Ki67 Proliferation Index as a Tool for Chemotherapy Decisions During and After Neoadjuvant Aromatase Inhibitor Treatment of Breast Cancer: Results From the American College of Surgeons Oncology Group Z1031 Trial (Alliance). Journal Of Clinical Oncology 2017, 35: jco.2016.69.440. PMID: 28045625, PMCID: PMC5455353, DOI: 10.1200/jco.2016.69.4406.Peer-Reviewed Original ResearchMeSH KeywordsAgedAnastrozoleAndrostadienesAntineoplastic Combined Chemotherapy ProtocolsAromatase InhibitorsBreast NeoplasmsClinical Decision-MakingFemaleFollow-Up StudiesHumansKi-67 AntigenLetrozoleMiddle AgedMitotic IndexNeoadjuvant TherapyNeoplasm MetastasisNeoplasm Recurrence, LocalNeoplasm StagingNitrilesPredictive Value of TestsPrognosisProportional Hazards ModelsReceptors, EstrogenReceptors, ProgesteroneSurvival RateTranscriptomeTriazolesConceptsPreoperative endocrine prognostic indexBreast cancerNeoadjuvant chemotherapyAmerican CollegeEstrogen receptor-positive primary breast cancerNeoadjuvant aromatase inhibitor therapyPathologic complete response rateER-positive breast cancerAromatase inhibitor therapyComplete response rateER-positive tumorsPrimary breast cancerRisk of relapseAromatase inhibitor treatmentKi67 proliferation indexEndocrine monotherapyNeoadjuvant AIsAI therapyPCR ratePostmenopausal womenInhibitor therapyCox modelingOptimal therapyPrognostic indexRelapse risk
2014
Adjuvant Ovarian Suppression in Premenopausal Breast Cancer
Francis PA, Regan MM, Fleming GF, Láng I, Ciruelos E, Bellet M, Bonnefoi HR, Climent MA, Da Prada GA, Burstein HJ, Martino S, Davidson NE, Geyer CE, Walley BA, Coleman R, Kerbrat P, Buchholz S, Ingle JN, Winer EP, Rabaglio-Poretti M, Maibach R, Ruepp B, Giobbie-Hurder A, Price KN, Colleoni M, Viale G, Coates AS, Goldhirsch A, Gelber RD. Adjuvant Ovarian Suppression in Premenopausal Breast Cancer. New England Journal Of Medicine 2014, 372: 436-446. PMID: 25495490, PMCID: PMC4341825, DOI: 10.1056/nejmoa1412379.Peer-Reviewed Original ResearchConceptsTamoxifen plus ovarian suppressionOvarian suppressionRate of freedomBreast cancerTamoxifen groupPremenopausal womenPrimary analysisDisease-free survival ratesPositive early breast cancerAdjuvant ovarian suppressionNonreceipt of chemotherapyYears of tamoxifenDisease-free survivalPremenopausal breast cancerEarly breast cancerOvarian estrogen productionOverall study populationSuppression groupGreater treatment effectUse of exemestaneAdjuvant chemotherapyPrior chemotherapyMost recurrencesPrognostic factorsPrior receiptAdjuvant Exemestane with Ovarian Suppression in Premenopausal Breast Cancer
Pagani O, Regan MM, Walley BA, Fleming GF, Colleoni M, Láng I, Gomez HL, Tondini C, Burstein HJ, Perez EA, Ciruelos E, Stearns V, Bonnefoi HR, Martino S, Geyer CE, Pinotti G, Puglisi F, Crivellari D, Ruhstaller T, Winer EP, Rabaglio-Poretti M, Maibach R, Ruepp B, Giobbie-Hurder A, Price KN, Bernhard J, Luo W, Ribi K, Viale G, Coates AS, Gelber RD, Goldhirsch A, Francis PA. Adjuvant Exemestane with Ovarian Suppression in Premenopausal Breast Cancer. New England Journal Of Medicine 2014, 371: 107-118. PMID: 24881463, PMCID: PMC4175521, DOI: 10.1056/nejmoa1404037.Peer-Reviewed Original ResearchMeSH KeywordsAdultAndrostadienesAntineoplastic Agents, HormonalAntineoplastic Combined Chemotherapy ProtocolsAromatase InhibitorsBreast NeoplasmsChemotherapy, AdjuvantDisease-Free SurvivalEstradiolFemaleFollow-Up StudiesHumansKaplan-Meier EstimateMastectomyMiddle AgedOsteoporosisPremenopauseQuality of LifeTamoxifenTriptorelin PamoateConceptsPositive early breast cancerEarly breast cancerOvarian suppressionBreast cancerPostmenopausal womenPremenopausal womenTamoxifen plus ovarian suppressionSuppression groupRate of freedomDisease-free survivalPhase 3 trialPremenopausal breast cancerOvarian estrogen productionPositive breast cancerAromatase inhibitor exemestaneAdjuvant exemestaneOvarian irradiationAdjuvant therapyAdjuvant treatmentAdverse eventsOverall survivalEstrogen productionAromatase inhibitorsGrade 3Primary analysis
2009
A Comparative Study of Exemestane Versus Anastrozole in Patients with Postmenopausal Breast Cancer with Visceral Metastases
Campos SM, Guastalla JP, Subar M, Abreu P, Winer EP, Cameron DA. A Comparative Study of Exemestane Versus Anastrozole in Patients with Postmenopausal Breast Cancer with Visceral Metastases. Clinical Breast Cancer 2009, 9: 39-44. PMID: 19299239, DOI: 10.3816/cbc.2009.n.007.Peer-Reviewed Original ResearchConceptsPostmenopausal breast cancerBreast cancer metastasisBreast cancerPostmenopausal patientsVisceral metastasesAdverse eventsObjective responseVisceral sitesVisceral lesionsClinical benefitTreatment-related adverse eventsCancer metastasisAromatase inhibitor studiesAdvanced breast cancerResponse Evaluation CriteriaExemestane groupEndocrine therapyPostmenopausal womenPrimary endpointSecondary endpointsMedian survivalOverall survivalSuch patientsTreat analysisStudy closure
2007
Cost-Effectiveness of Switching to Exemestane after 2 to 3 Years of Therapy with Tamoxifen in Postmenopausal Women with Early-Stage Breast Cancer
Thompson D, Taylor DC, Montoya EL, Winer EP, Jones SE, Weinstein MC. Cost-Effectiveness of Switching to Exemestane after 2 to 3 Years of Therapy with Tamoxifen in Postmenopausal Women with Early-Stage Breast Cancer. Value In Health 2007, 10: 367-376. PMID: 17888101, DOI: 10.1111/j.1524-4733.2007.00190.x.Peer-Reviewed Original ResearchMeSH KeywordsAgedAndrostadienesAntineoplastic ProtocolsAromatase InhibitorsBreast NeoplasmsCost-Benefit AnalysisDrug Administration ScheduleFemaleForecastingHumansMarkov ChainsMiddle AgedNeoplasm Recurrence, LocalPostmenopauseQuality-Adjusted Life YearsSEER ProgramSelective Estrogen Receptor ModulatorsTamoxifenConceptsIntergroup Exemestane StudyDisease-free survivalDisease-related eventsTreatment strategiesEarly-stage breast cancer patientsEarly-stage breast cancerProlongs disease-free survivalCost-effective treatment strategyIncremental cost-effectiveness ratioYears of tamoxifenYears of therapyBreast cancer patientsSEER-Medicare dataBreast cancer statusLifetime medical care costsMedical care costsCost-effectiveness ratioTamoxifen therapyPostmenopausal womenRecurrence rateCancer careCancer patientsPatient transitionsAromatase inhibitorsBreast cancer