2023
Effect of a telephone-based weight loss intervention (WLI) on weight at 12-months in women with early breast cancer: Results from the Breast Cancer Weight Loss (BWEL) trial.
Ligibel J, Ballman K, McCall L, Goodwin P, Weiss A, Delahanty L, Alfano C, Crane T, Neuhouser M, Spears P, Hershman D, Paskett E, Hopkins J, Bernstein V, Stearns V, White J, Wadden T, Winer E, Partridge A, Carey L. Effect of a telephone-based weight loss intervention (WLI) on weight at 12-months in women with early breast cancer: Results from the Breast Cancer Weight Loss (BWEL) trial. Journal Of Clinical Oncology 2023, 41: 12001-12001. DOI: 10.1200/jco.2023.41.16_suppl.12001.Peer-Reviewed Original ResearchWeight loss interventionBody mass indexEarly breast cancerWeight loss trialBreast cancerHealth educationTumor factorsWeight lossLoss trialHER2-negative breast cancerInvasive disease-free survivalTelephone-based health coachingBreast cancer ptsBaseline body weightDisease-free survivalMeaningful weight lossMonths of diagnosisPoor prognostic factorTime of diagnosisBreast cancer patientsSignificant weight lossMultivariable regression modelsRace/ethnicityCancer ptsEligible pts
2022
Adjuvant Exemestane With Ovarian Suppression in Premenopausal Breast Cancer: Long-Term Follow-Up of the Combined TEXT and SOFT Trials
Pagani O, Walley B, Fleming G, Colleoni M, Láng I, Gomez H, Tondini C, Burstein H, Goetz M, Ciruelos E, Stearns V, Bonnefoi H, Martino S, Geyer C, Chini C, Puglisi F, Spazzapan S, Ruhstaller T, Winer E, Ruepp B, Loi S, Coates A, Gelber R, Goldhirsch A, Regan M, Francis P, Group F. Adjuvant Exemestane With Ovarian Suppression in Premenopausal Breast Cancer: Long-Term Follow-Up of the Combined TEXT and SOFT Trials. Journal Of Clinical Oncology 2022, 41: 1376-1382. PMID: 36521078, PMCID: PMC10419413, DOI: 10.1200/jco.22.01064.Peer-Reviewed Original ResearchConceptsDistant recurrence-free intervalOvarian function suppressionDisease-free survivalPrimary end pointOverall survivalAdjuvant exemestaneEnd pointBreast cancerReceptor-positive early breast cancerHuman epidermal growth factor receptorClinical trial updateYears of exemestaneOverall survival benefitHigh-risk patientsPremenopausal breast cancerRecurrence-free intervalEarly breast cancerGrade 3 tumorsRisk of recurrenceEpidermal growth factor receptorGrowth factor receptorSOFT trialTreat populationOvarian suppressionPremenopausal womenSurrogacy of Pathologic Complete Response in Trials of Neoadjuvant Therapy for Early Breast Cancer
Conforti F, Pala L, Bagnardi V, De Pas T, Colleoni M, Buyse M, Hortobagyi G, Gianni L, Winer E, Loibl S, Cortes J, Piccart M, Wolff AC, Viale G, Gelber RD. Surrogacy of Pathologic Complete Response in Trials of Neoadjuvant Therapy for Early Breast Cancer. JAMA Oncology 2022, 8: 1668-1675. PMID: 36201176, DOI: 10.1001/jamaoncol.2022.3755.Peer-Reviewed Original ResearchConceptsSurrogate end pointsPathologic complete responseEarly breast cancerBreast cancerEnd pointComplete responseClinical outcomesClinical benefitEvent-free survival dataLong-term patient outcomesReliable surrogate end pointsTrial levelPatient clinical benefitPatients' clinical outcomesAccelerated approval processNeoadjuvant RCTNeoadjuvant therapyPatient survivalClinical trialsDrug regulatory policyEffective therapyPathological responsePatient outcomesPatient levelDrug effectsTreatment Exposure and Discontinuation in the PALbociclib CoLlaborative Adjuvant Study of Palbociclib With Adjuvant Endocrine Therapy for Hormone Receptor-Positive/Human Epidermal Growth Factor Receptor 2-Negative Early Breast Cancer (PALLAS/AFT-05/ABCSG-42/BIG-14-03).
Mayer EL, Fesl C, Hlauschek D, Garcia-Estevez L, Burstein HJ, Zdenkowski N, Wette V, Miller KD, Balic M, Mayer IA, Cameron D, Winer EP, Ponce Lorenzo JJ, Lake D, Pristauz-Telsnigg G, Haddad TC, Shepherd L, Iwata H, Goetz M, Cardoso F, Traina TA, Sabanathan D, Breitenstein U, Ackerl K, Metzger Filho O, Zehetner K, Solomon K, El-Abed S, Theall KP, Lu DR, Dueck A, Gnant M, DeMichele A. Treatment Exposure and Discontinuation in the PALbociclib CoLlaborative Adjuvant Study of Palbociclib With Adjuvant Endocrine Therapy for Hormone Receptor-Positive/Human Epidermal Growth Factor Receptor 2-Negative Early Breast Cancer (PALLAS/AFT-05/ABCSG-42/BIG-14-03). Journal Of Clinical Oncology 2022, 40: 449-458. PMID: 34995105, PMCID: PMC9851679, DOI: 10.1200/jco.21.01918.Peer-Reviewed Original ResearchMeSH KeywordsAntineoplastic Agents, HormonalAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsChemotherapy, AdjuvantDisease-Free SurvivalFemaleHumansNeoplasm StagingPiperazinesProtein Kinase InhibitorsPyridinesReceptor, ErbB-2Receptors, EstrogenReceptors, ProgesteroneRisk FactorsTime FactorsConceptsInvasive disease-free survivalAdjuvant endocrine therapyHuman epidermal growth factor receptorEndocrine therapyEpidermal growth factor receptorPalbociclib exposureGrowth factor receptorBreast cancerHormone Receptor-Positive/Human Epidermal Growth Factor ReceptorAddition of palbociclibNovel adjuvant treatmentDisease-free survivalEarly breast cancerFactor receptorOral cancer therapyProtocol analysisPALLAS studyAdjuvant treatmentEarly discontinuationAdjuvant studiesDiscontinuation ratesDose modificationAnalysis populationCDK4/6 inhibitorsDrug persistence
2021
Trastuzumab Emtansine Plus Pertuzumab Versus Taxane Plus Trastuzumab Plus Pertuzumab After Anthracycline for High-Risk Human Epidermal Growth Factor Receptor 2–Positive Early Breast Cancer: The Phase III KAITLIN Study
Krop IE, Im SA, Barrios C, Bonnefoi H, Gralow J, Toi M, Ellis PA, Gianni L, Swain SM, Im YH, De Laurentiis M, Nowecki Z, Huang CS, Fehrenbacher L, Ito Y, Shah J, Boulet T, Liu H, Macharia H, Trask P, Song C, Winer EP, Harbeck N. Trastuzumab Emtansine Plus Pertuzumab Versus Taxane Plus Trastuzumab Plus Pertuzumab After Anthracycline for High-Risk Human Epidermal Growth Factor Receptor 2–Positive Early Breast Cancer: The Phase III KAITLIN Study. Journal Of Clinical Oncology 2021, 40: 438-448. PMID: 34890214, PMCID: PMC8824393, DOI: 10.1200/jco.21.00896.Peer-Reviewed Original ResearchConceptsInvasive disease-free survivalOverall populationTrastuzumab emtansineHigh-risk human epidermal growth factor receptorHuman epidermal growth factor receptor 2End pointEpidermal growth factor receptor 2Early breast cancer treatmentHuman epidermal growth factor receptorAnthracycline-based chemotherapyCoprimary end pointsPrimary end pointDisease-free survivalSerious adverse eventsEarly breast cancerGlobal health statusGrowth factor receptor 2Treatment completion ratesStandard of careBreast cancer treatmentFactor receptor 2Epidermal growth factor receptorGrowth factor receptorEndocrine therapyAdverse eventsAdjuvant Palbociclib for Early Breast Cancer: The PALLAS Trial Results (ABCSG-42/AFT-05/BIG-14-03)
Gnant M, Dueck AC, Frantal S, Martin M, Burstein HJ, Greil R, Fox P, Wolff AC, Chan A, Winer EP, Pfeiler G, Miller KD, Colleoni M, Suga JM, Rubovsky G, Bliss JM, Mayer IA, Singer CF, Nowecki Z, Hahn O, Thomson J, Wolmark N, Amillano K, Rugo HS, Steger GG, de Aránguiz B, Haddad TC, Perelló A, Bellet M, Fohler H, Filho O, Jallitsch-Halper A, Solomon K, Schurmans C, Theall KP, Lu DR, Tenner K, Fesl C, DeMichele A, Mayer EL, groups and investigators O. Adjuvant Palbociclib for Early Breast Cancer: The PALLAS Trial Results (ABCSG-42/AFT-05/BIG-14-03). Journal Of Clinical Oncology 2021, 40: 282-293. PMID: 34874182, PMCID: PMC10476784, DOI: 10.1200/jco.21.02554.Peer-Reviewed Original ResearchMeSH KeywordsAntineoplastic Agents, HormonalAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsChemotherapy, AdjuvantDisease ProgressionDisease-Free SurvivalFemaleHumansMastectomyMiddle AgedNeoadjuvant TherapyNeoplasm StagingPiperazinesProgression-Free SurvivalProspective StudiesProtein Kinase InhibitorsPyridinesTime FactorsConceptsHormone receptor-positive breast cancerInvasive disease-free survivalReceptor-positive breast cancerAdjuvant endocrine therapyCancer-free survivalEndocrine therapyEarly breast cancerBreast cancerAdjuvant palbociclibPALLAS trialEnd pointEarly hormone receptor-positive breast cancerBreast cancer-free survivalDistant recurrence-free survivalHuman epidermal growth factor receptorProtocol-defined analysisStandard endocrine therapyPrimary end pointSecondary end pointsAdvanced breast cancerDisease-free survivalNew safety signalsRecurrence-free survivalEvent end pointsCyclin-dependent kinase 4Prospective Study Testing a Simplified Paclitaxel Premedication Regimen in Patients with Early Breast Cancer
Barroso-Sousa R, Vaz-Luis I, Di Meglio A, Hu J, Li T, Rees R, Sinclair N, Milisits L, Leone JP, Constantine M, Faggen M, Briccetti F, Block C, Partridge A, Burstein H, Waks AG, Tayob N, Trippa L, Tolaney SM, Hassett MJ, Winer EP, Lin NU. Prospective Study Testing a Simplified Paclitaxel Premedication Regimen in Patients with Early Breast Cancer. The Oncologist 2021, 26: 927-933. PMID: 34472667, PMCID: PMC8571744, DOI: 10.1002/onco.13960.Peer-Reviewed Original ResearchConceptsGrade hypersensitivity reactionsHypersensitivity reactionsPaclitaxel cyclesCycle 3Breast cancerCycle 1Grade 2 hypersensitivity reactionGrade 3 hypersensitivity reactionDose-dense doxorubicinDose-dense paclitaxelGrade 3 eventsUse of corticosteroidsEarly breast cancerSingle-arm studyAdministration of antihistaminesHistamine H2 blockersCycle 2Corticosteroid premedicationDd ACDexamethasone premedicationPaclitaxel regimenPremedication protocolDexamethasone usePaclitaxel doseProtocol therapyCustomizing local and systemic therapies for women with early breast cancer: the St. Gallen International Consensus Guidelines for treatment of early breast cancer 2021
Burstein HJ, Curigliano G, Thürlimann B, Weber WP, Poortmans P, Regan MM, Senn HJ, Winer EP, Gnant M, Conference P, Aebi S, André F, Barrios C, Bergh J, Bonnefoi H, Morales D, Brucker S, Burstein H, Cameron D, Cardoso F, Carey L, Chua B, Ciruelos E, Colleoni M, Curigliano G, Delaloge S, Denkert C, Dubsky P, Ejlertsen B, Fitzal F, Francis P, Galimberti V, Mahmoud H, Garber J, Gnant M, Gradishar W, Gulluoglu B, Harbeck N, Huang C, Huober J, Ilbawi A, Jiang Z, Johnston S, Lee E, Loibl S, Morrow M, Partridge A, Piccart M, Poortmans P, Prat A, Regan M, Rubio I, Rugo H, Rutgers E, Sedlmayer F, Semiglazov V, Senn H, Shao Z, Spanic T, Tesarova P, Thürlimann B, Tjulandin S, Toi M, Trudeau M, Turner N, Luis I, Viale G, Watanabe T, Weber W, Winer E, Xu B. Customizing local and systemic therapies for women with early breast cancer: the St. Gallen International Consensus Guidelines for treatment of early breast cancer 2021. Annals Of Oncology 2021, 32: 1216-1235. PMID: 34242744, PMCID: PMC9906308, DOI: 10.1016/j.annonc.2021.06.023.Peer-Reviewed Original ResearchConceptsEarly-stage breast cancerBreast cancerSystemic therapyEarly breast cancerTime of diagnosisBreast cancer patientsInternational consensus guidelinesBreast cancer riskRadiation oncology providersBreast cancer diagnosisNeoadjuvant therapyMultidisciplinary careOncology providersClinical featuresConsensus guidelinesCancer patientsPatient preferencesTreatment recommendationsTreatment responseCancer riskClinical careClinical informationConsensus conferenceEarly breast cancer diagnosisPatient experience42O Biomarker analysis from KAITLIN, a randomised phase III study of adjuvant trastuzumab emtansine (TDM-1; K) plus pertuzumab (P) versus trastuzumab (H) plus taxane (T) plus P after anthracyclines (AC) for high-risk HER2-positive early breast cancer (EBC)
Metzger O, Lambertini C, Krop I, Phillips G, Perou C, Symmans F, Melero I, Harbeck N, Winer E, Im S, Barrios C, Bonnefoi H, Gralow J, Ellis P, Gianni L, Toi M, Swain S, Boulet T, Song C, de Haas S. 42O Biomarker analysis from KAITLIN, a randomised phase III study of adjuvant trastuzumab emtansine (TDM-1; K) plus pertuzumab (P) versus trastuzumab (H) plus taxane (T) plus P after anthracyclines (AC) for high-risk HER2-positive early breast cancer (EBC). Annals Of Oncology 2021, 32: s37-s38. DOI: 10.1016/j.annonc.2021.03.056.Peer-Reviewed Original ResearchPalbociclib with adjuvant endocrine therapy in early breast cancer (PALLAS): interim analysis of a multicentre, open-label, randomised, phase 3 study
Mayer EL, Dueck AC, Martin M, Rubovszky G, Burstein HJ, Bellet-Ezquerra M, Miller KD, Zdenkowski N, Winer EP, Pfeiler G, Goetz M, Ruiz-Borrego M, Anderson D, Nowecki Z, Loibl S, Moulder S, Ring A, Fitzal F, Traina T, Chan A, Rugo HS, Lemieux J, Henao F, Lyss A, Antolin Novoa S, Wolff AC, Vetter M, Egle D, Morris PG, Mamounas EP, Gil-Gil MJ, Prat A, Fohler H, Metzger Filho O, Schwarz M, DuFrane C, Fumagalli D, Theall KP, Lu DR, Bartlett CH, Koehler M, Fesl C, DeMichele A, Gnant M. Palbociclib with adjuvant endocrine therapy in early breast cancer (PALLAS): interim analysis of a multicentre, open-label, randomised, phase 3 study. The Lancet Oncology 2021, 22: 212-222. PMID: 33460574, DOI: 10.1016/s1470-2045(20)30642-2.Peer-Reviewed Original ResearchConceptsInvasive disease-free survivalAdjuvant endocrine therapyDisease-free survivalInvasive disease-free survival eventsDisease-free survival eventsEndocrine therapySecond interim analysisBreast cancerInterim analysisAdverse eventsEastern Cooperative Oncology Group performance scoreSecond pre-planned interim analysisHER2-negative breast cancerEarly-stage breast cancerSurvival eventsIndependent data monitoring committeePre-planned interim analysisCommon grade 3Treatment-related deathsSerious adverse eventsProgression-free survivalEarly breast cancerMetastatic breast cancerInteractive response technologyGroup performance score
2020
Perceptions of patients with early stage breast cancer toward research biopsies
Seah DS, Leone JP, Openshaw TH, Scott SM, Tayob N, Hu J, Lederman RI, Frank ES, Sohl JJ, Stadler ZK, Erick TK, Silverman SG, Peppercorn JM, Winer EP, Come SE, Lin NU. Perceptions of patients with early stage breast cancer toward research biopsies. Cancer 2020, 127: 1208-1219. PMID: 33320362, PMCID: PMC8247276, DOI: 10.1002/cncr.33371.Peer-Reviewed Original ResearchMeSH KeywordsAcademies and InstitutesAdultAgedAged, 80 and overAnalysis of VarianceAttitudeBiomedical ResearchBiopsyBlood DonorsBreastBreast NeoplasmsCancer Care FacilitiesFemaleHealth Services AccessibilityHumansMiddle AgedNeoplasm StagingSocioeconomic FactorsSurveys and QuestionnairesTissue and Organ ProcurementTissue DonorsConceptsEarly-stage breast cancerEarly breast cancerStage breast cancerResearch biopsiesBreast cancerMore patientsClinical trialsBreast biopsyMultivariate analysisProportion of patientsAcademic sitesCommunity oncology practicesPerceptions of patientsPerspectives of patientsCommunity-based sitesCommunity sitesMost patientsOncology sitesModifiable factorsPatients' willingnessUnivariate analysisOncology practiceBiopsyPatientsAcademic centersResponse to neoadjuvant chemotherapy and the 21-gene Breast Recurrence Score test in young women with estrogen receptor-positive early breast cancer
Sella T, Gelber SI, Poorvu PD, Kim HJ, Dominici L, Guzman-Arocho YD, Collins L, Ruddy KJ, Tamimi RM, Peppercorn JM, Schapira L, Borges VF, Come SE, Warner E, Snow C, Jakubowski DM, Russell CA, Winer EP, Rosenberg SM, Partridge AH. Response to neoadjuvant chemotherapy and the 21-gene Breast Recurrence Score test in young women with estrogen receptor-positive early breast cancer. Breast Cancer Research And Treatment 2020, 186: 157-165. PMID: 33150547, DOI: 10.1007/s10549-020-05989-5.Peer-Reviewed Original ResearchConceptsRecurrence Score resultsNeoadjuvant chemotherapyPathological complete responseBreast cancerBreast Cancer StudyYoung womenEstrogen receptor-positive early breast cancerReceptor-positive early breast cancerYoung Women's Breast Cancer StudyHER2-negative breast cancerScore resultsEarly breast cancerLogistic regression modelingAdjuvant chemotherapyNeoadjuvant therapyProspective cohortComplete responseMedian ageMultivariable analysisRecurrence scoreVs. 5Clinical careTumor specimensStage IPatientsPALLAS: A randomized phase III trial of adjuvant palbociclib with endocrine therapy versus endocrine therapy alone for HR+/HER2- early breast cancer
Mayer E, Gnant M, DeMichele A, Martin M, Burstein H, Prat A, Rubovszky G, Miller K, Pfeiler G, Winer E, Zdenkowski N, Anderson D, Nowecki Z, Loibl S, Fohler H, Metzger O, Fumagalli D, Theall K, Fesl C, Dueck A. PALLAS: A randomized phase III trial of adjuvant palbociclib with endocrine therapy versus endocrine therapy alone for HR+/HER2- early breast cancer. Annals Of Oncology 2020, 31: s1145. DOI: 10.1016/j.annonc.2020.08.2240.Peer-Reviewed Original ResearchA Food and Drug Administration analysis of survival outcomes comparing the Adjuvant Paclitaxel and Trastuzumab trial with an external control from historical clinical trials
Amiri-Kordestani L, Xie D, Tolaney SM, Bloomquist E, Tang S, Ibrahim A, Goldberg KB, Theoret MR, Pazdur R, Sridhara R, Winer EP, Beaver JA. A Food and Drug Administration analysis of survival outcomes comparing the Adjuvant Paclitaxel and Trastuzumab trial with an external control from historical clinical trials. Annals Of Oncology 2020, 31: 1704-1708. PMID: 32866625, DOI: 10.1016/j.annonc.2020.08.2106.Peer-Reviewed Original ResearchConceptsInvasive disease-free survivalEarly breast cancerHER2-positive early breast cancerTH armOverall survivalAdjuvant paclitaxelTrastuzumab trialsReceptor statusLow-risk early breast cancerHuman epidermal growth factor receptor 2Positive early breast cancerPropensity scoreEpidermal growth factor receptor 2De-escalate therapyDisease-free survivalGrowth factor receptor 2Progesterone receptor statusSingle-arm studyEstrogen receptor statusSingle-arm trialPatient-level dataFactor receptor 2Drug Administration analysisCovariates of ageHistorical clinical trialsResponse to neoadjuvant chemotherapy and the 21-gene breast recurrence score in young women with estrogen receptor-positive early breast cancer.
Sella T, Gelber S, Poorvu P, Kim H, Guzman Arocho Y, Collins L, Ruddy K, Tamimi R, Peppercorn J, Schapira L, Borges V, Come S, Warner E, Snow C, Jakubowski D, Russell C, Winer E, Rosenberg S, Partridge A. Response to neoadjuvant chemotherapy and the 21-gene breast recurrence score in young women with estrogen receptor-positive early breast cancer. Journal Of Clinical Oncology 2020, 38: 514-514. DOI: 10.1200/jco.2020.38.15_suppl.514.Peer-Reviewed Original ResearchPathologic complete responseBreast Recurrence ScoreNeoadjuvant chemotherapyBreast cancerRecurrence scoreBreast Cancer StudyYoung womenHER2- BCEstrogen receptor-positive early breast cancerHER-2 negative breast cancerReceptor-positive early breast cancerYoung Women's Breast Cancer StudyNeoadjuvant endocrine therapyResidual invasive tumorEarly breast cancerPost-menopausal womenNegative breast cancerHigh gradeLogistic regression modelingAdjuvant chemotherapyDuctal histologyPgR negativityEndocrine therapyNeoadjuvant therapyProspective cohortPrimary analysis of KAITLIN: A phase III study of trastuzumab emtansine (T-DM1) + pertuzumab versus trastuzumab + pertuzumab + taxane, after anthracyclines as adjuvant therapy for high-risk HER2-positive early breast cancer (EBC).
Harbeck N, Im S, Barrios C, Bonnefoi H, Gralow J, Toi M, Ellis P, Gianni L, Swain S, Im Y, De Laurentiis M, Nowecki Z, Shah J, Boulet T, Liu H, Macharia H, Trask P, Song C, Winer E, Krop I. Primary analysis of KAITLIN: A phase III study of trastuzumab emtansine (T-DM1) + pertuzumab versus trastuzumab + pertuzumab + taxane, after anthracyclines as adjuvant therapy for high-risk HER2-positive early breast cancer (EBC). Journal Of Clinical Oncology 2020, 38: 500-500. DOI: 10.1200/jco.2020.38.15_suppl.500.Peer-Reviewed Original ResearchHER2-positive early breast cancerInvasive disease-free survivalEarly breast cancerPatient-reported outcomesCo-primary endpointsStandard of careT-DM1ITT populationOverall survivalAnthracycline-based chemotherapyOpen-label studyDisease-free survivalPhase III studyWeeks of surgeryHigh-risk populationChemotherapy-associated toxicityAdjuvant taxanesConcurrent trastuzumabEndocrine therapySecondary endpointsAdjuvant radiotherapyAdjuvant therapyIII studyNodal statusMore patients
2019
Estimating the benefits of therapy for early-stage breast cancer: the St. Gallen International Consensus Guidelines for the primary therapy of early breast cancer 2019
Burstein H, Curigliano G, Loibl S, Dubsky P, Gnant M, Poortmans P, Colleoni M, Denkert C, Piccart-Gebhart M, Regan M, Senn H, Winer E, Thurlimann B, 2019 M. Estimating the benefits of therapy for early-stage breast cancer: the St. Gallen International Consensus Guidelines for the primary therapy of early breast cancer 2019. Annals Of Oncology 2019, 30: 1541-1557. PMID: 31373601, DOI: 10.1093/annonc/mdz235.Peer-Reviewed Original ResearchConceptsEarly-stage breast cancerBreast cancerBreast cancer histologyClinical benefitCancer histologySt. Gallen Consensus ConferenceEarly breast cancerInternational consensus guidelinesBenefits of therapyBreast cancer recurrenceSubstantial new evidenceMagnitude of benefitAdjuvant therapyLack of evidencePrimary therapyOverall survivalSystemic therapyHealthy womenConsensus guidelinesCancer recurrenceAppropriate treatmentClinical studiesIndividual patientsPatient participationConsensus conferenceA phase II feasibility study of palbociclib in combination with adjuvant endocrine therapy for hormone receptor-positive invasive breast carcinoma
Mayer EL, DeMichele A, Rugo HS, Miller K, Waks AG, Come SE, Mulvey T, Jeselsohn R, Overmoyer B, Guo H, Barry WT, Bartlett C, Koehler M, Winer EP, Burstein HJ. A phase II feasibility study of palbociclib in combination with adjuvant endocrine therapy for hormone receptor-positive invasive breast carcinoma. Annals Of Oncology 2019, 30: 1514-1520. PMID: 31250880, DOI: 10.1093/annonc/mdz198.Peer-Reviewed Original ResearchMeSH KeywordsAdultAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsChemotherapy, AdjuvantDisease-Free SurvivalEstradiolFeasibility StudiesFemaleFulvestrantHumansMiddle AgedNeoplasm InvasivenessNeoplasm StagingPiperazinesProtein Kinase InhibitorsPyridinesReceptor, ErbB-2Receptors, EstrogenReceptors, ProgesteroneConceptsEarly breast cancerEndocrine therapyAdjuvant palbociclibBreast cancerHormone receptor-positive/HER2-negative metastatic breast cancerHER2-negative metastatic breast cancerPhase II feasibility studyProlong progression-free survivalRandomized phase III trialAdjuvant endocrine therapyPrimary end pointStage III diseasePhase II trialPhase III trialsProgression-free survivalMetastatic breast cancerYears of therapyStart of treatmentInvasive breast carcinomaEligible patientsFebrile neutropeniaPrior chemotherapyWeeks on/1II trialCumulative incidenceRandomized Trial of Standard Adjuvant Chemotherapy Regimens Versus Capecitabine in Older Women With Early Breast Cancer: 10-Year Update of the CALGB 49907 Trial.
Muss HB, Polley MC, Berry DA, Liu H, Cirrincione CT, Theodoulou M, Mauer AM, Kornblith AB, Partridge AH, Dressler LG, Cohen HJ, Kartcheske PA, Perez EA, Wolff AC, Gralow JR, Burstein HJ, Mahmood AA, Sutton LM, Magrinat G, Parker BA, Hart RD, Grenier D, Hurria A, Jatoi A, Norton L, Hudis CA, Winer EP, Carey L. Randomized Trial of Standard Adjuvant Chemotherapy Regimens Versus Capecitabine in Older Women With Early Breast Cancer: 10-Year Update of the CALGB 49907 Trial. Journal Of Clinical Oncology 2019, 37: 2338-2348. PMID: 31339827, PMCID: PMC6900836, DOI: 10.1200/jco.19.00647.Peer-Reviewed Original ResearchConceptsRecurrence-free survivalStandard adjuvant chemotherapyEarly breast cancerAdjuvant chemotherapyAge 65 yearsStandard chemotherapyBreast cancerOlder womenBreast cancer-specific survival ratesSurvival rateHormone receptor-negative diseaseHormone receptor-negative patientsHormone receptor-positive patientsCancer-specific survival ratesPatients age 65 yearsWomen age 65 yearsReceptor-negative patientsReceptor-positive patientsOverall survival benefitPrimary end pointReceptor-negative diseaseOverall survival rateAdaptive Bayesian designNonbreast cancersRFS ratesClinical significance of circulating tumor cells (CTCs) in hormone receptor-positive (HR+) metastatic breast cancer (MBC) patients (pts) receiving letrozole (Let) or Let plus bevacizumab (Bev): CALGB 40503 (Alliance).
Magbanua M, Oleksandr Savenkov O, Asmus E, Ballman K, Scott J, Park J, Dickler M, Partridge A, Carey L, Winer E, Rugo H. Clinical significance of circulating tumor cells (CTCs) in hormone receptor-positive (HR+) metastatic breast cancer (MBC) patients (pts) receiving letrozole (Let) or Let plus bevacizumab (Bev): CALGB 40503 (Alliance). Journal Of Clinical Oncology 2019, 37: 1049-1049. DOI: 10.1200/jco.2019.37.15_suppl.1049.Peer-Reviewed Original ResearchProgression-free survivalOverall survivalCTC statusHormone receptor-positive metastatic breast cancer patientsPredictive valueLonger median progression-free survivalImproved progression-free survivalMedian progression-free survivalMetastatic breast cancer patientsWorse progression-free survivalAddition of BevFirst-line therapyCox regression analysisEarly breast cancerInitiation of treatmentBreast cancer patientsPotential predictive valueML of bloodMetastatic diseaseMultivariable analysisCancer patientsClinical significanceBreast cancerUS FDATumor cells