2024
Adjuvant Pertuzumab and Trastuzumab in Early Human Epidermal Growth Factor Receptor 2–Positive Breast Cancer in the APHINITY Trial: Third Interim Overall Survival Analysis With Efficacy Update
Loibl S, Jassem J, Sonnenblick A, Parlier D, Winer E, Bergh J, Gelber R, Restuccia E, Im Y, Huang C, Dalenc F, Calvo I, Procter M, Caballero C, Clark E, Raimbault A, McConnell R, Monturus E, de Azambuja E, Gomez H, Bliss J, Viale G, Bines J, Piccart M, Aebi S, Andersson M, Bergh J, Bines J, Bliss J, Bonnefoi H, Caballero C, Cameron D, Cardoso F, Clark E, de Azambuja E, de Haas S, Dent S, Fein L, Frank E, Gelber R, Gnant M, Gomez Moreno H, Im S, Jackisch C, Janni W, Jassem J, Krop I, Kümmel S, Liu T, Loi S, Loibl S, Masuda N, Nili Gam-Yal E, Nyawira B, Pascual T, Piccart M, Pienkowski T, Procter M, Restuccia E, Rodríguez-Lescure Á, Suter T, Thomssen C, Tjan-Heijnen V, Tomasello G, Torres Ulloa M, Twelves C, Viale G, Walshe J, Wilcken N, Winer E. Adjuvant Pertuzumab and Trastuzumab in Early Human Epidermal Growth Factor Receptor 2–Positive Breast Cancer in the APHINITY Trial: Third Interim Overall Survival Analysis With Efficacy Update. Journal Of Clinical Oncology 2024, 42: 3643-3651. PMID: 39259927, DOI: 10.1200/jco.23.02505.Peer-Reviewed Original ResearchInvasive disease-free survivalNode-negative cohortNode-positive cohortOverall survivalBreast cancerAPHINITY trialHuman epidermal growth factor receptor 2-positiveEpidermal growth factor receptor 2-positiveInvasive disease-free survival benefitHER2+) breast cancerHuman epidermal growth factor receptor 2-positive breast cancerInterim overall survival analysisYears of median follow-upIntent-to-treat populationInterim analysisHormone receptor-negativeDisease-free survivalMedian follow-upPrimary end pointOverall survival analysisAdjuvant pertuzumabAdjuvant trastuzumabReceptor-negativePlacebo groupClinical trial update
2021
Palbociclib 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
2019
Atezolizumab plus nab-paclitaxel as first-line treatment for unresectable, locally advanced or metastatic triple-negative breast cancer (IMpassion130): updated efficacy results from a randomised, double-blind, placebo-controlled, phase 3 trial
Schmid P, Rugo HS, Adams S, Schneeweiss A, Barrios CH, Iwata H, Diéras V, Henschel V, Molinero L, Chui SY, Maiya V, Husain A, Winer EP, Loi S, Emens LA, Investigators I. Atezolizumab plus nab-paclitaxel as first-line treatment for unresectable, locally advanced or metastatic triple-negative breast cancer (IMpassion130): updated efficacy results from a randomised, double-blind, placebo-controlled, phase 3 trial. The Lancet Oncology 2019, 21: 44-59. PMID: 31786121, DOI: 10.1016/s1470-2045(19)30689-8.Peer-Reviewed Original ResearchMeSH KeywordsAdolescentAdultAgedAlbuminsAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsBiomarkers, TumorDouble-Blind MethodFemaleFollow-Up StudiesHumansMiddle AgedNeoplasm InvasivenessNeoplasm MetastasisPaclitaxelPrognosisReceptor, ErbB-2Receptors, EstrogenReceptors, ProgesteroneSurvival RateTriple Negative Breast NeoplasmsYoung AdultConceptsMetastatic triple-negative breast cancerInterim overall survival analysisTriple-negative breast cancerOverall survival analysisTreatment-related deathsMedian overall survivalNab-paclitaxelPhase 3 trialOverall survivalTreat populationBreast cancerSurvival analysisAtezolizumab groupPlacebo groupInterim analysisTreatment groupsEastern Cooperative Oncology Group performance statusDay 1Interactive voice-web response systemInvestigator-assessed progression-free survivalMeaningful overall survival benefitNew treatment-related deathsProgression-free survival resultsSolid Tumors version 1.1Tumor-infiltrating immune cells
2017
Updated results from MONALEESA-2, a phase 3 trial of first-line ribociclib + letrozole in 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, Petrakova K, Blackwell K, Winer E, Janni W, Verma S, Conte P, Arteaga C, Cameron D, Xuan F, Miller M, Germa C, Hirawat S, O'Shaughnessy J. Updated results from MONALEESA-2, a phase 3 trial of first-line ribociclib + letrozole in hormone receptor-positive (HR+), HER2-negative (HER2–), advanced breast cancer (ABC). Journal Of Clinical Oncology 2017, 35: 1038-1038. DOI: 10.1200/jco.2017.35.15_suppl.1038.Peer-Reviewed Original ResearchAdvanced breast cancerProgression-free survivalMONALEESA-2Treatment benefitInterim analysisHER2- ABCLET armEndocrine therapyPostmenopausal womenGrade 3/4 laboratory abnormalitiesFirst-line ribociclibElevated alanine aminotransferasePhase 3 trialSecond interim analysisFirst-line treatmentFirst interim analysisET resistancePFS ratesPrimary endpointPrior therapySecondary endpointsLaboratory abnormalitiesMedian durationOverall survivalPFS events
2015
Randomized Phase III Trial of Paclitaxel Once Per Week Compared With Nanoparticle Albumin-Bound Nab-Paclitaxel Once Per Week or Ixabepilone With Bevacizumab As First-Line Chemotherapy for Locally Recurrent or Metastatic Breast Cancer: CALGB 40502/NCCTG N063H (Alliance)
Rugo HS, Barry WT, Moreno-Aspitia A, Lyss AP, Cirrincione C, Leung E, Mayer EL, Naughton M, Toppmeyer D, Carey LA, Perez EA, Hudis C, Winer EP. Randomized Phase III Trial of Paclitaxel Once Per Week Compared With Nanoparticle Albumin-Bound Nab-Paclitaxel Once Per Week or Ixabepilone With Bevacizumab As First-Line Chemotherapy for Locally Recurrent or Metastatic Breast Cancer: CALGB 40502/NCCTG N063H (Alliance). Journal Of Clinical Oncology 2015, 33: 2361-2369. PMID: 26056183, PMCID: PMC4500830, DOI: 10.1200/jco.2014.59.5298.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAlbuminsAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsBevacizumabBreast NeoplasmsDrug Administration ScheduleEpothilonesFemaleHumansMiddle AgedNanoparticlesNeoplasm MetastasisNeoplasm Recurrence, LocalPaclitaxelTreatment OutcomeConceptsAdvanced breast cancerProgression-free survivalNab-paclitaxelBreast cancerInterim analysisMedian progression-free survivalRandomized phase III trialEarly dose reductionSecond interim analysisFirst-line therapyPhase III trialsMetastatic breast cancerFirst interim analysisEligible patientsLine chemotherapyNonhematologic toxicityPalliative chemotherapyHazard ratioIII trialsOverall survivalPeripheral neuropathyTreatment failureExperimental armLocally RecurrentArm C
2012
CALGB 40502/NCCTG N063H: Randomized phase III trial of weekly paclitaxel (P) compared to weekly nanoparticle albumin bound nab-paclitaxel (NP) or ixabepilone (Ix) with or without bevacizumab (B) as first-line therapy for locally recurrent or metastatic breast cancer (MBC).
Rugo H, Barry W, Moreno-Aspitia A, Lyss A, Cirrincione C, Mayer E, Naughton M, Layman R, Carey L, Somer R, Perez E, Hudis C, Winer E. CALGB 40502/NCCTG N063H: Randomized phase III trial of weekly paclitaxel (P) compared to weekly nanoparticle albumin bound nab-paclitaxel (NP) or ixabepilone (Ix) with or without bevacizumab (B) as first-line therapy for locally recurrent or metastatic breast cancer (MBC). Journal Of Clinical Oncology 2012, 30: cra1002-cra1002. DOI: 10.1200/jco.2012.30.18_suppl.cra1002.Peer-Reviewed Original ResearchProgression-free survivalMetastatic breast cancerNab-paclitaxelPhase III trialsSensory neuropathyHazard ratioIII trialsInterim analysisGrade 2 sensory neuropathyMedian progression-free survivalAlbumin-bound formulationWeekly nanoparticle albuminPrimary end pointFirst-line therapyHormone receptor statusCause deathMeasurable diseaseWeek dosingWeekly paclitaxelHematologic toxicityFree survivalReceptor statusTaxane useExperimental armNanoparticle albumin