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 updateAssociation of higher baseline stress and pain with clinical outcomes: Secondary analysis from Alliance A011502.
Gandhi S, Ballman K, Holmes M, Visvanathan K, Symington B, Carvan M, Matyka C, Weiss A, Winer E, Razaq W, Carey L, Partridge A, Chen W. Association of higher baseline stress and pain with clinical outcomes: Secondary analysis from Alliance A011502. Journal Of Clinical Oncology 2024, 42: 11016-11016. DOI: 10.1200/jco.2024.42.16_suppl.11016.Peer-Reviewed Original ResearchInvasive disease-free survivalBrief Pain InventoryPerceived Stress ScaleOverall survivalPittsburgh Sleep Quality IndexMultivariate Cox modelClinical outcomesBreast cancerCESD-RClinical trialsAssociated with worse clinical outcomesDouble-blind clinical trialCox modelBrief Pain Inventory scoresHormone receptor statusDisease-free survivalEpidemiologic Studies Depression Scale-RevisedCenter for Epidemiologic Studies Depression Scale-RevisedHigher Perceived Stress ScaleBody mass indexNonmetastatic breast cancerSleep qualityCESD-R scoresPerceived Stress Scale scoresPittsburgh Sleep Quality Index scoreAspirin vs Placebo as Adjuvant Therapy for Breast Cancer
Chen W, Ballman K, Partridge A, Hahn O, Briccetti F, Irvin W, Symington B, Visvanathan K, Pohlmann P, Openshaw T, Weiss A, Winer E, Carey L, Holmes M. Aspirin vs Placebo as Adjuvant Therapy for Breast Cancer. JAMA 2024, 331: 1714-1721. PMID: 38683596, PMCID: PMC11059055, DOI: 10.1001/jama.2024.4840.Peer-Reviewed Original ResearchSurvivors of breast cancerInvasive disease-free survival eventsDisease-free survival eventsNonmetastatic breast cancerBreast cancer recurrenceBreast cancerFollow-upRisk of breast cancer recurrenceHazard ratioInvasive cancer eventOverall survivalPrevent breast cancer recurrenceCancer recurrenceBreast cancer survivalInvasive disease-free survivalRates of grade 3Adjuvant breast cancer treatmentTrial of aspirinSurvival eventsDisease-free survivalMedian follow-upDouble-blind trialDaily aspirin therapyStudies of aspirinBreast cancer treatment
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 ptsAdjuvant paclitaxel and trastuzumab for node-negative, HER2-positive breast cancer: final 10-year analysis of the open-label, single-arm, phase 2 APT trial
Tolaney S, Tarantino P, Graham N, Tayob N, Parè L, Villacampa G, Dang C, Yardley D, Moy B, Marcom P, Albain K, Rugo H, Ellis M, Shapira I, Wolff A, Carey L, Barroso-Sousa R, Villagrasa P, DeMeo M, DiLullo M, Zanudo J, Weiss J, Wagle N, Partridge A, Waks A, Hudis C, Krop I, Burstein H, Prat A, Winer E. Adjuvant paclitaxel and trastuzumab for node-negative, HER2-positive breast cancer: final 10-year analysis of the open-label, single-arm, phase 2 APT trial. The Lancet Oncology 2023, 24: 273-285. PMID: 36858723, DOI: 10.1016/s1470-2045(23)00051-7.Peer-Reviewed Original ResearchConceptsHER2-positive breast cancerInvasive disease-free survivalDisease-free survivalRecurrence-free intervalAdjuvant paclitaxelBreast cancerEastern Cooperative Oncology Group performance statusInvasive disease-free survival eventsDisease-free survival eventsHormone receptor-positive diseaseNew contralateral breast cancerBreast cancer-specific survivalProtocol-defined treatmentCancer-specific survivalReceptor-positive diseasePhase 2 studyContralateral breast cancerLong-term outcomesAPT trialCause deathEligible patientsIntravenous paclitaxelTrastuzumab weeklyDistant recurrenceIpsilateral recurrence
2022
A randomized phase III, double-blinded, placebo-controlled trial of aspirin as adjuvant therapy for breast cancer (A011502): The Aspirin after Breast Cancer (ABC) Trial
Chen W, Ballman K, Winer E, Openshaw T, Hahn O, Briccetti F, Irvin W, Pohlmann P, Carey L, Partridge A, Weiss A, McCall L, Matyka C, Carvan M, Holmes M. A randomized phase III, double-blinded, placebo-controlled trial of aspirin as adjuvant therapy for breast cancer (A011502): The Aspirin after Breast Cancer (ABC) Trial. Journal Of Clinical Oncology 2022, 40: 360922-360922. DOI: 10.1200/jco.2022.40.36_suppl.360922.Peer-Reviewed Original ResearchInvasive disease-free survivalHER2-negative breast cancerStratified hazard ratioDisease-free survivalHazard ratioBreast cancerIDFS eventsAspirin usersCardiovascular diseaseGrade 3/4 adverse eventsAspirin/non-steroidal anti-inflammatory drugsNon-steroidal anti-inflammatory drugsAdjuvant aspirin therapyRandomized phase IIIRegular aspirin usersPlacebo-controlled trialDouble-blinded fashionBreast cancer survivorsBody mass indexBreast cancer trialsBreast cancer survivalBreast cancer recurrenceMultiple epidemiologic studiesAnti-inflammatory drugsAnti-tumor 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 persistenceLocal Therapy Outcomes and Toxicity From the ATEMPT Trial (TBCRC 033): A Phase II Randomized Trial of Adjuvant Trastuzumab Emtansine Versus Paclitaxel in Combination With Trastuzumab in Women With Stage I HER2-Positive Breast Cancer
Bellon JR, Tayob N, Yang DD, Tralins J, Dang CT, Isakoff SJ, DeMeo M, Burstein HJ, Partridge AH, Winer EP, Krop IE, Tolaney SM. Local Therapy Outcomes and Toxicity From the ATEMPT Trial (TBCRC 033): A Phase II Randomized Trial of Adjuvant Trastuzumab Emtansine Versus Paclitaxel in Combination With Trastuzumab in Women With Stage I HER2-Positive Breast Cancer. International Journal Of Radiation Oncology • Biology • Physics 2022, 113: 117-124. PMID: 34990776, DOI: 10.1016/j.ijrobp.2021.12.173.Peer-Reviewed Original ResearchConceptsHER2-positive breast cancerBreast-conserving surgeryStage I HER2-positive breast cancerT-DM1 armBreast radiation therapyT-DM1Radiation therapySkin toxicityBreast cancerBCS patientsWBRT patientsInvasive disease-free survival eventsDisease-free survival eventsInvasive disease-free survivalHuman epidermal growth factor receptor 2Phase II Randomized TrialWhole breast radiation therapyEpidermal growth factor receptor 2Adjuvant T-DM1Adjuvant trastuzumab emtansineEfficacy of HER2RT-related toxicityWeeks of therapyAcute skin toxicityAnti-HER2 therapy
2021
The Breast Cancer Weight Loss trial (Alliance A011401): A description and evidence for the lifestyle intervention
Delahanty LM, Wadden TA, Goodwin PJ, Alfano CM, Thomson CA, Irwin ML, Neuhouser ML, Crane TE, Frank E, Spears PA, Gillis BP, Hershman DL, Paskett ED, Hopkins J, Bernstein V, Stearns V, White J, Hudis C, Winer EP, Carey L, Partridge AH, Ligibel JA. The Breast Cancer Weight Loss trial (Alliance A011401): A description and evidence for the lifestyle intervention. Obesity 2021, 30: 28-38. PMID: 34932888, PMCID: PMC9186690, DOI: 10.1002/oby.23287.Peer-Reviewed Original ResearchConceptsWeight loss interventionWeight loss trialLifestyle interventionHealth education materialsWeight lossLoss trialPhysical activityInvasive disease-free survivalDisease-free survivalBreast cancer patientsBreast cancer diagnosisCare of thousandsEducation materialsBaseline weightCancer outcomesCancer patientsHealth coachesCancer recurrenceBreast cancerCaloric restrictionStage IITrialsCancer diagnosisInterventionWomenTrastuzumab 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 4Adjuvant Trastuzumab Emtansine Versus Paclitaxel in Combination With Trastuzumab for Stage I HER2-Positive Breast Cancer (ATEMPT): A Randomized Clinical Trial
Tolaney SM, Tayob N, Dang C, Yardley DA, Isakoff SJ, Valero V, Faggen M, Mulvey T, Bose R, Hu J, Weckstein D, Wolff AC, Reeder-Hayes K, Rugo HS, Ramaswamy B, Zuckerman D, Hart L, Gadi VK, Constantine M, Cheng K, Briccetti F, Schneider B, Garrett AM, Marcom K, Albain K, DeFusco P, Tung N, Ardman B, Nanda R, Jankowitz RC, Rimawi M, Abramson V, Pohlmann PR, Van Poznak C, Forero-Torres A, Liu M, Ruddy K, Zheng Y, Rosenberg SM, Gelber RD, Trippa L, Barry W, DeMeo M, Burstein H, Partridge A, Winer EP, Krop I. Adjuvant Trastuzumab Emtansine Versus Paclitaxel in Combination With Trastuzumab for Stage I HER2-Positive Breast Cancer (ATEMPT): A Randomized Clinical Trial. Journal Of Clinical Oncology 2021, 39: 2375-2385. PMID: 34077270, DOI: 10.1200/jco.20.03398.Peer-Reviewed Original ResearchConceptsInvasive disease-free survivalT-DM1Breast cancerStage IStage I HER2-positive breast cancerHER2-positive breast cancerHuman epidermal growth factor receptorAdjuvant T-DM1Co-primary objectivesDisease-free survivalPatient-reported outcomesEpidermal growth factor receptorGrowth factor receptorProtocol therapyAnalysis populationTrastuzumab emtansineClinical trialsRelevant toxicityPatientsFactor receptorLess toxicityWeeksTrastuzumabCancerPaclitaxelALEXANDRA/IMpassion030: A phase 3 study of standard adjuvant chemotherapy with or without atezolizumab in patients with early-stage triple-negative breast cancer.
Saji S, McArthur H, Ignatiadis M, Bailey A, El-Abed S, Brandao M, Metzger O, Lai C, Guillaume S, Fumagalli D, Agbor-tarh D, Seiller A, Xifro R, Honvault V, Viale G, DuFrane C, Barata T, Winer E, Gelber R, Piccart-Gebhart M. ALEXANDRA/IMpassion030: A phase 3 study of standard adjuvant chemotherapy with or without atezolizumab in patients with early-stage triple-negative breast cancer. Journal Of Clinical Oncology 2021, 39: tps597-tps597. DOI: 10.1200/jco.2021.39.15_suppl.tps597.Peer-Reviewed Original ResearchTriple-negative breast cancerInvasive disease-free survivalEarly-stage triple-negative breast cancerPD-L1Breast cancerAdjuvant chemotherapyStage triple-negative breast cancerMetastatic triple-negative breast cancerPD-L1 negative tumorsF. Hoffmann-La Roche LtdBreast International GroupOperable stage IIRandomized phase 3Same chemotherapy regimenStandard adjuvant chemotherapyCentral pathology reviewDisease-free survivalPD-L1 statusPhase 3 studyPhase 3 trialType of surgeryNegative breast cancerQuality of lifeAtezolizumab 1200Weekly paclitaxelPalbociclib 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
A 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 trialsABC trial (A011502): A randomized phase III double-blinded placebo-controlled trial of aspirin as adjuvant therapy breast cancer.
Chen W, Winer E, Ballman K, Partridge A, Carey L, Carvan M, Matyka C, Openshaw T, Visvanathan K, Symington B, Holmes M. ABC trial (A011502): A randomized phase III double-blinded placebo-controlled trial of aspirin as adjuvant therapy breast cancer. Journal Of Clinical Oncology 2020, 38: tps600-tps600. DOI: 10.1200/jco.2020.38.15_suppl.tps600.Peer-Reviewed Original ResearchInvasive disease-free survivalAspirin usersCardiovascular diseaseBreast cancerHER2-negative breast cancer patientsBlinded placebo-controlled trialHER2-negative breast cancerNegative breast cancer patientsRandomized phase IIIRegular aspirin usersPlacebo-controlled trialDisease-free survivalHormone receptor statusDouble-blinded fashionMonths of diagnosisBreast cancer survivorsTime of presentationBody mass indexBreast cancer patientsTherapy-Breast CancerBreast cancer survivalMultiple epidemiologic studiesNegative breast cancerAnti-tumor effectsDaily aspirinPrimary 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
289TiP ALEXANDRA/IMpassion030: A phase III study of standard adjuvant chemotherapy with or without atezolizumab in early stage triple negative breast cancer
Ignatiadis M, McArthur H, Bailey A, Martinez J, de Azambuja E, Metzger O, Lai C, Franzoi M, Goulioti T, Daly F, Bouhlel A, Balta V, Maetens M, Viale G, André B, DuFRane C, Nguyen D, Gelber R, Piccart M, Winer E. 289TiP ALEXANDRA/IMpassion030: A phase III study of standard adjuvant chemotherapy with or without atezolizumab in early stage triple negative breast cancer. Annals Of Oncology 2019, 30: v97. DOI: 10.1093/annonc/mdz240.112.Peer-Reviewed Original ResearchTriple-negative breast cancerInvasive disease-free survivalEarly-stage triple-negative breast cancerStage triple-negative breast cancerBreast International GroupNegative breast cancerBreast cancerAdjuvant chemotherapyPD-L1Seattle GeneticsRoche/GenentechMetastatic triple-negative breast cancerRoche-GenentechJules BordetOperable stage IIRandomized phase 3Same chemotherapy regimenStandard adjuvant chemotherapyCentral pathology reviewDisease-free survivalPD-L1 statusPhase 3 trialPhase III studyLymph node statusPD-L1 antibodiesABC trial (A011502): A randomized phase III double-blinded placebo controlled trial of aspirin as adjuvant therapy breast cancer.
Chen W, Winer E, Ballman K, Partridge A, Carey L, Carvan M, Matyka C, Visvanathan K, Symington B, Holmes M. ABC trial (A011502): A randomized phase III double-blinded placebo controlled trial of aspirin as adjuvant therapy breast cancer. Journal Of Clinical Oncology 2019, 37: tps599-tps599. DOI: 10.1200/jco.2019.37.15_suppl.tps599.Peer-Reviewed Original ResearchInvasive disease-free survivalAspirin usersCardiovascular diseaseBreast cancerHER2-negative breast cancer patientsHER2-negative breast cancerNegative breast cancer patientsRandomized phase IIIRegular aspirin usersTrial of aspirinDisease-free survivalHormone receptor statusDouble-blinded fashionMonths of diagnosisBreast cancer survivorsTime of presentationBody mass indexBreast cancer patientsTherapy-Breast CancerBreast cancer survivalMultiple epidemiologic studiesNegative breast cancerAnti-tumor effectsDaily aspirinIDFS events
2017
Randomized phase III trial evaluating the role of weight loss in adjuvant treatment of overweight and obese women with early breast cancer (Alliance A011401): study design
Ligibel JA, Barry WT, Alfano C, Hershman DL, Irwin M, Neuhouser M, Thomson CA, Delahanty L, Frank E, Spears P, Paskett ED, Hopkins J, Bernstein V, Stearns V, White J, Hahn O, Hudis C, Winer EP, Wadden TA, Goodwin PJ. Randomized phase III trial evaluating the role of weight loss in adjuvant treatment of overweight and obese women with early breast cancer (Alliance A011401): study design. Npj Breast Cancer 2017, 3: 37. PMID: 28948213, PMCID: PMC5608692, DOI: 10.1038/s41523-017-0040-8.Peer-Reviewed Original ResearchEarly breast cancerWeight loss interventionWeight loss programBreast cancer recurrenceBreast cancerBody weightWeight lossLoss interventionLoss programCancer recurrencePhysical activityHER-2 negative breast cancerInvasive disease-free survivalRandomized phase III trialDana-Farber Cancer InstitutePurposeful weight lossBaseline body weightCancer diagnosisDisease-free survivalExcess body weightPhase III trialsPoor prognostic factorIncidence of comorbiditiesBody mass indexWeight loss trial