2024
Final analysis of the ALTTO trial: adjuvant trastuzumab in sequence or in combination with lapatinib in patients with HER2-positive early breast cancer [BIG 2-06/NCCTG N063D (Alliance)]
de Azambuja E, Piccart-Gebhart M, Fielding S, Townend J, Hillman D, Colleoni M, Roylance R, Kelly C, Lombard J, El-Abed S, Choudhury A, Korde L, Vicente M, Chumsri S, Rodeheffer R, Ellard S, Wolff A, Holtschmidt J, Lang I, Untch M, Boyle F, Xu B, Werutsky G, Tujakowski J, Huang C, Baruch N, Bliss J, Ferro A, Gralow J, Kim S, Kroep J, Krop I, Kuemmel S, McConnell R, Moscetti L, Knop A, van Duijnhoven F, Gomez H, Cameron D, Di Cosimo S, Gelber R, Moreno-Aspitia A. Final analysis of the ALTTO trial: adjuvant trastuzumab in sequence or in combination with lapatinib in patients with HER2-positive early breast cancer [BIG 2-06/NCCTG N063D (Alliance)]. ESMO Open 2024, 9: 103938. PMID: 39418883, PMCID: PMC11532431, DOI: 10.1016/j.esmoop.2024.103938.Peer-Reviewed Original ResearchDisease-free survivalHER2-positive early breast cancerEarly breast cancerOverall survivalALTTO trialBreast cancerFollow-upMetastatic HER2-positive breast cancerDual anti-HER2 blockadeAnti-human epidermal growth factor receptor 2HER2-positive breast cancerEpidermal growth factor receptor 2Lapatinib to trastuzumabAnti-HER2 therapyAnti-HER2 blockadeTreatment groupsOutcomes of patientsAdjuvant trastuzumabOpen-labelAdjuvant chemotherapyPrimary endpointSecondary endpointsEfficacy analysisMulticenter studyAnti-HER2
2021
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)
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 ResearchAdjuvant Pertuzumab and Trastuzumab in Early HER2-Positive Breast Cancer in the APHINITY Trial: 6 Years' Follow-Up
Piccart M, Procter M, Fumagalli D, de Azambuja E, Clark E, Ewer MS, Restuccia E, Jerusalem G, Dent S, Reaby L, Bonnefoi H, Krop I, Liu TW, Pieńkowski T, Toi M, Wilcken N, Andersson M, Im YH, Tseng LM, Lueck HJ, Colleoni M, Monturus E, Sicoe M, Guillaume S, Bines J, Gelber RD, Viale G, Thomssen C. Adjuvant Pertuzumab and Trastuzumab in Early HER2-Positive Breast Cancer in the APHINITY Trial: 6 Years' Follow-Up. Journal Of Clinical Oncology 2021, 39: 1448-1457. PMID: 33539215, DOI: 10.1200/jco.20.01204.Peer-Reviewed Original ResearchConceptsInvasive disease-free survivalBreast cancerHazard ratioOverall survivalHigh-risk node-negative breast cancerEarly HER2-positive breast cancerHER2-positive early breast cancerNode-negative breast cancerHuman epidermal growth factor receptor 2HER2-positive breast cancerEpidermal growth factor receptor 2HR-negative diseaseHR-positive diseaseInterim overall survivalNode-negative cohortNode-positive cohortPrimary cardiac eventsSix-year OSStandard adjuvant chemotherapyDisease-free survivalNew safety signalsEarly breast cancerGrowth factor receptor 2Standard adjuvant therapyPositive breast cancer
2020
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).
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
2012
Evaluation of gene expression by RNA-seq after single dose of trastuzumab (T) reveals predictors of pathologic complete response (pCR) in HER2-positive early breast cancer.
Galanina N, Sprecher E, Bossuyt V, Sarkar S, Krop I, Winer E, Tuck D, Bruce C, Harris L. Evaluation of gene expression by RNA-seq after single dose of trastuzumab (T) reveals predictors of pathologic complete response (pCR) in HER2-positive early breast cancer. Journal Of Clinical Oncology 2012, 30: 10558-10558. DOI: 10.1200/jco.2012.30.15_suppl.10558.Peer-Reviewed Original ResearchPathologic complete responseSingle doseClinical trialsHER2-positive early breast cancerEarly breast cancer patientsEarly breast cancerBreast cancer patientsTumor core biopsiesSubsequent clinical trialsWeek time pointMost gene expression changesComplete responseCancer patientsPredictive markerCore biopsyBreast cancerImmune pathwaysTumorsTime pointsB2MGene expression changesBrief exposureHER2DoseTrials