Pauletti G., Dandekar S., Rong H., Ramos L., Peng H., Seshadri R., Slamon D.J. Assessment of methods for tissue-based detection of the HER-2/neu alteration in human breast cancer: a direct comparison of fluorescence in situ hybridization and immunohistochemistry. J Clin Oncol. 2000;18(21):3651– 3664. https://doi.org/10.1200/JCO.2000.18.21.3651..
DOI: 10.1200/JCO.2000.18.21.3651
Slamon D.J., Clark G.M., Wong S.G., Levin W.J., Ullrich A., McGuire W.L. Human breast cancer: correlation of relapse and survival with amplification of the HER-2/neu oncogene. Science. 1987;235(4785):177–182. https://doi.org/10.1126/science.3798106..
DOI: 10.1126/science.3798106
Cossetti R.J.D., Tyldesley S., Speers C., Zheng Y., Gelmon K.A. Comparison of breast cancer recurrence and outcome patterns between patients treated from 1986 to 1992 and from 2004 to 2008. J Clin Oncol. 2015;33(1):65–73. https://doi.org/10.1200/JCO.2014.57.2461..
DOI: 10.1200/JCO.2014.57.2461
Lambertini M., Pondé N.F., Solinas C., de Azambuja E. Adjuvant trastuzumab: a 10-year overview of its benefit. Expert Rev Anticancer Ther. 2017;17(1):61–74. https://doi.org/10.1080/14737140.2017.1264876..
DOI: 10.1080/14737140.2017.1264876
Romond E.H., Perez E.A., Bryant J., Suman V.J., Geyer Jr C.E., Davidson N.E., et al. Trastuzumab plus adjuvant chemotherapy for operable HER2- positive breast cancer. N Engl J Med. 2005;353(16):1673–1684. https://doi. org/10.1056/NEJMoa052122..
DOI: 10.1056/NEJMoa052122
Slamon D., Eiermann W., Robert N., Pienkowski T., Martin M., Press M. et al. Adjuvant trastuzumab in HER2-positive breast cancer. N Engl J Med. 2011;365(14):1273–1283. https://doi.org/10.1056/NEJMoa0910383..
DOI: 10.1056/NEJMoa0910383
Gianni L., Eiermann W., Semiglazov V., Lluch A., Tjulandin S., Zambetti M. et al. Neoadjuvant and adjuvant trastuzumab in patients with HER2- positive locally advanced breast cancer (NOAH): follow-up of a randomised controlled superiority trial with a parallel HER2-negative cohort. Lancet Oncol. 2014;15(6):640–647. https://doi.org/10.1016/S1470-2045(14)70080-4..
DOI: 10.1016/S1470-2045(14)70080-4
De Azambuja E., Holmes A.P., Piccart-Gebhart M., Holmes E., Di Cosimo S., Swaby R.F. et al. Lapatinib with trastuzumab for HER2-positive early breast cancer (NeoALTTO): survival outcomes of a randomised, open-label, multicentre, phase 3 trial and their association with pathological complete response. Lancet Oncol. 2014;15(10):1137–1146. https://doi.org/10.1016/S1470-2045(14)70320-1..
DOI: 10.1016/S1470-2045(14)70320-1
Carey L.A., Berry D.A., Cirrincione C.T., Barry W.T., Pitcher B.N., Harris L.N., et al. Molecular heterogeneity and response to neoadjuvant human epidermal growth factor receptor 2 targeting in CALGB 40601, a randomized phase III trial of paclitaxel plus trastuzumab with or without lapatinib. J Clin Oncol. 2016;34(6):542–548. https://doi.org/10.1200/JCO.2015.62.1268..
DOI: 10.1200/JCO.2015.62.1268
Robidoux A., Tang G., Rastogi P., Geyer Jr C.E., Azar C.A., Atkins J.N. et al. Lapatinib as a component of neoadjuvant therapy for HER2-positive operable breast cancer (NSABP protocol B-41): an open-label, randomised phase 3 trial. Lancet Oncol. 2013;14(12):1183–1192. https://doi. org/10.1016/S1470-2045(13)70411-X..
DOI: 10.1016/S1470-2045(13)70411-X
Gianni L., Pienkowski T., Im Y.H., Roman L., Tseng L.M., Liu M.C. et al. Efficacy and safety of neoadjuvant pertuzumab and trastuzumab in women with locally advanced, inflammatory, or early HER2-positive breast cancer (NeoSphere): a randomised multicentre, open-label, phase 2 trial. Lancet Oncol. 2012;13(1):25–32. https://doi.org/10.1016/S1470-2045(11)70336-9..
DOI: 10.1016/S1470-2045(11)70336-9
Gianni L., Pienkowski T., Im Y.H., Tseng L.M., Liu M.C., Lluch A. et al. 5-year analysis of neoadjuvant pertuzumab and trastuzumab in patients with locally advanced, inflammatory, or early-stage HER2-positive breast cancer (NeoSphere): a multicentre, open-label, phase 2 randomised trial. Lancet Oncol. 2016;17(6):791–800. https://doi.org/10.1016/S1470-2045(16)00163-7..
DOI: 10.1016/S1470-2045(16)00163-7
Schneeweiss A., Chia S., Hickish T., Harvey V., Eniu A., Hegg R., et al. Pertuzumab plus trastuzumab in combination with standard neoadjuvant anthracycline-containing and anthracycline-free chemotherapy regimens in patients with HER2-positive early breast cancer: a randomized phase II cardiac safety study (TRYPHAENA) Ann Oncol. 2013;24(9):2278–2284. https://doi.org/10.1093/annonc/mdt182..
DOI: 10.1093/annonc/mdt182
Cortazar P., Zhang L., Untch M., Mehta K., Costantino J.P., Wolmark N. et al. Pathological complete response and long-term clinical benefit in breast cancer: The CTNeoBC pooled analysis. Lancet. 2014;384(9938):164–172. https://doi.org/10.1016/S0140-6736(13)62422-8..
DOI: 10.1016/S0140-6736(13)62422-8
Spring L.M., Fell G., Arfe A., Sharma C., Greenup R., Reynolds K.L. et al. Pathologic Complete Response after Neoadjuvant Chemotherapy and Impact on Breast Cancer Recurrence and Survival: A Comprehensive Metaanalysis. Clin Cancer Res. 2020;26(12):2838–2848. https://doi.org/10.1158/1078-0432.CCR-19-3492..
DOI: 10.1158/1078-0432.CCR-19-3492
Jackisch C., Cortazar P., Geyer Jr C.E., Gianni L., Gligorov J., Machackova Z. et al. Risk-based decision-making in the treatment of HER2-positive early breast cancer: Recommendations based on the current state of knowledge. Cancer Treat Rev. 2021;99:102229. https://doi.org/10.1016/j.ctrv.2021.102229..
DOI: 10.1016/j.ctrv.2021.102229
Untch M., Fasching P.A., Konecny G.E., Hasmüller S., Lebeau A., Kreienberg R. et al. Pathologic complete response after neoadjuvant chemotherapy plus trastuzumab predicts favorable survival in human epidermal growth factor receptor 2–overexpressing breast cancer: results from the TECHNO trial of the AGO and GBG study groups. J Clin Oncol. 2011;29(25):3351–3357. Https://doi.org/10.1200/JCO.2010.31.4930..
DOI: 10.1200/JCO.2010.31.4930
Schneeweiss A., Chia S., Hickish T., Harvey V., Eniu A., Waldron-Lynch M. et al. Long-term efficacy analysis of the randomised, phase II TRYPHAENA cardiac safety study: evaluating pertuzumab and trastuzumab plus standard neoadjuvant anthracycline-containing and anthracycline-free chemotherapy regimens in patients with HER2-positive early breast cancer. Eur J Cancer. 2018;89:27–35. https://doi.org/10.1016/j.ejca.2017.10.021..
DOI: 10.1016/j.ejca.2017.10.021
Von Minckwitz G., Huang C.S., Mano M.S., Loibl S., Mamounas E.P., Untch M. et al. Trastuzumab emtansine for residual invasive HER2-positive breast cancer. N Engl J Med. 2019;380(7):617–628. https://doi.org/10.1056/NEJMoa1814017..
DOI: 10.1056/NEJMoa1814017
Birrer M.J., Moore K.N., Betella I., Bates, R.C. Antibody-drug conjugatebased therapeutics: state of the science. J Natl Cancer Inst. 2019;111(6):538–549. https://doi.org/10.1093/jnci/djz035..
DOI: 10.1093/jnci/djz035
Diéras V., Miles D., Verma S., Pegram M., Welslau M., Baselga J. et al. Trastuzumab emtansine versus capecitabine plus lapatinib in patients with previously treated HER2-positive advanced breast cancer (EMILIA): a descriptive analysis of final overall survival results from a randomised, open-label, phase 3 trial. Lancet Oncol. 2017;18(6):732–742. https://doi.org/10.1016/S1470-2045(17)30312-1..
DOI: 10.1016/S1470-2045(17)30312-1
Krop I.E., Kim S.B., González-Martín A., LoRusso P.M., Ferrero J.M., Smitt M. et al. Trastuzumab emtansine versus treatment of physician’s choice for pretreated HER2-positive advanced breast cancer (TH3RESA): a randomised, open-label, phase 3 trial. Lancet Oncol. 2014;15(7):689–699. https://doi.org/10.1016/S1470-2045(14)70178-0..
DOI: 10.1016/S1470-2045(14)70178-0
Mamounas E.P., Untch M., Mano M.S., Huang C.S., Geyer Jr C.E., von Minckwitz G. et al. Adjuvant T-DM1 versus trastuzumab in patients with residual invasive disease after neoadjuvant therapy for HER2-positive breast cancer: subgroup analyses from KATHERINE. Ann Oncol. 2021;32(8):1005–1014. https://doi.org/10.1016/j.annonc.2021.04.011..
DOI: 10.1016/j.annonc.2021.04.011
Hanusch C., Schneeweiss A., Loibl S., Untch M., Paepke S., Kümmel S. et al. Dual blockade with AFatinib and trastuzumab as NEoadjuvant treatment for patients with locally advanced or operable breast cancer receiving taxane–anthracycline containing chemotherapy—DAFNE (GBG-70). Clin Cancer Res. 2015;21(13):2924–2931. https://doi.org/10.1158/1078-0432.CCR-14-2774..
DOI: 10.1158/1078-0432.CCR-14-2774
Van Ramshorst M.S., van der Voort A., van Werkhoven E.D., Mandjes I.A., Kemper I., Dezentjé V.O. et al. Neoadjuvant chemotherapy with or without anthracyclines in the presence of dual HER2 blockade for HER2-positive breast cancer (TRAIN-2): a multicentre, open-label, randomised, phase 3 trial. Lancet Oncol. 2018;19(12):1630–1640. https://doi.org/10.1016/S1470-2045(18)30570-9..
DOI: 10.1016/S1470-2045(18)30570-9
Жукова Л.Г., Смолин С.А. Постнеоадъювантная терапия-новый подход в лечении HER2-положительного рака молочной железы (результаты исследования KATHERINE). Медицинский совет. 2019;(19):44–49. https://doi.org/10.21518/2079-701X-2019-19-44-49..
DOI: 10.21518/2079-701X-2019-19-44-49
Denkert C., Lambertini C., Fasching P.A., Pogue-Geile K.L., Mano M.S., Untch M. et al. Biomarker data from KATHERINE: A phase III study of adjuvant trastuzumab emtansine (T-DM1) versus trastuzumab (H) in patients with residual invasive disease after neoadjuvant therapy for HER2- positive breast cancer. J Clin Oncol. 2020; 38(15_suppl):502–502. http://doi.org/10.1200/JCO.2020.38.15_suppl.502..
DOI: 10.1200/JCO.2020.38.15_suppl.502
Huang C.S.., Yang Y., Kwong A., Chen S.C., Tseng L.M., Liu M.C. et al. Trastuzumab emtansine (T-DM1) versus trastuzumab in Chinese patients with residual invasive disease after neoadjuvant chemotherapy and HER2-targeted therapy for HER2-positive breast cancer in the phase 3 KATHERINE study. Breast Cancer Res Treat. 2021;187(3):759–768. https://doi.org/10.1007/s10549-021-06166-y..
DOI: 10.1007/s10549-021-06166-y
Wedam S., Fashoyin-Aje L., Gao X., Bloomquist E., Tang S., Sridhara R. et al. FDA Approval Summary: Ado-trastuzumab emtansine for the adjuvant treatment of HER2-positive early breast cancer. Clin Cancer Res. 2020;26(16):4180–4185. https://doi.org/10.1158/1078-0432.CCR-19-3980..
DOI: 10.1158/1078-0432.CCR-19-3980
Schneeweiss A., Loibl S., Mamounas E.P., Minckwitz G.V., Mano M.S., Untch M. et al. Patient-reported outcomes (PROs) from KATHERINE: A phase III study of adjuvant trastuzumab emtansine (T-DM1) versus trastuzumab (H) in patients (pts) with residual invasive disease after neoadjuvant therapy for HER2-positive breast cancer. Cancer. 2020;126(13):3132–3139. https://doi.org/10.1002/cncr.32873..
DOI: 10.1002/cncr.32873