Lewis Phillips GD, Li G, Dugger DL, Crocker LM, Parsons KL, Mai E, et al. Targeting HER2-positive breast cancer with trastuzumab-DM1, an antibody-cytotoxic drug conjugate. Cancer Res. 2008;68(22):9280–90.
Article
CAS
Google Scholar
Junttila T, Li G, Parsons K, Phillips GL, Sliwkowski MX. Trastuzumab-DM1 (T-DM1) retains all the mechanisms of action of trastuzumab and efficiently inhibits growth of lapatinib insensitive breast cancer cells. Breast Cancer Res Treat. 2011;128:347–56.
Article
CAS
Google Scholar
Verma S, Miles D, Gianni L, Krop IE, Welslau M, Baselga J, et al. Trastuzumab emtansine for HER2-positive advanced breast cancer. N Engl J Med. 2012;367(19):1783–91.
Article
CAS
Google Scholar
von Minckwitz G, Huang CS, Mano MS, Loibl S, Mamounas EP, Untch M, et al. Trastuzumab emtansine for residual invasive HER2-positive breast cancer. N Engl J Med. 2019;380(7):617–28.
Article
Google Scholar
Kadcyla® prescribing information: Genentech, Inc; 2019. https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125427s105lbl.pdf. Accessed 30 Mar 2021.
Agus DB, Akita RW, Fox WD, Lewis GD, Higgins B, Pisacane PI, et al. Targeting ligand-activated ErbB2 signaling inhibits breast and prostate tumor growth. Cancer Cell. 2002;2(2):127–37.
Article
CAS
Google Scholar
Baselga J, Cortés J, Kim SB, Im SA, Hegg R, Im YH, et al. Pertuzumab plus trastuzumab plus docetaxel for metastatic breast cancer. N Engl J Med. 2012;366(2):109–19.
Article
CAS
Google Scholar
Gianni L, Pienkowski T, Im YH, Roman L, Tseng LM, Liu MC, 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.
Article
CAS
Google Scholar
Perez EA, Barrios C, Eiermann W, Toi M, Im YH, Conte P, et al. Trastuzumab emtansine with or without pertuzumab versus trastuzumab plus taxane for human epidermal growth factor receptor 2-positive, advanced breast cancer: primary results from the phase III MARIANNE study. J Clin Oncol. 2017;35:141–8.
Article
CAS
Google Scholar
Hurvitz SA, Martin M, Symmans WF, Jung KH, Huang CS, Thompson AM, et al. Neoadjuvant trastuzumab, pertuzumab, and chemotherapy versus trastuzumab emtansine plus pertuzumab in patients with HER2-positive breast cancer (KRISTINE): a randomised, open-label, multicentre, phase 3 trial. Lancet Oncol. 2018;19(1):115–26.
Article
CAS
Google Scholar
Hurvitz SA, Martin M, Jung KH, Huang CS, Harbeck N, Valero V, et al. Neoadjuvant trastuzumab emtansine and pertuzumab in human epidermal growth factor receptor 2-positive breast cancer: three-year outcomes from the phase III KRISTINE study. J Clin Oncol. 2019;37(25):2206–16.
Article
CAS
Google Scholar
Prat A, Guarneri V, Pare L, Griguolo G, Pascual T, Dieci MV, et al. A multivariable prognostic score to guide systemic therapy in early-stage HER2-positive breast cancer: a retrospective study with an external evaluation. Lancet Oncol. 2020;21:1455–64.
Article
CAS
Google Scholar
Baselga J, Lewis Phillips GD, Verma S, Ro J, Huober J, Guardino AE, et al. Relationship between tumor biomarkers and efficacy in EMILIA, a phase III study of trastuzumab emtansine in HER2-positive metastatic breast cancer [published correction appears in Clin Cancer Res. 2018;24(21):5486]. Clin Cancer Res. 2016;22(15):3755–63.
Article
CAS
Google Scholar
Kim SB, Wildiers H, Krop IE, Smitt M, Yu R, de Haas SL, et al. Relationship between tumor biomarkers and efficacy in TH3RESA, a phase III study of trastuzumab emtansine (T-DM1) vs treatment of physician’s choice in previously treated HER2-positive advanced breast cancer. Int J Cancer. 2016;139(10):2336–42.
Article
CAS
Google Scholar
Perez EA, de Haas SL, Eiermann W, Barrios CH, Toi M, Im YH, et al. Relationship between tumor biomarkers and efficacy in MARIANNE, a phase III study of trastuzumab emtansine ± pertuzumab versus trastuzumab plus taxane in HER2-positive advanced breast cancer [published correction appears in BMC Cancer. 2019 Jun 24;19(1):620]. BMC Cancer. 2019;19(1):517.
Article
Google Scholar
Schneeweiss A, Chia S, Hegg R, Tausch C, Deb R, Ratnayake J, et al. Evaluating the predictive value of biomarkers for efficacy outcomes in response to pertuzumab- and trastuzumab-based therapy: an exploratory analysis of the TRYPHAENA study. Breast Cancer Res. 2014;16(4):R73.
Article
Google Scholar
Bianchini G, Kiermaier A, Bianchi GV, Im YH, Pienkowski T, Liu MC, et al. Biomarker analysis of the NeoSphere study: Pertuzumab, trastuzumab, and docetaxel versus trastuzumab plus docetaxel, pertuzumab plus trastuzumab, or pertuzumab plus docetaxel for the neoadjuvant treatment of HER2-positive breast cancer. Breast Cancer Res. 2017;19(1):16.
Article
Google Scholar
Prat A, Bianchini G, Thomas M, Belousov A, Cheang MCU, Koehler A, et al. Research-based PAM50 subtype predictor identifies higher responses and improved survival outcomes in HER2-positive breast cancer in the NOAH study. Clin Cancer Res. 2014;20:511–21.
Article
CAS
Google Scholar
Dieci MV, Prat A, Tagliafico E, Paré L, Ficarra G, Bisagni G, et al. Integrated evaluation of PAM50 subtypes and immune modulation of pCR in HER2-positive breast cancer patients treated with chemotherapy and HER2-targeted agents in the CherLOB trial. Ann Oncol. 2016;27:1867–73.
Article
CAS
Google Scholar
Schettini F, Pascual T, Conte B, Chic N, Brasó-Maristany F, Galván P, et al. HER2-enriched subtype and pathological complete response in HER2-positive breast cancer: a systematic review and meta-analysis. Cancer Treat Rev. 2020;84: 101965.
Article
CAS
Google Scholar
Prat A, Pascual T, De Angelis C, Gurierrez C, Llombart-Cussac A, Wang T, et al. HER2-enriched subtype and ERBB2 expression in HER2-positive breast cancer treated with dual HER2 blockage. J Natl Cancer Inst. 2020;112:46–54.
Article
Google Scholar
Prat A, Carey LA, Adamo B, Vidal M, Tabernero J, Cortes J, et al. Molecular features and survival outcomes of the intrinsic subtypes within HER2-positive breast cancer. J Natl Cancer Inst. 2014;106:dju152.
Article
Google Scholar
Krop IE, Paulson J, Campbell C, Kiermaier A, Andre F, Fumagalli D, et al. Genomic correlates of response to adjuvant trastuzumab (H) and pertuzumab (P) in HER2+ breast cancer (BC): biomarker analysis of the APHINITY trial. J Clin Oncol. 2019;37(suppl 15):1012.
Article
Google Scholar
Ignatiadis M, Van den Eynden G, Roberto S, Fornili M, Bareche Y, Desmedt C, et al. Tumor-infiltrating lymphocytes in patients receiving trastuzumab/pertuzumab-based chemotherapy: a TRYPHAENA substudy. J Natl Cancer Inst. 2019;111(1):69–77.
Article
Google Scholar
Salgado R, Denkert C, Campbell C, Savas P, Nuciforo P, Aura C, et al. Tumor-infiltrating lymphocytes and associations with pathological complete response and event-free survival in HER2-positive early-stage breast cancer treated with lapatinib and trastuzumab: a secondary analysis of the NeoALTTO trial. JAMA Oncol. 2015;1(4):448–54.
Article
Google Scholar
Ingold Heppner B, Untch M, Denkert C, Pfitzner BM, Lederer B, Schmitt W, et al. Tumor-infiltrating lymphocytes: a predictive and prognostic biomarker in neoadjuvant-treated HER2-positive breast cancer. Clin Cancer Res. 2016;22(23):5747–54.
Article
CAS
Google Scholar
Fumagalli D, Venet D, Ignatiadis M, Hatem AA, Maetens M, Rothe F, et al. RNA sequencing to predict response to neoadjuvant anti-HER2 therapy: a secondary analysis of the NeoALTTO randomized clinical trial. JAMA Oncol. 2017;3(2):227–34.
Article
Google Scholar
Perez EA, Thompson EA, Ballman KV, Anderson SK, Asmann YW, Kalari KR, et al. Genomic analysis reveals that immune function genes are strongly linked to clinical outcome in the North Central Cancer Treatment Group n9831 Adjuvant Trastuzumab Trial. J Clin Oncol. 2015;33(7):701–8.
Article
CAS
Google Scholar
Zoeller JJ, Vagodny A, Taneja K, Tan BY, O’Brien N, Slamon DJ, et al. Neutralization of BCL-2/X L enhances the cytotoxicity of T-DM1 in vivo. Mol Cancer Ther. 2019;18:1115–26.
Article
CAS
Google Scholar
Li G, Guo J, Shen BQ, Yadav DB, Sliwkowski MX, Crocker LM, et al. Mechanisms of acquired resistance to trastuzumab emtansine in breast cancer cells. Mol Cancer Ther. 2018;17:1441–53.
Article
CAS
Google Scholar
Kim J, Kim JH, Im S, Kim YJ, Han H-S, Kim J-S, et al. ABCB1, FCGR2A, and FCGR3A polymorphisms in patients with HER2-positive metastatic breast cancer who were treated with first-line taxane plus trastuzumab chemotherapy. Oncology. 2012;83(4):218–27.
Article
CAS
Google Scholar
Taheri M, Mahjoubi F, Omranipour R. Effect of MDR1 polymorphism on multidrug resistance expression in breast cancer patients. Genet Mol Res. 2010;9(1):34–40.
Article
CAS
Google Scholar
McClelland RA, Finlay P, Walker KJ, Nicholson D, Robertson JF, Blamey RW, et al. Automated quantitation of immunocytochemically localized estrogen receptors in human breast cancer. Cancer Res. 1990;50(12):3545–50.
CAS
Google Scholar
Parker JS, Mullins M, Cheang MC, Leung S, Voduc D, Vickery T, et al. Supervised risk predictor of breast cancer based on intrinsic subtypes. J Clin Oncol. 2009;27(8):1160–7.
Article
Google Scholar
Wilson TR, Yu J, Lu X, Spoerke JM, Xiao Y, O’Brien C, et al. The molecular landscape of high-risk early breast cancer: comprehensive biomarker analysis of a phase III adjuvant population. NPJ Breast Cancer. 2016;2:16022.
Article
Google Scholar
Emens LA, Molinero L, Loi S, Rugo HS, Schneeweiss A, Diéras V, et al. Atezolizumab and nab-paclitaxel in advanced triple-negative breast cancer: biomarker evaluation of the IMpassion130 Study. J Natl Cancer Inst. 2021;113(8):1005–16.
Article
Google Scholar
Hurvitz SA, Caswell-Jin JL, McNamara KL, Zoeller JJ, Bean GR, Dichmann R, et al. Pathologic and molecular responses to neoadjuvant trastuzumab and/or lapatinib from a phase II randomized trial in HER2-positive breast cancer (TRIO-US B07). Nat Commun. 2020;11:5824.
Article
CAS
Google Scholar
Griguolo G, Brasó-Maristany F, González-Farré B, Pascual T, Chic N, Saurí T, et al. ERBB2 mRNA expression and response to ado-trastuzumab emtansine (T-DM1) in HER2-positive breast cancer. Cancers (Basel). 2020;12:1902.
Article
CAS
Google Scholar
Prat A, Guarneri V, Pascual T, Brasó-Maristany F, Sanfeliu E, Paré L, et al. Development and validation of the new HER2DX assay for predicting pathological response and survival outcome in early-stage HER2-positive breast cancer. EBioMedicine. 2022;75: 103801.
Article
CAS
Google Scholar
Gianni L, Eiermann W, Semiglazov V, Manikhas A, Lluch A, Tjulandin S, et al. Neoadjuvant chemotherapy with trastuzumab followed by adjuvant trastuzumab versus neoadjuvant chemotherapy alone, in patients with HER2-positive locally advanced breast cancer (the NOAH trial): a randomised controlled superiority trial with a parallel HER2-negative cohort. Lancet. 2010;375(9712):377–84.
Article
CAS
Google Scholar
Baselga J, Bradbury I, Eidtmann H, Di Cosimo S, de Azambuja E, Aura C, NeoALTTO Study Team, et al. Lapatinib with trastuzumab for HER2-positive early breast cancer (NeoALTTO): a randomised, open-label, multicentre, phase 3 trial. Lancet. 2012;379(9816):633–40.
Article
CAS
Google Scholar
Loibl S, Majewski I, Guarneri V, Nekljudova V, Holmes E, Bria E, et al. PIK3CA mutations are associated with reduced pathological complete response rates in primary HER2-positive breast cancer: pooled analysis of 967 patients from five prospective trials investigating lapatinib and trastuzumab. Ann Oncol. 2016;27:1519–25.
Article
CAS
Google Scholar
Pogue-Geile KL, Song N, Jeong JH, Gavin PG, Kim SR, Blackmon NL, et al. Intrinsic subtypes, PIK3CA mutation, and the degree of benefit from adjuvant trastuzumab in the NSABP B-31 trial. J Clin Oncol. 2015;33(12):1340–7.
Article
CAS
Google Scholar
Denkert C, Lambertini C, Fasching PA, Pogue-Geile KL, Mano MS, 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(suppl 15):502.
Article
Google Scholar
Metzger O, Lambertini C, Krop I, Phillips GL, Perou CM, Symmans I, et al. 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). Ann Oncol. 2021;32(suppl 2):S37-47.
Article
Google Scholar
Brasó-Maristany F, Griguolo G, Pascual T, Paré L, Nuciforo P, Llombart-Cussac A, et al. Phenotypic changes of HER2-positive breast cancer during and after dual HER2 blockade. Nat Commun. 2020;11(1):385.
Article
Google Scholar
Carey LA, Berry DA, Cirrincione CT, Barry WT, Pitcher BN, Harris LN, 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):542–9.
Article
CAS
Google Scholar
Aftimos P, Oliveira M, Irrthum A, Fumagalli D, Sotiriou C, Gal-Yam EN, et al. Genomic and transcriptomic analyses of breast cancer primaries and matched metastases in AURORA, the Breast International Group (BIG) Molecular Screening Initiative. Cancer Discov. 2021;11:2796–811.
Article
CAS
Google Scholar
Martin K, Müller P, Schreiner J, Prince SS, Lardinois D, Heinzelmann-Schwarz VA, et al. The microtubule-depolymerizing agent ansamitocin P3 programs dendritic cells toward enhanced anti-tumor immunity. Cancer Immunol Immunother. 2014;63:925–38.
Article
CAS
Google Scholar
Griguolo G, Serna G, Pascual T, Paré L, Nuciforo P, Llombart-Cussac A, et al. Immune microenvironment characterization and dynamics during anti-HER2-based neoadjuvant treatment in HER2-positive breast cancer. NPJ Precis Oncol. 2021;5:23.
Article
CAS
Google Scholar
Mittendorf EA, Zhang H, Barrios CH, Saji S, Jung KH, Hegg R, et al. Neoadjuvant atezolizumab in combination with sequential nab-paclitaxel and anthracycline-based chemotherapy versus placebo and chemotherapy in patients with early-stage triple-negative breast cancer (IMpassion031): a randomised, double-blind, phase 3 trial. Lancet. 2020;396:1090–100.
Article
CAS
Google Scholar
Schmid P, Cortes J, Pusztai L, McArthur H, Kümmel S, Bergh J, et al. Pembrolizumab for early triple-negative breast cancer. N Engl J Med. 2020;382:810–21.
Article
CAS
Google Scholar