REFERENCES
1. Haque R, Ahmed SA, Inzhakova G, et al. Impact of breast cancer subtypes and treatment on survival: an analysis spanning two decades. Cancer Epidemiol Biomarkers Prev 2012;21:1848-55.
2. Slamon DJ, Leyland-jones B, Shak S, et al. Use of chemotherapy plus a monoclonal antibody against HER2 for metastatic breast cancer that overexpresses HER2. N Engl J Med 2001;344:783-92.
3. Perez EA, Romond EH, Suman VJ, et al. Trastuzumab plus adjuvant chemotherapy for human epidermal growth factor receptor
4. Valabrega G, Montemurro F, Aglietta M. Trastuzumab: mechanism of action, resistance and future perspectives in HER2-overexpressing breast cancer. Ann Oncol 2007;18:977-84.
5. Mukohara T. Mechanisms of resistance to anti-human epidermal growth factor receptor 2 agents in breast cancer. Cancer Sci 2011;102:1-8.
6. Metzger-Filho O, Winer EP, Krop I. Pertuzumab: optimizing HER2 blockade. Clin Cancer Res 2013;19:5552-6.
7. Swain SM, Miles D, Kim S, et al. Pertuzumab, trastuzumab, and docetaxel for HER2-positive metastatic breast cancer (CLEOPATRA): end-of-study results from a double-blind, randomised, placebo-controlled, phase 3 study. Lancet Oncol 2020;21:519-30.
8. Diéras V, Miles D, Verma S, 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;18:732-42.
9. Verma S, Miles D, Gianni L, et al. EMILIA Study Group. Trastuzumab emtansine for HER2-positive advanced breast cancer. N Engl J Med 2012;367:1783-91.
10. Perez EA, Barrios C, Eiermann W, et al. Trastuzumab emtansine with or without pertuzumab versus trastuzumab with taxane for human epidermal growth factor receptor 2-positive advanced breast cancer: final results from MARIANNE. Cancer 2019;125:3974-84.
11. Hurvitz SA, Martin M, Jung KH, 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;37:2206-16.
12. von Minckwitz G, Huang CS, Mano MS, et al; KATHERINE Investigators. Trastuzumab emtansine for residual invasive HER2-positive breast cancer. N Engl J Med 2019;380:617-28.
13. Hunter FW, Barker HR, Lipert B, et al. Mechanisms of resistance to trastuzumab emtansine (T-DM1) in HER2-positive breast cancer. Br J Cancer 2020;122:603-12.
14. Trail PA, Dubowchik GM, Lowinger TB. Antibody drug conjugates for treatment of breast cancer: novel targets and diverse approaches in ADC design. Pharmacol Ther 2018;181:126-42.
15. Erickson HK, Park PU, Widdison WC, et al. Antibody-maytansinoid conjugates are activated in targeted cancer cells by lysosomal degradation and linker-dependent intracellular processing. Cancer Res 2006;66:4426-33.
16. Mittendorf EA, Wu Y, Scaltriti M, et al. Loss of HER2 amplification following trastuzumab-based neoadjuvant systemic therapy and survival outcomes. Clin Cancer Res 2009;15:7381-8.
17. Sakai H, Tsurutani J, Iwasa T, et al. HER2 genomic amplification in circulating tumor DNA and estrogen receptor positivity predict primary resistance to trastuzumab emtansine (T-DM1) in patients with HER2-positive metastatic breast cancer. Breast Cancer 2018;25:605-13.
18. Gebhart G, Lamberts LE, Wimana Z, et al. Molecular imaging as a tool to investigate heterogeneity of advanced HER2-positive breast cancer and to predict patient outcome under trastuzumab emtansine (T-DM1): the ZEPHIR trial. Ann Oncol 2016;27:619-24.
19. Filho OM, Viale G, Stein S, et al. Impact of HER2 heterogeneity on treatment response of early-stage HER2-positive breast cancer: phase II neoadjuvant clinical trial of T-DM1 combined with pertuzumab. Cancer Discov 2021;11:2474-87.
20. Kovtun YV, Audette CA, Mayo MF, et al. Antibody-maytansinoid conjugates designed to bypass multidrug resistance. Cancer Res 2010;70:2528-37.
21. Sabbaghi M, Gil-Gómez G, Guardia C, et al. Defective cyclin B1 induction in trastuzumab-emtansine (T-DM1) acquired resistance in HER2-positive breast cancer. Clin Cancer Res 2017;23:7006-19.
22. Emens LA, Esteva FJ, Beresford M, et al. Trastuzumab emtansine plus atezolizumab versus trastuzumab emtansine plus placebo in previously treated, HER2-positive advanced breast cancer (KATE2): a phase 2, multicentre, randomised, double-blind trial. Lancet Oncol 2020;21:1283-95.
23. ClinicalTrials.gov. A study evaluating the efficacy and safety of adjuvant atezolizumab or placebo and trastuzumab emtansine for participants with HER2-positive breast cancer at high risk of recurrence following preoperative therapy (Astefania). Available from: https://clinicaltrials.gov/ct2/show/NCT04873362 [Last accessed on 29 Dec 2022].
24. ClinicalTrials.gov. A study of tucatinib vs. placebo in combination with ado-trastuzumab emtansine (T-DM1) for patients with advanced or metastatic HER2+ breast cancer. Available from: https://clinicaltrials.gov/ct2/show/NCT03975647 [Last accessed on 29 Dec 2022].
25. Modi S, Jacot W, Yamashita T, et al. DESTINY-Breast04 Trial Investigators. Trastuzumab deruxtecan in previously treated HER2-low advanced breast cancer. N Engl J Med 2022;387:9-20.
26. Ferraro E, Drago JZ, Modi S. Implementing antibody-drug conjugates (ADCs) in HER2-positive breast cancer: state of the art and future directions. Breast Cancer Res 2021;23:84.
27. Rinnerthaler G, Gampenrieder SP, Greil R. HER2 directed antibody-drug-conjugates beyond T-DM1 in breast cancer. Int J Mol Sci 2019;20:1115.
28. Li L, Zhang D, Liu B, et al. Antibody-drug conjugates in HER2-positive breast cancer. Chin Med J 2021;135:261-7.
29. Ogitani Y, Aida T, Hagihara K, et al. DS-8201a, a novel HER2-targeting ADC with a novel DNA topoisomerase I inhibitor, demonstrates a promising antitumor efficacy with differentiation from T-DM1. Clin Cancer Res 2016;22:5097-108.
30. Tamura K, Tsurutani J, Takahashi S, et al. Trastuzumab deruxtecan (DS-8201a) in patients with advanced HER2-positive breast cancer previously treated with trastuzumab emtansine: a dose-expansion, phase 1 study. Lancet Oncol 2019;20:816-26.
31. Modi S, Saura C, Yamashita T, et al. DESTINY-Breast01 Investigators. Trastuzumab deruxtecan in previously treated HER2-positive breast cancer. N Engl J Med 2020;382:610-21.
32. Modi S, Saura C, Yamashita T, et al. Updated results from DESTINY-Breast01, a phase 2 trial of trastuzumab deruxtecan (T-DXd) in HER2-positive metastatic breast cancer. San Antonio Breast Cancer Symposium; 2020.
33. Cortés J, Kim SB, Chung WP, et al. DESTINY-Breast03 Trial Investigators. Trastuzumab deruxtecan versus trastuzumab emtansine for breast cancer. N Engl J Med 2022;386:1143-54.
34. Gennari A, André F, Barrios CH, et al. ESMO Guidelines Committee. Electronic address: [email protected]. ESMO Clinical Practice Guideline for the diagnosis, staging and treatment of patients with metastatic breast cancer. Ann Oncol 2021;32:1475-95.
35. ClinicalTrials.gov. Trastuzumab deruxtecan (T-DXd) with or without pertuzumab versus taxane, trastuzumab and pertuzumab in HER2-positive metastatic breast cancer (DESTINY-Breast09). Available from: https://clinicaltrials.gov/ct2/show/NCT04784715 [Last accessed on 29 Dec 2022].
36. ClinicalTrials.gov. A study of trastuzumab deruxtecan (T-DXd) versus trastuzumab emtansine (T-DM1) in high-risk HER2-positive participants with residual invasive breast cancer following neoadjuvant therapy (DESTINY-Breast05). Available from: https://clinicaltrials.gov/ct2/show/NCT04622319 [Last accessed on 29 Dec 2022].
37. ClinicalTrials.gov. Trastuzumab deruxtecan (T-DXd) alone or in sequence with THP, versus standard treatment (ddAC-THP), in HER2-positive early breast cancer. Available from: https://clinicaltrials.gov/ct2/show/NCT05113251 [Last accessed on 29 Dec 2022].
38. Elgersma RC, Coumans RG, Huijbregts T, et al. Design, synthesis, and evaluation of linker-duocarmycin payloads: toward selection of HER2-targeting antibody-drug conjugate SYD985. Mol Pharm 2015;12:1813-35.
39. van der Lee MM, Groothuis PG, Ubink R, et al. The preclinical profile of the duocarmycin-based HER2-targeting ADC SYD985 predicts for clinical benefit in low HER2-expressing breast cancers. Mol Cancer Ther 2015;14:692-703.
40. Banerji U, van Herpen CML, Saura C, et al. Trastuzumab duocarmazine in locally advanced and metastatic solid tumours and HER2-expressing breast cancer: a phase 1 dose-escalation and dose-expansion study. Lancet Oncol 2019;20:1124-35.
41. Manich CS, O’Shaughnessy J, Aftimos PG, et al. LBA15 primary outcome of the phase III SYD985.002/TULIP trial comparing
42. Skidmore L, Sakamuri S, Knudsen NA, et al. ARX788, a site-specific anti-HER2 antibody-drug conjugate, demonstrates potent and selective activity in HER2-low and T-DM1-resistant breast and gastric cancers. Mol Cancer Ther 2020;19:1833-43.
43. Zhang J, Ji D, Shen W, Xiao Q, Gu Y. Safety and anti-tumoractivity of ARX788 in HER2-positive metastatic breast cancer patients whose disease is resistant/refractory to HER2 targeted agents (trastuzumab, ADCs, TKIs, and bispecific antibodies): ACE-Breast-01 trial results. San Antonio Breast Cancer Symposium; 2021.
44. ClinicalTrials.gov. ARX788 in HER2-positive, metastatic breast cancer subjects (ACE-Breast-03). Available from: https://clinicaltrials.gov/ct2/show/study/NCT04829604 [Last accessed on 29 Dec 2022].
45. Wang J, Liu Y, Zhang Q, et al. RC48-ADC, a HER2-targeting antibody-drug conjugate, in patients with HER2-positive and HER2-low expressing advanced or metastatic breast cancer: a pooled analysis of two studies. J Clin Oncol 2021;39:1022-1022.
46. ClinicalTrials.gov. A study of RC48-ADC administered intravenously to patients with HER2-positive metastatic breast cancer with or without liver metastases. Available from: https://clinicaltrials.gov/ct2/show/NCT03500380 [Last accessed on 29 Dec 2022].
47. Saura C, Oliveira M, Feng YH, et al. NALA Investigators. Neratinib plus capecitabine versus lapatinib plus capecitabine in HER2-positive metastatic breast cancer previously treated with ≥ 2 HER2-directed regimens: phase III NALA trial. J Clin Oncol 2020;38:3138-49.
48. Xu B, Yan M, Ma F, et al. Pyrotinib plus capecitabine versus lapatinib plus capecitabine for the treatment of HER2-positive metastatic breast cancer (PHOEBE): a multicentre, open-label, randomised, controlled, phase 3 trial. Lancet Oncol 2021;22:351-60.
49. Hamblett K, Barnscher S, Davies R, et al. Abstract P6-17-13: ZW49, a HER2 targeted biparatopic antibody drug conjugate for the treatment of HER2 expressing cancers. Cancer Res 2019;79:P6-17.
50. ClinicalTrials.gov. A dose finding study of ZW49 in patients with HER2-positive cancers. Available from: https://clinicaltrials.gov/ct2/show/NCT03821233 [Last accessed on 29 Dec 2022].
51. Jhaveri K, Han H, Dotan E, et al. 460MO preliminary results from a phase I study using the bispecific, human epidermal growth factor 2 (HER2)-targeting antibody-drug conjugate (ADC) zanidatamab zovodotin (ZW49) in solid cancers. Ann Oncol 2022;33:S197-S224.
52. Pegram MD, Hamilton EP, Tan AR, et al. First-in-human, phase 1 dose-escalation study of biparatopic anti-HER2 antibody-drug conjugate MEDI4276 in patients with HER2-positive advanced breast or gastric cancer. Mol Cancer Ther 2021;20:1442-53.
53. de Dieras V, Lusque A. Trastuzumab deruxtecan for advanced breast cancer patients, regardless of HER2 status: a phase II study with biomarkers analysis (DAISY). San Antonio Breast Cancer Symposium; 2021.
54. Mosele MF, Lusque A, Dieras V, et al. LBA1 unraveling the mechanism of action and resistance to trastuzumab deruxtecan (T-DXd): biomarker analyses from patients from DAISY trial. Ann Oncol 2022;33:S123-S147.
55. Mosele MF, Lusque A, Dieras VC, et al. LBA72 unraveling the mechanism of action and resistance to trastuzumab deruxtecan (T-DXd): biomarker analyses from patients from DAISY trial. Ann Oncol 2022;33:S808-S869.
56. Montemurro F, Delaloge S, Barrios CH, et al. Trastuzumab emtansine (T-DM1) in patients with HER2-positive metastatic breast cancer and brain metastases: exploratory final analysis of cohort 1 from KAMILLA, a single-arm phase IIIb clinical trial(☆). Ann Oncol 2020;31:1350-8.
57. Pérez-García JM, Batista MV, Cortez P, et al. Trastuzumab deruxtecan in patients with central nervous system involvement from HER2-positive breast cancer: the DEBBRAH trial. Neuro Oncol ;2022:noac144.
58. Bartsch R, Berghoff AS, Furtner J, et al. Trastuzumab deruxtecan in HER2-positive breast cancer with brain metastases: a single-arm, phase 2 trial. Nat Med 2022;28:1840-7.
59. ClinicalTrials.gov. A study of T-DXd in participants with or without brain metastasis who have previously treated advanced or metastatic HER2 positive breast cancer (DESTINY-B12). Available from: https://clinicaltrials.gov/ct2/show/NCT04739761 [Last accessed on 29 Dec 2022].
60. ClinicalTrials.gov. Evaluation of safety and efficacy of sodium thiosulfate (BYON5667) eye drops to reduce ocular toxicity in cancer patients treated with SYD985. Available from: https://clinicaltrials.gov/ct2/show/NCT04983238 [Last accessed on 29 Dec 2022].