1 |
Schneeweiss A, Park-Simon TW, Albanell J, et al. Phase Ⅰb study evaluating safety and clinical activity of the anti-HER3 antibody lumretuzumab combined with the anti-HER2 antibody pertuzumab and paclitaxel in HER3-positive, HER2-low metastatic breast cancer [J]. Invest New Drugs, 2018, 36(5): 848.
|
2 |
Wolff AC, Hammond ME, Hicks DG, et al. Recommendations for human epidermal growth factor receptor 2 testing in breast cancer: American Society of Clinical Oncology/College of American Pathologists clinical practice guideline update [J]. J Clin Oncol, 2013, 31(31): 3997.
|
3 |
Hammond ME, Hayes DF, Dowsett M, et al. American Society of Clinical Oncology/College Of American Pathologists guideline recommendations for immunohistochemical testing of estrogen and progesterone receptors in breast cancer [J]. J Clin Oncol, 2010, 28(16): 2784.
|
4 |
Wolff AC, Hammond ME, Allison KH, et al. Human epidermal growth factor receptor 2 testing in breast cancer: American Society of Clinical Oncology/College of American Pathologists Clinical Practice Guideline Focused Update [J]. J Clin Oncol, 2018, 36(20): 2105.
|
5 |
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 [J]. Lancet Oncol, 2019, 20(8): 1124.
|
6 |
Clifton GT, Hale D, Vreeland TJ, et al. Results of a randomized phase Ⅱb trial of nelipepimut-S + Trastuzumab versus Trastuzumab to prevent recurrences in patients with high-risk HER2 low-expressing breast cancer [J]. Clin Cancer Res, 2020, 26(11): 2515.
|
7 |
Mittendorf EA, Lu B, Melisko M, et al. Efficacy and safety analysis of nelipepimut-S vaccine to prevent breast cancer recurrence: a randomized, multicenter, phase Ⅲ clinical trial [J]. Clin Cancer Res, 2019, 25(14): 4248.
|
8 |
Modi S, Park H, Murthy RK, et al. Antitumor activity and safety of Trastuzumab Deruxtecan in patients with HER2-low-expressing advanced breast cancer: results from a phase Ⅰb study [J]. J Clin Oncol, 2020, 38(17): 1887.
|
9 |
Pondé N, Aftimos P, Piccart M. Antibody-drug conjugates in breast cancer: a comprehensive review [J]. Curr Treat Options Oncol, 2019, 20(5): 37.
|
10 |
Rinnerthaler G, Gampenrieder SP, Greil R. HER2 directed antibody-drug-conjugates beyond T-DM1 in breast cancer [J]. Int J Mol Sci, 2019, 20(5): 1115.
|
11 |
Clifton GT, Peace KM, Holmes JP, et al. Initial safety analysis of a randomized phase Ⅱ trial of nelipepimut-S + GM-CSF and Trastuzumab compared to Trastuzumab alone to prevent recurrence in breast cancer patients with HER2 low-expressing tumors [J]. Clin Immunol, 2019, 201: 48.
|
12 |
Schalper KA, Kumar S, Hui P, et al. A retrospective population-based comparison of HER2 immunohistochemistry and fluorescence in situ hybridization in breast carcinomas: impact of 2007 American Society of Clinical Oncology/College of American Pathologists criteria [J]. Arch Pathol Lab Med, 2014, 138(2): 213.
|
13 |
Fehrenbacher L, Cecchini RS, Geyer CE, et al. NSABP B-47/NRG oncology phase Ⅲ randomized trial comparing adjuvant chemotherapy with or without Trastuzumab in high-risk invasive breast cancer negative for HER2 by FISH and with IHC 1+ or 2 [J]. J Clin Oncol, 2020, 38(5): 444.
|
14 |
Gianni L, Lladó A, Bianchi G, et al. Open-label, phase Ⅱ, multicenter, randomized study of the efficacy and safety of two dose levels of Pertuzumab, a human epidermal growth factor receptor 2 dimerization inhibitor, in patients with human epidermal growth factor receptor 2-negative metastatic breast cancer [J]. J Clin Oncol, 2010, 28(7): 1131.
|
15 |
Lanbein K, Van Bockstal M, Vandemeale L, et al. Distinguishing score 0 from score 1+ in HER2 immunohistochemistry-negative breast cancer: clinical and pathobiological relevance [J]. Am J Clin Pathol, 2013, 140(4): 561.
|
16 |
Press MF, Slamon DJ, Flom KJ, et al. Evaluation of HER-2/neu gene amplification and overexpression: comparison of frequently used assay methods in a molecularly characterized cohort of breast cancer specimens [J]. J Clin Oncol, 2002, 20(14): 3095.
|
17 |
Jacquemier J, Spyratos F, Esterni B, et al. SISH/CISH or qPCR as alternative techniques to FISH for determination of HER2 amplification status on breast tumors core needle biopsies: a multicenter experience based on 840 cases [J]. BMC Cancer, 2013, 13: 351.
|
18 |
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 [J]. Mol Cancer Ther, 2015, 14(3): 692.
|
19 |
Takegawa N, Tsurutani J, Kawakami H, et al. [fam-] Trastuzumab Deruxtecan, antitumor activity is dependent on HER2 expression level rather than on HER2 amplification [J]. Int J Cancer, 2019, 145(12): 3414.
|
20 |
Baehner FL, Achacoso N, Maddala T, et al. Human epidermal growth factor receptor 2 assessment in a case-control study: comparison of fluorescence in situ hybridization and quantitative reverse transcription polymerase chain reaction performed by central laboratories [J]. J Clin Oncol, 2010, 28(28): 4300.
|
21 |
Lehmann-che J, Amira-bouhidel F, Turpin E, et al. Immunohistochemical and molecular analyses of HER2 status in breast cancers are highly concordant and complementary approaches [J]. Br J Cancer, 2011, 104(11): 1739.
|
22 |
Dabbs DJ, Klein ME, Mohsin SK, et al. High false-negative rate of HER2 quantitative reverse transcription polymerase chain reaction of the oncotype DX test: an independent quality assurance study [J]. J Clin Oncol, 2011, 29(32): 4279.
|
23 |
Noske A, Loibl S, Darb-Esfahani S, et al. Comparison of different approaches for assessment of HER2 expression on protein and mRNA level: prediction of chemotherapy response in the neoadjuvant Gepar Trio trial (NCT00544765) [J]. Breast Cancer Res Treat, 2011, 126(1): 109.
|
24 |
Tang Y, Tang F, Yang Y, et al. Real-time analysis on drug-antibody ratio of antibody-drug conjugates for synthesis, process optimization, and quality control [J]. Sci Rep, 2017, 7(1): 7763.
|
25 |
Krop IE, Beeram M, Modi S, et al. Phase Ⅰ study of trastuzumab-DM1, an HER2 antibody-drug conjugate, given every 3 weeks to patients with HER2-positive metastatic breast cancer [J]. J Clin Oncol, 2010, 28(16): 2698.
|
26 |
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 [J]. Lancet Oncol, 2017, 18(6): 732.
|
27 |
Von Minckwitz G, Huang CS, Mano MS, et al. Trastuzumab Emtansine for residual invasive HER2-positive breast cancer [J]. N Engl J Med, 2019, 380(7): 617.
|
28 |
Burris HA, Rugo HS, Vukelja SJ, et al. Phase Ⅱ study of the antibody drug conjugate trastuzumab-DM1 for the treatment of human epidermal growth factor receptor 2 (HER2)-positive breast cancer after prior HER2-directed therapy [J]. J Clin Oncol, 2011, 29(4): 398.
|
29 |
Krop IE, Lorusso P, Miller KD, et al. A phase Ⅱ study of trastuzumab emtansine in patients with human epidermal growth factor receptor 2-positive metastatic breast cancer who were previously treated with trastuzumab, lapatinib, an anthracycline, a taxane, and capecitabine [J]. J Clin Oncol, 2012, 30(26): 3234.
|
30 |
Perez EA, Hurvitz SA, Amler LC, et al. Relationship between HER2 expression and efficacy with first-line trastuzumab emtansine compared with trastuzumab plus docetaxel in TDM4450g: a randomized phase Ⅱ study of patients with previously untreated HER2-positive metastatic breast cancer [J]. Breast Cancer Res, 2014, 16(3): R50.
|
31 |
Baselga J, Lewis Phillips GD, Verma S, et al. Relationship between tumor biomarkers and efficacy in EMILIA, a phase Ⅲ study of Trastuzumab Emtansine in HER2-positive metastatic breast cancer [J]. Clin Cancer Res, 2016, 22(15): 3755.
|
32 |
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 [J]. Clin Cancer Res, 2016, 22(20): 5097.
|
33 |
Modi S, Saura C, Yamashita T, et al. Trastuzumab Deruxtecan in previously treated HER2-positive breast cancer [J]. N Engl J Med, 2020, 382(7): 610.
|