[1]DITTRICH A,GAUTREY H,BROWELL D,et al.The HER-2 signaling network in breast cancer-like a spider in its web［J］.Journal of Mammary Gland Biology and Neoplasia,2014,19(3-4):253-270.
[2]LOIBL S,POORTMANS P,MORROW M,et al.Breast cancer［J］.Lancet,2021,397(10286):1750-1769.
[3]SLAMON DJ,LEYLAND-JONES B,SHAK S,et al.Use of chemotherapy plus a monoclonal antibody against HER-2 for metastatic breast cancer that overexpresses HER-2［J］.New England Journal of Medicine,2001,344(11):783-792.
[4]CHUMSRI S,LI Z,SERIE DJ,et al.Incidence of late relapses in patients with HER-2-positive breast cancer receiving adjuvant trastuzumab:combined analysis of NCCTG N9831(Alliance)and NRG oncology/NSABP B-31［J］.Journal of Clinical Oncology,2019,37(35):3425.
[5]GIANNI L,EIERMANN W,SEMIGLAZOV V,et al.Neoadjuvant and adjuvant trastuzumab in patients with HER-2-positive locally advanced breast cancer(NOAH):follow-up of a randomised controlled superiority trial with a parallel HER-2-negative cohort［J］.The Lancet Oncology,2014,15(6):640-647.
[6]GIANNI L,PIENKOWSKI T,IM YH,et al.5-year analysis of neoadjuvant pertuzumab and trastuzumab in patients with locally advanced,inflammatory,or early-stage HER-2-positive breast cancer(NeoSphere):a multicentre,open-label,phase 2 randomised trial［J］.The Lancet Oncology,2016,17(6):791-800.
[7]SWAIN SM,MILES D,KIM SB,et al.Pertuzumab,trastuzumab,and docetaxel for HER-2-positive metastatic breast cancer(CLEOPATRA):end-of-study results from a double-blind,randomised,placebo-controlled,phase 3 study［J］.The Lancet Oncology,2020,21(4):519-530.
[8]VON MINCKWITZ G,PROCTER M,DE AZAMBUJA E,et al.Adjuvant pertuzumab and trastuzumab in early HER-2-positive breast cancer［J］.New England Journal of Medicine,2017,377(2):122-131.
[9]DIERAS V,MILES D,VERMA S,et al.Trastuzumab emtansine versus capecitabine plus lapatinib in patients with previously treated HER-2-positive advanced breast cancer(EMILIA):a descriptive analysis of final overall survival results from a randomised,open-label,phase 3 trial［J］.The Lancet Oncology,2017,18(6):732-742.
[10]XU B,YAN M,MA F,et al.Pyrotinib plus capecitabine versus lapatinib plus capecitabine for the treatment of HER-2-positive metastatic breast cancer(PHOEBE):a multicentre,open-label,randomised,controlled,phase 3 trial［J］.The Lancet Oncology,2021,22(3):351-360.
[11]SAURA C,OLIVEIRA M,FENG YH,et al.Neratinib plus capecitabine versus lapatinib plus capecitabine in HER-2-positive metastatic breast cancer previously treated with≥ 2 HER-2-directed regimens:phase Ⅲ NALA trial［J］.Journal of Clinical Oncology,2020,38(27):3138.
[12]VON MINCKWITZ G,HUANG CS,MANO MS,et al.Trastuzumab emtansine for residual invasive HER-2-positive breast cancer［J］.New England Journal of Medicine,2019,380(7):617-628.
[13]MARTIN M,HOLMES FA,EJLERTSEN B,et al.Neratinib after trastuzumab-based adjuvant therapy in HER-2-positive breast cancer(ExteNET):5-year analysis of a randomised,double-blind,placebo-controlled,phase 3 trial［J］.The Lancet Oncology,2017,18(12):1688-1700.
[14]DUCHNOWSKA R,SPERINDE J,CHENNA A,et al.Quantitative HER-2 and p95HER-2 levels in primary breast cancers and matched brain metastases［J］.Neuro-Oncology,2015,17(9):1241-1249.
[15]CHUMSRI S,SPERINDE J,LIU H,et al.High p95HER-2/HER-2 ratio associated with poor outcome in trastuzumab-treated HER-2-positive metastatic breast cancer NCCTG N0337 and NCCTG 98-32-52(Alliance)［J］.Clinical Cancer Research,2018,24(13):3053-3058.
[16]KIM SB,DO IG,TSANG J,et al.BioPATH:a biomarker study in Asian patients with HER-2+ advanced breast cancer treated with lapatinib and other anti-HER-2 therapy［J］.Cancer Research and Treatment,2019,51(4):1527-1539.
[17]VOLPI CC,PIETRANTONIO F,GLOGHINI A,et al.The landscape of d16HER-2 splice variant expression across HER-2-positive cancers［J］.Scientific Reports,2019,9(1):1-12.
[18]CASTAGNOLI L,IEZZI M,GHEDINI GC,et al.Activated d16HER 2 homodimers and SRC kinase mediate optimal efficacy for trastuzumab［J］.Cancer Research,2014,74(21):6248-6259.
[19]TURPIN J,LING C,CROSBY EJ,et al.The ErbB2ΔEx16 splice variant is a major oncogenic driver in breast cancer that promotes a pro-metastatic tumor microenvironment［J］.Oncogene,2016,35(47):6053-6064.
[20]METZGER FILHO O,VIALE G,STEIN S,et al.Impact of HER-2 heterogeneity on treatment response of early-stage HER-2-positive breast cancer:phase Ⅱ neoadjuvant clinical trial of T-DM1 combined with pertuzumab［J］.Cancer Discovery,2021,11(10):2474-2487.
[21]KONG XY,ZHANG K,WANG XY,et al.Mechanism of trastuzumab resistance caused by HER-2 mutation in breast carcinomas［J］.Cancer Management and Research,2019,11:5971-5982.
[22]KUMAGAI S,KOYAMA S,NISHIKAWA H.Antitumour immunity regulated by aberrant ERBB family signalling［J］.Nature Reviews Cancer,2021,21(3):181-197.
[23]VERNIERI C,MILANO M,BRAMBILLA M,et al.Resistance mechanisms to anti-HER-2 therapies in HER-2-positive breast cancer:Current knowledge,new research directions and therapeutic perspectives［J］.Critical Reviews in Oncology/Hematology,2019,139:53-66.
[24]JOHNSTON SR,HEGG R,IM SA,et al.Phase Ⅲ,randomized study of dual human epidermal growth factor receptor 2(HER-2)blockade with lapatinib plus trastuzumab in combination with an aromatase inhibitor in postmenopausal women with HER-2-positive,hormone receptor-positive metastatic breast cancer:updated results of ALTERNATIVE［J］.Journal of Clinical Oncology,2021,39(1):79-89.
[25]SUDHAN DR,SCHWARZ LJ,GUERRERO-ZOTANO A,et al.Extended adjuvant therapy with Neratinib plus Fulvestrant blocks ER/HER-2 crosstalk and maintains complete responses of ER+/HER-2+ breast cancers:implications to the ExteNET trial［J］.Clinical Cancer Research,2019,25(2):771-783.
[26]GIANNI L,BISAGNI G,COLLEONI M,et al.Neoadjuvant treatment with trastuzumab and pertuzumab plus palbociclib and fulvestrant in HER-2-positive,ER-positive breast cancer(NA-PHER-2):an exploratory,open-label,phase 2 study［J］.The Lancet Oncology,2018,19(2):249-256.
[27]VERRET B,CORTES J,BACHELOT T,et al.Efficacy of PI3K inhibitors in advanced breast cancer［J］.Annals of Oncology,2019,30(10):x12-x20.
[28]SHIMOI T,HAMADA A,YAMAGISHI M,et al.PIK3CA mutation profiling in patients with breast cancer,using a highly sensitive detection system［J］.Cancer Science,2018,109(8):2558-2566.
[29]HURVITZ SA,ANDRE F,JIANG Z,et al.Combination of everolimus with trastuzumab plus paclitaxel as first-line treatment for patients with HER-2-positive advanced breast cancer(BOLERO-1):a phase 3,randomised,double-blind,multicentre trial［J］.The Lancet Oncology,2015,16(7):816-829.
[30]ANDRE F,OREGAN R,OZGUROGLU M,et al.Everolimus for women with trastuzumab-resistant,HER-2-positive,advanced breast cancer(BOLERO-3):a randomised,double-blind,placebo-controlled phase 3 trial［J］.The Lancet Oncology,2014,15(6):580-591.
[31]BANG YJ,GIACCONE G,IM SA,et al.First-in-human phase 1 study of margetuximab(MGAH22),an Fc-modified chimeric monoclonal antibody,in patients with HER-2-positive advanced solid tumors［J］.Annals of Oncology,2017,28(4):855-861.
[32]RUGO HS,IM SA,CARDOSO F,et al.Efficacy of margetuximab vs trastuzumab in patients with pretreated ERBB2-positive advanced breast cancer:a phase 3 randomized clinical trial［J］.JAMA Oncology,2021,7(4):573-584.
[33]KUROZUMI S,INOUE K,MATSUMOTO H,et al.Clinicopathological values of PD-L1 expression in HER-2-positive breast cancer［J］.Scientific Reports,2019,9(1):1-8.
[34]SUN C,MEZZADRA R,SCHUMACHER TN.Regulation and function of the PD-L1 checkpoint［J］.Immunity,2018,48(3):434-452.
[35]MARTINEZ VG,O' NEILL S,SALIMU J,et al.Resistance to HER-2-targeted anti-cancer drugs is associated with immune evasion in cancer cells and their derived extracellular vesicles［J］.Oncoimmunology,2017,6(12):e1362530.
[36]LOI S,GIOBBIE-HURDER A,GOMBOS A,et al.Pembrolizumab plus trastuzumab in trastuzumab-resistant,advanced,HER-2-positive breast cancer(PANACEA):a single-arm,multicentre,phase 1b-2 trial［J］.The Lancet Oncology,2019,20(3):371-382.
[37]EMENS LA,ESTEVA FJ,BERESFORD M,et al.Trastuzumab emtansine plus atezolizumab versus trastuzumab emtansine plus placebo in previously treated,HER-2-positive advanced breast cancer(KATE2):a phase 2,multicentre,randomised,double-blind trial［J］.The Lancet Oncology,2020,21(10):1283-1295.
[38]HUOBER J,HOLMES E,BASELGA J,et al.Survival outcomes of the NeoALTTO study(BIG 1-06):updated results of a randomised multicenter phase Ⅲ neoadjuvant clinical trial in patients with HER-2-positive primary breast cancer［J］.European Journal of Cancer,2019,118:169-177.
[39]LIN NU,BORGES V,ANDERS C,et al.Intracranial efficacy and survival with tucatinib plus trastuzumab and capecitabine for previously treated HER-2-positive breast cancer with brain metastases in the HER-2 CLIMB trial［J］.J Clin Oncoi,2020,38(23):2610-2619.
[40]NAYAR U,COHEN O,KAPSTAD C,et al.Acquired HER-2 mutations in ER+ metastatic breast cancer confer resistance to estrogen receptor-directed therapies［J］.Nature Genetics,2019,51(2):207-216.
[41]YUAN Y,LEE JS,YOST SE,et al.Phase Ⅱ study of neratinib in older adults with HER-2 amplified or HER-2/3 mutated metastatic breast cancer［J］.Journal of Geriatric Oncology,2021,12(5):752-758.
[42]SMYTH LM,PIHA-PAUL SA,WON HH,et al.Efficacy and determinants of response to HER kinase inhibition in HER-2-mutant metastatic breast cancer［J］.Cancer Discovery,2020,10(2):198-213.
[43]SMYTH L,SAURA C,PIHA-PAUL S,et al.Update on the phase Ⅱ SUMMIT trial:Neratinib+Fulvestrant for HER-2-mutant,HR-positive,metastatic breast cancer［J］.Annals of Oncology,2019,30:10-11.
[44]GARCIA-ALONSO S,OCANA A,PANDIELLA A.Trastuzumab emtansine:mechanisms of action and resistance,clinical progress,and beyond［J］.Trends in Cancer,2020,6(2):130-146.
[45]HUNTER FW,BARKER HR,LIPERT B,et al.Mechanisms of resistance to trastuzumab emtansine(T-DM1)in HER-2-positive breast cancer［J］.British Journal of Cancer,2020,122(5):603-612.
[46]NAKADA T,SUGIHARA K,JIKOH T,et al.The latest research and development into the antibody-drug conjugate,［fam-］trastuzumab deruxtecan(ds-8201a),for HER-2 cancer therapy［J］.Chemical and Pharmaceutical Bulletin,2019,67(3):173-185.
[47]OGITANI Y,AIDA T,HAGIHARA K,et al.DS-8201a,a novel HER-2-targeting ADC with a novel DNA topoisomerase I inhibitor,demonstrates a promising antitumor efficacy with differentiation from T-DM1［J］.Clinical Cancer Research,2016,22(20):5097-5108.
[48]MODI S,SAURA C,YAMASHITA T,et al.Trastuzumab deruxtecan in previously treated HER-2-positive breast cancer［J］.New England Journal of Medicine,2020,382(7):610-621.
[49]XU B,WANG J,FANG J,et al.Abstract PD4-06:Early clinical development of RC48-ADC in patients with HER-2 positive metastatic breast cancer［C］.Philadelphia,PA:American Association for Cancer Research,2020:04-06.
[50]WANG J,LIU Y,ZHANG Q,et al.RC48-ADC,a HER-2-targeting antibody-drug conjugate,in patients with HER-2-positive and HER-2-low expressing advanced or metastatic breast cancer:A pooled analysis of two studies［C］.Alexandria,VA:American Society of Clinical Oncology,2020:1022.
[51]XU B,WANG J,ZHANG Q,et al.An open-label,multicenter,phase Ib study to evaluate RC48-ADC in patients with HER-2-positive metastatic breast cancer［C］.ASCO,2018:1028.
[52]GONG J,SHEN L,WANG W,et al.Safety,pharmacokinetics and efficacy of RC48-ADC in a phase Ⅰ study in patients with HER-2-overexpression advanced solid cancer［C］.Alexandria,VA:American Society of Clinical Oncology,2018:e16059.
[53]MANICH CS,O'SHAUGHNESSY J,AFTIMOS PG,et al.LBA15 Primary outcome of the phase Ⅲ SYD985.002/TULIP trial comparing trastuzumab duocarmazine to physician's choice treatment in patients with pre-treated HER-2-positive locally advanced or metastatic breast cancer［J］.Annals of Oncology,2021,32:S1288.