|
1
|
Johnson JD and Young B: Demographics of
brain metastasis. Neurosurg Clin N Am. 7:337–344. 1996.PubMed/NCBI
|
|
2
|
Siegel RL, Miller KD, Fuchs HE and Jemal
A: Cancer statistics, 2022. CA Cancer J Clin. 72:7–33.
2022.PubMed/NCBI View Article : Google Scholar
|
|
3
|
Pasquier D, Darlix A, Louvel G, Fraisse J,
Jacot W, Brain E, Petit A, Mouret-Reynier MA, Goncalves A, Dalenc
F, et al: Treatment and outcomes in patients with central nervous
system metastases from breast cancer in the real-life ESME MBC
cohort. Eur J Cancer. 125:22–30. 2020.PubMed/NCBI View Article : Google Scholar
|
|
4
|
Lin NU, Amiri-Kordestani L, Palmieri D,
Liewehr DJ and Steeg PS: CNS metastases in breast cancer: Old
challenge, new frontiers. Clin Cancer Res. 19:6404–6418.
2013.PubMed/NCBI View Article : Google Scholar
|
|
5
|
Watase C, Shiino S, Shimoi T, Noguchi E,
Kaneda T, Yamamoto Y, Yonemori K, Takayama S and Suto A: Breast
cancer brain metastasis-overview of disease state, treatment
options and future perspectives. Cancers (Basel).
13(1078)2021.PubMed/NCBI View Article : Google Scholar
|
|
6
|
Gaspar L, Scott C, Rotman M, Asbell S,
Phillips T, Wasserman T, McKenna WG and Byhardt R: Recursive
partitioning analysis (RPA) of prognostic factors in three
radiation therapy oncology group (RTOG) brain metastases trials.
Int J Radiat Oncol Biol Phys. 37:745–751. 1997.PubMed/NCBI View Article : Google Scholar
|
|
7
|
Siegel RL, Miller KD, Wagle NS and Jemal
A: Cancer statistics, 2023. CA Cancer J Clin. 73:17–48.
2023.PubMed/NCBI View Article : Google Scholar
|
|
8
|
Tsukada Y, Fouad A, Pickren JW and Lane
WW: Central nervous system metastasis from breast carcinoma.
Autopsy study. Cancer. 52:2349–2354. 1983.PubMed/NCBI View Article : Google Scholar
|
|
9
|
Raghunath A, Desai K and Ahluwalia MS:
Current treatment options for breast cancer brain metastases. Curr
Treat Options Oncol. 20(19)2019.PubMed/NCBI View Article : Google Scholar
|
|
10
|
Soffietti R, Abacioglu U, Baumert B, Combs
SE, Kinhult S, Kros JM, Marosi C, Metellus P, Radbruch A, Villa
Freixa SS, et al: Diagnosis and treatment of brain metastases from
solid tumors: Guidelines from the European association of
neuro-oncology (EANO). Neuro Oncol. 19:162–174. 2017.PubMed/NCBI View Article : Google Scholar
|
|
11
|
Brown PD, Asher AL, Ballman KV, Farace E,
Cerhan JH, Anderson SK, Carrero XW, Barker FG, Deming RL, Burri S,
et al: NCCTG N0574 (Alliance): A phase III randomized trial of
whole brain radiation therapy (WBRT) in addition to radiosurgery
(SRS) in patients with 1 to 3 brain metastases. J Clin Oncol. 33
(18 Suppl)(LBA4)2015.
|
|
12
|
Sneed PK, Mendez J, Vemer-van den Hoek JG,
Seymour ZA, Ma L, Molinaro AM, Fogh SE, Nakamura JL and McDermott
MW: Adverse radiation effect after stereotactic radiosurgery for
brain metastases: Incidence, time course, and risk factors. J
Neurosurg. 123:373–386. 2015.PubMed/NCBI View Article : Google Scholar
|
|
13
|
Znidaric T, Gugic J, Marinko T, Gojkovic
Horvat A, Paulin Kosir MS, Golo D, Ivanetic Pantar M and Ratosa I:
Breast cancer patients with brain metastases or leptomeningeal
disease: 10-year results of a national cohort with validation of
prognostic indexes. Breast J. 25:1117–1125. 2019.PubMed/NCBI View Article : Google Scholar
|
|
14
|
Gao C, Wang F, Suki D, Strom E, Li J,
Sawaya R, Hsu L, Raghavendra A, Tripathy D and Ibrahim NK: Effects
of systemic therapy and local therapy on outcomes of 873 breast
cancer patients with metastatic breast cancer to brain: MD Anderson
cancer center experience. Int J Cancer. 148:961–970.
2021.PubMed/NCBI View Article : Google Scholar
|
|
15
|
Ferraro E, Reiner AS, Bou Nassif R, Tosi
U, Brown S, Zeller S, Dang CT, Seidman AD and Moss NS: Survival
among patients with ERBB2-positive metastatic breast cancer and
central nervous system disease. JAMA Netw Open.
8(e2457483)2025.PubMed/NCBI View Article : Google Scholar
|
|
16
|
Bartsch R, Cameron D, Ciruelos E,
Criscitiello C, Curigliano G, Duhoux FP, Foukakis T, Gligorov J,
Harbeck N, LeVasseur N, et al: Expert recommendations on treatment
sequencing and challenging clinical scenarios in human epidermal
growth factor receptor 2-positive (HER2-positive) metastatic breast
cancer. Cancer Treat Rev. 132(102853)2025.PubMed/NCBI View Article : Google Scholar
|
|
17
|
Rostami R, Mittal S, Rostami P, Tavassoli
F and Jabbari B: Brain metastasis in breast cancer: A comprehensive
literature review. J Neurooncol. 127:407–414. 2016.PubMed/NCBI View Article : Google Scholar
|
|
18
|
Voldborg BR, Damstrup L, Spang-Thomsen M
and Poulsen HS: Epidermal growth factor receptor (EGFR) and EGFR
mutations, function and possible role in clinical trials. Ann
Oncol. 8:1197–1206. 1997.PubMed/NCBI View Article : Google Scholar
|
|
19
|
Dalle S, Thieblemont C, Thomas L and
Dumontet C: Monoclonal antibodies in clinical oncology. Anticancer
Agents Med Chem. 8:523–532. 2008.PubMed/NCBI View Article : Google Scholar
|
|
20
|
Galanti D, Inno A, La Vecchia M,
Borsellino N, Incorvaia L, Russo A and Gori S: Current treatment
options for HER2-positive breast cancer patients with brain
metastases. Crit Rev Oncol Hematol. 161(103329)2021.PubMed/NCBI View Article : Google Scholar
|
|
21
|
Valabrega G, Montemurro F and Aglietta M:
Trastuzumab: Mechanism of action, resistance and future
perspectives in HER2-overexpressing breast cancer. Ann Oncol.
18:977–984. 2007.PubMed/NCBI View Article : Google Scholar
|
|
22
|
Vu T and Claret FX: Trastuzumab: Updated
mechanisms of action and resistance in breast cancer. Front Oncol.
2(62)2012.PubMed/NCBI View Article : Google Scholar
|
|
23
|
Pardridge WM: Drug delivery to the brain.
J Cereb Blood Flow Metab. 17:713–731. 1997.PubMed/NCBI View Article : Google Scholar
|
|
24
|
Dijkers EC, Oude Munnink TH, Kosterink JG,
Brouwers AH, Jager PL, de Jong JR, van Dongen GA, Schröder CP,
Lub-de Hooge MN and de Vries EG: Biodistribution of
89Zr-trastuzumab and PET imaging of HER2-positive lesions in
patients with metastatic breast cancer. Clin Pharmacol Ther.
87:586–592. 2010.PubMed/NCBI View Article : Google Scholar
|
|
25
|
Dawood S, Broglio K, Esteva FJ, Ibrahim
NK, Kau SW, Islam R, Aldape KD, Yu TK, Hortobagyi GN and
Gonzalez-Angulo AM: Defining prognosis for women with breast cancer
and CNS metastases by HER2 status. Ann Oncol. 19:1242–1248.
2008.PubMed/NCBI View Article : Google Scholar
|
|
26
|
Garcia-Alvarez A, Papakonstantinou A and
Oliveira M: Brain metastases in HER2-positive breast cancer:
Current and novel treatment strategies. Cancers (Basel).
13(2927)2021.PubMed/NCBI View Article : Google Scholar
|
|
27
|
Lockman PR, Mittapalli RK, Taskar KS,
Rudraraju V, Gril B, Bohn KA, Adkins CE, Roberts A, Thorsheim HR,
Gaasch JA, et al: Heterogeneous blood-tumor barrier permeability
determines drug efficacy in experimental brain metastases of breast
cancer. Clin Cancer Res. 16:5664–5678. 2010.PubMed/NCBI View Article : Google Scholar
|
|
28
|
Brufsky AM, Mayer M, Rugo HS, Kaufman PA,
Tan-Chiu E, Tripathy D, Tudor IC, Wang LI, Brammer MG, Shing M, et
al: Central nervous system metastases in patients with
HER2-positive metastatic breast cancer: Incidence, treatment, and
survival in patients from registHER. Clin Cancer Res. 17:4834–4843.
2011.PubMed/NCBI View Article : Google Scholar
|
|
29
|
Meng Y, Reilly RM, Pezo RC, Trudeau M,
Sahgal A, Singnurkar A, Perry J, Myrehaug S, Pople CB, Davidson B,
et al: MR-guided focused ultrasound enhances delivery of
trastuzumab to Her2-positive brain metastases. Sci Transl Med.
13(eabj4011)2021.PubMed/NCBI View Article : Google Scholar
|
|
30
|
Tosi G, Duskey JT and Kreuter J:
Nanoparticles as carriers for drug delivery of macromolecules
across the blood-brain barrier. Expert Opin Drug Deliv. 17:23–32.
2020.PubMed/NCBI View Article : Google Scholar
|
|
31
|
McKeage K and Perry CM: Trastuzumab: A
review of its use in the treatment of metastatic breast cancer
overexpressing HER2. Drugs. 62:209–243. 2002.PubMed/NCBI View Article : Google Scholar
|
|
32
|
Nahta R, Hung MC and Esteva FJ: The
HER-2-targeting antibodies trastuzumab and pertuzumab
synergistically inhibit the survival of breast cancer cells. Cancer
Res. 64:2343–2346. 2004.PubMed/NCBI View Article : Google Scholar
|
|
33
|
Swain SM, Miles D, Kim SB, Im YH, Im SA,
Semiglazov V, Ciruelos E, Schneeweiss A, Loi S, Monturus E, 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. 21:519–530. 2020.PubMed/NCBI View Article : Google Scholar
|
|
34
|
Swain SM, Baselga J, Miles D, Im YH, Quah
C, Lee LF and Cortés J: Incidence of central nervous system
metastases in patients with HER2-positive metastatic breast cancer
treated with pertuzumab, trastuzumab, and docetaxel: Results from
the randomized phase III study CLEOPATRA. Ann Oncol. 25:1116–1121.
2014.PubMed/NCBI View Article : Google Scholar
|
|
35
|
Bergen ES, Binter A, Starzer AM, Heller G,
Kiesel B, Tendl-Schulz K, Bago-Horvath Z, Furtner J, Leitner J,
Exner R, et al: Favourable outcome of patients with breast cancer
brain metastases treated with dual HER2 blockade of trastuzumab and
pertuzumab. Ther Adv Med Oncol.
13(17588359211009002)2021.PubMed/NCBI View Article : Google Scholar
|
|
36
|
Lin NU, Pegram M, Sahebjam S, Ibrahim N,
Fung A, Cheng A, Nicholas A, Kirschbrown W and Kumthekar P:
Pertuzumab plus high-dose trastuzumab in patients with progressive
brain metastases and HER2-positive metastatic breast cancer:
Primary analysis of a phase II study. J Clin Oncol. 39:2667–2675.
2021.PubMed/NCBI View Article : Google Scholar
|
|
37
|
Lin NU, Kumthekar P, Sahebjam S, Ibrahim
N, Fung A, Cheng A, Nicholas A, Sussell J and Pegram M: Pertuzumab
plus high-dose trastuzumab for HER2-positive breast cancer with
brain metastases: PATRICIA final efficacy data. NPJ Breast Cancer.
9(94)2023.PubMed/NCBI View Article : Google Scholar
|
|
38
|
Nordstrom JL, Gorlatov S, Zhang W, Yang Y,
Huang L, Burke S, Li H, Ciccarone V, Zhang T, Stavenhagen J, et al:
Anti-tumor activity and toxicokinetics analysis of MGAH22, an
anti-HER2 monoclonal antibody with enhanced Fcγ receptor binding
properties. Breast Cancer Res. 13(R123)2011.PubMed/NCBI View Article : Google Scholar
|
|
39
|
Rugo HS, Im SA, Cardoso F, Cortés J,
Curigliano G, Musolino A, Pegram MD, Wright GS, Saura C,
Escrivá-de-Romaní S, et al: Efficacy of margetuximab vs trastuzumab
in patients with pretreated ERBB2-positive advanced breast cancer:
A phase 3 randomized clinical trial. JAMA Oncol. 7:573–584.
2021.PubMed/NCBI View Article : Google Scholar
|
|
40
|
Angeli E and Bousquet G: Brain metastasis
treatment: The place of tyrosine kinase inhibitors and how to
facilitate their diffusion across the blood-brain barrier.
Pharmaceutics. 13(1446)2021.PubMed/NCBI View Article : Google Scholar
|
|
41
|
Wang W, He H, Marín-Ramos NI, Zeng S,
Swenson SD, Cho HY, Fu J, Beringer PM, Neman J, Chen L, et al:
Enhanced brain delivery and therapeutic activity of trastuzumab
after blood-brain barrier opening by NEO100 in mouse models of
brain-metastatic breast cancer. Neuro Oncol. 23:1656–1667.
2021.PubMed/NCBI View Article : Google Scholar
|
|
42
|
Chien AJ and Rugo HS: Tyrosine kinase
inhibitors for human epidermal growth factor receptor 2-positive
metastatic breast cancer: Is personalizing therapy within reach? J
Clin Oncol. 35:3089–3091. 2017.PubMed/NCBI View Article : Google Scholar
|
|
43
|
Traxler P: Tyrosine kinases as targets in
cancer therapy-successes and failures. Expert Opin Ther Targets.
7:215–234. 2003.PubMed/NCBI View Article : Google Scholar
|
|
44
|
Bachelot T, Romieu G, Campone M, Diéras V,
Cropet C, Dalenc F, Jimenez M, Le Rhun E, Pierga JY, Gonçalves A,
et al: Lapatinib plus capecitabine in patients with previously
untreated brain metastases from HER2-positive metastatic breast
cancer (LANDSCAPE): A single-group phase 2 study. Lancet Oncol.
14:64–71. 2013.PubMed/NCBI View Article : Google Scholar
|
|
45
|
Kim IA, Winter KA, Sperduto PW, De Los
Santos JF, Peereboom DM, Ogunleye T, Boulter D, Fritz JM, Cho KH,
Shin KH, et al: Concurrent lapatinib with brain radiation therapy
in patients with HER2+ breast cancer with brain metastases: NRG
oncology-KROG/RTOG 1119 phase 2 randomized trial. Int J Radiat
Oncol Biol Phys. 118:1391–1401. 2024.PubMed/NCBI View Article : Google Scholar
|
|
46
|
Blair HA: Pyrotinib: First global
approval. Drugs. 78:1751–1755. 2018.PubMed/NCBI View Article : Google Scholar
|
|
47
|
Yan M, Ouyang Q, Sun T, Niu L, Yang J, Li
L, Song Y, Hao C, Chen Z, Orlandi A, et al: Pyrotinib plus
capecitabine for patients with human epidermal growth factor
receptor 2-positive breast cancer and brain metastases (PERMEATE):
A multicentre, single-arm, two-cohort, phase 2 trial. Lancet Oncol.
23:353–361. 2022.PubMed/NCBI View Article : Google Scholar
|
|
48
|
Yan M, Ouyang Q, Sun T, Niu L, Yang J, Li
L, Song Y, Hao C and Chen Z: Pyrotinib plus capecitabine for
patients with HER2-positive metastatic breast cancer and brain
metastases: 3-year follow-up results from the phase 2 PERMEATE
trial. J Clin Oncol. 41 (16 Suppl)(S1048)2023.PubMed/NCBI View Article : Google Scholar
|
|
49
|
Yang Z, Meng J, Mei X, Mo M, Xiao Q, Han
X, Zhang L, Shi W, Chen X, Ma J, et al: Brain radiotherapy with
pyrotinib and capecitabine in patients with ERBB2-positive advanced
breast cancer and brain metastases: A nonrandomized phase 2 trial.
JAMA Oncol. 10:335–341. 2024.PubMed/NCBI View Article : Google Scholar
|
|
50
|
Xuhong JC, Qi XW, Zhang Y and Jiang J:
Mechanism, safety and efficacy of three tyrosine kinase inhibitors
lapatinib, neratinib and pyrotinib in HER2-positive breast cancer.
Am J Cancer Res. 9:2103–2119. 2019.PubMed/NCBI
|
|
51
|
Awada A, Colomer R, Inoue K, Bondarenko I,
Badwe RA, Demetriou G, Lee SC, Mehta AO, Kim SB, Bachelot T, et al:
Neratinib plus paclitaxel vs trastuzumab plus paclitaxel in
previously untreated metastatic ERBB2-positive breast cancer: The
NEfERT-T randomized clinical trial. JAMA Oncol. 2:1557–1564.
2016.PubMed/NCBI View Article : Google Scholar
|
|
52
|
Hurvitz SA, Saura C, Oliveira M, Trudeau
ME, Moy B, Delaloge S, Gradishar W, Kim SB, Haley B, Ryvo L, et al:
Efficacy of neratinib plus capecitabine in the subgroup of patients
with central nervous system involvement from the NALA trial.
Oncologist. 26:e1327–e1338. 2021.PubMed/NCBI View Article : Google Scholar
|
|
53
|
Freedman RA, Gelman RS, Anders CK, Melisko
ME, Parsons HA, Cropp AM, Silvestri K, Cotter CM, Componeschi KP,
Marte JM, et al: TBCRC 022: A phase II trial of neratinib and
capecitabine for patients with human epidermal growth factor
receptor 2-positive breast cancer and brain metastases. J Clin
Oncol. 37:1081–1089. 2019.PubMed/NCBI View Article : Google Scholar
|
|
54
|
Moulder SL, Borges VF, Baetz T, Mcspadden
T, Fernetich G, Murthy RK, Chavira R, Guthrie K, Barrett E and Chia
SK: Phase I study of ONT-380, a HER2 inhibitor, in patients with
HER2+-advanced solid tumors, with an expansion cohort in
HER2+ metastatic breast cancer (MBC). Clin Cancer Res.
23:3529–3536. 2017.PubMed/NCBI View Article : Google Scholar
|
|
55
|
Lin NU, Borges V, Anders C, Murthy RK,
Paplomata E, Hamilton E, Hurvitz S, Loi S, Okines A, Abramson V, et
al: Intracranial efficacy and survival with tucatinib plus
trastuzumab and capecitabine for previously treated HER2-positive
breast cancer with brain metastases in the HER2CLIMB trial. J Clin
Oncol. 38:2610–2619. 2020.PubMed/NCBI View Article : Google Scholar
|
|
56
|
Lin NU, Murthy RK, Abramson V, Anders C,
Bachelot T, Bedard PL, Borges V, Cameron D, Carey LA, Chien AJ, et
al: Tucatinib vs placebo, both in combination with trastuzumab and
capecitabine, for previously treated ERBB2 (HER2)-positive
metastatic breast cancer in patients with brain metastases: Updated
exploratory analysis of the HER2CLIMB randomized clinical trial.
JAMA Oncol. 9:197–205. 2023.PubMed/NCBI View Article : Google Scholar
|
|
57
|
Chau CH, Steeg PS and Figg WD:
Antibody-drug conjugates for cancer. Lancet. 394:793–804.
2019.PubMed/NCBI View Article : Google Scholar
|
|
58
|
Barok M, Joensuu H and Isola J:
Trastuzumab emtansine: Mechanisms of action and drug resistance.
Breast Cancer Res. 16(209)2014.PubMed/NCBI View Article : Google Scholar
|
|
59
|
Krop IE, Lin NU, Blackwell K, Guardino E,
Huober J, Lu M, Miles D, Samant M, Welslau M and Diéras V:
Trastuzumab emtansine (T-DM1) versus lapatinib plus capecitabine in
patients with HER2-positive metastatic breast cancer and central
nervous system metastases: A retrospective, exploratory analysis in
EMILIA. Ann Oncol. 26:113–119. 2015.PubMed/NCBI View Article : Google Scholar
|
|
60
|
Eisenhauer EA, Therasse P, Bogaerts J,
Schwartz LH, Sargent D, Ford R, Dancey J, Arbuck S, Gwyther S,
Mooney M, et al: New response evaluation criteria in solid tumours:
Revised RECIST guideline (version 1.1). Eur J Cancer. 45:228–247.
2009.PubMed/NCBI View Article : Google Scholar
|
|
61
|
Krop IE, Kim SB, González-Martín A,
LoRusso PM, Ferrero JM, Smitt M, Yu R, Leung AC and Wildiers H:
TH3RESA study collaborators. 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. 15:689–699. 2014.PubMed/NCBI View Article : Google Scholar
|
|
62
|
Schwartz LH, Litière S, de Vries E, Ford
R, Gwyther S, Mandrekar S, Shankar L, Bogaerts J, Chen A, Dancey J,
et al: RECIST 1.1-update and clarification: From the RECIST
committee. Eur J Cancer. 62:132–137. 2016.PubMed/NCBI View Article : Google Scholar
|
|
63
|
Montemurro F, Delaloge S, Barrios CH,
Wuerstlein R, Anton A, Brain E, Hatschek T, Kelly CM, Peña-Murillo
C, Yilmaz M, 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. 31:1350–1358.
2020.PubMed/NCBI View Article : Google Scholar
|
|
64
|
Ogitani Y, Hagihara K, Oitate M, Naito H
and Agatsuma T: Bystander killing effect of DS-8201a, a novel
anti-human epidermal growth factor receptor 2 antibody-drug
conjugate, in tumors with human epidermal growth factor receptor 2
heterogeneity. Cancer Sci. 107:1039–1046. 2016.PubMed/NCBI View Article : Google Scholar
|
|
65
|
Keam SJ: Trastuzumab deruxtecan: First
approval. Drugs. 80:501–508. 2020.PubMed/NCBI View Article : Google Scholar
|
|
66
|
Ogitani Y, Aida T, Hagihara K, Yamaguchi
J, Ishii C, Harada N, Soma M, Okamoto H, Oitate M, Arakawa S, 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.
22:5097–5108. 2016.PubMed/NCBI View Article : Google Scholar
|
|
67
|
Hurvitz S, Kim SB, Chung WP, Im SA, Park
YH, Hegg R, Kim MH, Tseng LM, Petry V, Chung CF, et al: Abstract
GS3-01: Trastuzumab deruxtecan (T-DXd; DS-8201a) vs trastuzumab
emtansine (T-DM1) in patients (pts) with HER2+ metastatic breast
cancer (mBC): Subgroup analyses from the randomized phase 3 study
DESTINY-Breast03. Cancer Res. 82 (Suppl 4):GS3–01. 2022.
|
|
68
|
Hurvitz SA, Hegg R, Chung WP, Im SA, Jacot
W, Ganju V, Chiu JWY, Xu B, Hamilton E, Madhusudan S, et al:
Trastuzumab deruxtecan versus trastuzumab emtansine in patients
with HER2-positive metastatic breast cancer: Updated results from
DESTINY-Breast03, a randomised, open-label, phase 3 trial. Lancet.
401:105–117. 2023.PubMed/NCBI View Article : Google Scholar
|
|
69
|
Bartsch R, Berghoff AS, Furtner J, Marhold
M, Bergen ES, Roider-Schur S, Starzer AM, Forstner H, Rottenmanner
B, Dieckmann K, et al: Trastuzumab deruxtecan in HER2-positive
breast cancer with brain metastases: A single-arm, phase 2 trial.
Nat Med. 28:1840–1847. 2022.PubMed/NCBI View Article : Google Scholar
|
|
70
|
Lin NU, Lee EQ, Aoyama H, Barani IJ,
Barboriak DP, Baumert BG, Bendszus M, Brown PD, Camidge DR, Chang
SM, et al: Response assessment criteria for brain metastases:
Proposal from the RANO group. Lancet Oncol. 16:e270–e278.
2015.PubMed/NCBI View Article : Google Scholar
|
|
71
|
Bartsch R, Berghoff AS, Furtner J, Marhold
M, Bergen ES, Roider-Schur S, Mair MJ, Starzer AM, Forstner H,
Rottenmanner B, et al: Final outcome analysis from the phase II
TUXEDO-1 trial of trastuzumab-deruxtecan in HER2-positive breast
cancer patients with active brain metastases. Neuro Oncol.
26:2305–2315. 2024.PubMed/NCBI View Article : Google Scholar
|
|
72
|
Niikura N, Yamanaka T, Nomura H, Shiraishi
K, Kusama H, Yamamoto M, Matsuura K, Inoue K, Takahara S, Kita S,
et al: Treatment with trastuzumab deruxtecan in patients with
HER2-positive breast cancer and brain metastases and/or
leptomeningeal disease (ROSET-BM). NPJ Breast Cancer.
9(82)2023.PubMed/NCBI View Article : Google Scholar
|
|
73
|
Pérez-García JM, Vaz Batista M, Cortez P,
Ruiz-Borrego M, Cejalvo JM, de la Haba-Rodriguez J, Garrigós L,
Racca F, Servitja S, Blanch S, et al: Trastuzumab deruxtecan in
patients with central nervous system involvement from HER2-positive
breast cancer: The DEBBRAH trial. Neuro Oncol. 25:157–166.
2023.PubMed/NCBI View Article : Google Scholar
|
|
74
|
Lin NU, Ciruelos EM, Jerusalem G, Müller
V, Niikura N, Viale G, Oscroft E, Anand S, Walker G and Harbeck N:
CLRM-14. Open-label, multinational, multicenter, phase 3B/4 study
of trastuzumab deruxtecan (T-DXD) in patients with or without
baseline brain metastasis (BM) with previously treated
advanced/metastatic human epidermal growth factor receptor
2-positive breast cancer (HER2+ BC): Destiny-BREAST12. Neuro-Oncol
Adv. 3 (Suppl 4)(iv4)2021.
|
|
75
|
Humphreys RC, Kirtely J, Hewit A, Biroc S,
Knudsen N, Skidmore L and Wahl A: Abstract 639: Site specific
conjugation of ARX-788, an antibody drug conjugate (ADC) targeting
HER2, generates a potent and stable targeted therapeutic for
multiple cancers. Cancer Res. 75 (15 Suppl)(S639)2015.
|
|
76
|
Hu X, Zhang Q, Wang L, Zhang J, Ouyang Q,
Wang X, Li W, Xie W, Tong Z, Wang S, et al: ACE-breast-02: A
randomized phase III trial of ARX788 versus lapatinib plus
capecitabine for HER2-positive advanced breast cancer. Signal
Transduct Target Ther. 10(56)2025.PubMed/NCBI View Article : Google Scholar
|
|
77
|
Barok M, Le Joncour V, Martins A, Isola J,
Salmikangas M, Laakkonen P and Joensuu H: ARX788, a novel anti-HER2
antibody-drug conjugate, shows anti-tumor effects in preclinical
models of trastuzumab emtansine-resistant HER2-positive breast
cancer and gastric cancer. Cancer Lett. 473:156–163.
2020.PubMed/NCBI View Article : Google Scholar
|
|
78
|
Yu J, Fang T, Yun C, Liu X and Cai X:
Antibody-drug conjugates targeting the human epidermal growth
factor receptor family in cancers. Front Mol Biosci.
9(847835)2022.PubMed/NCBI View Article : Google Scholar
|
|
79
|
Yao X, Jiang J, Wang X, Huang C, Li D, Xie
K, Xu Q, Li H, Li Z, Lou L and Fang J: A novel humanized anti-HER2
antibody conjugated with MMAE exerts potent anti-tumor activity.
Breast Cancer Res Treat. 153:123–133. 2015.PubMed/NCBI View Article : Google Scholar
|
|
80
|
Wang J, Liu Y, Zhang Q, Feng J, Fang J,
Chen X, Han Y, Li Q, Zhang P, Yuan P, 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. 39 (15
Suppl)(S1022)2021.
|
|
81
|
Wang J, Liu Y, Zhang Q, Li W, Feng J, Wang
X, Fang J, Han Y and Xu B: Disitamab vedotin, a HER2-directed
antibody-drug conjugate, in patients with HER2-overexpression and
HER2-low advanced breast cancer: A phase I/Ib study. Cancer Commun
(Lond). 44:833–851. 2024.PubMed/NCBI View Article : Google Scholar
|
|
82
|
Meric-Bernstam F, Beeram M, Mayordomo JI,
Hanna DL, Ajani JA, Murphy MAB, Murthy RK, Piha-Paul SA, Bauer TM,
Bendell JC, et al: Single agent activity of ZW25, a HER2-targeted
bispecific antibody, in heavily pretreated HER2-expressing cancers.
J Clin Oncol. 36 (15 Suppl)(S2500)2018.
|
|
83
|
Bartsch R and Bergen E: ASCO 2018:
Highlights in HER2-positive metastatic breast cancer. Memo.
11:280–283. 2018.PubMed/NCBI View Article : Google Scholar
|
|
84
|
Meric-Bernstam F, Beeram M, Hamilton E, Oh
DY, Hanna DL, Kang YK, Elimova E, Chaves J, Goodwin R, Lee J, et
al: Zanidatamab, a novel bispecific antibody, for the treatment of
locally advanced or metastatic HER2-expressing or HER2-amplified
cancers: A phase 1, dose-escalation and expansion study. Lancet
Oncol. 23:1558–1570. 2022.PubMed/NCBI View Article : Google Scholar
|
|
85
|
Wang X, Lee KS, Zeng X, Sun T, Im YH, Li
H, Wang K, Li H, Zhou P, Bao Y and Jiang Z: Zanidatamab (zani), a
HER2-targeted bispecific antibody, in combination with docetaxel as
first-line therapy (1L) for patients (pts) with advanced
HER2-positive breast cancer (BC): Updated results from a phase 1b/2
study. J Clin Oncol. 41 (16 Suppl)(S1044)2023.
|
|
86
|
Wei H, Cai H, Jin Y, Wang P, Zhang Q, Lin
Y, Wang W, Cheng J, Zeng N, Xu T and Zhou A: Structural basis of a
novel heterodimeric Fc for bispecific antibody production.
Oncotarget. 8:51037–51049. 2017.PubMed/NCBI View Article : Google Scholar
|
|
87
|
Zhang J, Ji D, Cai L, Yao H, Yan M, Wang
X, Shen W, Du Y, Pang H, Lai X, et al: First-in-human HER2-targeted
bispecific antibody KN026 for the treatment of patients with
HER2-positive metastatic breast cancer: Results from a phase I
study. Clin Cancer Res. 28:618–628. 2022.PubMed/NCBI View Article : Google Scholar
|
|
88
|
Liu M, Wang SJ and Ji Y: The i3+3 design
for phase I clinical trials. J Biopharm Stat. 30:294–304.
2020.PubMed/NCBI View Article : Google Scholar
|
|
89
|
Goyette MA, Stevens LE, DePinho CR,
Seehawer M, Nishida J, Li Z, Wilde CM, Li R, Qiu X, Pyke AL, et al:
Cancer-stromal cell interactions in breast cancer brain metastases
induce glycocalyx-mediated resistance to HER2-targeting therapies.
Proc Natl Acad Sci USA. 121(e2322688121)2024.PubMed/NCBI View Article : Google Scholar
|
|
90
|
Drago JZ, Modi S and Chandarlapaty S:
Unlocking the potential of antibody-drug conjugates for cancer
therapy. Nat Rev Clin Oncol. 18:327–344. 2021.PubMed/NCBI View Article : Google Scholar
|
|
91
|
Freedman R, Ren S, Tayob N, Gelman R,
Smith KL, Davis R, Pereslete A, Attaya V, Cotter C, Chen WY, et al:
Abstract PD7-03: Translational breast cancer research consortium
trial 022: Neratinib and trastuzumab-emtansine for HER2+ breast
cancer brain metastases (BCBM). Cancer Res. 83 (5 Suppl):PD7–03.
2023.
|
|
92
|
Hurvitz S, Loi S, O'Shaughnessy J, Okines
A, Tolaney S, Sohn JH, Saura C, Zhu X, Cameron D, Bachelot T, et
al: Abstract GS01-10: HER2CLIMB-02: Randomized, double-blind phase
3 trial of tucatinib and trastuzumab emtansine for previously
treated HER2-positive metastatic breast caner. Cancer Res. 84
(Suppl 9):GS01–10. 2024.https://doi.org/10.1158/1538-7445.SABCS23-GS01-10.
|
|
93
|
Carey LA, Krop I, Ramos J, Feng W and
Hamilton E: 331TiP HER2CLIMB-04: Phase II trial of tucatinib +
trastuzumab deruxtecan in patients with HER2+ locally advanced or
metastatic breast cancer with and without brain metastases. Ann
Oncol. 32 (Suppl 5):S510–S511. 2021.
|
|
94
|
O'Sullivan CC, Ballman KV, McCall L,
Kommalapati A, Zemla T, Weiss A, Mitchell M, Blinder V, Tung NM,
Irvin WJ, et al: Alliance A011801 (compassHER2 RD): Postneoadjuvant
T-DM1 + tucatinib/placebo in patients with residual HER2-positive
invasive breast cancer. Future Oncol. 17:4665–4676. 2021.PubMed/NCBI View Article : Google Scholar
|
|
95
|
Xu M, Du X, Liu M, Li S, Li X, Fu YX and
Wang S: The tumor immunosuppressive microenvironment impairs the
therapy of anti-HER2/neu antibody. Protein Cell. 3:441–449.
2012.PubMed/NCBI View Article : Google Scholar
|
|
96
|
Stagg J, Loi S, Divisekera U, Ngiow SF,
Duret H, Yagita H, Teng MW and Smyth MJ: Anti-ErbB-2 mAb therapy
requires type I and II interferons and synergizes with anti-PD-1 or
anti-CD137 mAb therapy. Proc Natl Acad Sci USA. 108:7142–7147.
2011.PubMed/NCBI View Article : Google Scholar
|
|
97
|
Yao H, Ryu MH, Park J, Voskoboynik M, Kim
JH, Liu K, Barve M, Acuna-Villaorduna A, Im SA, Roy AC, et al:
656MO The HER2-targeting ADC SHR-A1811 in HER2-expressing/mutated
advanced non-breast solid tumors (STs): Results from the global
phase I study. Ann Oncol. 34 (Suppl 2):S461–S462. 2023.
|
|
98
|
Wang J, Zhou C, Yao W, Wang Q, Min X, Chen
G, Xu X, Li X, Xu F, Fang Y, et al: Adebrelimab or placebo plus
carboplatin and etoposide as first-line treatment for
extensive-stage small-cell lung cancer (CAPSTONE-1): A multicentre,
randomised, double-blind, placebo-controlled, phase 3 trial. Lancet
Oncol. 23:739–747. 2022.PubMed/NCBI View Article : Google Scholar
|
|
99
|
Mercer JAM, DeCarlo SJ, Roy Burman SS,
Sreekanth V, Nelson AT, Hunkeler M, Chen PJ, Donovan KA, Kokkonda
P, Tiwari PK, et al: Continuous evolution of compact protein
degradation tags regulated by selective molecular glues. Science.
383(eadk4422)2024.PubMed/NCBI View Article : Google Scholar
|
|
100
|
Gadd MS, Testa A, Lucas X, Chan KH, Chen
W, Lamont DJ, Zengerle M and Ciulli A: Structural basis of PROTAC
cooperative recognition for selective protein degradation. Nat Chem
Biol. 13:514–521. 2017.PubMed/NCBI View Article : Google Scholar
|
|
101
|
Hu M, Li Y, Li J, Zhou H, Liu C, Liu Z,
Gong Y, Ying B and Xie Y: Discovery of potent and selective HER2
PROTAC degrader based Tucatinib with improved efficacy against HER2
positive cancers. Eur J Med Chem. 244(114775)2022.PubMed/NCBI View Article : Google Scholar
|
|
102
|
Feins S, Kong W, Williams EF, Milone MC
and Fraietta JA: An introduction to chimeric antigen receptor (CAR)
T-cell immunotherapy for human cancer. Am J Hematol. 94 (S1):S3–S9.
2019.PubMed/NCBI View Article : Google Scholar
|
|
103
|
Zhang BL, Qin DY, Mo ZM, Li Y, Wei W, Wang
YS, Wang W and Wei YQ: Hurdles of CAR-T cell-based cancer
immunotherapy directed against solid tumors. Sci China Life Sci.
59:340–348. 2016.PubMed/NCBI View Article : Google Scholar
|
|
104
|
Chen T, Wang M, Chen Y and Liu Y: Current
challenges and therapeutic advances of CAR-T cell therapy for solid
tumors. Cancer Cell Int. 24(133)2024.PubMed/NCBI View Article : Google Scholar
|
|
105
|
Szöőr Á, Tóth G, Zsebik B, Szabó V, Eshhar
Z, Abken H and Vereb G: Trastuzumab derived HER2-specific CARs for
the treatment of trastuzumab-resistant breast cancer: CAR T cells
penetrate and eradicate tumors that are not accessible to
antibodies. Cancer Lett. 484:1–8. 2020.PubMed/NCBI View Article : Google Scholar
|
|
106
|
Priceman SJ, Tilakawardane D, Jeang B,
Aguilar B, Murad JP, Park AK, Chang WC, Ostberg JR, Neman J,
Jandial R, et al: Regional delivery of chimeric antigen
receptor-engineered T cells effectively targets HER2+
breast cancer metastasis to the brain. Clin Cancer Res. 24:95–105.
2018.PubMed/NCBI View Article : Google Scholar
|
|
107
|
Brown CE, Alizadeh D, Starr R, Weng L,
Wagner JR, Naranjo A, Ostberg JR, Blanchard MS, Kilpatrick J,
Simpson J, et al: Regression of glioblastoma after chimeric antigen
receptor T-cell therapy. N Engl J Med. 375:2561–2569.
2016.PubMed/NCBI View Article : Google Scholar
|
