| [1] |
Bianchini G, De Angelis C, Licata L, et al. Treatment landscape of triple-negative breast cancer-expanded options, evolving needs[J]. Nat Rev Clin Oncol, 2022, 19: 91-113. DOI: 10.1038/s41571-021-00565-2.
|
| [2] |
中国医药教育协会肿瘤药物临床研究专家委员会, 中国初级卫生保健基金会乳腺癌专业委员会. 三阴性乳腺癌免疫检查点抑制剂临床应用专家共识(2025版)[J]. 中华医学杂志, 2025, 105(38): 3394-3406. DOI: 10.3760/cma.j.cn112137-20250411-00895.
|
| [3] |
Keenan TE, Tolaney SM. Role of immunotherapy in triple-negative breast cancer[J]. J Natl Compr Canc Netw, 2020, 18(4): 479-489. DOI: 10.6004/jnccn.2020.7554.
|
| [4] |
Winer EP, Lipatov O, Im SA, et al. Pembrolizumab versus investigator-choice chemotherapy for metastatic triple-negative breast cancer (KEYNOTE-119): a randomised, open-label, phase 3 trial[J]. Lancet Oncol, 2021, 22(4): 499-511. DOI: 10.1016/S1470-2045(20)30754-3.
|
| [5] |
Duvivier HL, Rothe M, Mangat PK, et al. Pembrolizumab in patients with tumors with high tumor mutational burden: results from the targeted agent and profiling utilization registry study[J]. J Clin Oncol, 2023, 41(33): 5140-5150. DOI: 10.1200/JCO.23.00702.
|
| [6] |
He Q, Peng YC, Sun J, et al. Platinum-based chemotherapy and immunotherapy in early triple-negative breast cancer: a meta-analysis and indirect treatment comparison[J]. Front Oncol, 2021, 11: 693542. DOI: 10.3389/fonc.2021.693542.
|
| [7] |
Sternschuss M, Yerushalmi R, Saleh RR, et al. Efficacy and safety of neoadjuvant immune checkpoint inhibitors in early-stage triple-negative breast cancer: a systematic review and meta-analysis[J]. Cancer Res Clin Oncol, 2021, 147(11): 3369-3379. DOI: 10.1007/s00432-021-03591-w.
|
| [8] |
Tarantino P, Gandini S, Trapani D, et al. Immunotherapy addition to neoadjuvant chemotherapy for early triple negative breast cancer: a systematic review and meta-analysis of randomized clinical trials[J]. Crit Rev Oncol Hematol, 2021, 159: 103223. DOI: 10.1016/j.critrevonc.2021.103223.
|
| [9] |
中国临床肿瘤学会指南工作委员会. 中国临床肿瘤学会(CSCO)乳腺癌诊疗指南2025[M]. 北京: 人民卫生出版社, 2025.
|
| [10] |
Gradishar WJ, Moran MS, Abraham J, et al. NCCN guidelines® insights: breast cancer, version 5.2025[J]. J Natl Compr Canc Netw, 2025, 23(11): 426-436. DOI: 10.6004/jnccn.2025.0053.
|
| [11] |
Adams S, Diéras V, Barrios CH, et al. Patient-reported outcomes from the phase Ⅲ IMpassion130 trial of atezolizumab plus nab-paclitaxel in metastatic triple-negative breast cancer[J]. Ann Oncol, 2020, 31(5): 582-589. DOI: 10.1016/j.annonc.2020.02.003.
|
| [12] |
Miles D, Gligorov J, André F, et al. Primary results from IMpassion131, a double-blind, placebo-controlled, randomised phase Ⅲ trial of first-line paclitaxel with or without atezolizumab for unresectable locally advanced/metastatic triple-negative breast cancer[J]. Ann Oncol, 2021, 32(8): 994-1004. DOI: 10.1016/j.annonc.2021.05.801.
|
| [13] |
Zhang YY, Chen HY, Mo HN, et al. Distinct cellular mechanisms underlie chemotherapies and PD-L1 blockade combinations in triple-negative breast cancer[J]. Cancer Cell, 2025, 43(3): 446-463.e7. DOI: 10.1016/j.ccell.2025.01.007.
|
| [14] |
Dent R, André F, Gonçalves A, et al. IMpassion132 double-blind randomised phase Ⅲ trial of chemotherapy with or without atezolizumab for early relapsing unresectable locally advanced or metastatic triple-negative breast cancer[J]. Ann Oncol, 2024, 35(7): 630-642. DOI: 10.1016/j.annonc.2024.04.001.
|
| [15] |
Cortes J, Cescon DW, Rugo HS, et al. Pembrolizumab plus chemotherapy versus placebo plus chemotherapy for previously untreated locally recurrent inoperable or metastatic triple-negative breast cancer (KEYNOTE-355): a randomised, placebo-controlled, double-blind, phase 3 clinical trial[J]. Lancet, 2020, 396(10265): 1817-1828. DOI: 10.1016/S0140-6736(20)32531-9.
|
| [16] |
Jiang ZF, Ouyang Q, Sun T, et al. Toripalimab plus nab-paclitaxel in metastatic or recurrent triple-negative breast cancer: a randomized phase 3 trial[J]. Nat Med, 2024, 30: 249-256. DOI: 10.1038/s41591-023-02677-x.
|
| [17] |
Robson M, Im SA, Senkus E, et al. Olaparib for metastatic breast cancer in patients with a germline BRCA mutation[J]. N Engl J Med, 2017, 377(6): 523-533. DOI: 10.1056/NEJMoa1706450.
|
| [18] |
Rugo HS, Cescon DW, Robson ME, et al. KEYLYNK-009: pembrolizumab plus olaparib in locally recurrent inoperable or metastatic triple-negative breast cancer after clinical benefit from first-line pembrolizumab plus chemotherapy[J]. Clin Cancer Res, 2025, 32(5): 883-893. DOI: 10.1158/1078-0432.CCR-25-1818.
|
| [19] |
Vinayak S, Tolaney SM, Schwartzberg L, et al. Open-label clinical trial of niraparib combined with pembrolizumab for treatment of advanced or metastatic triple-negative breast cancer[J]. JAMA Oncol, 2019, 5(8): 1132-1140. DOI: 10.1001/jamaoncol.2019.1029.
|
| [20] |
Wang L, Zhang LF, Zhao L, et al. VEGFA/NRP-1/GAPVD1 axis promotes progression and cancer stemness of triple-negative breast cancer by enhancing tumor cell-macrophage crosstalk[J]. Int J Biol Sci, 2024, 20(2): 446-463. DOI: 10.7150/ijbs.86085.
|
| [21] |
Li Q, Wang YF, Jia WJ, et al. Low-dose anti-angiogenic therapy sensitizes breast cancer to PD-1 blockade[J]. Clin Cancer Res, 2020, 26(7): 1712-1724. DOI: 10.1158/1078-0432.CCR-19-2179.
|
| [22] |
Liu JQ, Liu Q, Li Y, et al. Efficacy and safety of camrelizumab combined with apatinib in advanced triple-negative breast cancer: an open-label phase Ⅱ trial[J]. J Immunother Cancer, 2020, 8(1): e000696. DOI: 10.1136/jitc-2020-000696.
|
| [23] |
Gion M, Blancas I, Cortez-Castedo P, et al. Atezolizumab plus paclitaxel and bevacizumab as first-line treatment of advanced triple-negative breast cancer: the ATRACTIB phase 2 trial[J]. Nat Med, 2025, 31(8): 2746-2754. DOI: 10.1038/s41591-025-03734-3.
|
| [24] |
Chung HC, Saada-Bouzid E, Longo F, et al. Lenvatinib plus pembrolizumab for patients with previously treated, advanced, triple-negative breast cancer: results from the triple-negative breast cancer cohort of the phase 2 LEAP-005 study[J]. Cancer, 2024, 130(19): 3278-3288. DOI: 10.1002/cncr.35387.
|
| [25] |
Hu YX, Zhu YX, Qi D, et al. Trop2-targeted therapy in breast cancer[J]. Biomark Res, 2024, 12(1): 82. DOI: 10.1186/s40364-024-00633-6.
|
| [26] |
Tolaney SM, de Azambuja E, Kalinsky K, et al. Sacituzumab govitecan (SG)+pembrolizumab (pembro) vs chemotherapy (chemo)+pembro in previously untreated PD-L1-positive advanced triple-negative breast cancer (TNBC): primary results from the randomized phase 3 ASCENT-04/KEYNOTE-D19 study[J]. J Clin Oncol, 2025, 43(suppl 17): LBA109. DOI: 10.1200/JCO.2025.43.17_suppl.LBA109.
|
| [27] |
Ho AY, Shiao S, Kobald SA, et al. PEARL: a phase Ⅰb/Ⅱ biomarker study of adding radiation therapy to pembrolizumab before neoadjuvant chemotherapy in human epidermal growth factor receptor 2-negative breast cancer[J]. J Clin Oncol, 2024, 42(36): 4282-4293. DOI: 10.1200/JCO.24.00003.
|
| [28] |
Ho AY, Barker CA, Arnold BB, et al. A phase 2 clinical trial assessing the efficacy and safety of pembrolizumab and radiotherapy in patients with metastatic triple-negative breast cancer[J]. Cancer, 2020, 126(4): 850-860. DOI: 10.1002/cncr.32599.
|
| [29] |
Syed YY. Catumaxomab: first approval[J]. Drugs, 2025, 85(7): 957-963. DOI: 10.1007/s40265-025-02187-9.
|
| [30] |
Muik A, Garralda E, Altintas I, et al. Preclinical characterization and phase Ⅰ trial results of a bispecific antibody targeting PD-L1 and 4-1BB (GEN1046) in patients with advanced refractory solid tumors[J]. Cancer Discov, 2022, 12(5): 1248-1265. DOI: 10.1158/2159-8290.CD-21-1345.
|
| [31] |
Li Q, Liu JX, Zhang QY, et al. The anti-PD-L1/CTLA-4 bispecific antibody KN046 in combination with nab-paclitaxel in first-line treatment of metastatic triple-negative breast cancer: a multicenter phase Ⅱ trial[J]. Nat Commun, 2024, 15(1): 1015. DOI: 10.1038/s41467-024-45160-y.
|
| [32] |
Andtbacka RH, Kaufman HL, Collichio F, et al. Talimogene laherparepvec improves durable response rate in patients with advanced melanoma[J]. J Clin Oncol, 2015, 33(25): 2780-2788. DOI: 10.1200/JCO.2014.58.3377.
|
| [33] |
Pérez-Larraya JG, Garcia-Moure M, Labiano S, et al. Oncolytic DNX-2401 virus for pediatric diffuse intrinsic pontine glioma[J]. N Engl J Med, 2022, 386(26): 2471-2481. DOI: 10.1056/NEJMoa2202028.
|
| [34] |
Tang S, Yong LY, Cui Y, et al. Harnessing oncolytic viruses for targeted therapy in triple-negative breast cancer[J]. Int J Med Sci, 2025, 22(9): 2186-2207. DOI: 10.7150/ijms.105683.
|
| [35] |
Schmid P, Cortes J, Dent R, et al. Event-free survival with pembrolizumab in early triple-negative breast cancer[J]. N Engl J Med, 2022, 386(6): 556-567. DOI: 10.1056/NEJMoa2112651.
|
| [36] |
Soliman H, Hogue D, Han H, et al. Oncolytic T-VEC virotherapy plus neoadjuvant chemotherapy in nonmetastatic triple-negative breast cancer: a phase 2 trial[J]. Nat Med, 2023, 29(2): 450-457. DOI: 10.1038/s41591-023-02210-0.
|
| [37] |
Knutson KL, Abu-Fares H, Keating P, et al. A phase Ⅱ trial to evaluate the safety and immunogenicity of two doses of a folate receptor alpha vaccine in patients with triple-negative breast cancer[J]. Clin Cancer Res, 2026, 32(1): 106-117. DOI: 10.1158/1078-0432.CCR-25-2763.
|
| [38] |
Toh U, Sakurai S, Saku S, et al. Early phase Ⅱ study of mixed 19-peptide vaccine monotherapy for refractory triple-negative breast cancer[J]. Cancer Sci, 2020, 111(8): 2760-2769. DOI: 10.1111/cas.14510.
|
| [39] |
Tan ZY, Kan C, Sun MQ, et al. Mapping breast cancer microenvironment through single-cell omics[J]. Front Immunol, 2022, 13: 868813. DOI: 10.3389/fimmu.2022.868813.
|
| [40] |
Fattori S, Le Roy A, Houacine J, et al. CD25 high effector regulatory T cells hamper responses to PD-1 blockade in triple-negative breast cancer[J]. Cancer Res, 2023, 83(18): 3026-3044. DOI: 10.1158/0008-5472.CAN-23-0613.
|
| [41] |
O'Connell BC, Hubbard C, Zizlsperger N, et al. Eganelisib combined with immune checkpoint inhibitor therapy and chemotherapy in frontline metastatic triple-negative breast cancer triggers macrophage reprogramming, immune activation and extracellular matrix reorganization in the tumor microenvironment[J]. J Immunother Cancer, 2024, 12(8): e009160. DOI: 10.1136/jitc-2024-009160.
|
| [42] |
Jia HY, Chen XM, Zhang LL, et al. Cancer associated fibroblasts in cancer development and therapy[J]. J Hematol Oncol, 2025, 18(1): 36. DOI: 10.1186/s13045-025-01688-0.
|
| [43] |
Hu DD, Li ZQ, Zheng B, et al. Cancer-associated fibroblasts in breast cancer: challenges and opportunities[J]. Cancer Commun (Lond), 2022, 42(5): 401-434. DOI: 10.1002/cac2.12291.
|
| [44] |
Serrano García L, Jávega B, Llombart Cussac A, et al. Patterns of immune evasion in triple-negative breast cancer and new potential therapeutic targets: a review[J]. Front Immunol, 2024, 15: 1513421. DOI: 10.3389/fimmu.2024.1513421.
|
| [45] |
Yang YY, Wang WD. Recent progress in immune evasion mechanisms of triple-negative breast cancer[J]. J Transl Med, 2025, 23(1): 1314. DOI: 10.1186/s12967-025-07370-w.
|
| [46] |
Sánchez-Elsner T, Botella LM, Velasco B, et al. Synergistic coope-ration between hypoxia and transforming growth factor-β pathways on human vascular endothelial growth factor gene expression[J]. J Biol Chem, 2001, 276(42): 38527-38535. DOI: 10.1074/jbc.M104536200.
|
| [47] |
Niu MK, Yi M, Wu YZ, et al. Synergistic efficacy of simultaneous anti-TGF-β/VEGF bispecific antibody and PD-1 blockade in cancer therapy[J]. J Hematol Oncol, 2023, 16(1): 94. DOI: 10.1186/s13045-023-01487-5.
|
| [48] |
Zhao CH, Shi JH, Chai XL, et al. First-in-human study of ZGGS18, a dual specific antibody targeting VEGF and TGF-β, as monotherapy in patients with advanced solid tumors[J]. J Clin Oncol, 2024, 42(16): 2523. DOI: 10.1200/JCO.2024.42.16_suppl.2523.
|
| [49] |
Tan QR, Yin S, Zhou D, et al. Potential predictive and prognostic value of biomarkers related to immune checkpoint inhibitor therapy of triple-negative breast cancer[J]. Front Oncol, 2022, 12: 779786. DOI: 10.3389/fonc.2022.779786.
|
| [50] |
Bullock KK, Richmond A. Beyond anti-PD-1/PD-L1: improving immune checkpoint inhibitor responses in triple-negative breast cancer[J]. Cancers (Basel), 2024, 16(12): 2189. DOI: 10.3390/cancers16122189.
|