REFERENCES
1. Perou CM, Sørlie T, Eisen MB, et al. Molecular portraits of human breast tumours. Nature 2000;406:747-52.
2. Wang C, Kar S, Lai X, et al. Triple negative breast cancer in Asia: An insider's view. Cancer Treat Rev 2018;62:29-38.
3. Thakur KK, Bordoloi D, Kunnumakkara AB. Alarming burden of triple-negative breast cancer in India. Clin Breast Cancer 2018;18:e393-9.
4. Wolff AC, Hammond MEH, 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. Arch Pathol Lab Med 2018;142:1364-82.
5. 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 Clin Oncol 2010;28:2784-95.
6. Foulkes WD, Smith IE, Reis-Filho JS. Triple-negative breast cancer. N Engl J Med 2010;363:1938-48.
7. Liedtke C, Mazouni C, Hess KR, et al. Response to neoadjuvant therapy and long-term survival in patients with triple-negative breast cancer. J Clin Oncol 2008;26:1275-81.
8. Carey LA, Dees EC, Sawyer L, et al. The triple negative paradox: primary tumor chemosensitivity of breast cancer subtypes. Clin Cancer Res 2007;13:2329-34.
9. Lin NU, Vanderplas A, Hughes ME, et al. Clinicopathologic features, patterns of recurrence, and survival among women with triple-negative breast cancer in the National Comprehensive Cancer Network. Cancer 2012;118:5463-72.
10. Dent R, Trudeau M, Pritchard KI, et al. Triple-negative breast cancer: clinical features and patterns of recurrence. Clin Cancer Res 2007;13:4429-34.
11. Cortazar P, Zhang LJ, Untch M, et al. Pathological complete response and long-term clinical benefit in breast cancer: the CTNeoBC pooled analysis. Lancet 2014;384:164-72.
12. von Minckwitz G, Schneeweiss A, Loibl S, et al. Neoadjuvant carboplatin in patients with triple-negative and HER2-positive early breast cancer (GeparSixto; GBG 66): a randomised phase 2 trial. Lancet Oncol 2014;15:747-56.
13. Sikov WM, Berry DA, Perou CM, et al. Impact of the addition of carboplatin and/or bevacizumab to neoadjuvant once-per-week paclitaxel followed by dose-dense doxorubicin and cyclophosphamide on pathologic complete response rates in stage II to III triple-negative breast cancer: CALGB 40603 (Alliance). J Clin Oncol 2015;33:13-21.
14. Herschkowitz JI, Simin K, Weigman VJ, et al. Identification of conserved gene expression features between murine mammary carcinoma models and human breast tumors. Genome Biol 2007;8:R76.
15. Prat A, Parker JS, Karginova O, et al. Phenotypic and molecular characterization of the claudin-low intrinsic subtype of breast cancer. Breast Cancer Res 2010;12:R68.
16. Prat A, Perou CM. Deconstructing the molecular portraits of breast cancer. Mol Oncol 2011;5:5-23.
17. Lehmann BD, Bauer JA, Chen X, et al. Identification of human triple-negative breast cancer subtypes and preclinical models for selection of targeted therapies. J Clin Invest 2011;121:2750-67.
18. Masuda H, Baggerly KA, Wang Y, et al. Differential response to neoadjuvant chemotherapy among 7 triple-negative breast cancer molecular subtypes. Clin Cancer Res 2013;19:5533-40.
19. Lehmann BD, Jovanović B, Chen X, et al. Refinement of Triple-negative breast cancer molecular subtypes: Implications for neoadjuvant chemotherapy selection. PLoS One 2016;11:e0157368.
20. Burstein MD, Tsimelzon A, Poage GM, et al. Comprehensive genomic analysis identifies novel subtypes and targets of triple-negative breast cancer. Clin Cancer Res 2015;21:1688-98.
21. Koboldt DC, Steinberg KM, Larson DE, et al. The next-generation sequencing revolution and its impact on genomics. Cell 2013;155:27-38.
22. Shah SP, Roth A, Goya R, et al. The clonal and mutational evolution spectrum of primary triple-negative breast cancers. Nature 2012;486:395-9.
23. Wang Y, Waters J, Leung ML, et al. Clonal evolution in breast cancer revealed by single nucleus genome sequencing. Nature 2014;512:155-60.
24. Yates LR, Gerstung M, Knappskog S, et al. Subclonal diversification of primary breast cancer revealed by multiregion sequencing. Nat Med 2015;21:751-9.
25. Gao R, Davis A, McDonald TO, et al. Punctuated copy number evolution and clonal stasis in triple-negative breast cancer. Nat Genet 2016;48:1119-30.
26. Sottoriva A, Kang H, Ma Z, et al. A Big Bang model of human colorectal tumor growth. Nat Genet 2015;47:209-16.
27. Williams MJ, Werner B, Barnes CP, et al. Identification of neutral tumor evolution across cancer types. Nat Genet 2016;48:238-44.
28. Ng C, Bidard FC, Piscuoglio S, et al. Genetic heterogeneity in therapy-naïve synchronous primary breast cancers and their metastases. Clin Cancer Res 2017;23:4402-15.
29. Bertucci F, Ng CKY, Patsouris A, et al. Genomic characterization of metastatic breast cancers. Nature 2019;569:560-4.
30. Angus L, Smid M, Wilting SM, et al. The genomic landscape of metastatic breast cancer highlights changes in mutation and signature frequencies. Nat Genet 2019;51:1450-8.
31. Nik-Zainal S, Davies H, Staaf J, et al. Landscape of somatic mutations in 560 breast cancer whole-genome sequences. Nature 2016;534:47-54.
32. Balko JM, Cook RS, Vaught DB, et al. Profiling of residual breast cancers after neoadjuvant chemotherapy identifies DUSP4 deficiency as a mechanism of drug resistance. Nat Med 2012;18:1052-9.
33. Almendro V, Cheng YK, Randles A, et al. Inference of tumor evolution during chemotherapy by computational modeling and in situ analysis of genetic and phenotypic cellular diversity. Cell Rep 2014;6:514-27.
34. Al-Hajj M, Wicha MS, Benito-Hernandez A, et al. Prospective identification of tumorigenic breast cancer cells. Proc Natl Acad Sci U S A 2003;100:3983-8.
35. Wright MH, Robles AI, Herschkowitz JI, et al. Molecular analysis reveals heterogeneity of mouse mammary tumors conditionally mutant for Brca1. Mol Cancer 2008;7:29.
36. Kim C, Gao R, Sei E, et al. Chemoresistance evolution in triple-negative breast cancer delineated by single-cell sequencing. Cell 2018;173:879-93.e13.
37. O'Shaughnessy J, Brezden-Masley C, Cazzaniga M, et al. Prevalence of germline BRCA mutations in HER2-negative metastatic breast cancer: global results from the real-world, observational BREAKOUT study. Breast Cancer Res 2020;22:114.
38. Sharma P, Klemp JR, Kimler BF, et al. Germline BRCA mutation evaluation in a prospective triple-negative breast cancer registry: implications for hereditary breast and/or ovarian cancer syndrome testing. Breast Cancer Res Treat 2014;145:707-14.
39. Ray Chaudhuri A, Callen E, Ding X, et al. Replication fork stability confers chemoresistance in BRCA-deficient cells. Nature 2016;535:382-7.
40. Hahnen E, Lederer B, Hauke J, et al. Germline mutation status, pathological complete response, and disease-free survival in triple-negative breast cancer: Secondary analysis of the GeparSixto randomized clinical trial. JAMA Oncol 2017;3:1378-85.
41. Tutt A, Tovey H, Cheang M, et al. Carboplatin in BRCA1/2-mutated and triple-negative breast cancer BRCAness subgroups: the TNT Trial. Nat Med 2018;24:628-37.
42. Robson M, Im SA, Senkus E, et al. Olaparib for metastatic breast cancer in patients with a germline BRCA mutation. N Engl J Med 2017;377:523-33.
43. IDMC has concluded that OlympiA trial of Lynparza crossed superiority boundary for invasive disease-free survival vs. placebo at planned interim analysis. Available from: https://www.astrazeneca.com/media-centre/press-releases/2021/olympia-trial-of-lynparza-idmc-recommend-early-analysis.html [Last accessed on 24 Mar 2021].
44. Silver DP, Richardson AL, Eklund AC, et al. Efficacy of neoadjuvant Cisplatin in triple-negative breast cancer. J Clin Oncol 2010;28:1145-53.
45. Akashi-Tanaka S, Watanabe C, Takamaru T, et al. BRCAness predicts resistance to taxane-containing regimens in triple negative breast cancer during neoadjuvant chemotherapy. Clin Breast Cancer 2015;15:80-5.
46. Winter C, Nilsson MP, Olsson E, et al. Targeted sequencing of BRCA1 and BRCA2 across a large unselected breast cancer cohort suggests that one-third of mutations are somatic. Ann Oncol 2016;27:1532-8.
47. Abkevich V, Timms KM, Hennessy BT, et al. Patterns of genomic loss of heterozygosity predict homologous recombination repair defects in epithelial ovarian cancer. Br J Cancer 2012;107:1776-82.
48. Birkbak NJ, Wang Z, Kim JY, et al. Telomeric allelic imbalance indicates defective DNA repair and sensitivity to DNA-damaging agents. Cancer Discov 2012;2:366-75.
49. Popova T, Manié E, Rieunier G, et al. Ploidy and large-scale genomic instability consistently identify basal-like breast carcinomas with BRCA1/2 inactivation. Cancer Res 2012;72:5454-62.
50. Davies H, Glodzik D, Morganella S, et al. HRDetect is a predictor of BRCA1 and BRCA2 deficiency based on mutational signatures. Nat Med 2017;23:517-25.
51. Esteller M, Silva JM, Dominguez G, et al. Promoter hypermethylation and BRCA1 inactivation in sporadic breast and ovarian tumors. J Natl Cancer Inst 2000;92:564-9.
52. Saal LH, Gruvberger-Saal SK, Persson C, et al. Recurrent gross mutations of the PTEN tumor suppressor gene in breast cancers with deficient DSB repair. Nat Genet 2008;40:102-7.
53. Turner NC, Reis-Filho JS, Russell AM, et al. BRCA1 dysfunction in sporadic basal-like breast cancer. Oncogene 2007;26:2126-32.
54. Timms KM, Abkevich V, Hughes E, et al. Association of BRCA1/2 defects with genomic scores predictive of DNA damage repair deficiency among breast cancer subtypes. Breast Cancer Res 2014;16:475.
55. Mayer EL, Abramson V, Jankowitz R, et al. TBCRC 030: a phase II study of preoperative cisplatin versus paclitaxel in triple-negative breast cancer: evaluating the homologous recombination deficiency (HRD) biomarker. Ann Oncol 2020;31:1518-25.
56. Telli ML, Metzger O, Timms K, et al. Evaluation of homologous recombination deficiency (HRD) status with pathological response to carboplatin +/- veliparib in BrighTNess, a randomized phase 3 study in early stage TNBC. J Clin Oncol 2018;36:519.
57. Loibl S, Weber KE, Timms KM, et al. Survival analysis of carboplatin added to an anthracycline/taxane-based neoadjuvant chemotherapy and HRD score as predictor of response-final results from GeparSixto. Ann Oncol 2018;29:2341-7.
58. Telli ML, Hellyer J, Audeh W, et al. Homologous recombination deficiency (HRD) status predicts response to standard neoadjuvant chemotherapy in patients with triple-negative or BRCA1/2 mutation-associated breast cancer. Breast Cancer Res Treat 2018;168:625-30.
59. Telli ML, Timms KM, Reid J, et al. Homologous recombination deficiency (HRD) score predicts response to platinum-containing neoadjuvant chemotherapy in patients with triple-negative breast cancer. Clin Cancer Res 2016;22:3764-73.
60. Staaf J, Glodzik D, Bosch A, et al. Whole-genome sequencing of triple-negative breast cancers in a population-based clinical study. Nat Med 2019;25:1526-33.
61. Chopra N, Tovey H, Pearson A, et al. Homologous recombination DNA repair deficiency and PARP inhibition activity in primary triple negative breast cancer. Nat Commun 2020;11:2662.
62. Gulhan DC, Lee JJ, Melloni GEM, et al. Detecting the mutational signature of homologous recombination deficiency in clinical samples. Nat Genet 2019;51:912-9.
63. Quereda V, Bayle S, Vena F, et al. Therapeutic targeting of CDK12/CDK13 in triple-negative breast cancer. Cancer Cell 2019;36:545-58.e7.
65. Genome Atlas Network. Comprehensive molecular portraits of human breast tumours. Nature 2012;490:61-70.
66. Curtis C, Shah SP, Chin SF, et al. The genomic and transcriptomic architecture of 2,000 breast tumours reveals novel subgroups. Nature 2012;486:346-52.
67. Schmid P, Abraham J, Chan S, et al. Capivasertib plus paclitaxel versus placebo plus paclitaxel as first-line therapy for metastatic triple-negative breast cancer: The PAKT trial. J Clin Oncol 2020;38:423-33.
68. Takeshita T, Yamamoto Y, Yamamoto-Ibusuki M, et al. Clinical significance of plasma cell-free DNA mutations in PIK3CA, AKT1, and ESR1 gene according to treatment lines in ER-positive breast cancer. Mol Cancer 2018;17:67.
69. Yuan H, Chen J, Liu Y, et al. Association of PIK3CA mutation status before and after neoadjuvant chemotherapy with response to chemotherapy in women with breast cancer. Clinical Cancer Research 2015;21:4365-72.
70. Bareche Y, Venet D, Ignatiadis M, et al. Unravelling triple-negative breast cancer molecular heterogeneity using an integrative multiomic analysis. Ann Oncol 2018;29:895-902.
71. Kim SB, Dent R, Im SA, et al. Ipatasertib plus paclitaxel versus placebo plus paclitaxel as first-line therapy for metastatic triple-negative breast cancer (LOTUS): a multicentre, randomised, double-blind, placebo-controlled, phase 2 trial. Lancet Oncol 2017;18:1360-72.
73. Verma S, Miles D, Gianni L, et al. Trastuzumab emtansine for HER2-positive advanced breast cancer. N Engl J Med 2012;367:1783-91.
74. von Minckwitz G, Huang CS, Mano MS, et al. Trastuzumab emtansine for residual invasive HER2-positive breast cancer. N Engl J Med 2019;380:617-28.
75. Modi S, Saura C, Yamashita T, et al. Trastuzumab Deruxtecan in previously treated HER2-positive breast cancer. N Engl J Med 2020;382:610-21.
76. Bardia A, Mayer IA, Vahdat LT, et al. Sacituzumab Govitecan-hziy in refractory metastatic triple-negative breast cancer. N Engl J Med 2019;380:741-51.
77. Sacituzumab govitecan package insert. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761115s000lbl.pdf. [Last accessed on 24 Mar 2021].
78. Bardia A, Tolaney SM, Loirat D, et al. ASCENT: A randomized phase III study of sacituzumab govitecan (SG) vs treatment of physician’s choice (TPC) in patients (pts) with previously treated metastatic triple-negative breast cancer (mTNBC). Ann Oncol 2020;31:S1149-50.
79. Hurvitz SA, Tolaney SM, Punie K, et al. Biomarker evaluation in the phase 3 ASCENT study of sacituzumab govitecan versus chemotherapy in patients with metastatic triple-negative breast cancer. San Antonio Breast Cancer Symposium 2020.
80. Han H, Diab S, Alemany C, et al. .
81. Ogitani Y, Hagihara K, Oitate M, et al. 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 2016;107:1039-46.
82. 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.
83. 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 Clin Oncol 2020;38:1887-96.
84. Banerji U, van Herpen CML, Saura C, et al. Trastuzumab duocarmazine in locally advanced and metastatic solid tumors and HER2-expressing breast cancer: A phase 1 dose-escalation and dose-expansion study. Lancet Oncol 2019;20:1124-35.
85. Tolcher AW. The evolution of antibody-drug conjugates: A positive inflexion point. Am Soc Clin Oncol Educ Book 2020;40:1-8.
86. Doane AS, Danso M, Lal P, et al. An estrogen receptor-negative breast cancer subset characterized by a hormonally regulated transcriptional program and response to androgen. Oncogene 2006;25:3994-4008.
87. Loibl S, Müller BM, von Minckwitz G, et al. Androgen receptor expression in primary breast cancer and its predictive and prognostic value in patients treated with neoadjuvant chemotherapy. Breast Cancer Res Treat 2011;130:477-87.
88. Cochrane DR, Bernales S, Jacobsen BM, et al. Role of the androgen receptor in breast cancer and preclinical analysis of enzalutamide. Breast Cancer Res 2014;16:R7.
89. Jia LY, Shanmugam MK, Sethi G, et al. Potential role of targeted therapies in the treatment of triple-negative breast cancer. Anticancer Drugs 2016;27:147-55.
90. Gucalp A, Tolaney S, Isakoff SJ, et al. Phase II trial of bicalutamide in patients with androgen receptor-positive, estrogen receptor-negative metastatic breast cancer. Clin Cancer Res 2013;19:5505-12.
91. Bonnefoi H, Grellety T, Tredan O, et al. A phase II trial of abiraterone acetate plus prednisone in patients with triple-negative androgen receptor positive locally advanced or metastatic breast cancer (UCBG 12-1). Ann Oncol 2016;27:812-8.
92. Traina TA, Miller K, Yardley DA, et al. Enzalutamide for the treatment of androgen receptor-expressing triple-negative breast cancer. J Clin Oncol 2018;36:884-90.
94. Ahn J, Xia T, Rabasa Capote A, et al. Extrinsic phagocyte-dependent STING signaling dictates the immunogenicity of dying cells. Cancer Cell 2018;33:862-73.e5.
96. Loi S, Drubay D, Adams S, et al. Tumor-infiltrating lymphocytes and prognosis: A pooled individual patient analysis of early-stage triple-negative breast cancers. J Clin Oncol 2019;37:559-69.
97. Topalian SL, Drake CG, Pardoll DM. Immune checkpoint blockade: a common denominator approach to cancer therapy. Cancer Cell 2015;27:450-61.
98. Karn T, Jiang T, Hatzis C, et al. Association between genomic metrics and immune infiltration in triple-negative breast cancer. JAMA Oncol 2017;3:1707-11.
99. Dushyanthen S, Beavis PA, Savas P, et al. Relevance of tumor-infiltrating lymphocytes in breast cancer. BMC Med 2015;13:202.
100. Azizi E, Carr AJ, Plitas G, et al. Single-cell map of diverse immune phenotypes in the breast tumor microenvironment. Cell 2018;174:1293-308.e36.
101. Chung W, Eum HH, Lee HO, et al. Single-cell RNA-seq enables comprehensive tumour and immune cell profiling in primary breast cancer. Nat Commun 2017;8:15081.
102. Wagner J, Rapsomaniki MA, Chevrier S, et al. A single-cell atlas of the tumor and immune ecosystem of human breast cancer. Cell 2019;177:1330-45.e18.
103. Kim IS, Gao Y, Welte T, et al. Immuno-subtyping of breast cancer reveals distinct myeloid cell profiles and immunotherapy resistance mechanisms. Nat Cell Biol 2019;21:1113-26.
104. Naik A, Decock J. Lactate metabolism and immune modulation in breast cancer: A focused review on triple negative breast tumors. Front Oncol 2020;10:598626.
105. Pilon-Thomas S, Kodumudi KN, El-Kenawi AE, et al. Neutralization of tumor acidity improves antitumor responses to immunotherapy. Cancer Res 2016;76:1381-90.
106. Pötzl J, Roser D, Bankel L, et al. Reversal of tumor acidosis by systemic buffering reactivates NK cells to express IFN-γ and induces NK cell-dependent lymphoma control without other immunotherapies. Int J Cancer 2017;140:2125-33.
107. O'Sullivan D, Sanin DE, Pearce EJ, et al. Metabolic interventions in the immune response to cancer. Nat Rev Immunol 2019;19:324-35.
108. Nanda R, Chow LQ, Dees EC, et al. Pembrolizumab in patients with advanced triple-negative breast cancer: phase Ib KEYNOTE-012 study. J Clin Oncol 2016;34:2460-7.
109. Adams S, Schmid P, Rugo HS, et al. Pembrolizumab monotherapy for previously treated metastatic triple-negative breast cancer: cohort A of the phase II KEYNOTE-086 study. Ann Oncol 2019;30:397-404.
110. Szekely B, Bossuyt V, Li X, et al. Immunological differences between primary and metastatic breast cancer. Ann Oncol 2018;29:2232-9.
111. Hutchinson KE, Yost SE, Chang CW, et al. Comprehensive profiling of poor-risk paired primary and recurrent triple-negative breast cancers reveals immune phenotype shifts. Clin Cancer Res 2020;26:657-68.
112. Nanda R, Liu MC, Yau C, Shatsky R, et al. Effect of pembrolizumab plus neoadjuvant chemotherapy on pathologic complete response in women with early-stage breast cancer: An analysis of the ongoing phase 2 adaptively randomized I-SPY2 trial. JAMA Oncol 2020;6:676-84.
113. Schmid P, Cortes J, Pusztai L, et al. Pembrolizumab for early triple-negative breast cancer. N Engl J Med 2020;382:810-21.
114. Oncologic Drugs Advisory Committee (ODAC) Meeting Briefing Materials. Available from: https://www.fda.gov/media/145654/download. [Last accessed on 24 Mar 2021].
115. Mittendorf EA, Zhang H, Barrios CH, et al. Neoadjuvant atezolizumab in combination with sequential nab-paclitaxel and anthracycline-based chemotherapy versus placebo and chemotherapy in patients with early-stage triple-negative breast cancer (IMpassion031): a randomised, double-blind, phase 3 trial. Lancet 2020;396:1090-100.
118. Voorwerk L, Slagter M, Horlings HM, et al. Immune induction strategies in metastatic triple-negative breast cancer to enhance the sensitivity to PD-1 blockade: the TONIC trial. Nat Med 2019;25:920-8.
119. Loibl S, Untch M, Burchardi N, et al. A randomised phase II study investigating durvalumab in addition to an anthracycline taxane-based neoadjuvant therapy in early triple-negative breast cancer: clinical results and biomarker analysis of GeparNuevo study. Ann Oncol 2019;30:1279-88.
120. Cortés J, Lipatov O, Im S, et al. KEYNOTE-119: phase 3 study of pembrolizumab (pembro) versus single-agent chemotherapy (chemo) for metastatic triple negative breast cancer (MTNBC). Ann Oncol 2019;30:v851-934.
121. Dirix LY, Takacs I, Jerusalem G, et al. Avelumab, an anti-PD-L1 antibody, in patients with locally advanced or metastatic breast cancer: a phase 1b JAVELIN solid tumor study. Breast Cancer Res 2018;167:671-86.
122. Galluzzi L, Buqué A, Kepp O, et al. Immunological effects of conventional chemotherapy and targeted anticancer agents. Cancer Cell 2015;28:690-714.
123. Schmid P, Adams S, Rugo HS, et al. Atezolizumab and nab-paclitaxel in advanced triple-negative breast cancer. N Engl J Med 2018;379:2108-21.
124. Emens LA, Adams S, Barrios CH, et al. IMpassion130: Final OS analysis from the pivotal phase III study of atezolizumab + nab-paclitaxel vs placebo + nab-paclitaxel in previously untreated locally advanced or metastatic triple-negative breast cancer. Ann Oncol 2020;31:S1148.
125. Miles DW, Gligorov J, André F, et al. Primary results from IMpassion131, a double-blind placebo-controlled randomised phase III trial of first-line paclitaxel (PAC) ± atezolizumab (atezo) for unresectable locally advanced/metastatic triple-negative breast cancer (mTNBC). Ann Oncol 2020;31:S1147-8.
126. Rugo HS, Schmid P, Cescon DW, et al. Additional efficacy endpoints from the phase 3 KEYNOTE-355 study of pembrolizumab plus chemotherapy vs placebo plus chemotherapy as first-line therapy for locally recurrent inoperable or metastatic triple-negative breast cancer. San Antonio Breast Cancer Symposium 2020.
127. Cortés J, Cescon DW, Rugo HS, et al. KEYNOTE-355: Randomized, double-blind, phase III study of pembrolizumab + chemotherapy versus placebo + chemotherapy for previously untreated locally recurrent inoperable or metastatic triple-negative breast cancer. J Clin Oncol 2020;38:1000.
128. Huang X, Ding Q, Guo H, et al. Comparison of three FDA-approved diagnostic immunohistochemistry assays of PD-L1 in triple-negative breast carcinoma. Hum Pathol 2020;108:42-50.
129. Lee SE, Park HY, Lim SD, et al. Concordance of Programmed death-ligand 1 expression between SP142 and 22C3/SP263 assays in triple-negative breast cancer. J Breast Cancer 2020;23:303-13.
130. Noske A, Ammann JU, Wagner DC, et al. A multicentre analytical comparison study of inter-reader and inter-assay agreement of four programmed death-ligand 1 immunohistochemistry assays for scoring in triple-negative breast cancer. Histopathology 2021;78:567-77.
131. Gonzalez-Ericsson PI, Stovgaard ES, Sua LF, et al. The path to a better biomarker: application of a risk management framework for the implementation of PD-L1 and TILs as immuno-oncology biomarkers in breast cancer clinical trials and daily practice. J Pathol 2020;250:667-84.
132. Samstein RM, Lee CH, Shoushtari AN, et al. Tumor mutational load predicts survival after immunotherapy across multiple cancer types. Nat Genet 2019;51:202-6.
133. Barroso-Sousa R, Keenan TE, Pernas S, et al. Tumor mutational burden and PTEN alterations as molecular correlates of response to PD-1/L1 blockade in metastatic triple-negative breast cancer. Clin Cancer Res 2020;26:2565-72.
134. Lu S, Stein JE, Rimm DL, et al. Comparison of biomarker modalities for predicting response to PD-1/PD-L1 checkpoint blockade: A systematic review and meta-analysis. JAMA Oncol 2019;5:1195-204.
135. Keren L, Bosse M, Marquez D, et al. A structured tumor-immune microenvironment in triple negative breast cancer revealed by multiplexed Ion beam imaging. Cell 2018;174:1373-87.e19.
136. Schürch CM, Bhate SS, Barlow GL, et al. . Coordinated cellular neighborhoods orchestrate antitumoral immunity at the colorectal cancer invasive front. 2020;182:1341-59.e19.
137. Coombes RC, Page K, Salari R, et al. Personalized detection of circulating tumor DNA antedates breast cancer metastatic recurrence. Clin Cancer Res 2019;25:4255-63.
138. Bratman SV, Yang SY, Iafolla MAJ, et al. Personalized circulating tumor DNA analysis as a predictive biomarker in solid tumor patients treated with pembrolizumab. Nat Cancer 2020;1:873-81.
139. Volovat SR, Volovat C, Hordila I, et al. MiRNA and LncRNA as potential biomarkers in triple-negative breast cancer: A review. Front Oncol 2020;10:526850.
140. Piña-Sánchez P, Valdez-Salazar H, Ruiz-Tachiquín M. Circulating microRNAs and their role in the immune response in triple-negative breast cancer. Oncol Lett 2020;20:224.
