“Diagnostic and Prognostic Biomarkers of Luminal Breast Cancer: Where are We Now?”

References

• Siegel RL, Miller KD, Fuchs HE, Jemal A. Cancer statistics, 2022. CA Cancer J Clin. 2022;72:7–33. doi:10.3322/caac.21708
   PubMed Web of Science ®Google Scholar
• Perou CM, Sørlie T, Eisen MB, et al. Molecular portraits of human breast tumours. Nature. 2000;406:747–752. doi:10.1038/35021093
   PubMed Web of Science ®Google Scholar
• Yersal O, Barutca S. Biological subtypes of breast cancer: prognostic and therapeutic implications. World J Clin Oncol. 2014;5:412–424. doi:10.5306/wjco.v5.i3.412
   PubMedGoogle Scholar
• Richards MA, Westcombe AM, Love SB, Littlejohns P, Ramirez AJ. Influence of delay on survival in patients with breast cancer: a systematic review. Lancet. 1999;353:1119–1126. doi:10.1016/s0140-6736(99)02143-1
   PubMed Web of Science ®Google Scholar
• Waks AG, Winer EP. Breast Cancer Treatment: a Review. JAMA. 2019;321:288–300. doi:10.1001/jama.2018.19323
   PubMed Web of Science ®Google Scholar
• Hayes DF, Isaacs C, Stearns V. Prognostic factors in breast cancer: current and new predictors of metastasis. J Mammary Gland Biol Neoplasia. 2001;6:375–392. doi:10.1023/a:1014778713034
   PubMed Web of Science ®Google Scholar
• Weigel MT, Dowsett M. Current and emerging biomarkers in breast cancer: prognosis and prediction. Endocr Relat Cancer. 2010;17:R245–262. doi:10.1677/ERC-10-0136
   PubMed Web of Science ®Google Scholar
• Denoix PF, Baclesse F. Presentation of the project for clinical classification of malignant breast tumors by the international union for cancer control. Mem Acad Chir. 1956;82:407–410.
   PubMedGoogle Scholar
• Toft D, Shyamala G, Gorski J. A receptor molecule for estrogens: studies using a cell-free system. Proc Natl Acad Sci U S A. 1967;57:1740–1743. doi:10.1073/pnas.57.6.1740
   PubMed Web of Science ®Google Scholar
• Jensen EV, DeSombre ER. Estrogen-receptor interaction. Science. 1973;182:126–134. doi:10.1126/science.182.4108.126
   PubMed Web of Science ®Google Scholar
• Rakha EA, Reis-Filho JS, Ellis IO. Combinatorial biomarker expression in breast cancer. Breast Cancer Res Treat. 2010;120:293–308. doi:10.1007/s10549-010-0746-x
   PubMed Web of Science ®Google Scholar
• Slamon DJ, Clark GM, Wong SG, et al. Human Breast Cancer: Correlation of Relapse and Survival with Amplification of the HER-2/ neu Oncogene. Science. 1987;235:177–182. doi:10.1126/science.3798106
   PubMed Web of Science ®Google Scholar
• Kolata G. Breaking ranks, lab offers test to assess risk of breast cancer. N Y Times Web. 1996;A1–A15.
   PubMedGoogle Scholar
• Sorlie T, Perou CM, Tibshirani R, et al. Gene expression patterns of breast carcinomas distinguish tumor subclasses with clinical implications. Proc Natl Acad Sci US A. 2001;98:10869–10874. doi:10.1073/pnas.191367098
   PubMed Web of Science ®Google Scholar
• Parker JS, Mullins M, Cheang MC, et al. Supervised risk predictor of breast cancer based on intrinsic subtypes. J Clin Oncol. 2009;27:1160–1167. doi:10.1200/JCO.2008.18.1370
   PubMed Web of Science ®Google Scholar
• Sotiriou C, Pusztai L. Gene-expression signatures in breast cancer. N Engl J Med. 2009;360:790–800. doi:10.1056/NEJMra0801289
   PubMed Web of Science ®Google Scholar
• Paik S, Shak S, Tang G, et al. A multigene assay to predict recurrence of tamoxifen-treated, node-negative breast cancer. N Engl J Med. 2004;351:2817–2826. doi:10.1056/NEJMoa041588
   PubMed Web of Science ®Google Scholar
• Sparano JA, Gray RJ, Makower DF, et al. Prospective validation of a 21-gene expression assay in breast cancer. N Engl J Med. 2015;373:2005–2014. doi:10.1056/NEJMoa1510764
   PubMed Web of Science ®Google Scholar
• Dowsett M, Nielsen TO, A’Hern R, et al. Assessment of Ki67 in breast cancer: recommendations from the International Ki67 in Breast Cancer working group. J Natl Cancer Inst. 2011;103:1656–1664. doi:10.1093/jnci/djr393
   PubMed Web of Science ®Google Scholar
• Cancer Genome Atlas N. Comprehensive molecular portraits of human breast tumours. Nature. 2012;490:61–70. doi:10.1038/nature11412
   PubMed Web of Science ®Google Scholar
• Cole MP, Jones CT, Todd ID. A new anti-oestrogenic agent in late breast cancer. An early clinical appraisal of ICI46474. Br J Cancer. 1971;25:270–275. doi:10.1038/bjc.1971.33
   PubMed Web of Science ®Google Scholar
• Baum M. Anastrozole alone or in combination with tamoxifen versus tamoxifen alone for adjuvant treatment of postmenopausal women with early breast cancer: first results of the ATAC randomised trial. Lancet. 2002;359:2131–2139. doi:10.1016/s0140-6736(02)09088-8
   PubMed Web of Science ®Google Scholar
• Howell A, Robertson JFR, Quaresma Albano J, et al. Fulvestrant,formerly ICI 182,780,is as effective as anastrozole in postmenopausal women with advanced breast cancer progressing after prior endocrine treatment. J Clin Oncol. 2002;20:3396–3403. doi:10.1200/JCO.2002.10.057
   PubMed Web of Science ®Google Scholar
• Pegram MD, Lipton A, Hayes DF, et al. Phase II study of receptor-enhanced chemosensitivity using recombinant humanized anti-p185HER2/neu monoclonal antibody plus cisplatin in patients with HER2/neu-overexpressing metastatic breast cancer refractory to chemotherapy treatment. J Clin Oncol. 1998;16:2659–2671. doi:10.1200/JCO.1998.16.8.2659
   PubMed Web of Science ®Google Scholar
• Geyer CE, Cameron D, Lindquist D. Lapatinib plus capecitabine for HER2-positive advanced breast cancer. N Engl J Med. 2006;355:2733–2743. doi:10.1056/NEJMoa064320
   PubMed Web of Science ®Google Scholar
• Baselga J, Cortés J, Kim SB, et al. Pertuzumab plus trastuzumab plus docetaxel for metastatic breast cancer. N Engl J Med. 2012;366:109–119. doi:10.1056/NEJMoa1113216
   PubMed Web of Science ®Google Scholar
• Verma S, Miles D, Gianni L, et al. Trastuzumab emtansine for HER2-positive advanced breast cancer. N Engl J Med. 2012;367:1783–1791. doi:10.1056/NEJMoa1209124
   PubMed Web of Science ®Google Scholar
• Modi S, Jacot W, Yamashita T, et al. Trastuzumab deruxtecan in previously treated HER2-low advanced breast cancer. N Engl J Med. 2022;387:9–20. doi:10.1056/NEJMoa2203690
   PubMed Web of Science ®Google Scholar
• Robson M, Im S-A, Senkus E, et al. Olaparib for metastatic breast cancer in patients with a germline BRCA mutation. N Engl J Med. 2017;377:523–533. doi:10.1056/NEJMoa1706450
   PubMed Web of Science ®Google Scholar
• Litton JK, Rugo HS, Ettl J, et al. Talazoparib in patients with advanced breast cancer and a germline BRCA mutation. N Engl J Med. 2018;379:753–763. doi:10.1056/NEJMoa1802905
   PubMed Web of Science ®Google Scholar
• Piccart M, Sørlie T, Perou CM, et al. 70-gene signature as an aid for treatment decisions in early breast cancer: updated results of the phase 3 randomised MINDACT trial with an exploratory analysis by age. Lancet Oncol. 2021;22:476–488. doi:10.1016/S1470-2045(21)00007-3
   PubMed Web of Science ®Google Scholar
• Andre F, Ismaila N, Henry NL, et al. Use of biomarkers to guide decisions on adjuvant systemic therapy for women with early-stage invasive breast cancer: ASCO clinical practice guideline update-integration of results from TAILORx. J Clin Oncol. 2019;37:1956–1964. doi:10.1200/JCO.19.00945
   PubMed Web of Science ®Google Scholar
• Kalinsky K, Barlow WE, Gralow JR, et al. 21-gene assay to inform chemotherapy benefit in node-positive breast cancer. N Engl J Med. 2021;385:2336–2347. doi:10.1056/NEJMoa2108873
   PubMed Web of Science ®Google Scholar
• Andre F. Alpelisib for PIK3CA-Mutated, Hormone Receptor-Positive Advanced Breast Cancer. N Engl J Med. 2019;380:1929–1940. doi:10.1056/NEJMoa1813904
   PubMed Web of Science ®Google Scholar
• Finn RS, Martin M, Rugo HS, et al. Palbociclib and letrozole in advanced breast cancer. N Engl J Med. 2016;375(20):1925–1936. doi:10.1056/NEJMoa1607303
   PubMed Web of Science ®Google Scholar
• Hortobagyi GN, Stemmer SM, Burris HA, et al. Ribociclib as First-Line Therapy for HR-Positive, Advanced Breast Cancer. N Engl J Med. 2016;375:1738–1748. doi:10.1056/NEJMoa1609709
   PubMed Web of Science ®Google Scholar
• Sledge GW Jr, Toi M, Neven P, et al. MONARCH 2: abemaciclib in combination with fulvestrant in women with HR+/HER2- advanced breast cancer who had progressed while receiving endocrine therapy. J Clin Oncol. 2017;35:2875–2884. doi:10.1200/JCO.2017.73.7585
   PubMed Web of Science ®Google Scholar
• Simon RM, Paik S, Hayes DF. Use of archived specimens in evaluation of prognostic and predictive biomarkers. J Natl Cancer Inst. 2009;101:1446–1452. doi:10.1093/jnci/djp335
   PubMed Web of Science ®Google Scholar
• Atkins D. Grading quality of evidence and strength of recommendations. BMJ. 2004;328:1490. doi:10.1136/bmj.328.7454.1490
   PubMed Web of Science ®Google Scholar
• Ebell MH, Siwek J, Weiss BD, et al. Strength of recommendation taxonomy (SORT): a patient-centered approach to grading evidence in the medical literature. J Am Board Fam Pract. 2004;17:59–67. doi:10.3122/jabfm.17.1.59
   PubMedGoogle Scholar
• McShane LM, Chauhan SP, Ward TC, et al. Reporting recommendations for tumor marker prognostic studies (REMARK). J Natl Cancer Inst. 2005;97:1180–1184. doi:10.1093/jnci/dji237
   PubMed Web of Science ®Google Scholar
• Giuliano AE, Edge SB, Hortobagyi GN. Eighth edition of the AJCC cancer staging manual: breast cancer. Ann Surg Oncol. 2018;25:1783–1785. doi:10.1245/s10434-018-6486-6
   PubMed Web of Science ®Google Scholar
• Narod SA. Tumour size predicts long-term survival among women with lymph node-positive breast cancer. Curr Oncol. 2012;19:249–253. doi:10.3747/co.19.1043
   PubMed Web of Science ®Google Scholar
• Sopik V, Narod SA. The relationship between tumour size, nodal status and distant metastases: on the origins of breast cancer. Breast Cancer Res Treat. 2018;170:647–656. doi:10.1007/s10549-018-4796-9
   PubMed Web of Science ®Google Scholar
• Schijven MP, Vingerhoets AJ, Rutten HJ, et al. Comparison of morbidity between axillary lymph node dissection and sentinel node biopsy. Eur J Surg Oncol. 2003;29:341–350. doi:10.1053/ejso.2002.1385
   PubMed Web of Science ®Google Scholar
• Galimberti V, Cole BF, Zurrida S, et al. Axillary dissection versus no axillary dissection in patients with sentinel-node micrometastases (IBCSG 23-01): a phase 3 randomised controlled trial. Lancet Oncol. 2013;14:297–305. doi:10.1016/S1470-2045(13)70035-4
   PubMed Web of Science ®Google Scholar
• Hersh EH, King TA. De-escalating axillary surgery in early-stage breast cancer. Breast. 2022;62(1):S43–S49. doi:10.1016/j.breast.2021.11.018
   PubMedGoogle Scholar
• Gennari A, André F, Barrios CH, et al. ESMO clinical practice guideline for the diagnosis, staging and treatment of patients with metastatic breast cancer. Ann Oncol. 2021;32:1475–1495. doi:10.1016/j.annonc.2021.09.019
   PubMed Web of Science ®Google Scholar
• Groheux D, Cochet A, Humbert O, et al. 18 F-FDG PET/CT for Staging and Restaging of Breast Cancer. J Nucl Med. 2016;57(1):17S–26S. doi:10.2967/jnumed.115.157859
   PubMedGoogle Scholar
• Groheux D, Hindie E. Breast cancer: initial workup and staging with FDG PET/CT. Clin Transl Imaging. 2021;9:221–231. doi:10.1007/s40336-021-00426-z
   PubMed Web of Science ®Google Scholar
• Arnaout A, Varela NP, Allarakhia M, et al. Baseline staging imaging for distant metastasis in women with stages I, II, and III breast cancer. Curr Oncol. 2020;27:e123–e145. doi:10.3747/co.27.6147
   PubMed Web of Science ®Google Scholar
• Elston CW, Ellis IO. Pathological prognostic factors in breast cancer. I. The value of histological grade in breast cancer: experience from a large study with long-term follow-up. Histopathology. 2002;41:154–161.
   PubMedGoogle Scholar
• Ellis IO, GALEA M, BROUGHTON N, et al. Pathological prognostic factors in breast cancer. II. Histological type. Relationship with survival in a large study with long-term follow-up. Histopathology. 1992;20:479–489. doi:10.1111/j.1365-2559.1992.tb01032.x
   PubMed Web of Science ®Google Scholar
• Galea MH, Blamey RW, Elston CE, Ellis IO. The Nottingham Prognostic Index in primary breast cancer. Breast Cancer Res Treat. 1992;22:207–219. doi:10.1007/BF01840834
   PubMed Web of Science ®Google Scholar
• Rakha EA, Reis-Filho JS, Baehner F, et al. Breast cancer prognostic classification in the molecular era: the role of histological grade. Breast Cancer Res. 2010;12:207. doi:10.1186/bcr2607
   PubMed Web of Science ®Google Scholar
• Sundquist M, Thorstenson S, Brudin L, Nordenskjold B. Applying the Nottingham Prognostic Index to a Swedish breast cancer population. South East Swedish Breast Cancer Study Group. Breast Cancer Res Treat. 1999;53:1–8. doi:10.1023/a:1006052115874
   PubMed Web of Science ®Google Scholar
• Rakha EA, El-Sayed ME, Lee AHS, et al. Prognostic significance of Nottingham histologic grade in invasive breast carcinoma. J Clin Oncol. 2008;26:3153–3158. doi:10.1200/JCO.2007.15.5986
   PubMed Web of Science ®Google Scholar
• Henson DE, Ries L, Freedman LS, Carriaga M. Relationship among outcome, stage of disease, and histologic grade for 22,616 cases of breast cancer. The basis for a prognostic index. Cancer. 1991;68:2142–2149. doi:10.1002/1097-0142(19911115)68:10<2142::aid-cncr2820681010>3.0.co;2-d
   PubMed Web of Science ®Google Scholar
• Duffy MJ, Harbeck N, Nap M, et al. Clinical use of biomarkers in breast cancer: updated guidelines from the European Group on Tumor Markers (EGTM). Eur J Cancer. 2017;75:284–298. doi:10.1016/j.ejca.2017.01.017
   PubMed Web of Science ®Google Scholar
• Gradishar WJ, Moran MS, Abraham J, et al. Breast Cancer,Version 3.2022, NCCN clinical practice guidelines in oncology. J Natl Compr Canc Netw. 2022;20:691–722. doi:10.6004/jnccn.2022.0030
   PubMedGoogle Scholar
• Cardoso F, Kyriakides S, Ohno S, et al. Early breast cancer: ESMO clinical practice guidelines for diagnosis, treatment and follow-updagger. Ann Oncol. 2019;30:1194–1220. doi:10.1093/annonc/mdz173
   PubMed Web of Science ®Google Scholar
• Early Breast Cancer Trialists’ Collaborative, G, et al. Relevance of breast cancer hormone receptors and other factors to the efficacy of adjuvant tamoxifen: patient-level meta-analysis of randomised trials. Lancet. 2011;378:771–784. doi:10.1016/S0140-6736(11)60993-8
   PubMed Web of Science ®Google Scholar
• Elledge RM, Green S, Pugh R, et al. Estrogen receptor (ER) and progesterone receptor (PgR), by ligand-binding assay compared with ER, PgR and pS2, by immuno-histochemistry in predicting response to tamoxifen in metastatic breast cancer: a Southwest Oncology Group Study. Int J Cancer. 2000;89:111–117. doi:10.1002/(SICI)1097-0215(20000320)89:2<111::AID-IJC2>3.0.CO;2-W
   PubMed Web of Science ®Google Scholar
• Ruhstaller T, Giobbie-Hurder A, Colleoni M, et al. Adjuvant Letrozole and Tamoxifen Alone or Sequentially for Postmenopausal Women With Hormone Receptor-Positive Breast Cancer: Long-Term Follow-Up of the BIG 1-98 Trial. J Clin Oncol. 2019;37:105–114. doi:10.1200/JCO.18.00440
   PubMed Web of Science ®Google Scholar
• Howell A. Results of the ATAC (Arimidex, Tamoxifen, Alone or in Combination) trial after completion of 5 years’ adjuvant treatment for breast cancer. Lancet. 2005;365:60–62. doi:10.1016/S0140-6736(04)17666-6
   PubMed Web of Science ®Google Scholar
• Paterni I, Granchi C, Katzenellenbogen JA, Minutolo F. Estrogen receptors alpha (ERalpha) and beta (ERbeta): subtype-selective ligands and clinical potential. Steroids. 2014;90:13–29. doi:10.1016/j.steroids.2014.06.012
   PubMed Web of Science ®Google Scholar
• Kastner P, Krust A, Turcotte B, et al. Two distinct estrogen-regulated promoters generate transcripts encoding the two functionally different human progesterone receptor forms A and B. EMBO J. 1990;9:1603–1614. doi:10.1002/j.1460-2075.1990.tb08280.x
   PubMed Web of Science ®Google Scholar
• Yu WC, Leung BS, Gao YL. Effects of 17 beta-estradiol on progesterone receptors and the uptake of thymidine in human breast cancer cell line CAMA-1. Cancer Res. 1981;41:5004–5009.
   PubMed Web of Science ®Google Scholar
• Hilton HN, Clarke CL, Graham JD. Estrogen and progesterone signalling in the normal breast and its implications for cancer development. Mol Cell Endocrinol. 2018;466:2–14. doi:10.1016/j.mce.2017.08.011
   PubMed Web of Science ®Google Scholar
• 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;28:2784–2795. doi:10.1200/JCO.2009.25.6529
   PubMed Web of Science ®Google Scholar
• Dowsett M, Houghton J, Iden C, et al. Benefit from adjuvant tamoxifen therapy in primary breast cancer patients according oestrogen receptor, progesterone receptor, EGF receptor and HER2 status. Ann Oncol. 2006;17:818–826. doi:10.1093/annonc/mdl016
   PubMed Web of Science ®Google Scholar
• Ravdin PM, Green S, Dorr TM, et al. Prognostic significance of progesterone receptor levels in estrogen receptor-positive patients with metastatic breast cancer treated with tamoxifen: results of a prospective Southwest Oncology Group study. J Clin Oncol. 1992;10:1284–1291. doi:10.1200/JCO.1992.10.8.1284
   PubMed Web of Science ®Google Scholar
• Clark GM, Osborne CK, McGuire WL. Correlations between estrogen receptor, progesterone receptor, and patient characteristics in human breast cancer. J Clin Oncol. 1984;2:1102–1109. doi:10.1200/JCO.1984.2.10.1102
   PubMed Web of Science ®Google Scholar
• Reinert T, Cascelli F, Resende CAAD, et al. Clinical implication of low estrogen receptor (ER-low) expression in breast cancer. Front Endocrinol (Lausanne). 2022;13:1015388. doi:10.3389/fendo.2022.1015388
   PubMed Web of Science ®Google Scholar
• Allison KH, Hammond MEH, Dowsett M, et al. Estrogen and Progesterone Receptor Testing in Breast Cancer: ASCO/CAP Guideline Update. J Clin Oncol. 2020;38:1346–1366. doi:10.1200/JCO.19.02309
   PubMed Web of Science ®Google Scholar
• Harvey JM, Clark GM, Osborne CK, Allred DC. Estrogen receptor status by immunohistochemistry is superior to the ligand-binding assay for predicting response to adjuvant endocrine therapy in breast cancer. J Clin Oncol. 1999;17:1474–1481. doi:10.1200/JCO.1999.17.5.1474
   PubMed Web of Science ®Google Scholar
• Remmele W, Stegner HE. Recommendation for uniform definition of an immunoreactive score (IRS) for immunohistochemical estrogen receptor detection (ER-ICA) in breast cancer tissue. Pathologe. 1987;8:138–140.
   PubMed Web of Science ®Google Scholar
• Pecci A, Ogara MF, Sanz RT, Vicent GP. Choosing the right partner in hormone-dependent gene regulation: Glucocorticoid and progesterone receptors crosstalk in breast cancer cells. Front Endocrinol (Lausanne). 2022;13:1037177. doi:10.3389/fendo.2022.1037177
   PubMed Web of Science ®Google Scholar
• Belachew EB, Sewasew DT. Molecular mechanisms of endocrine resistance in estrogen-positive breast cancer. Front Endocrinol (Lausanne). 2021;12:599586. doi:10.3389/fendo.2021.599586
   PubMed Web of Science ®Google Scholar
• Roskoski R Jr. Cyclin-dependent protein kinase inhibitors including palbociclib as anticancer drugs. Pharmacol Res. 2016;107:249–275. doi:10.1016/j.phrs.2016.03.012
   PubMed Web of Science ®Google Scholar
• Andrade de Oliveira K, Sengupta S, Yadav AK, Clarke R. The complex nature of heterogeneity and its roles in breast cancer biology and therapeutic responsiveness. Front Endocrinol (Lausanne). 2023;14:1083048. doi:10.3389/fendo.2023.1083048
   PubMed Web of Science ®Google Scholar
• Sgroi DC, Carney E, Zarrella E, et al. Prediction of late disease recurrence and extended adjuvant letrozole benefit by the HOXB13/IL17BR biomarker. J Natl Cancer Inst. 2013;105:1036–1042. doi:10.1093/jnci/djt146
   PubMedGoogle Scholar
• Sgroi DC, Sestak I, Cuzick J, et al. Prediction of late distant recurrence in patients with oestrogen-receptor-positive breast cancer: a prospective comparison of the breast-cancer index (BCI) assay, 21-gene recurrence score, and IHC4 in the TransATAC study population. Lancet Oncol. 2013;14:1067–1076. doi:10.1016/S1470-2045(13)70387-5
   PubMed Web of Science ®Google Scholar
• Gerdes J, Schwab U, Lemke H, Stein H. Production of a mouse monoclonal antibody reactive with a human nuclear antigen associated with cell proliferation. Int J Cancer. 1983;31:13–20. doi:10.1002/ijc.2910310104
   PubMed Web of Science ®Google Scholar
• Lopez F, Belloc F, Lacombe F, et al. Modalities of synthesis of Ki67 antigen during the stimulation of lymphocytes. Cytometry. 1991;12:42–49. doi:10.1002/cyto.990120107
   PubMedGoogle Scholar
• Guarneri V, Piacentini F, Ficarra G, et al. A prognostic model based on nodal status and Ki-67 predicts the risk of recurrence and death in breast cancer patients with residual disease after preoperative chemotherapy. Ann Oncol. 2009;20:1193–1198. doi:10.1093/annonc/mdn761
   PubMed Web of Science ®Google Scholar
• Urruticoechea A, Smith IE, Dowsett M. Proliferation marker Ki-67 in early breast cancer. J Clin Oncol. 2005;23:7212–7220. doi:10.1200/JCO.2005.07.501
   PubMed Web of Science ®Google Scholar
• Goldhirsch A, Wood WC, Coates AS, et al. Strategies for subtypes--dealing with the diversity of breast cancer: highlights of the St. Gallen international expert consensus on the primary therapy of early breast cancer 2011. Ann Oncol. 2011;22:1736–1747. doi:10.1093/annonc/mdr304
   PubMed Web of Science ®Google Scholar
• Goldhirsch A, Winer EP, Coates AS, et al. Personalizing the treatment of women with early breast cancer: highlights of the St gallen international expert consensus on the primary therapy of early breast cancer 2013. Ann Oncol. 2013;24:2206–2223. doi:10.1093/annonc/mdt303
   PubMed Web of Science ®Google Scholar
• Luporsi E, André F, Spyratos F, et al. Ki-67: level of evidence and methodological considerations for its role in the clinical management of breast cancer: analytical and critical review. Breast Cancer Res Treat. 2012;132:895–915. doi:10.1007/s10549-011-1837-z
   PubMed Web of Science ®Google Scholar
• Yerushalmi R, Woods R, Ravdin PM, Hayes MM, Gelmon KA. Ki67 in breast cancer: prognostic and predictive potential. Lancet Oncol. 2010;11:174–183. doi:10.1016/S1470-2045(09)70262-1
   PubMed Web of Science ®Google Scholar
• Viale G, Giobbie-Hurder A, Regan MM, et al. Prognostic and predictive value of centrally reviewed Ki-67 labeling index in postmenopausal women with endocrine-responsive breast cancer: results from Breast International Group Trial 1-98 comparing adjuvant tamoxifen with letrozole. J Clin Oncol. 2008;26:5569–5575. doi:10.1200/JCO.2008.17.0829
   PubMed Web of Science ®Google Scholar
• Dumontet C, Krajewska M, Treilleux I, et al. BCIRG 001 molecular analysis: prognostic factors in node-positive breast cancer patients receiving adjuvant chemotherapy. Clin Cancer Res. 2010;16:3988–3997. doi:10.1158/1078-0432.CCR-10-0079
   PubMed Web of Science ®Google Scholar
• Anderson RL, Balasas T, Callaghan J, et al. A framework for the development of effective anti-metastatic agents. Nat Rev Clin Oncol. 2019;16:185–204. doi:10.1038/s41571-018-0134-8
   PubMed Web of Science ®Google Scholar
• Polley MY, Leung SCY, Gao D, et al. An international study to increase concordance in Ki67 scoring. Mod Pathol. 2015;28:778–786. doi:10.1038/modpathol.2015.38
   PubMed Web of Science ®Google Scholar
• Varga Z, Diebold J, Dommann-Scherrer C, et al. How reliable is Ki-67 immunohistochemistry in grade 2 breast carcinomas? A QA study of the Swiss Working Group of Breast- and Gynecopathologists. PLoS One. 2012;7:e37379. doi:10.1371/journal.pone.0037379
   PubMed Web of Science ®Google Scholar
• Slamon DJ, Godolphin W, Jones LA, et al. Studies of the HER-2/ neu proto-oncogene in human breast and ovarian cancer. Science. 1989;244:707–712. doi:10.1126/science.2470152
   PubMed Web of Science ®Google Scholar
• Wolff AC, Elizabeth Hale Hammond M, 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 Clin Oncol. 2018;36:2105–2122. doi:10.1200/JCO.2018.77.8738
   PubMed Web of Science ®Google Scholar
• Vogel CL, Cobleigh MA, Tripathy D, et al. Efficacy and safety of trastuzumab as a single agent in first-line treatment of HER2-overexpressing metastatic breast cancer. J Clin Oncol. 2002;20:719–726. doi:10.1200/JCO.2002.20.3.719
   PubMed Web of Science ®Google Scholar
• Slamon DJ, Leyland-Jones B, Shak S, et al. Use of chemotherapy plus a monoclonal antibody against HER2 for metastatic breast cancer that overexpresses HER2. N Engl J Med. 2001;344:783–792. doi:10.1056/NEJM200103153441101
   PubMed Web of Science ®Google Scholar
• Ogitani Y, Hagihara K, Oitate M, Naito H, 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. 2016;107:1039–1046. doi:10.1111/cas.12966
   PubMed Web of Science ®Google Scholar
• Tarantino P, Hamilton E, Tolaney SM, et al. HER2-low breast cancer: pathological and clinical landscape. J Clin Oncol. 2020;38:1951–1962. doi:10.1200/JCO.19.02488
   PubMed Web of Science ®Google Scholar
• Zhang X, Huang AC, Chen F, et al. Novel development strategies and challenges for anti-Her2 antibody-drug conjugates. Antib Ther. 2022;5:18–29. doi:10.1093/abt/tbac001
   PubMedGoogle Scholar
• Li J, Ma M, Yang X, et al. Circular HER2 RNA positive triple negative breast cancer is sensitive to Pertuzumab. Mol Cancer. 2020;19:142. doi:10.1186/s12943-020-01259-6
   PubMed Web of Science ®Google Scholar
• Pegram M, Jackisch C, Johnston SRD. Estrogen/HER2 receptor crosstalk in breast cancer: combination therapies to improve outcomes for patients with hormone receptor-positive/HER2-positive breast cancer. NPJ Breast Cancer. 2023;9:45. doi:10.1038/s41523-023-00533-2
   PubMed Web of Science ®Google Scholar
• Burstein HJ. Systemic Therapy for Estrogen Receptor-Positive, HER2-Negative Breast Cancer. N Engl J Med. 2020;383:2557–2570. doi:10.1056/NEJMra1307118
   PubMed Web of Science ®Google Scholar
• Turner NC, Swift C, Kilburn L, et al. ESR1 Mutations and Overall Survival on Fulvestrant versus Exemestane in Advanced Hormone Receptor-Positive Breast Cancer: a Combined Analysis of the Phase III SoFEA and EFECT Trials. Clin Cancer Res. 2020;26:5172–5177. doi:10.1158/1078-0432.CCR-20-0224
   PubMed Web of Science ®Google Scholar
• Hurtado A, Holmes KA, Ross-Innes CS, Schmidt D, Carroll JS. FOXA1 is a key determinant of estrogen receptor function and endocrine response. Nat Genet. 2011;43:27–33. doi:10.1038/ng.730
   PubMed Web of Science ®Google Scholar
• Mukherjee S, Conrad SE. c-Myc suppresses p21WAF1/CIP1 expression during estrogen signaling and antiestrogen resistance in human breast cancer cells. J Biol Chem. 2005;280:17617–17625. doi:10.1074/jbc.M502278200
   PubMed Web of Science ®Google Scholar
• Zwijsen RM, Wientjens E, Klompmaker R, et al. CDK-independent activation of estrogen receptor by cyclin D1. Cell. 1997;88:405–415. doi:10.1016/s0092-8674(00)81879-6
   PubMed Web of Science ®Google Scholar
• Sabine VS, Crozier C, Brookes CL, et al. Mutational analysis of PI3K/AKT signaling pathway in tamoxifen exemestane adjuvant multinational pathology study. J Clin Oncol. 2014;32:2951–2958. doi:10.1200/JCO.2013.53.8272
   PubMed Web of Science ®Google Scholar
• Bosch A, Li Z, Bergamaschi A, et al. PI3K inhibition results in enhanced estrogen receptor function and dependence in hormone receptor-positive breast cancer. Sci Transl Med. 2015;7:283ra251. doi:10.1126/scitranslmed.aaa4442
   Web of Science ®Google Scholar
• Henry NL, Somerfield MR, Dayao Z, et al. Biomarkers for systemic therapy in metastatic breast cancer: ASCO guideline update. J Clin Oncol. 2022;40:3205–3221. doi:10.1200/JCO.22.01063
   PubMed Web of Science ®Google Scholar
• Baselga J, Campone M, Piccart M, et al. Everolimus in postmenopausal hormone-receptor-positive advanced breast cancer. N Engl J Med. 2012;366:520–529. doi:10.1056/NEJMoa1109653
   PubMed Web of Science ®Google Scholar
• Spring LM, Wander SA, Andre F, et al. Cyclin-dependent kinase 4 and 6 inhibitors for hormone receptor-positive breast cancer: past, present, and future. Lancet. 2020;395:817–827. doi:10.1016/S0140-6736(20)30165-3
   PubMed Web of Science ®Google Scholar
• Turner NC, Slamon DJ, Ro J, et al. Overall survival with palbociclib and fulvestrant in advanced breast cancer. N Engl J Med. 2018;379:1926–1936. doi:10.1056/NEJMoa1810527
   PubMed Web of Science ®Google Scholar
• Im SA, Lu Y-S, Bardia A, et al. Overall survival with ribociclib plus endocrine therapy in breast cancer. N Engl J Med. 2019;381:307–316. doi:10.1056/NEJMoa1903765
   PubMed Web of Science ®Google Scholar
• Sledge GW Jr, Toi M, Neven P, et al. The effect of abemaciclib plus fulvestrant on overall survival in hormone receptor-positive, ERBB2-negative breast cancer that progressed on endocrine therapy-MONARCH 2: a Randomized clinical trial. JAMA Oncol. 2020;6:116–124. doi:10.1001/jamaoncol.2019.4782
   PubMed Web of Science ®Google Scholar
• Cottu P, D’Hondt V, Dureau S, et al. Letrozole and palbociclib versus chemotherapy as neoadjuvant therapy of high-risk luminal breast cancer. Ann Oncol. 2018;29:2334–2340. doi:10.1093/annonc/mdy448
   PubMed Web of Science ®Google Scholar
• Johnston SRD, Harbeck N, Hegg R, et al. Abemaciclib combined with endocrine therapy for the adjuvant treatment of HR+, HER2-, node-positive, high-risk, early breast cancer (monarchE). J Clin Oncol. 2020;38:3987–3998. doi:10.1200/JCO.20.02514
   PubMed Web of Science ®Google Scholar
• Trenner A, Sartori AA. Harnessing DNA double-strand break repair for cancer treatment. Front Oncol. 2019;9:1388. doi:10.3389/fonc.2019.01388
   PubMed Web of Science ®Google Scholar
• Kurian AW, Gong GD, John EM, et al. Performance of prediction models for BRCA mutation carriage in three racial/ethnic groups: findings from the Northern California breast cancer family registry. Cancer Epidemiol Biomarkers Prev. 2009;18:1084–1091. doi:10.1158/1055-9965.EPI-08-1090
   PubMed Web of Science ®Google Scholar
• Malone KE, Daling JR, Doody DR, et al. Prevalence and Predictors of BRCA1 and BRCA2 Mutations in a Population-Based Study of Breast Cancer in White and Black American Women Ages 35 to 64 Years. Cancer Res. 2006;66:8297–8308. doi:10.1158/0008-5472.CAN-06-0503
   PubMed Web of Science ®Google Scholar
• Harbeck N, Schmitt M, Meisner C, et al. Ten-year analysis of the prospective multicentre Chemo-N0 trial validates American Society of Clinical Oncology (ASCO)-recommended biomarkers uPA and PAI-1 for therapy decision making in node-negative breast cancer patients. Eur J Cancer. 2013;49:1825–1835. doi:10.1016/j.ejca.2013.01.007
   PubMed Web of Science ®Google Scholar
• Harbeck N, Kates RE, Look MP, et al. Enhanced benefit from adjuvant chemotherapy in breast cancer patients classified high-risk according to urokinase-type plasminogen activator (uPA) and plasminogen activator inhibitor type 1 (n = 3424). Cancer Res. 2002;62(62):4617–4622.
   PubMedGoogle Scholar
• Cheung KL, Graves CR, Robertson JF. Tumour marker measurements in the diagnosis and monitoring of breast cancer. Cancer Treat Rev. 2000;26:91–102. doi:10.1053/ctrv.1999.0151
   PubMed Web of Science ®Google Scholar
• Harris L, Fritsche H, Mennel R, et al. American Society of Clinical Oncology 2007 update of recommendations for the use of tumor markers in breast cancer. J Clin Oncol. 2007;25:5287–5312. doi:10.1200/JCO.2007.14.2364
   PubMed Web of Science ®Google Scholar
• Kwa M, Makris A, Esteva FJ. Clinical utility of gene-expression signatures in early stage breast cancer. Nat Rev Clin Oncol. 2017;14:595–610. doi:10.1038/nrclinonc.2017.74
   PubMed Web of Science ®Google Scholar
• Sparano JA, Bornschein R, Brown K, et al. adjuvant chemotherapy guided by a 21-gene expression assay in breast cancer. N Engl J Med. 2018;379:111–121. doi:10.1056/NEJMoa1804710
   PubMed Web of Science ®Google Scholar
• Dubsky P, Brase JC, Jakesz R, et al. The EndoPredict score provides prognostic information on late distant metastases in ER+/HER2- breast cancer patients. Br J Cancer. 2013;109:2959–2964. doi:10.1038/bjc.2013.671
   PubMed Web of Science ®Google Scholar
• Paik S, Tang G, Shak S, et al. Gene expression and benefit of chemotherapy in women with node-negative, estrogen receptor-positive breast cancer. J Clin Oncol. 2006;24:3726–3734. doi:10.1200/JCO.2005.04.7985
   PubMed Web of Science ®Google Scholar
• Mamounas EP, Tang G, Fisher B, et al. Association between the 21-gene recurrence score assay and risk of locoregional recurrence in node-negative, estrogen receptor-positive breast cancer: results from NSABP B-14 and NSABP B-20. J Clin Oncol. 2010;28:1677–1683. doi:10.1200/JCO.2009.23.7610
   PubMed Web of Science ®Google Scholar
• Albain KS, Barlow WE, Shak S, et al. Prognostic and predictive value of the 21-gene recurrence score assay in postmenopausal women with node-positive, oestrogen-receptor-positive breast cancer on chemotherapy: a retrospective analysis of a randomised trial. Lancet Oncol. 2010;11:55–65. doi:10.1016/S1470-2045(09)70314-6
   PubMed Web of Science ®Google Scholar
• Dowsett M, Cuzick J, Wale C, et al. Prediction of risk of distant recurrence using the 21-gene recurrence score in node-negative and node-positive postmenopausal patients with breast cancer treated with anastrozole or tamoxifen: a TransATAC study. J Clin Oncol. 2010;28:1829–1834. doi:10.1200/JCO.2009.24.4798
   PubMed Web of Science ®Google Scholar
• Drukker CA, Bueno‐de‐Mesquita JM, Retèl VP, et al. A prospective evaluation of a breast cancer prognosis signature in the observational RASTER study. Int J Cancer. 2013;133:929–936. doi:10.1002/ijc.28082
   PubMed Web of Science ®Google Scholar
• van ‘t Veer LJ, Dai H, van de Vijver MJ, et al. Gene expression profiling predicts clinical outcome of breast cancer. Nature. 2002;415:530–536. doi:10.1038/415530a
   PubMed Web of Science ®Google Scholar
• van de Vijver MJ, He YD, van ‘t Veer LJ, et al. A gene-expression signature as a predictor of survival in breast cancer. N Engl J Med. 2002;347:1999–2009. doi:10.1056/NEJMoa021967
   PubMed Web of Science ®Google Scholar
• Cardoso F, Van’t Veer LJ, Bogaerts J, et al. 70-gene signature as an aid to treatment decisions in early-stage breast cancer. N Engl J Med. 2016;375:717–729. doi:10.1056/NEJMoa1602253
   PubMed Web of Science ®Google Scholar
• Martin M, Brase JC, Calvo L, et al. Clinical validation of the EndoPredict test in node-positive, chemotherapy-treated ER+/HER2- breast cancer patients: results from the GEICAM 9906 trial. Breast Cancer Res. 2014;16:R38. doi:10.1186/bcr3642
   PubMed Web of Science ®Google Scholar
• Gnant M, Filipits M, Greil R, et al. Predicting distant recurrence in receptor-positive breast cancer patients with limited clinicopathological risk: using the PAM50 Risk of Recurrence score in 1478 postmenopausal patients of the ABCSG-8 trial treated with adjuvant endocrine therapy alone. Ann Oncol. 2014;25:339–345. doi:10.1093/annonc/mdt494
   PubMed Web of Science ®Google Scholar
• Sestak I, Cuzick J, Dowsett M, et al. Prediction of late distant recurrence after 5 years of endocrine treatment: a combined analysis of patients from the Austrian breast and colorectal cancer study group 8 and arimidex, tamoxifen alone or in combination randomized trials using the PAM50 risk of recurrence score. J Clin Oncol. 2015;33:916–922. doi:10.1200/JCO.2014.55.6894
   PubMed Web of Science ®Google Scholar
• Bartlett JM, Bayani J, Marshall A, et al. Comparing breast cancer multiparameter tests in the OPTIMA prelim trial: no test is more equal than the others. J Natl Cancer Inst. 2016;108:djw050. doi:10.1093/jnci/djw050
   PubMedGoogle Scholar
• Buus R, Sestak I, Kronenwett R, et al. Molecular Drivers of Onco type DX, Prosigna, EndoPredict, and the Breast Cancer Index: a TransATAC Study. J Clin Oncol. 2021;39:126–135. doi:10.1200/JCO.20.00853
   PubMed Web of Science ®Google Scholar
• Ignatiadis M, Sledge GW, Jeffrey SS. Liquid biopsy enters the clinic - implementation issues and future challenges. Nat Rev Clin Oncol. 2021;18:297–312. doi:10.1038/s41571-020-00457-x
   PubMed Web of Science ®Google Scholar
• Alix-Panabieres C, Pantel K. Liquid Biopsy: From Discovery to Clinical Application. Cancer Discov. 2021;11:858–873. doi:10.1158/2159-8290.CD-20-1311
   PubMed Web of Science ®Google Scholar
• Kalluri R, LeBleu VS. The biology, function, and biomedical applications of exosomes. Science. 2020;367. doi:10.1126/science.aau6977
   PubMed Web of Science ®Google Scholar
• Hamam R, Kassem M, Zaher W, et al. Circulating microRNAs in breast cancer: novel diagnostic and prognostic biomarkers. Cell Death Dis. 2017;8:e3045. doi:10.1038/cddis.2017.440
   PubMed Web of Science ®Google Scholar
• Amelio I, Bernassola F, Candi E. Emerging roles of long non-coding RNAs in breast cancer biology and management. Semin Cancer Biol. 2021;72:36–45. doi:10.1016/j.semcancer.2020.06.019
   PubMed Web of Science ®Google Scholar
• Ring A, Nguyen-Strauli BD, Wicki A, Aceto N. Biology, vulnerabilities and clinical applications of circulating tumour cells. Nat Rev Cancer. 2022;22:1–17. doi:10.1038/s41568-022-00536-4
   PubMedGoogle Scholar
• Martinez-Jimenez F, Movasati A, Brunner SR, et al. Pan-cancer whole-genome comparison of primary and metastatic solid tumours. Nature. 2023;618:333–341. doi:10.1038/s41586-023-06054-z
   PubMed Web of Science ®Google Scholar
• Bidard FC, Peeters DJ, Fehm T, et al. Clinical validity of circulating tumour cells in patients with metastatic breast cancer: a pooled analysis of individual patient data. Lancet Oncol. 2014;15:406–414. doi:10.1016/S1470-2045(14)70069-5
   PubMed Web of Science ®Google Scholar
• Cristofanilli M, Matera J, Miller MC, et al. Circulating tumor cells, disease progression, and survival in metastatic breast cancer. N Engl J Med. 2004;351:781–791. doi:10.1056/NEJMoa040766
   PubMed Web of Science ®Google Scholar
• Allard WJ, Repollet M. Connelly MC, et al. Tumor cells circulate in the peripheral blood of all major carcinomas but not in healthy subjects or patients with nonmalignant diseases. Clin Cancer Res. 2004;10:6897–6904. doi:10.1158/1078-0432.CCR-04-0378
   PubMed Web of Science ®Google Scholar
• Hayes DF, Miller EM, GV MJ. Circulating tumor cells at each follow-up time point during therapy of metastatic breast cancer patients predict progression-free and overall survival. Clin Cancer Res. 2006;12:4218–4224. doi:10.1158/1078-0432.CCR-05-2821
   PubMed Web of Science ®Google Scholar
• Giuliano M, Giordano A, Jackson S, et al. Circulating tumor cells as prognostic and predictive markers in metastatic breast cancer patients receiving first-line systemic treatment. Breast Cancer Res. 2011;13:R67. doi:10.1186/bcr2907
   PubMed Web of Science ®Google Scholar
• Rack B, Schindlbeck C, Jückstock J, et al. Circulating tumor cells predict survival in early average-to-high risk breast cancer patients. J Natl Cancer Inst. 2014;106. doi:10.1093/jnci/dju066
   PubMedGoogle Scholar
• Ignatiadis M, Litière S, Rothe F, et al. Trastuzumab versus observation for HER2 nonamplified early breast cancer with circulating tumor cells (EORTC 90091-10093, BIG 1-12, Treat CTC): a randomized phase II trial. Ann Oncol. 2018;29:1777–1783. doi:10.1093/annonc/mdy211
   PubMed Web of Science ®Google Scholar
• Janni WJ, Rack B, Terstappen LWMM, et al. Pooled Analysis of the Prognostic Relevance of Circulating Tumor Cells in Primary Breast Cancer. Clin Cancer Res. 2016;22:2583–2593. doi:10.1158/1078-0432.CCR-15-1603
   PubMed Web of Science ®Google Scholar
• Cristofanilli M, Pierga J-Y, Reuben J, et al. The clinical use of circulating tumor cells (CTCs) enumeration for staging of metastatic breast cancer (MBC): international expert consensus paper. Crit Rev Oncol Hematol. 2019;134:39–45. doi:10.1016/j.critrevonc.2018.12.004
   PubMed Web of Science ®Google Scholar
• Riethdorf S, Müller V, Zhang L, et al. Detection and HER2 expression of circulating tumor cells: prospective monitoring in breast cancer patients treated in the neoadjuvant GeparQuattro trial. Clin Cancer Res. 2010;16:2634–2645. doi:10.1158/1078-0432.CCR-09-2042
   PubMed Web of Science ®Google Scholar
• Pierga JY, Bidard F-C, Mathiot C, et al. Circulating tumor cell detection predicts early metastatic relapse after neoadjuvant chemotherapy in large operable and locally advanced breast cancer in a phase II randomized trial. Clin Cancer Res. 2008;14:7004–7010. doi:10.1158/1078-0432.CCR-08-0030
   PubMed Web of Science ®Google Scholar
• Georgoulias V, Bozionelou V, Agelaki S, et al. Trastuzumab decreases the incidence of clinical relapses in patients with early breast cancer presenting chemotherapy-resistant CK-19mRNA-positive circulating tumor cells: results of a randomized phase II study. Ann Oncol. 2012;23:1744–1750. doi:10.1093/annonc/mds020
   PubMed Web of Science ®Google Scholar
• Smerage JB, Barlow WE, Hortobagyi GN, et al. Circulating tumor cells and response to chemotherapy in metastatic breast cancer: SWOG S0500. J Clin Oncol. 2014;32:3483–3489. doi:10.1200/JCO.2014.56.2561
   PubMed Web of Science ®Google Scholar
• Jacot W, Cottu P, Berger F, et al. Actionability of HER2-amplified circulating tumor cells in HER2-negative metastatic breast cancer: the CirCe T-DM1 trial. Breast Cancer Res. 2019;21:121. doi:10.1186/s13058-019-1215-z
   PubMed Web of Science ®Google Scholar
• Pestrin M, Bessi S, Puglisi F, et al. Final results of a multicenter phase II clinical trial evaluating the activity of single-agent lapatinib in patients with HER2-negative metastatic breast cancer and HER2-positive circulating tumor cells. A proof-of-concept study. Breast Cancer Res Treat. 2012;134:283–289. doi:10.1007/s10549-012-2045-1
   PubMed Web of Science ®Google Scholar
• Bidard FC, Jacot W, Kiavue N, et al. Efficacy of circulating tumor cell count-driven vs clinician-driven first-line therapy choice in hormone receptor-positive, ERBB2-negative metastatic breast cancer: the STIC CTC randomized clinical trial. JAMA Oncol. 2021;7:34–41. doi:10.1001/jamaoncol.2020.5660
   PubMed Web of Science ®Google Scholar
• Muller V, Banys-Paluchowski M, Friedl TWP, et al. Prognostic relevance of the HER2 status of circulating tumor cells in metastatic breast cancer patients screened for participation in the DETECT study program. ESMO Open. 2021;6:100299. doi:10.1016/j.esmoop.2021.100299
   PubMed Web of Science ®Google Scholar
• Riethdorf S, Fritsche H, Muller V, et al. Detection of circulating tumor cells in peripheral blood of patients with metastatic breast cancer: a validation study of the CellSearch system. Clin Cancer Res. 2007;13:920–928. doi:10.1158/1078-0432.CCR-06-1695
   PubMed Web of Science ®Google Scholar
• Miller MC, Robinson PS, Wagner C, et al. The Parsortix Cell Separation System-A versatile liquid biopsy platform. Cytometry A. 2018;93:1234–1239. doi:10.1002/cyto.a.23571
   PubMedGoogle Scholar
• Lin D, Shen L, Luo M, et al. Circulating tumor cells: biology and clinical significance. Signal Transduct Target Ther. 2021;6:404. doi:10.1038/s41392-021-00817-8
   PubMed Web of Science ®Google Scholar
• Saucedo-Zeni N, Mewes S, Niestroj R, et al. A novel method for the in vivo isolation of circulating tumor cells from peripheral blood of cancer patients using a functionalized and structured medical wire. Int J Oncol. 2012;41:1241–1250. doi:10.3892/ijo.2012.1557
   PubMed Web of Science ®Google Scholar
• Eifler RL, Lind J, Falkenhagen D, et al. Enrichment of circulating tumor cells from a large blood volume using leukapheresis and elutriation: proof of concept. Cytometry B Clin Cytom. 2011;80B:100–111. doi:10.1002/cyto.b.20560
   Web of Science ®Google Scholar
• Crosbie PA, Shah R, Krysiak P, et al. Circulating Tumor Cells Detected in the Tumor-Draining Pulmonary Vein Are Associated with Disease Recurrence after Surgical Resection of NSCLC. J Thorac Oncol. 2016;11:1793–1797. doi:10.1016/j.jtho.2016.06.017
   PubMed Web of Science ®Google Scholar
• Chemi F, Rothwell DG, McGranahan N, et al. Pulmonary venous circulating tumor cell dissemination before tumor resection and disease relapse. Nat Med. 2019;25:1534–1539. doi:10.1038/s41591-019-0593-1
   PubMed Web of Science ®Google Scholar
• Diamantopoulou Z, Castro-Giner F, Schwab FD, et al. The metastatic spread of breast cancer accelerates during sleep. Nature. 2022;607:156–162. doi:10.1038/s41586-022-04875-y
   PubMed Web of Science ®Google Scholar
• Donato C, Buczak K, Schmidt A, Aceto N. Mass spectrometry analysis of circulating breast cancer cells from a Xenograft mouse model. STAR Protoc. 2021;2:100480. doi:10.1016/j.xpro.2021.100480
   PubMedGoogle Scholar
• Donato C, Kunz L, Castro-Giner F, et al. Hypoxia triggers the intravasation of clustered circulating tumor cells. Cell Rep. 2020;32:108105. doi:10.1016/j.celrep.2020.108105
   PubMed Web of Science ®Google Scholar
• Gkountela S, Castro-Giner F, Szczerba BM, et al. Circulating tumor cell clustering shapes DNA methylation to enable metastasis seeding. Cell. 2019;176:98–112.e114. doi:10.1016/j.cell.2018.11.046
   PubMed Web of Science ®Google Scholar
• Szczerba BM, Castro-Giner F, Vetter M, et al. Neutrophils escort circulating tumour cells to enable cell cycle progression. Nature. 2019;566:553–557. doi:10.1038/s41586-019-0915-y
   PubMed Web of Science ®Google Scholar
• Yu M, Bardia A, Aceto N, et al. Cancer therapy. Ex vivo culture of circulating breast tumor cells for individualized testing of drug susceptibility. Science. 2014;345:216–220. doi:10.1126/science.1253533
   PubMed Web of Science ®Google Scholar
• Garcia-Murillas I, Schiavon G, Weigelt B, et al. Mutation tracking in circulating tumor DNA predicts relapse in early breast cancer. Sci Transl Med. 2015;7:302ra133. doi:10.1126/scitranslmed.aab0021
   PubMed Web of Science ®Google Scholar
• McDonald BR, Contente-Cuomo T, Sammut S-J, et al. Personalized circulating tumor DNA analysis to detect residual disease after neoadjuvant therapy in breast cancer. Sci Transl Med. 2019;11. doi:10.1126/scitranslmed.aax7392
   PubMed Web of Science ®Google Scholar
• Rothe F, Silva MJ, Venet D, et al. Circulating Tumor DNA in HER2-Amplified Breast Cancer: A Translational Research Substudy of the NeoALTTO Phase III Trial. Clin Cancer Res. 2019;25:3581–3588. doi:10.1158/1078-0432.CCR-18-2521
   PubMed Web of Science ®Google Scholar
• Turner NC, Kingston B, Kilburn LS, et al. Circulating tumour DNA analysis to direct therapy in advanced breast cancer (plasmaMATCH): a multicentre, multicohort, phase 2a, platform trial. Lancet Oncol. 2020;21:1296–1308. doi:10.1016/S1470-2045(20)30444-7
   PubMed Web of Science ®Google Scholar
• Schiavon G, Hrebien S, Garcia-Murillas I, et al. Analysis of ESR1 mutation in circulating tumor DNA demonstrates evolution during therapy for metastatic breast cancer. Sci Transl Med. 2015;7:313ra182. doi:10.1126/scitranslmed.aac7551
   PubMed Web of Science ®Google Scholar
• Kodahl AR, Ehmsen S, Pallisgaard N, et al. Correlation between circulating cell-free PIK 3 CA tumor DNA levels and treatment response in patients with PIK 3 CA -mutated metastatic breast cancer. Mol Oncol. 2018;12:925–935. doi:10.1002/1878-0261.12305
   PubMed Web of Science ®Google Scholar
• Cullinane C, Fleming C, O’Leary DP, et al. Association of circulating tumor DNA with disease-free survival in breast cancer: a systematic review and meta-analysis. JAMA Netw Open. 2020;3:e2026921. doi:10.1001/jamanetworkopen.2020.26921
   PubMed Web of Science ®Google Scholar
• Magbanua MJM, Swigart LB, Wu H-T, et al. Circulating tumor DNA in neoadjuvant-treated breast cancer reflects response and survival. Ann Oncol. 2021;32:229–239. doi:10.1016/j.annonc.2020.11.007
   PubMed Web of Science ®Google Scholar
• Lipsyc-Sharf M, de Bruin EC, Santos K, et al. Circulating Tumor DNA and Late Recurrence in High-Risk Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Breast Cancer. J Clin Oncol. 2022;40:2408–2419. doi:10.1200/JCO.22.00908
   PubMedGoogle Scholar
• Cristiano S, Leal A, Phallen J, et al. Genome-wide cell-free DNA fragmentation in patients with cancer. Nature. 2019;570:385–389. doi:10.1038/s41586-019-1272-6
   PubMed Web of Science ®Google Scholar
• Surveillance, Epidemiology, and End Results (SEER) Program SEER*Stat Database: Mortality - All COD, Aggregated With State, Total U.S. (1969–2019) <Katrina/Rita Population Adjustment>, National Cancer Institute, DCCPS, Surveillance Research Program, released April 2021. Underlying mortality data provided by NCHS. Available from: www.cdc.gov/nchs. Accessed July 20, 2023.
   Google Scholar
• Tevaarwerk AJ, Gray RJ, Schneider BP, et al. Survival in patients with metastatic recurrent breast cancer after adjuvant chemotherapy: little evidence of improvement over the past 30 years. Cancer. 2013;119:1140–1148. doi:10.1002/cncr.27819
   PubMed Web of Science ®Google Scholar
• Pedersen RN, Esen BÖ, Mellemkjær L, et al. The incidence of breast cancer recurrence 10–32 years after primary diagnosis. J Natl Cancer Inst. 2022;114:391–399. doi:10.1093/jnci/djab202
   PubMedGoogle Scholar
• Hu Z, Ding J, Ma Z, et al. Quantitative evidence for early metastatic seeding in colorectal cancer. Nat Genet. 2019;51:1113–1122. doi:10.1038/s41588-019-0423-x
   PubMed Web of Science ®Google Scholar
• Friberg S, Nystrom A. Cancer Metastases: Early Dissemination and Late Recurrences. Cancer Growth Metastasis. 2015;8:43–49. doi:10.4137/CGM.S31244
   PubMedGoogle Scholar
• Phan TG, Croucher PI. The dormant cancer cell life cycle. Nat Rev Cancer. 2020;20:398–411. doi:10.1038/s41568-020-0263-0
   PubMed Web of Science ®Google Scholar
• Ring A, Spataro M, Wicki A, Aceto N. Clinical and biological aspects of disseminated tumor cells and dormancy in breast cancer. Front Cell Dev Biol. 2022;10:929893. doi:10.3389/fcell.2022.929893
   PubMed Web of Science ®Google Scholar
• Park SY, Nam JS. The force awakens: metastatic dormant cancer cells. Exp Mol Med. 2020;52:569–581. doi:10.1038/s12276-020-0423-z
   PubMed Web of Science ®Google Scholar