2025 São Paulo Breast Symposium Guidelines: luminal breast cancer and axillary surgery
DOI:
https://doi.org/10.29289/259453942025030%20Palavras-chave:
breast neoplasms, luminal breast cancer, estrogen receptors, endocrine therapy, axillary surgery, neoadjuvant therapyResumo
Introduction: This study aims to disseminate evidence-based expert consensus statements derived from the 2025 International Symposium on Breast Diseases of Inland São Paulo (SIMIP), addressing four critical areas in breast cancer management: (1) initial treatment strategies for luminal breast cancer with imaging-positive (iN1) and clinically positive axilla (cN1); (2) therapeutic approaches for estrogen receptor–low (ER-low) breast cancer; (3) optimal duration of adjuvant endocrine therapy (ET) in luminal tumors; and (4) criteria for omitting axillary surgery in early breast cancer. Methods: The 2025 São Paulo Breast Diseases Symposium was a two-day event held in São Paulo, Brazil, involving 110 panelists, including 99 mastologists (90%) and 11 professionals from related fields (pathology, breast imaging, radiotherapy, and clinical oncology). Panelists were selected based on recognized expertise, defined by at least 10 years of clinical experience or significant academic contribution. Four priority thematic axes were identified through a pre-symposium survey of Brazilian and South American specialists. Each topic was introduced by a 10-minute evidence-based lecture followed by a 50-minute technical debate. Anonymous electronic voting was conducted via a secure online platform during hybrid sessions, with consensus defined as agreement by ≥75% of participants. Results: For patients with imaging-positive axilla (iN1), 52% of panelists preferred upfront surgery, without reaching consensus. In clinically positive axilla (cN1), treatment choice between upfront surgery and neoadjuvant chemotherapy varied according to age and menopausal status, supported by 57% of voters, also without consensus. A consensus of 84% was achieved to manage ER-low breast cancer similarly to triple-negative disease, using chemotherapy combined with endocrine therapy. Regarding endocrine therapy duration, consensus was reached for 7–10 years in high-risk Luminal B tumors (97%) and for 5 years in low-risk Luminal A tumors (95%). Omission of axillary surgery was supported by 85% of panelists in patients with tumors ≤2 cm, clinically node-negative disease (cT1N0), hormone receptor-positive/HER2-negative tumors, and negative axillary ultrasound findings. Conclusions: These expert consensus statements support personalized, multidisciplinary strategies to optimize oncologic outcomes while minimizing morbidity. Consensus favors extended endocrine therapy for high-risk luminal disease, shorter therapy for low-risk tumors, combined chemotherapy and endocrine therapy for ER-low disease, and omission of axillary surgery in carefully selected early breast cancer cases. Management of iN1 and cN1 disease should remain individualized based on clinical and biological factors, particularly in Brazil, where late-stage presentation remains frequent.
Downloads
Referências
1. Navarro DTSM, Aguiar MG, Galvão MFO, Germano TCO, Lajus TBP, Oliveira TCA. Clinical andhistopathological axillary assessment. Mastology. 2018;28(1):7-10. https://doi.org/10.29289/Z2594539420180000255
2. Specht MC, Fey JV, Borgen PI, Hiram 3rd SC. Is the clinically positive axilla in breast cancer really a contraindication to sentinel lymph node biopsy? J Am Coll Surg. 2005;200(1):10-4. https://doi.org/10.1016/j.jamcollsurg.2004.09.010
3. Gradishar WJ, Moran MS, Abraham J, Abramson V, Aft R, Agnese D, et al. NCCN Guidelines® insights: breast cancer, version 5.2025. JNCCN. 2025;23(11):426-36. https://doi.org/10.6004/jnccn.2025.0053
4. Matar-Ujvary R, Sevilimedu V, Morrow M. Are clinically node-negative patients with a positive preoperative axillary lymph node biopsy appropriate candidates for sentinel lymph node biopsy? Ann Surg Oncol. 2025;32(1):92-7. https://doi.org/10.1245/s10434-024-16321-6
5. Liberale V, Rosso R, Arisio R, D'Alonzo M, Villasco A, Fuso L, et al. Axillary dissection in patients with preoperative positive nodal cytology: Genuine need or overtreatment? Breast J. 2020;26(2):168-75. https://doi.org/10.1111/tbj.13479
6. Samiei S, Simons JM, Engelen SME, Beets-Tan RGH, Classe JM, Smidt ML, et al. Axillary pathologic complete response after neoadjuvant systemic therapy by breast cancer subtype in patients with initially clinically node-positive disease: a systematic review and meta-analysis. JAMA Surg. 2021;156(6):e210891. https://doi.org/10.1001/jamasurg.2021.0891
7. Loibl S, André F, Bachelot T, Barrios CH, Bergh J, Burstein HJ, et al. Early breast cancer: ESMO Clinical Practice Guideline for diagnosis, treatment and follow-up. Ann Oncol. 2024;35(2):159-82. https://doi.org/10.1016/j.annonc.2023.11.016
8. Kalinsky K, Barlow WE, Gralow JR, Meric-Bernstam F, Albain KS, Hayes DF, et al. 21-gene assay to inform chemotherapy benefit in node-positive breast cancer. N Engl J Med. 2021;385(25):2336-47. https://doi.org/10.1056/NEJMoa2108873
9. Cardoso F, van’t Veer L, Bogaerts J, Slaets L, Viale G, Delaloge S, et al. 70-gene signature as an aid to treatment decisions in early-stage breast cancer. N Engl J Med. 2016;375(8):717-29. https://doi.org/10.1056/NEJMoa1602253
10. Ordonez L, Tornillo G, Kendrick H, Hay T, Smalley MJ. NOTCH and AKT signalling interact to drive mammary tumour heterogeneity. Cancers (Basel). 2023;15(17):4324. https://doi.org/10.3390/cancers15174324
11. Almahariq MF, Levitin R, Quinn TJ, Chen PY, Dekhne N, Kiran S, et al. Omission of axillary lymph node dissection is associated with inferior survival in breast cancer patients with residual n1 nodal disease following neoadjuvant chemotherapy. Ann Surg Oncol. 2021;28(2):930-40. https://doi.org/10.1245/s10434-020-08928-2
12. Albuainain RY, Althawadi R, Eid R, Abdulla HA. Oncological outcomes of omitting axillary surgery in early breast cancer: a systematic review and meta-analysis. J Surg Oncol. 2026;131(2):130-40. https://doi.org/10.1002/jso.70145
13. Limberg JN, Jones T, Thomas SM, Ntowe KW, Dalton JC, van den Bruele AB, et al. Omission of axillary lymph node dissection in patients with residual nodal disease after neoadjuvant chemotherapy. Ann Surg Oncol. 2024;31(13):8813-20. https://doi,org/10.1245/s10434-024-16143-6
14. Khan AJ, Montagna G. Contextual framework for understanding treatment de-escalation in patients with breast cancer. JCO Oncol Pract. 2025;21(3):278-80. https://doi.org/10.1200/OP-24-00870
15. Skarping I, Bendahl PO, Szulkin R, Alkner S, Andersson Y, Bergkvist L, et al. Prediction of high nodal burden in patients with sentinel node-positive luminal ERBB2-negative breast cancer. JAMA Surg. 2024;159(12):1393-403. https://doi.org/10.1001/jamasurg.2024.3944
16. Giuliano AE, Ballman KV, McCall L, Beitsch PD, Brennan MB, Kelemen PR, et al. Effect of axillary dissection vs no axillary dissection on 10-year overall survival among women with invasive breast cancer and sentinel node metastasis: the acosog z0011 (alliance) randomized clinical trial. JAMA. 2017;318(9):918-26. https://doi.org/10.1001/jama.2017.11470
17. Giuliano AE, Hunt KK, Ballman KV, Beitsch PD, Whitworth PW, Blumencranz PW, et al. Axillary dissection vs no axillary dissection in women with invasive breast cancer and sentinel node metastasis: a randomized clinical trial. JAMA. 2011;305(6):569-75. https://doi.org/10.1001/jama.2011.90
18. Allison KH, Hammond MEH, Dowsett M, McKernin SE, Carey LA, Fitzgibbons PL, et al. Estrogen and progesterone receptor testing in breast cancer: ASCO/CAP guideline update. J Clin Oncol. 2020;38(12):1346-66. https://doi.org/10.1200/JCO.19.02309
19. Perou CM, Sørlie T, Eisen MB, van de Rijn M, Jeffrey SS, Rees CA, et al. Molecular portraits of human breast tumours. Nature. 2000;406(6797):747-52. https://doi.org/10.1038/35021093
20. Yi M, Huo L, Koenig KB, Mittendorf EA, Meric-Bernstam F, Kuerer HM, et al. Which threshold for ER positivity? a retrospective study based on 9639 patients. Ann Oncol. 2014;25(5):1004-11. https//doi.org/10.1093/annonc/mdu053
21. Fusco N, Viale G. The “lows”: update on ER-low and HER2-low breast cancer. Breast. 2024;78:103831. https://doi.org;: 10.1016/j.breast.2024.103831
22. Poon IK, Tsang JY, Li J, Chan SK, Shea KH, Tse GM. The significance of highlighting the oestrogen receptor low category in breast cancer. Br J Cancer. 2020;123(8):1223-7. https://doi.org/10.1038/s41416-020-1009-1
23. Villegas SL, Nekljudova V, Pfarr N, Engel J, Untch M, Schrodi S, et al. Therapy response and prognosis of patients with early breast cancer with low positivity for hormone receptors - An analysis of 2765 patients from neoadjuvant clinical trials. Eur J Cancer. 2021:148:159-70. https://doi.org/10.1016/j.ejca.2021.02.020
24. Choong GM, Hoskin TL, Boughey JC, Ingle JN, Goetz MP. Endocrine therapy omission in estrogen receptor-low (1%-10%) early-stage breast cancer. J Clin Oncol. 2025;43(16):1875-85. https://doi.org/10.1200/JCO-24-02263
25. Choong GM, Nanda R, Carey LA. Adjuvant endocrine therapy improves survival in ER-low tumors. In: ASCO Annual Meeting Abstracts. Chicago; 2024.
26. Schmid P, Cortes J, Pusztai L, McArthur H, Kümmel S, Bergh J, et al. Pembrolizumab for Early Triple-Negative Breast Cancer. N Engl J Med. 2020;382(9):810-21. https://doi.org/10.1056/NEJMoa1910549
27. Loibl S, André F, Bachelot T, Barrios CH, Bergh J, Burstein HJ, et al. Early breast cancer: ESMO Clinical Practice Guideline for diagnosis, treatment and follow-up. Ann Oncol. 2024;35(2):159-82. https://doi.org/10.1016/j.annonc.2023.11.016
28. Goss PE. Letrozole in the extended adjuvant setting: MA.17. Breast Cancer Res Treat. 2007;105 Suppl 1(Suppl 1):45-53. https://doi.org/10.1007/s10549-007-9698-1
29. Xie M, Zhong Y, Yang Y, Shen F, Nie Y. Extended adjuvant endocrine therapy for women with hormone receptor-positive early breast cancer: a meta-analysis with trial sequential analysis of randomized controlled trials. Front Oncol. 2022;12:1015690. https://doi.org/10.3389/fonc.2022.1039320
30. Francis PA, Pagani O, Fleming GF, Walley BA, Colleoni M, Láng I, et al. Tailoring adjuvant endocrine therapy in premenopausal breast cancer. N Engl J Med. 2018;379(2):122-37. https://doi.org/10.1056/NEJMoa1803164
31. Pan H, Gray R, Braybrooke J, Davies C, Taylor C, McGale P, et al. 20-year risks of breast-cancer recurrence after stopping endocrine therapy at 5 years. N Engl J Med. 2017;377:1836-46. https://doi.org/10.1056/NEJMoa1701830
32. Hughes KS, Schnaper LA, Bellon JR, Cirrincione CT, Berry DA, McCormick B, et al. Lumpectomy plus tamoxifen with or without irradiation in women age 70 years or older with early breast cancer: long-term follow-up of CALGB 9343. J Clin Oncol. 2013;31(19):2382-7. https://doi.org/10.1200/JCO.2012.45.2615
33. Richman J, Ring A, Dowsett M, Sestak I. Clinical validity of clinical treatment score 5 (CTS5) for estimating risk of late recurrence in unselected, non-trial patients with early oestrogen receptor-positive breast cancer. Breast Cancer Res Treat. 2021186(1):115-23. https://doi.org/10.1007/s10549-020-06013-6
34. Liefers GJ, van de Velde CJH, Rutgers EJT. Predicting late recurrence using BCI and CTS5. In: San Antonio Breast Cancer Symposium; 2022. Abstract GS5-10.
35. Howell A, Cuzick J, Baum M, Buzdar A, Dowsett M, Forbes JF, et al. Results of the ATAC (Arimidex, Tamoxifen, Alone or in Combination) trial after completion of 5 years’ adjuvant treatment for breast cancer. Lancet. 2005;365(9453):60-2. https://doi.org/10.1016/S0140-6736(04)17666-6
36. Gentilini OD, Botteri E, Sangalli C, Galimberti V, Porpiglia M, Agresti R, et al. Sentinel lymph node biopsy vs no axillary surgery in patients with small breast cancer and negative results on ultrasonography of axillary lymph nodes: the SOUND randomized clinical trial. JAMA Oncol. 2023;9(11):1557-64. https://doi.org/10.1001/jamaoncol.2023.3759
37. Li X, Wang L, Wang Y, Ma L, Zheng R, Ding J, et al. Omission of sentinel lymph node biopsy in patients with clinically axillary lymph node-negative early breast cancer (OMSLNB): protocol for a prospective, non-inferiority, single-arm, phase II clinical trial in China. BMJ Open. 2024;14(9):e087700. https://doi.org/10.1136/bmjopen-2024-087700
38. Pilewskie M, Jochelson M, Gooch JC, Patil S, Stempel M, Morrow M. Is preoperative axillary imaging beneficial in identifying clinically node-negative patients requiring axillary lymph node dissection? J Am Coll Surg. 2016;222(2):138-45. https://doi.org/10.1016/j.jamcollsurg.2015.11.013
39. Giannakou A, Kantor O, Park KU, Waks A, Punglia R, Dominici L, et al. Real-world implications of the SOUND trial. Ann Surg Oncol. 2024;31(13):8776-85. https://doi.org/10.1245/s10434-024-16354-x
40. Park KU, Somerfield MR, Anne N, Brackstone M, Conlin AK, Couto HL, et al. Sentinel lymph node biopsy in early-stage breast cancer: ASCO Guideline update. J Clin Oncol. 2025;43(14):1720-41. https://doi.org/10.1200/JCO-25-00099
41. Almeida RJ, Luizaga CTM, Eluf-Neto J, Nunes HRC, Pessoa EC, Murta-Nascimento C. Impact of educational level and travel burden on breast cancer stage at diagnosis in the state of São Paulo, Brazil. Sci Rep. 2022;12(1):8357. https://doi.org/10.1038/s41598-022-12487-9
Downloads
Publicado
Como Citar
Edição
Seção
Licença
Copyright (c) 2026 Eduardo Carvalho Pessoa, Fabio Bagnoli, Marcelo Madeira, Joaquim Teodoro Araujo Neto, Giuliano Mendes Tosello, Fabricio Brenelli, Beatriz Baaklini Geronymo, Daniel de Araujo Buttros, Felipe Zerwes, Marcelo Antonini, Daniel Luiz Gimenes, Silvio Eduardo Bromberg, Augusto Tufi Hassan

Este trabalho está licenciado sob uma licença Creative Commons Attribution 4.0 International License.




