Skip to main content
Top
Published in: Clinical and Translational Oncology 9/2023

Open Access 16-06-2023 | Breast Cancer | CLINICAL GUIDES IN ONCOLOGY

SEOM-GEICAM-SOLTI clinical guidelines for early-stage breast cancer (2022)

Authors: Francisco Ayala de la Peña, Silvia Antolín Novoa, Joaquín Gavilá Gregori, Lucía González Cortijo, Fernando Henao Carrasco, María Teresa Martínez Martínez, Cristina Morales Estévez, Agostina Stradella, María Jesús Vidal Losada, Eva Ciruelos

Published in: Clinical and Translational Oncology | Issue 9/2023

Login to get access

Abstract

Breast cancer is the leading cause of cancer in women in Spain and its annual incidence is rapidly increasing. Thanks to the screening programs in place, nearly 90% of breast cancer cases are detected in early and potentially curable stages, despite the COVID-19 pandemic possibly having impacted these numbers (not yet quantified). In recent years, locoregional and systemic therapies are increasingly being directed by new diagnostic tools that have improved the balance between toxicity and clinical benefit. New therapeutic strategies, such as immunotherapy, targeted drugs, and antibody–drug conjugates have also improved outcomes in some patient subgroups. This clinical practice guideline is based on a systematic review of relevant studies and on the consensus of experts from GEICAM, SOLTI, and SEOM.
Literature
1.
go back to reference Sociedad Española de Oncología Médica (SEOM), Red Española de Registros del Cáncer (REDECAN). Las cifras del cáncer en España (2022). In: https://seom.org/images/LAS_CIFRAS_DEL_CANCER_EN_ESPANA_2022.pdf. Accessed 10 Nov 2022. Sociedad Española de Oncología Médica (SEOM), Red Española de Registros del Cáncer (REDECAN). Las cifras del cáncer en España (2022). In: https://​seom.​org/​images/​LAS_​CIFRAS_​DEL_​CANCER_​EN_​ESPANA_​2022.​pdf.​ Accessed 10 Nov 2022.
2.
go back to reference Bosch G, Posso M, Louro J, Roman M, Porta M, Castells X, et al. Impact of the COVID-19 pandemic on breast cancer screening indicators in a Spanish population-based program: a cohort study. Elife. 2022;11:1–16.CrossRef Bosch G, Posso M, Louro J, Roman M, Porta M, Castells X, et al. Impact of the COVID-19 pandemic on breast cancer screening indicators in a Spanish population-based program: a cohort study. Elife. 2022;11:1–16.CrossRef
3.
go back to reference Khan AR, Khan S, Zimmerman V, Baddour LM, Tleyjeh IM. Quality and strength of evidence of the Infectious Diseases Society of America clinical practice guidelines. Clin Infect Dis. 2010;51:1147–56.PubMedCrossRef Khan AR, Khan S, Zimmerman V, Baddour LM, Tleyjeh IM. Quality and strength of evidence of the Infectious Diseases Society of America clinical practice guidelines. Clin Infect Dis. 2010;51:1147–56.PubMedCrossRef
4.
go back to reference Giuliano AE, Connolly JL, Edge SB, Mittendorf EA, Rugo HS, Solin LJ, et al. Breast cancer-major changes in the american joint committee on cancer eighth edition cancer staging manual. Cancer J Clin. 2017;67:290–303.CrossRef Giuliano AE, Connolly JL, Edge SB, Mittendorf EA, Rugo HS, Solin LJ, et al. Breast cancer-major changes in the american joint committee on cancer eighth edition cancer staging manual. Cancer J Clin. 2017;67:290–303.CrossRef
5.
go back to reference Perry N, Broeders M, de Wolf C, Tornberg S, Holland R, von Karsa L. European guidelines for quality assurance in breast cancer screening and diagnosis. Fourth edition–summary document. Ann Oncol. 2007;19:614–22.PubMedCrossRef Perry N, Broeders M, de Wolf C, Tornberg S, Holland R, von Karsa L. European guidelines for quality assurance in breast cancer screening and diagnosis. Fourth edition–summary document. Ann Oncol. 2007;19:614–22.PubMedCrossRef
6.
go back to reference Sardanelli F, Boetes C, Borisch B, Decker T, Federico M, Gilbert FJ, et al. Magnetic resonance imaging of the breast: recommendations from the EUSOMA working group. Eur J Cancer. 2010;46:1296–316.PubMedCrossRef Sardanelli F, Boetes C, Borisch B, Decker T, Federico M, Gilbert FJ, et al. Magnetic resonance imaging of the breast: recommendations from the EUSOMA working group. Eur J Cancer. 2010;46:1296–316.PubMedCrossRef
7.
go back to reference López-Fernández T, Martín García A, Santaballa Beltrán A, Montero Luis Á, García Sanz R, Mazón Ramos P. Cardio-onco-hematology in clinical practice. Position paper recommendations. Rev Esp Cardiol. 2017;70(6):47. López-Fernández T, Martín García A, Santaballa Beltrán A, Montero Luis Á, García Sanz R, Mazón Ramos P. Cardio-onco-hematology in clinical practice. Position paper recommendations. Rev Esp Cardiol. 2017;70(6):47.
8.
go back to reference Louie RJ, Tonneson JE, Gowarty M, Goodney PP, Barth RJ, Rosenkranz KM. Complete blood counts, liver function tests, and chest x-rays as routine screening in early-stage breast cancer: value added or just cost? Breast Cancer Res Treat. 2015;154:99–103.PubMedCrossRef Louie RJ, Tonneson JE, Gowarty M, Goodney PP, Barth RJ, Rosenkranz KM. Complete blood counts, liver function tests, and chest x-rays as routine screening in early-stage breast cancer: value added or just cost? Breast Cancer Res Treat. 2015;154:99–103.PubMedCrossRef
9.
go back to reference Robertson IJ, Hand F, Kell MR. FDG-PET/CT in the staging of local/regional metastases in breast cancer. Breast. 2011;20:491–4.PubMedCrossRef Robertson IJ, Hand F, Kell MR. FDG-PET/CT in the staging of local/regional metastases in breast cancer. Breast. 2011;20:491–4.PubMedCrossRef
10.
go back to reference Koolen BB, Vrancken Peeters MJTFD, Aukema TS, Vogel VW, Oldenburg HSA, Hage JA. 18F-FDG PET/CT as a staging procedure in primary stage II and III breast cancer: Comparison with conventional imaging techniques. Breast Cancer Res Treat. 2012;131:117–26.PubMedCrossRef Koolen BB, Vrancken Peeters MJTFD, Aukema TS, Vogel VW, Oldenburg HSA, Hage JA. 18F-FDG PET/CT as a staging procedure in primary stage II and III breast cancer: Comparison with conventional imaging techniques. Breast Cancer Res Treat. 2012;131:117–26.PubMedCrossRef
11.
go back to reference Lakhani SR, Ellis IO, Schnitt SJ, Tan PH, van de Vijver MJ (Ed.). WHO Classification of Tumours of the Breast. World Health Organization Classification of tumours. Lyon, France; International Agency for Research on Cancer; 2012. Lakhani SR, Ellis IO, Schnitt SJ, Tan PH, van de Vijver MJ (Ed.). WHO Classification of Tumours of the Breast. World Health Organization Classification of tumours. Lyon, France; International Agency for Research on Cancer; 2012.
12.
go back to reference Tan PH, Ellis I, Allison K, Brogi E, Fox SB, Lakhani S. The 2019 world health organization classification of tumours of the breast. Histopathology. 2020;77:181–5.PubMedCrossRef Tan PH, Ellis I, Allison K, Brogi E, Fox SB, Lakhani S. The 2019 world health organization classification of tumours of the breast. Histopathology. 2020;77:181–5.PubMedCrossRef
13.
go back to reference Allison KH, Hammond EH, Dowsett M, McKermin SE, Carey LA, Fitzgibbons PL, et al. Estrogen and progesterone receptor testing in breast cancer: ASCO/CAP guideline update. J Clin Oncol. 2020;38:1346–66.PubMedCrossRef Allison KH, Hammond EH, Dowsett M, McKermin SE, Carey LA, Fitzgibbons PL, et al. Estrogen and progesterone receptor testing in breast cancer: ASCO/CAP guideline update. J Clin Oncol. 2020;38:1346–66.PubMedCrossRef
14.
go back to reference Wolff AC, McShane LM, Hammond MEH, Allison KH, Fitzgibbons P, Press MF. 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.PubMedCrossRef Wolff AC, McShane LM, Hammond MEH, Allison KH, Fitzgibbons P, Press MF. 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.PubMedCrossRef
15.
go back to reference Nielsen TO, Leung SCY, Rimm DL, Dodson A, Acs B, Badve S. Assessment of Ki67 in breast cancer: updated recommendations from the international ki67 in breast cancer working group. JNCI J Natl Cancer Inst. 2021;113:808–19.PubMedCrossRef Nielsen TO, Leung SCY, Rimm DL, Dodson A, Acs B, Badve S. Assessment of Ki67 in breast cancer: updated recommendations from the international ki67 in breast cancer working group. JNCI J Natl Cancer Inst. 2021;113:808–19.PubMedCrossRef
16.
go back to reference Denkert C, Minckwitz G, Darb-Esfahani S, Lederer B, Heppner BI, Weber KE. Tumour-infiltrating lymphocytes and prognosis in different subtypes of breast cancer: a pooled analysis of 3771 patients treated with neoadjuvant therapy. Lancet Oncol. 2018;19:40–50.PubMedCrossRef Denkert C, Minckwitz G, Darb-Esfahani S, Lederer B, Heppner BI, Weber KE. Tumour-infiltrating lymphocytes and prognosis in different subtypes of breast cancer: a pooled analysis of 3771 patients treated with neoadjuvant therapy. Lancet Oncol. 2018;19:40–50.PubMedCrossRef
17.
go back to reference Wein L, Savas P, Luen SJ, Virassamy B, Salgado R, Loi S. Clinical validity and utility of tumor-infiltrating lymphocytes in routine clinical practice for breast cancer patients: current and future directions. Front Oncol. 2017;7:156.PubMedPubMedCentralCrossRef Wein L, Savas P, Luen SJ, Virassamy B, Salgado R, Loi S. Clinical validity and utility of tumor-infiltrating lymphocytes in routine clinical practice for breast cancer patients: current and future directions. Front Oncol. 2017;7:156.PubMedPubMedCentralCrossRef
18.
go back to reference Balic M, Thomssen C, Würstlein R, Gnant M, Harbeck N. St. Gallen/Vienna 2019: A brief summary of the consensus discussion on the optimal primary breast cancer treatment. Breast Care (Basel). 2019;(14):103–10. Balic M, Thomssen C, Würstlein R, Gnant M, Harbeck N. St. Gallen/Vienna 2019: A brief summary of the consensus discussion on the optimal primary breast cancer treatment. Breast Care (Basel). 2019;(14):103–10.
19.
go back to reference Sparano JA, Gray RJ, Makower DF, Pritchard KI, Albain KS, Hayes DF, et al. Adjuvant chemotherapy guided by a 21-gene expression assay in breast cancer. N Engl J Med. 2018;379:111–21.PubMedPubMedCentralCrossRef Sparano JA, Gray RJ, Makower DF, Pritchard KI, Albain KS, Hayes DF, et al. Adjuvant chemotherapy guided by a 21-gene expression assay in breast cancer. N Engl J Med. 2018;379:111–21.PubMedPubMedCentralCrossRef
20.
go back to reference Piccart M, Van’t Veer L, Poncet C, Lopes Cardozo J, Delaloge S, Pierga J, 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;22:476–88.PubMedCrossRef Piccart M, Van’t Veer L, Poncet C, Lopes Cardozo J, Delaloge S, Pierga J, 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;22:476–88.PubMedCrossRef
21.
go back to reference Kevin Kalinsky MD, Barlow WE. 21- gene assay to inform chemotherapy benefit in node-positive breast cancer. N Engl J Med. 2021;385:2336–47.PubMedCrossRef Kevin Kalinsky MD, Barlow WE. 21- gene assay to inform chemotherapy benefit in node-positive breast cancer. N Engl J Med. 2021;385:2336–47.PubMedCrossRef
22.
go back to reference Prat A, Guarneri V, Pascual T, Brasó-Maristany F, Sanfeliu E, Paré L. Development and validation of the new HER2DX assay for predicting pathological response and survival outcome in early-stage HER2-positive breast cancer. Lancet Oncol. 2022;25:1–5. Prat A, Guarneri V, Pascual T, Brasó-Maristany F, Sanfeliu E, Paré L. Development and validation of the new HER2DX assay for predicting pathological response and survival outcome in early-stage HER2-positive breast cancer. Lancet Oncol. 2022;25:1–5.
24.
go back to reference Bueno-Muiño C, Echavarría I, López-Tarruella S, Roche-Molina M, Del Monte-Millán M, Massarrah T et al. Assessment of a genomic assay in patients with ERBB2-positive breast cancer following neoadjuvant trastuzumab-based chemotherapy with or without Pertuzumab. JAMA Oncol. 2023;27:e230187. https://doi.org/10.1001/jamaoncol.2023.0187.CrossRef Bueno-Muiño C, Echavarría I, López-Tarruella S, Roche-Molina M, Del Monte-Millán M, Massarrah T et al. Assessment of a genomic assay in patients with ERBB2-positive breast cancer following neoadjuvant trastuzumab-based chemotherapy with or without Pertuzumab. JAMA Oncol. 2023;27:e230187. https://​doi.​org/​10.​1001/​jamaoncol.​2023.​0187.CrossRef
26.
go back to reference Kimball CC, Nichols CI, Vose JG, Peled AW. Trends in lumpectomy and oncoplastic breast conserving surgery in the US, 2011–2016. Ann Surg Oncol. 2018;25:3867–73.PubMedCrossRef Kimball CC, Nichols CI, Vose JG, Peled AW. Trends in lumpectomy and oncoplastic breast conserving surgery in the US, 2011–2016. Ann Surg Oncol. 2018;25:3867–73.PubMedCrossRef
27.
go back to reference Lautner M, Lin H, Shen Y, Parker C, Kuerer H, Shaitelman S, et al. Disparities in the use of breast-conserving therapy among patients with early-stage breast cancer. JAMA Surg. 2015;150:778–86.PubMedPubMedCentralCrossRef Lautner M, Lin H, Shen Y, Parker C, Kuerer H, Shaitelman S, et al. Disparities in the use of breast-conserving therapy among patients with early-stage breast cancer. JAMA Surg. 2015;150:778–86.PubMedPubMedCentralCrossRef
28.
go back to reference Carter SA, Lyons GR, Kuerer HM, Bassett RL, Oates Thompson SA, et al. Operative and oncologic outcomes in 9861 patients with operable breast cancer: single-institution analysis of breast conservation with oncoplastic reconstruction. Ann Surg Oncol. 2016;23:3190–8.PubMedCrossRef Carter SA, Lyons GR, Kuerer HM, Bassett RL, Oates Thompson SA, et al. Operative and oncologic outcomes in 9861 patients with operable breast cancer: single-institution analysis of breast conservation with oncoplastic reconstruction. Ann Surg Oncol. 2016;23:3190–8.PubMedCrossRef
29.
go back to reference Jonczyk MM, Jean J, Graham R, Chatterjee A. Surgical trends in breast cancer: a rise in novel operative treatment options over a 12 year analysis. Breast Cancer Res Treat. 2019;173(2):267–74.PubMedCrossRef Jonczyk MM, Jean J, Graham R, Chatterjee A. Surgical trends in breast cancer: a rise in novel operative treatment options over a 12 year analysis. Breast Cancer Res Treat. 2019;173(2):267–74.PubMedCrossRef
30.
go back to reference Burstein HJ, Curigliano G, Loibl S, Dubsky P, Gnant M, Poortmans P, et al. Estimating the benefits of therapy for early-stage breast cancer: The St. Gallen international consensus guidelines for the primary therapy of early breast cancer 2019. Ann Oncol. 2019;30:1541–57.PubMedCrossRef Burstein HJ, Curigliano G, Loibl S, Dubsky P, Gnant M, Poortmans P, et al. Estimating the benefits of therapy for early-stage breast cancer: The St. Gallen international consensus guidelines for the primary therapy of early breast cancer 2019. Ann Oncol. 2019;30:1541–57.PubMedCrossRef
31.
go back to reference Tung NM, Boughey JC, Pierce LJ, Robson ME, Bedrosian I, Dietz JRD, et al. Management of hereditary breast cancer: american society of clinical oncology, american society for radiation oncology, and society of surgical society of surgical oncology guideline. J Clin Oncol. 2020;38:2080–106.PubMedCrossRef Tung NM, Boughey JC, Pierce LJ, Robson ME, Bedrosian I, Dietz JRD, et al. Management of hereditary breast cancer: american society of clinical oncology, american society for radiation oncology, and society of surgical society of surgical oncology guideline. J Clin Oncol. 2020;38:2080–106.PubMedCrossRef
32.
go back to reference Giuliano AE, Ballman KV. 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;318:918–26.PubMedPubMedCentralCrossRef Giuliano AE, Ballman KV. 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;318:918–26.PubMedPubMedCentralCrossRef
33.
go back to reference Donker M, van Tienhoven G, Straver ME, Meijnen P, van de Velde CJH, Mansel RE, et al. Radiotherapy or surgery of the axilla after a positive sentinel node in breast cancer (EORTC 10981–22023 AMAROS): a randomised, multicentre, open-label, phase 3 non-inferiority trial. Lancet Oncol Elsevier. 2014;15:1303–10.CrossRef Donker M, van Tienhoven G, Straver ME, Meijnen P, van de Velde CJH, Mansel RE, et al. Radiotherapy or surgery of the axilla after a positive sentinel node in breast cancer (EORTC 10981–22023 AMAROS): a randomised, multicentre, open-label, phase 3 non-inferiority trial. Lancet Oncol Elsevier. 2014;15:1303–10.CrossRef
34.
go back to reference Bernet L, Piñero A, Martínez M, Sicart SV, Algara M, Palomares E. Consenso de la Sociedad Española de Senología y Patología Mamaria (SESPM) sobre la biopsia selectiva del ganglio centinela (BSGC) y el manejo axilar en el cáncer de mama (2022). Rev Senol y Patol Mamar. 2022;35:243–59. Bernet L, Piñero A, Martínez M, Sicart SV, Algara M, Palomares E. Consenso de la Sociedad Española de Senología y Patología Mamaria (SESPM) sobre la biopsia selectiva del ganglio centinela (BSGC) y el manejo axilar en el cáncer de mama (2022). Rev Senol y Patol Mamar. 2022;35:243–59.
35.
go back to reference Simons JM, Nijnatten TJA, CC P. Diagnostic accuracy of different surgical procedures for axillary staging after neoadjuvant systemic therapy in node-positive breast cancer: a systematic review and meta-analysis. Ann Surg. 2019;269:432–42.PubMedCrossRef Simons JM, Nijnatten TJA, CC P. Diagnostic accuracy of different surgical procedures for axillary staging after neoadjuvant systemic therapy in node-positive breast cancer: a systematic review and meta-analysis. Ann Surg. 2019;269:432–42.PubMedCrossRef
36.
go back to reference Banys-Paluchowski M, Gasparri ML, Boniface J, Gentilini O, Stickeler E, Hartmann S, et al. Surgical management of the axilla in clinically node-positive breast cancer patients converting to clinical node negativity through neoadjuvant chemotherapy: current status, knowledge gaps, and rationale for the EUBREAST-03 AXSANA study. Cancers. 2021;13(7):1.CrossRef Banys-Paluchowski M, Gasparri ML, Boniface J, Gentilini O, Stickeler E, Hartmann S, et al. Surgical management of the axilla in clinically node-positive breast cancer patients converting to clinical node negativity through neoadjuvant chemotherapy: current status, knowledge gaps, and rationale for the EUBREAST-03 AXSANA study. Cancers. 2021;13(7):1.CrossRef
37.
go back to reference Shah C, Al-Hilli Z, Vicini F. Advances in breast cancer radiotherapy: implications for current and future practice. JCO Oncol Pr. 2021;17:697–706. Shah C, Al-Hilli Z, Vicini F. Advances in breast cancer radiotherapy: implications for current and future practice. JCO Oncol Pr. 2021;17:697–706.
38.
go back to reference Shah C, Bauer-Nilsen K, McNulty RH, Vicini F. Novel radiation therapy approaches for breast cancer treatment. Semin Oncol. 2020;47:209–16.PubMedCrossRef Shah C, Bauer-Nilsen K, McNulty RH, Vicini F. Novel radiation therapy approaches for breast cancer treatment. Semin Oncol. 2020;47:209–16.PubMedCrossRef
39.
go back to reference Brunt AM, Haviland JS, Wheatley DA. Hypofractionated breast radiotherapy for 1 week versus 3 weeks (FAST-Forward): 5-year efficacy and late normal tissue effects results from a multicenter, non-inferiority, randomised, phase 3 trial. Lancet. 2020;395:1613–26.CrossRef Brunt AM, Haviland JS, Wheatley DA. Hypofractionated breast radiotherapy for 1 week versus 3 weeks (FAST-Forward): 5-year efficacy and late normal tissue effects results from a multicenter, non-inferiority, randomised, phase 3 trial. Lancet. 2020;395:1613–26.CrossRef
40.
go back to reference Kunkler IH, Chir B, Williams LJ, Jack WJL, Cameron DA, Dixon JM. Breast-conserving surgery with or without irradiation in early breast cancer. N Engl J Med. 2023;388:585–94.PubMedCrossRef Kunkler IH, Chir B, Williams LJ, Jack WJL, Cameron DA, Dixon JM. Breast-conserving surgery with or without irradiation in early breast cancer. N Engl J Med. 2023;388:585–94.PubMedCrossRef
42.
go back to reference Andre F, Ismaila N, K A. Biomarkers for adjuvant endocrine and chemotherapy in early-stage breast cancer: ASCO guideline update. J Clin Oncol. 2022;40:1816–34.PubMedCrossRef Andre F, Ismaila N, K A. Biomarkers for adjuvant endocrine and chemotherapy in early-stage breast cancer: ASCO guideline update. J Clin Oncol. 2022;40:1816–34.PubMedCrossRef
43.
go back to reference Paik S, Shak S, Tang G, Kim C, Baker J, Cronin M, et al. A Multigene assay to predict recurrence of tamoxifen-treated, node-negative breast cancer. N Engl J Med. 2004;351:2817–26.PubMedCrossRef Paik S, Shak S, Tang G, Kim C, Baker J, Cronin M, et al. A Multigene assay to predict recurrence of tamoxifen-treated, node-negative breast cancer. N Engl J Med. 2004;351:2817–26.PubMedCrossRef
44.
go back to reference Paik S, Tang G, Shak S, Kim C, Baker J, Kim W, et al. Gene expression and benefit of chemotherapy in women with node-negative, estrogen receptor-positive breast cancer. J Clin Oncol. 2006;24:3726–34.PubMedCrossRef Paik S, Tang G, Shak S, Kim C, Baker J, Kim W, et al. Gene expression and benefit of chemotherapy in women with node-negative, estrogen receptor-positive breast cancer. J Clin Oncol. 2006;24:3726–34.PubMedCrossRef
45.
go back to reference Cardoso F, Van’t Veer LJ, 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;375:717–29.PubMedCrossRef Cardoso F, Van’t Veer LJ, 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;375:717–29.PubMedCrossRef
46.
go back to reference Sparano JA, Gray RJ, Makower DF, Pritchard KI, Albain KS, Hayes DF, et al. Prospective validation of a 21-gene expression assay in breast cancer. N Engl J Med. 2015;373:2005–14.PubMedPubMedCentralCrossRef Sparano JA, Gray RJ, Makower DF, Pritchard KI, Albain KS, Hayes DF, et al. Prospective validation of a 21-gene expression assay in breast cancer. N Engl J Med. 2015;373:2005–14.PubMedPubMedCentralCrossRef
47.
go back to reference Albain KS, Barlow WE, Shak S, Hortobagyi GN, Livingston RB, Yeh I-T, 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.PubMedCrossRef Albain KS, Barlow WE, Shak S, Hortobagyi GN, Livingston RB, Yeh I-T, 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.PubMedCrossRef
48.
go back to reference Lænkholm A-V, Jensen M-B, Eriksen JO, Rasmussen BB, Knoop AS, Buckingham W, et al. PAM50 risk of recurrence score predicts 10-year distant recurrence in a comprehensive Danish cohort of postmenopausal women allocated to 5 years of endocrine therapy for hormone receptor-positive early breast cancer. J Clin Oncol. 2018;36:735–40.PubMedCrossRef Lænkholm A-V, Jensen M-B, Eriksen JO, Rasmussen BB, Knoop AS, Buckingham W, et al. PAM50 risk of recurrence score predicts 10-year distant recurrence in a comprehensive Danish cohort of postmenopausal women allocated to 5 years of endocrine therapy for hormone receptor-positive early breast cancer. J Clin Oncol. 2018;36:735–40.PubMedCrossRef
49.
go back to reference Dubsky P, Brase JC, Jakesz R, Rudas M, Singer CF, Greil R, et al. The EndoPredict score provides prognostic information on late distant metastases in ER+/HER2− breast cancer patients. Br J Cancer. 2013;109:2959–64.PubMedPubMedCentralCrossRef Dubsky P, Brase JC, Jakesz R, Rudas M, Singer CF, Greil R, et al. The EndoPredict score provides prognostic information on late distant metastases in ER+/HER2− breast cancer patients. Br J Cancer. 2013;109:2959–64.PubMedPubMedCentralCrossRef
50.
go back to reference Kalinsky K, Barlow WE, Gralow J, Meric-Bernstam F, Albain K, Hayes DF. 21-gene assay to inform chemotherapy benefit in node-positive breast cancer. N Engl J Med. 2021;385:2336–47.PubMedPubMedCentralCrossRef Kalinsky K, Barlow WE, Gralow J, Meric-Bernstam F, Albain K, Hayes DF. 21-gene assay to inform chemotherapy benefit in node-positive breast cancer. N Engl J Med. 2021;385:2336–47.PubMedPubMedCentralCrossRef
51.
go back to reference Gnant M, Filipits M, Greil R, Stoeger H, Rudas M, Bago-Horvath Z, 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;25:339–45.PubMedCrossRef Gnant M, Filipits M, Greil R, Stoeger H, Rudas M, Bago-Horvath Z, 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;25:339–45.PubMedCrossRef
52.
go back to reference Smith I, Robertson J, Kilburn L, Wilcox M, Evans A, Holcombe C, et al. Long-term outcome and prognostic value of Ki67 after perioperative endocrine therapy in postmenopausal women with hormone-sensitive early breast cancer (POETIC): an open-label, multicentre, parallel-group, randomised, phase 3 trial. Lancet Oncol. 2020;21:1443–54.PubMedPubMedCentralCrossRef Smith I, Robertson J, Kilburn L, Wilcox M, Evans A, Holcombe C, et al. Long-term outcome and prognostic value of Ki67 after perioperative endocrine therapy in postmenopausal women with hormone-sensitive early breast cancer (POETIC): an open-label, multicentre, parallel-group, randomised, phase 3 trial. Lancet Oncol. 2020;21:1443–54.PubMedPubMedCentralCrossRef
53.
go back to reference Bradley R, Burrett J, Clarke M, Davies C, Duane F, Evans V, et al. Aromatase inhibitors versus tamoxifen in early breast cancer: Patient-level meta-analysis of the randomised trials. Lancet. 2015;386:1341–52.CrossRef Bradley R, Burrett J, Clarke M, Davies C, Duane F, Evans V, et al. Aromatase inhibitors versus tamoxifen in early breast cancer: Patient-level meta-analysis of the randomised trials. Lancet. 2015;386:1341–52.CrossRef
54.
go back to reference Lohrisch C, Paltiel C, Gelmon K. Impact on survival of time from definitive surgery to initiation of adjuvant chemotherapy for early-stage breast cancer. J Clin Oncol. 2006;24:4888–94.PubMedCrossRef Lohrisch C, Paltiel C, Gelmon K. Impact on survival of time from definitive surgery to initiation of adjuvant chemotherapy for early-stage breast cancer. J Clin Oncol. 2006;24:4888–94.PubMedCrossRef
55.
go back to reference Early Breast Cancer Trialists. Collaborative group (EBCTCG). Effects of chemotherapy and hormonal therapy for early breast cancer on recurrence and 15 year survival: an overview of the randomised trials. Lancet. 2005;365:1687–717.CrossRef Early Breast Cancer Trialists. Collaborative group (EBCTCG). Effects of chemotherapy and hormonal therapy for early breast cancer on recurrence and 15 year survival: an overview of the randomised trials. Lancet. 2005;365:1687–717.CrossRef
56.
go back to reference Davies C, Pan H, Godwin J, Gray R, Arriagada R, Raina V, et al. Long-term effects of continuing adjuvant tamoxifen to 10 years versus stopping at 5 years after diagnosis of oestrogen receptor-positive breast cancer: ATLAS, a randomised trial. Lancet. 2013;381:805–16.PubMedPubMedCentralCrossRef Davies C, Pan H, Godwin J, Gray R, Arriagada R, Raina V, et al. Long-term effects of continuing adjuvant tamoxifen to 10 years versus stopping at 5 years after diagnosis of oestrogen receptor-positive breast cancer: ATLAS, a randomised trial. Lancet. 2013;381:805–16.PubMedPubMedCentralCrossRef
58.
go back to reference Francis PA, Pagani O, Fleming GF, Walley BA, Colleoni M, Láng I, et al. Tailoring adjuvant endocrine therapy for premenopausal breast cancer. N Engl J Med. 2018;379:122–37.PubMedPubMedCentralCrossRef Francis PA, Pagani O, Fleming GF, Walley BA, Colleoni M, Láng I, et al. Tailoring adjuvant endocrine therapy for premenopausal breast cancer. N Engl J Med. 2018;379:122–37.PubMedPubMedCentralCrossRef
59.
go back to reference Cuzick J, Ambroisine L, Davidson N, Jakesz R, Kaufmann M, LHRH-agonists in Early Breast Cancer Overview group, et al. Use of luteinising-hormone-releasing hormone agonists as adjuvant treatment in premenopausal patients with hormone-receptor-positive breast cancer: a meta-analysis of individual patient data from randomised adjuvant trials. Lancet. 2007;369:1711–23.PubMedCrossRef Cuzick J, Ambroisine L, Davidson N, Jakesz R, Kaufmann M, LHRH-agonists in Early Breast Cancer Overview group, et al. Use of luteinising-hormone-releasing hormone agonists as adjuvant treatment in premenopausal patients with hormone-receptor-positive breast cancer: a meta-analysis of individual patient data from randomised adjuvant trials. Lancet. 2007;369:1711–23.PubMedCrossRef
60.
go back to reference 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;365:60–2.PubMedCrossRef 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;365:60–2.PubMedCrossRef
61.
go back to reference Mouridsen H, Giobbie-Hurder A, Goldhirsch A, Thürlimann B, Paridaens R, BIG 1-98 Collaborative Group, et al. Letrozole therapy alone or in sequence with tamoxifen in women with breast cancer. N Engl J Med. 2009;361:766–76.PubMedCrossRef Mouridsen H, Giobbie-Hurder A, Goldhirsch A, Thürlimann B, Paridaens R, BIG 1-98 Collaborative Group, et al. Letrozole therapy alone or in sequence with tamoxifen in women with breast cancer. N Engl J Med. 2009;361:766–76.PubMedCrossRef
62.
go back to reference Derks MGM, Blok EJ, Seynaeve C, Nortier JWR, Kranenbarg EM-K, Liefers G-J, et al. Adjuvant tamoxifen and exemestane in women with postmenopausal early breast cancer (TEAM): 10 year follow-up of a multicentre, open-label, randomised, phase 3 trial. Lancet Oncol. 2017;18:1211–20.PubMedCrossRef Derks MGM, Blok EJ, Seynaeve C, Nortier JWR, Kranenbarg EM-K, Liefers G-J, et al. Adjuvant tamoxifen and exemestane in women with postmenopausal early breast cancer (TEAM): 10 year follow-up of a multicentre, open-label, randomised, phase 3 trial. Lancet Oncol. 2017;18:1211–20.PubMedCrossRef
63.
go back to reference Boccardo F, Rubagotti A, Puntoni M, Guglielmini P, Amoroso D, Fini A, et al. Switching to anastrozole versus continued tamoxifen treatment of early breast cancer: preliminary results of the Italian tamoxifen anastrozole trial. J Clin Oncol. 2005;23:5138–47.PubMedCrossRef Boccardo F, Rubagotti A, Puntoni M, Guglielmini P, Amoroso D, Fini A, et al. Switching to anastrozole versus continued tamoxifen treatment of early breast cancer: preliminary results of the Italian tamoxifen anastrozole trial. J Clin Oncol. 2005;23:5138–47.PubMedCrossRef
64.
go back to reference Coombes RC, Hall E, Gibson LJ, Paridaens R, Jassem J, Delozier T, et al. A randomized trial of exemestane after two to three years of tamoxifen therapy in postmenopausal women with primary breast cancer. N Engl J Med. 2004;350:1081–92.PubMedCrossRef Coombes RC, Hall E, Gibson LJ, Paridaens R, Jassem J, Delozier T, et al. A randomized trial of exemestane after two to three years of tamoxifen therapy in postmenopausal women with primary breast cancer. N Engl J Med. 2004;350:1081–92.PubMedCrossRef
65.
go back to reference Jakesz R, Jonat W, Gnant M, Mittlboeck M, Greil R, Tausch C, et al. Switching of postmenopausal women with endocrine-responsive early breast cancer to anastrozole after 2 years’ adjuvant tamoxifen: combined results of ABCSG trial 8 and ARNO 95 trial. The Lancet. 2005;366:455–62.CrossRef Jakesz R, Jonat W, Gnant M, Mittlboeck M, Greil R, Tausch C, et al. Switching of postmenopausal women with endocrine-responsive early breast cancer to anastrozole after 2 years’ adjuvant tamoxifen: combined results of ABCSG trial 8 and ARNO 95 trial. The Lancet. 2005;366:455–62.CrossRef
66.
go back to reference Corona SP, Roviello G, Strina C. Efficacy of extended aromatase inhibitors for hormone-receptor-positive breast cancer: A literature-based meta-analysis of randomized trials. Breast. 2019;46:19–24.PubMedCrossRef Corona SP, Roviello G, Strina C. Efficacy of extended aromatase inhibitors for hormone-receptor-positive breast cancer: A literature-based meta-analysis of randomized trials. Breast. 2019;46:19–24.PubMedCrossRef
67.
go back to reference Zhang Y, Schroeder BE, Jerevall PL. A novel Breast Cancer Index for prediction of distant recurrence in HR+ early-stage breast cancer with one to three positive nodes. Clin Cancer Res. 2017;23:7217–24.PubMedCrossRef Zhang Y, Schroeder BE, Jerevall PL. A novel Breast Cancer Index for prediction of distant recurrence in HR+ early-stage breast cancer with one to three positive nodes. Clin Cancer Res. 2017;23:7217–24.PubMedCrossRef
68.
go back to reference Sgroi DC, Sestak I, Cuzick J. 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;14:1067–76.PubMedPubMedCentralCrossRef Sgroi DC, Sestak I, Cuzick J. 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;14:1067–76.PubMedPubMedCentralCrossRef
69.
go back to reference Bartlett JMS, Sgroi DC, Treuner K. Breast Cancer Index and prediction of benefit from extended endocrine therapy in breast cancer patients treated in the adjuvant tamoxifen-to offer more? (aTTom) trial. Ann Oncol. 2019;30:1776–83.PubMedPubMedCentralCrossRef Bartlett JMS, Sgroi DC, Treuner K. Breast Cancer Index and prediction of benefit from extended endocrine therapy in breast cancer patients treated in the adjuvant tamoxifen-to offer more? (aTTom) trial. Ann Oncol. 2019;30:1776–83.PubMedPubMedCentralCrossRef
70.
go back to reference Dhesy-Thind S, Fletcher GG, Blanchette PS, Clemons MJ, Dillmon MS, Frank ES, et al. Use of adjuvant bisphosphonates and other bone-modifying agents in breast cancer: a Cancer Care Ontario and American Society of Clinical Oncology clinical practice guideline. J Clin Oncol. 2017;35:2062–81.PubMedCrossRef Dhesy-Thind S, Fletcher GG, Blanchette PS, Clemons MJ, Dillmon MS, Frank ES, et al. Use of adjuvant bisphosphonates and other bone-modifying agents in breast cancer: a Cancer Care Ontario and American Society of Clinical Oncology clinical practice guideline. J Clin Oncol. 2017;35:2062–81.PubMedCrossRef
71.
go back to reference Johnston S, Harbeck N, Hegg R. Abemaciclib combined with endocrine therapy for the adjuvant treatment of HR+, HER2−, node-positive, high-risk, early breast cancer (monarchE). J Clin Oncol. 2020;38:3987–98.PubMedPubMedCentralCrossRef Johnston S, Harbeck N, Hegg R. Abemaciclib combined with endocrine therapy for the adjuvant treatment of HR+, HER2−, node-positive, high-risk, early breast cancer (monarchE). J Clin Oncol. 2020;38:3987–98.PubMedPubMedCentralCrossRef
72.
go back to reference Andrew Tutt NJ, MB, Ch B JEG. Adjuvant olaparib for patients with BRCA1- or BRCA2-mutated breast cancer. N Engl J Med. 2021;384:2394–405.PubMedCrossRef Andrew Tutt NJ, MB, Ch B JEG. Adjuvant olaparib for patients with BRCA1- or BRCA2-mutated breast cancer. N Engl J Med. 2021;384:2394–405.PubMedCrossRef
73.
go back to reference Curigliano G, Burstein HJ, Winer EP, Gnant M, Dubsky P, Loibl S, et al. De-escalating and escalating treatments for early-stage breast cancer: The St Gallen international expert consensus conference on the primary therapy of early breast cancer. Ann Oncol. 2017;28:1700–12.PubMedPubMedCentralCrossRef Curigliano G, Burstein HJ, Winer EP, Gnant M, Dubsky P, Loibl S, et al. De-escalating and escalating treatments for early-stage breast cancer: The St Gallen international expert consensus conference on the primary therapy of early breast cancer. Ann Oncol. 2017;28:1700–12.PubMedPubMedCentralCrossRef
74.
go back to reference Nitz U, Gluz O, Huober J. Final analysis of the prospective WSGAGO EC-doc versus FEC phase III trial in intermediate-risk (pN1) early breast cancer: efficacy and predictive value of Ki67 expression. Ann Oncol. 2017;28:2899.PubMedCrossRef Nitz U, Gluz O, Huober J. Final analysis of the prospective WSGAGO EC-doc versus FEC phase III trial in intermediate-risk (pN1) early breast cancer: efficacy and predictive value of Ki67 expression. Ann Oncol. 2017;28:2899.PubMedCrossRef
75.
go back to reference Samuel JA, Wilson JW, Bandos H. Abstract S3–02: nSABP B-36: a randomized phase III trial comparing six cycles of 5-fluorouracil (5-FU), epirubicin, and cyclophosphamide (FEC) to four cycles of Adriamycin and cyclophosphamide (AC) in patients (pts) with node negative breast cancer. Cancer Res. 2015;75:3–02.CrossRef Samuel JA, Wilson JW, Bandos H. Abstract S3–02: nSABP B-36: a randomized phase III trial comparing six cycles of 5-fluorouracil (5-FU), epirubicin, and cyclophosphamide (FEC) to four cycles of Adriamycin and cyclophosphamide (AC) in patients (pts) with node negative breast cancer. Cancer Res. 2015;75:3–02.CrossRef
76.
go back to reference Jones S, Holmes FA, O’Shaughnessy J. Shaughness. Docetaxel with cyclophosphamide is associated with an overall survival benefit compared with doxorubicin and cyclophosphamide: 7 year follow-up of US. J Clin Oncol. 2009;27:1177–83.PubMedCrossRef Jones S, Holmes FA, O’Shaughnessy J. Shaughness. Docetaxel with cyclophosphamide is associated with an overall survival benefit compared with doxorubicin and cyclophosphamide: 7 year follow-up of US. J Clin Oncol. 2009;27:1177–83.PubMedCrossRef
77.
go back to reference Early Breast Cancer Trialists. Collaborative Group (EBCTCG). Increasing the dose intensity of chemotherapy by more frequent administration or sequential scheduling: a patient-level meta-analysis of 37 298 women with early breast cancer in 26 randomised trials. Lancet. 2019;393:1440–52.CrossRef Early Breast Cancer Trialists. Collaborative Group (EBCTCG). Increasing the dose intensity of chemotherapy by more frequent administration or sequential scheduling: a patient-level meta-analysis of 37 298 women with early breast cancer in 26 randomised trials. Lancet. 2019;393:1440–52.CrossRef
78.
go back to reference Peto R, Davies C, J G,. Comparisons between different polychemotherapy regimens for early breast cancer: meta-analyses of longterm outcome among 100,000 women in 123 randomised trials. Lancet. 2012;379:432–44.PubMedCrossRef Peto R, Davies C, J G,. Comparisons between different polychemotherapy regimens for early breast cancer: meta-analyses of longterm outcome among 100,000 women in 123 randomised trials. Lancet. 2012;379:432–44.PubMedCrossRef
79.
go back to reference Eggemann H, Ignatov A, Smith BJ. Adjuvant therapy with tamoxifen compared to aromatase inhibitors for 257 male breast cancer patients. Breast Cancer Res Treat. 2013;137:465–70.PubMedCrossRef Eggemann H, Ignatov A, Smith BJ. Adjuvant therapy with tamoxifen compared to aromatase inhibitors for 257 male breast cancer patients. Breast Cancer Res Treat. 2013;137:465–70.PubMedCrossRef
80.
go back to reference Korde LA, Zujewski JA, Kamin L, Sousa B, Moser E, Cardoso F. Multidisciplinary meeting on male breast cancer: summary and research recommendations. J Clin Oncol. 2010;28:2114–22.PubMedPubMedCentralCrossRef Korde LA, Zujewski JA, Kamin L, Sousa B, Moser E, Cardoso F. Multidisciplinary meeting on male breast cancer: summary and research recommendations. J Clin Oncol. 2010;28:2114–22.PubMedPubMedCentralCrossRef
81.
go back to reference Sousa B, Moser E, Cardoso F. An update on male breast cancer and future directions for research and treatment. Eur J Pharmacol. 2013;717:71–83.PubMedCrossRef Sousa B, Moser E, Cardoso F. An update on male breast cancer and future directions for research and treatment. Eur J Pharmacol. 2013;717:71–83.PubMedCrossRef
82.
go back to reference Gianni L, Baselga J, Eiermann W. Phase III trial evaluating the addition of paclitaxel to doxorubicin followed by cyclophosphamide, methotrexate, and fluorouracil, as adjuvant or primary systemic therapy: European cooperative trial in operable breast cancer. J Clin Oncol. 2009;27:2474–81.PubMedCrossRef Gianni L, Baselga J, Eiermann W. Phase III trial evaluating the addition of paclitaxel to doxorubicin followed by cyclophosphamide, methotrexate, and fluorouracil, as adjuvant or primary systemic therapy: European cooperative trial in operable breast cancer. J Clin Oncol. 2009;27:2474–81.PubMedCrossRef
83.
go back to reference Smith IE, Dowsett M, Ebbs SR, Dixon JM, Skene A, Blohmer J-U, et al. Neoadjuvant treatment of postmenopausal breast cancer with anastrozole, tamoxifen, or both in combination: the immediate preoperative anastrozole, tamoxifen, or combined with tamoxifen (IMPACT) multicenter double-blind randomized trial. J Clin Oncol. 2005;23:5108–16.PubMedCrossRef Smith IE, Dowsett M, Ebbs SR, Dixon JM, Skene A, Blohmer J-U, et al. Neoadjuvant treatment of postmenopausal breast cancer with anastrozole, tamoxifen, or both in combination: the immediate preoperative anastrozole, tamoxifen, or combined with tamoxifen (IMPACT) multicenter double-blind randomized trial. J Clin Oncol. 2005;23:5108–16.PubMedCrossRef
84.
go back to reference Dowsett M, Ellis MJ, Dixon JM, Gluz O, Robertson J, Kates R, et al. Evidence-based guidelines for managing patients with primary ER+ HER2- breast cancer deferred from surgery due to the COVID-19 pandemic. NPJ Breast Cancer. 2020;6:21.PubMedPubMedCentralCrossRef Dowsett M, Ellis MJ, Dixon JM, Gluz O, Robertson J, Kates R, et al. Evidence-based guidelines for managing patients with primary ER+ HER2- breast cancer deferred from surgery due to the COVID-19 pandemic. NPJ Breast Cancer. 2020;6:21.PubMedPubMedCentralCrossRef
85.
go back to reference Masuda N, Sagara Y, Kinoshita T. Neoadjuvant anastrozole versus tamoxifen in patients receiving goserelin for premenopausal breast cancer (STAGE): a double-blind, randomised phase 3 trial. Lancet Oncol. 2012;13:345–52.PubMedCrossRef Masuda N, Sagara Y, Kinoshita T. Neoadjuvant anastrozole versus tamoxifen in patients receiving goserelin for premenopausal breast cancer (STAGE): a double-blind, randomised phase 3 trial. Lancet Oncol. 2012;13:345–52.PubMedCrossRef
86.
go back to reference Alba E, Calvo L, Albanell J, De la Haba JR, Arcusa Lanza A, Chacon JI, et al. Chemotherapy (CT) and hormonotherapy (HT) as neoadjuvant treatment in luminal breast cancer patients: results from the GEICAM/2006–03, a multicenter, randomized, phase-II study. Ann Oncol. 2012;23:3069–74.PubMedCrossRef Alba E, Calvo L, Albanell J, De la Haba JR, Arcusa Lanza A, Chacon JI, et al. Chemotherapy (CT) and hormonotherapy (HT) as neoadjuvant treatment in luminal breast cancer patients: results from the GEICAM/2006–03, a multicenter, randomized, phase-II study. Ann Oncol. 2012;23:3069–74.PubMedCrossRef
87.
go back to reference Ellis MJ, Suman VJ, Hoog J, Lin L, Snider J, Prat A, et al. Randomized phase II neoadjuvant comparison between letrozole, anastrozole, and exemestane for postmenopausal women with estrogen receptor-rich stage 2 to 3 breast cancer: clinical and biomarker outcomes and predictive value of the baseline PAM50-based intrinsic subtype–ACOSOG Z1031. J Clin Oncol. 2011;29:2342–9.PubMedPubMedCentralCrossRef Ellis MJ, Suman VJ, Hoog J, Lin L, Snider J, Prat A, et al. Randomized phase II neoadjuvant comparison between letrozole, anastrozole, and exemestane for postmenopausal women with estrogen receptor-rich stage 2 to 3 breast cancer: clinical and biomarker outcomes and predictive value of the baseline PAM50-based intrinsic subtype–ACOSOG Z1031. J Clin Oncol. 2011;29:2342–9.PubMedPubMedCentralCrossRef
88.
go back to reference Prat A, Galvan P, Jimenez B, Buckingham W, Jeiranian HA, Schaper C, et al. Prediction of response to neoadjuvant chemotherapy using core needle biopsy samples with the prosigna assay. Clin Cancer Res. 2016;22:560–6.PubMedCrossRef Prat A, Galvan P, Jimenez B, Buckingham W, Jeiranian HA, Schaper C, et al. Prediction of response to neoadjuvant chemotherapy using core needle biopsy samples with the prosigna assay. Clin Cancer Res. 2016;22:560–6.PubMedCrossRef
89.
go back to reference Cortazar P, Zhang L, Untch M, Mehta K, Costantino JP, Wolmark N, et al. Pathological complete response and long-term clinical benefit in breast cancer: the CTNeoBC pooled analysis. Lancet. 2014;384:164–72.PubMedCrossRef Cortazar P, Zhang L, Untch M, Mehta K, Costantino JP, Wolmark N, et al. Pathological complete response and long-term clinical benefit in breast cancer: the CTNeoBC pooled analysis. Lancet. 2014;384:164–72.PubMedCrossRef
90.
go back to reference Gianni L, Pienkowski T, Im Y-H, Roman L, Tseng L-M, Liu M-C, et al. Efficacy and safety of neoadjuvant pertuzumab and trastuzumab in women with locally advanced, inflammatory, or early HER2-positive breast cancer (NeoSphere): a randomised multicentre, open-label, phase 2 trial. Lancet Oncol. 2012;13:25–32.PubMedCrossRef Gianni L, Pienkowski T, Im Y-H, Roman L, Tseng L-M, Liu M-C, et al. Efficacy and safety of neoadjuvant pertuzumab and trastuzumab in women with locally advanced, inflammatory, or early HER2-positive breast cancer (NeoSphere): a randomised multicentre, open-label, phase 2 trial. Lancet Oncol. 2012;13:25–32.PubMedCrossRef
91.
go back to reference Swain SM, Miles D, Kim SB, Im Y, Im S, Semiglazov V, et al. Pertuzumab, trastuzumab, and docetaxel for HER2-positive metastatic breast cancer (CLEOPATRA): end-of-study results from a double-blind, randomised, placebo-controlled, phase 3 study. Lancet Oncol 2020; 21: 519–30. Swain SM, Miles D, Kim SB, Im Y, Im S, Semiglazov V, et al. Pertuzumab, trastuzumab, and docetaxel for HER2-positive metastatic breast cancer (CLEOPATRA): end-of-study results from a double-blind, randomised, placebo-controlled, phase 3 study. Lancet Oncol 2020; 21: 519–30.
92.
go back to reference Voort A, Ramshorst M, Werkhoven E, Mandjes I, Kemper I, Vulink A, et al. Three-year follow-up of neoadjuvant chemotherapy with or without anthracyclines in the presence of dual HER2-blockade for HER2-positive breast cancer (TRAIN-2): a randomized phase 3 trial. JAMA Oncol. 2021;7:978–84.PubMedCrossRef Voort A, Ramshorst M, Werkhoven E, Mandjes I, Kemper I, Vulink A, et al. Three-year follow-up of neoadjuvant chemotherapy with or without anthracyclines in the presence of dual HER2-blockade for HER2-positive breast cancer (TRAIN-2): a randomized phase 3 trial. JAMA Oncol. 2021;7:978–84.PubMedCrossRef
93.
go back to reference Schneeweiss A, Chia S, Hickish T, Harvey V, Eniu A, Hegg R, et al. Pertuzumab plus trastuzumab in combination with standard neoadjuvant anthracycline-containing and anthracycline-free chemotherapy regimens in patients with HER2-positive early breast cancer: a randomized phase II cardiac safety study (TRYPHAENA). Ann Oncol. 2013;24:2278–84.PubMedCrossRef Schneeweiss A, Chia S, Hickish T, Harvey V, Eniu A, Hegg R, et al. Pertuzumab plus trastuzumab in combination with standard neoadjuvant anthracycline-containing and anthracycline-free chemotherapy regimens in patients with HER2-positive early breast cancer: a randomized phase II cardiac safety study (TRYPHAENA). Ann Oncol. 2013;24:2278–84.PubMedCrossRef
94.
go back to reference Slamon D, Eiermann W, Robert N, Pienkowski T, Martin M, Press M, et al. Adjuvant trastuzumab in HER2-positive breast cancer. N Engl J Med. 2011;365:1273–83.PubMedPubMedCentralCrossRef Slamon D, Eiermann W, Robert N, Pienkowski T, Martin M, Press M, et al. Adjuvant trastuzumab in HER2-positive breast cancer. N Engl J Med. 2011;365:1273–83.PubMedPubMedCentralCrossRef
95.
go back to reference Cameron D, Piccart-Gebhart MJ, Gelber RD, Procter M, Goldhirsch A, de Azambuja E, et al. 11 years’ follow-up of trastuzumab after adjuvant chemotherapy in HER2-positive early breast cancer: final analysis of the HERceptin Adjuvant (HERA) trial. Lancet. 2017;389:1195–205.PubMedPubMedCentralCrossRef Cameron D, Piccart-Gebhart MJ, Gelber RD, Procter M, Goldhirsch A, de Azambuja E, et al. 11 years’ follow-up of trastuzumab after adjuvant chemotherapy in HER2-positive early breast cancer: final analysis of the HERceptin Adjuvant (HERA) trial. Lancet. 2017;389:1195–205.PubMedPubMedCentralCrossRef
96.
go back to reference Perez EA, Romond EH, Suman VJ, Jeong J-H, Sledge G, Geyer CE, et al. Trastuzumab plus adjuvant chemotherapy for human epidermal growth factor receptor 2–positive breast cancer: planned joint analysis of overall survival from NSABP B-31 and NCCTG N9831. J Clin Oncol. 2014;32:3744–52.PubMedPubMedCentralCrossRef Perez EA, Romond EH, Suman VJ, Jeong J-H, Sledge G, Geyer CE, et al. Trastuzumab plus adjuvant chemotherapy for human epidermal growth factor receptor 2–positive breast cancer: planned joint analysis of overall survival from NSABP B-31 and NCCTG N9831. J Clin Oncol. 2014;32:3744–52.PubMedPubMedCentralCrossRef
97.
go back to reference Inno A, Barni S, Ghidini A. One year versus a shorter duration of adjuvant trastuzumab for HER2-positive early breast cancer: a systematic review and meta-analysis. Breast Cancer Res Treat. 2019;173:247–54.PubMedCrossRef Inno A, Barni S, Ghidini A. One year versus a shorter duration of adjuvant trastuzumab for HER2-positive early breast cancer: a systematic review and meta-analysis. Breast Cancer Res Treat. 2019;173:247–54.PubMedCrossRef
98.
go back to reference Niraula S, Gyawali B. Optimal duration of adjuvant trastuzumab in treatment of early breast cancer: a meta-analysis of randomized controlled trials. Breast Cancer Res Treat. 2019;173:103–9.PubMedCrossRef Niraula S, Gyawali B. Optimal duration of adjuvant trastuzumab in treatment of early breast cancer: a meta-analysis of randomized controlled trials. Breast Cancer Res Treat. 2019;173:103–9.PubMedCrossRef
99.
go back to reference Tolaney SM, Guo H, Pernas S. Seven-year follow-up analysis of adjuvant paclitaxel and trastuzumab trial for node-negative, human epidermal growth factor receptor 2-positive breast cancer. J Clin Oncol. 2019;37:1868–75.PubMedPubMedCentralCrossRef Tolaney SM, Guo H, Pernas S. Seven-year follow-up analysis of adjuvant paclitaxel and trastuzumab trial for node-negative, human epidermal growth factor receptor 2-positive breast cancer. J Clin Oncol. 2019;37:1868–75.PubMedPubMedCentralCrossRef
100.
go back to reference Piccart M, Procter M, Fumagalli D, De Azambuja E, Clark E, Ewer MS, et al. Adjuvant pertuzumab and trastuzumab in early HER2-positive breast cancer in the APHINITY trial: 6 years’ follow-up. J Clin Oncol. 2021;39:1448–57.PubMedCrossRef Piccart M, Procter M, Fumagalli D, De Azambuja E, Clark E, Ewer MS, et al. Adjuvant pertuzumab and trastuzumab in early HER2-positive breast cancer in the APHINITY trial: 6 years’ follow-up. J Clin Oncol. 2021;39:1448–57.PubMedCrossRef
102.
go back to reference Arlene MB, Mansi J. Final efficacy results of neratinib in HER2-positive hormone receptorpositive early-stage breast cancer from the phase III ExteNET trial. Clin Breast Cancer. 2021;21:80–91.CrossRef Arlene MB, Mansi J. Final efficacy results of neratinib in HER2-positive hormone receptorpositive early-stage breast cancer from the phase III ExteNET trial. Clin Breast Cancer. 2021;21:80–91.CrossRef
103.
go back to reference Minckwitz G, Huang CS, Mano MS, Loibl S, Mamounas EP, Untch M, et al. Trastuzumab emtansine for residual invasive HER2-positive breast cancer. N Engl J Med. 2019;380(7):617–28.CrossRef Minckwitz G, Huang CS, Mano MS, Loibl S, Mamounas EP, Untch M, et al. Trastuzumab emtansine for residual invasive HER2-positive breast cancer. N Engl J Med. 2019;380(7):617–28.CrossRef
104.
go back to reference Perou CM, Sørlie T, Eisen MB, van de Rijn M, Jeffrey SS, Rees CA, et al. Molecular portraits of human breast tumours [Letter]. Nature. 2000;406:747–52.PubMedCrossRef Perou CM, Sørlie T, Eisen MB, van de Rijn M, Jeffrey SS, Rees CA, et al. Molecular portraits of human breast tumours [Letter]. Nature. 2000;406:747–52.PubMedCrossRef
106.
go back to reference An X, Lei X, Huang R. Adjuvant chemotherapy for small, lymph node-negative, triple-negative breast cancer: a single-center study and a meta-analysis of the published literature. Cancer. 2020;126:3837–46.PubMedCrossRef An X, Lei X, Huang R. Adjuvant chemotherapy for small, lymph node-negative, triple-negative breast cancer: a single-center study and a meta-analysis of the published literature. Cancer. 2020;126:3837–46.PubMedCrossRef
107.
go back to reference Poggio F, Bruzzone M, Ceppi M, Pondé N, La Valle G, Del Mastro L, et al. Platinum-based neoadjuvant chemotherapy in triple-negative breast cancer: a systematic review and metaanalysis. Ann Oncol. 2018;29:1497–508.PubMedCrossRef Poggio F, Bruzzone M, Ceppi M, Pondé N, La Valle G, Del Mastro L, et al. Platinum-based neoadjuvant chemotherapy in triple-negative breast cancer: a systematic review and metaanalysis. Ann Oncol. 2018;29:1497–508.PubMedCrossRef
108.
go back to reference Geyer C, Sikov W, Huober J, Rugo H, Wolmark N, O’Shaughnessy J, et al. Long-term efficacy and safety of addition of carboplatin with or without veliparib to standard neoadjuvant chemotherapy in triple-negative breast cancer: 4-year follow-up data from BrighTNess, a randomized phase III trial. Ann Oncol. 2022;33:384–94.PubMedCrossRef Geyer C, Sikov W, Huober J, Rugo H, Wolmark N, O’Shaughnessy J, et al. Long-term efficacy and safety of addition of carboplatin with or without veliparib to standard neoadjuvant chemotherapy in triple-negative breast cancer: 4-year follow-up data from BrighTNess, a randomized phase III trial. Ann Oncol. 2022;33:384–94.PubMedCrossRef
109.
go back to reference Schmid P, Cortes J, Dent R. Event-free survival with pembrolizumab in early triple-negative breast cancer. N Engl J Med. 2022;386:556–67.PubMedCrossRef Schmid P, Cortes J, Dent R. Event-free survival with pembrolizumab in early triple-negative breast cancer. N Engl J Med. 2022;386:556–67.PubMedCrossRef
110.
go back to reference Mittendorf EA, Zhang H, Barrios CH. 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 tri. Lancet. 2020;396:1090–100.PubMedCrossRef Mittendorf EA, Zhang H, Barrios CH. 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 tri. Lancet. 2020;396:1090–100.PubMedCrossRef
111.
go back to reference Mackelenbergh M, Seither F, Möbus V, O’Shaughnessy J, Martin M, Joensuu H, et al. Effects of capecitabine as part of neo-/adjuvant chemotherapy. A meta-analysis of individual patient data from 12 randomized trials including 15,457 patients. Eur J Cancer. 2022;166:185–201.PubMedCrossRef Mackelenbergh M, Seither F, Möbus V, O’Shaughnessy J, Martin M, Joensuu H, et al. Effects of capecitabine as part of neo-/adjuvant chemotherapy. A meta-analysis of individual patient data from 12 randomized trials including 15,457 patients. Eur J Cancer. 2022;166:185–201.PubMedCrossRef
112.
113.
go back to reference Barnadas A, Algara M, Cordoba O, Casas A, Gonzalez M, Marzo M, et al. Recommendations for the follow-up care of female breast cancer survivors: a guideline of the Spanish Society of Medical Oncology (SEOM), Spanish Society of General Medicine (SEMERGEN), Spanish Society for Family and Community Medicine (SEMFYC), Spanish Society for General and Family Physicians (SEMG), Spanish Society of Obstetrics and Gynecology (SEGO), Spanish Society of Radiation Oncology (SEOR), Spanish Society of Senology and Breast Pathology (SESPM), and Spanish Society of Cardiology (SEC). Clin Transl Oncol. 2018;20:687–94.PubMedCrossRef Barnadas A, Algara M, Cordoba O, Casas A, Gonzalez M, Marzo M, et al. Recommendations for the follow-up care of female breast cancer survivors: a guideline of the Spanish Society of Medical Oncology (SEOM), Spanish Society of General Medicine (SEMERGEN), Spanish Society for Family and Community Medicine (SEMFYC), Spanish Society for General and Family Physicians (SEMG), Spanish Society of Obstetrics and Gynecology (SEGO), Spanish Society of Radiation Oncology (SEOR), Spanish Society of Senology and Breast Pathology (SESPM), and Spanish Society of Cardiology (SEC). Clin Transl Oncol. 2018;20:687–94.PubMedCrossRef
114.
go back to reference Cardoso F, Kyriakides S, Ohno S, Penault-Llorca F, Poortmans P, Rubio IT, et al. Early breast cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2019;30:1194–220.PubMedCrossRef Cardoso F, Kyriakides S, Ohno S, Penault-Llorca F, Poortmans P, Rubio IT, et al. Early breast cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2019;30:1194–220.PubMedCrossRef
115.
go back to reference NCCN Guidelines. Version 2.2021. Invasive Breast Cancer. 2021. NCCN Guidelines. Version 2.2021. Invasive Breast Cancer. 2021.
Metadata
Title
SEOM-GEICAM-SOLTI clinical guidelines for early-stage breast cancer (2022)
Authors
Francisco Ayala de la Peña
Silvia Antolín Novoa
Joaquín Gavilá Gregori
Lucía González Cortijo
Fernando Henao Carrasco
María Teresa Martínez Martínez
Cristina Morales Estévez
Agostina Stradella
María Jesús Vidal Losada
Eva Ciruelos
Publication date
16-06-2023
Publisher
Springer International Publishing
Published in
Clinical and Translational Oncology / Issue 9/2023
Print ISSN: 1699-048X
Electronic ISSN: 1699-3055
DOI
https://doi.org/10.1007/s12094-023-03215-4

Other articles of this Issue 9/2023

Clinical and Translational Oncology 9/2023 Go to the issue
Webinar | 19-02-2024 | 17:30 (CET)

Keynote webinar | Spotlight on antibody–drug conjugates in cancer

Antibody–drug conjugates (ADCs) are novel agents that have shown promise across multiple tumor types. Explore the current landscape of ADCs in breast and lung cancer with our experts, and gain insights into the mechanism of action, key clinical trials data, existing challenges, and future directions.

Dr. Véronique Diéras
Prof. Fabrice Barlesi
Developed by: Springer Medicine