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Abstract Blue Waves

SDM POSSIBLE - Shared Decision Making For People Over Seventy With Stage I Breast Cancer To Learn And Engage Trial

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Guidelines & expert reviews

Guidelines and expert reviews that include information on treating women aged 70 and older with Stage I, ER+, HER2- breast cancer.

Guidelines & expert reviews
SIOG
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Lymph node testing 

Lymph node testing

Key randomized clinical trials (RCTs) on lymph node

testing in older women with early-stage breast cancer 

Articles - 

1. Reimer T, Stachs A, Veselinovic K, Kühn T, Heil J, Polata S, Marmé F, Müller T, Hildebrandt G, Krug D, Ataseven B, Reitsamer R, Ruth S, Denkert C, Bekes I, Zahm DM, Thill M, Golatta M, Holtschmidt J, Knauer M, Nekljudova V, Loibl S, Gerber B. Axillary Surgery in Breast Cancer - Primary Results of the INSEMA Trial. N Engl J Med. 2025 Mar 13;392(11):1051-1064. doi: 10.1056/NEJMoa2412063. Epub 2024 Dec 12. PMID: 39665649.

2. Gentilini OD, Botteri E, Sangalli C, Galimberti V, Porpiglia M, Agresti R, Luini A, Viale G, Cassano E, Peradze N, Toesca A, Massari G, Sacchini V, Munzone E, Leonardi MC, Cattadori F, Di Micco R, Esposito E, Sgarella A, Cattaneo S, Busani M, Dessena M, Bianchi A, Cretella E, Ripoll Orts F, Mueller M, Tinterri C, Chahuan Manzur BJ, Benedetto C, Veronesi P; SOUND Trial Group. 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 Nov 1;9(11):1557-1564. doi: 10.1001/jamaoncol.2023.3759. PMID: 37733364; PMCID: PMC10514873.

3. Martelli G, Boracchi P, Ardoino I, Lozza L, Bohm S, Vetrella G, Agresti R. Axillary dissection versus no axillary dissection in older patients with T1N0 breast cancer: 15-year results of a randomized controlled trial. Ann Surg. 2012 Dec;256(6):920-4. doi: 10.1097/SLA.0b013e31827660a8. PMID: 23154393.

4. Krag DN, Anderson SJ, Julian TB, Brown AM, Harlow SP, Costantino JP, Ashikaga T, Weaver DL, Mamounas EP, Jalovec LM, Frazier TG, Noyes RD, Robidoux A, Scarth HM, Wolmark N. Sentinel-lymph-node resection compared with conventional axillary-lymph-node dissection in clinically node-negative patients with breast cancer: overall survival findings from the NSABP B-32 randomised phase 3 trial. Lancet Oncol. 2010 Oct;11(10):927-33. doi: 10.1016/S1470-2045(10)70207-2. PMID: 20863759; PMCID: PMC3041644.

5. International Breast Cancer Study Group; Rudenstam CM, Zahrieh D, Forbes JF, Crivellari D, Holmberg SB, Rey P, Dent D, Campbell I, Bernhard J, Price KN, Castiglione-Gertsch M, Goldhirsch A, Gelber RD, Coates AS. Randomized trial comparing axillary clearance versus no axillary clearance in older patients with breast cancer: first results of International Breast Cancer Study Group Trial 10-93. J Clin Oncol. 2006 Jan 20;24(3):337-44. doi: 10.1200/JCO.2005.01.5784. Epub 2005 Dec 12. PMID: 16344321.

6. Mansel RE, Fallowfield L, Kissin M, Goyal A, Newcombe RG, Dixon JM, Yiangou C, Horgan K, Bundred N, Monypenny I, England D, Sibbering M, Abdullah TI, Barr L, Chetty U, Sinnett DH, Fleissig A, Clarke D, Ell PJ. Randomized multicenter trial of sentinel node biopsy versus standard axillary treatment in operable breast cancer: the ALMANAC Trial. J Natl Cancer Inst. 2006 May 3;98(9):599-609. doi: 10.1093/jnci/djj158. Erratum in: J Natl Cancer Inst. 2006 Jun 21;98(12):876. PMID: 16670385.

Key RCTs

Population-based and prospective studies on

lymph node testing in older women 

Articles - 

1.Xu Z, Chen G, Cao B, Zhang M, Ruan P. Evaluating the role of sentinel lymph node biopsy in cT1-2N0M0 breast cancer: a SEER-based study. Gland Surg. 2025 Aug 31;14(8):1585-1598. doi: 10.21037/gs-2025-171. Epub 2025 Aug 25. PMID: 40948919; PMCID: PMC12432964.

2. Chung AP, Dang CM, Karlan SR, Amersi FF, Phillips EM, Boyle MK, Cui Y, Giuliano AE. A Prospective Study of Sentinel Node Biopsy Omission in Women Age ≥ 65 Years with ER+ Breast Cancer. Ann Surg Oncol. 2024 May;31(5):3160-3167. doi: 10.1245/s10434-024-15000-w. Epub 2024 Feb 12. PMID: 38345718; PMCID: PMC10997698.

3. Castelo M, Sutradhar R, Faught N, Mata DGMM, Hahn E, Nguyen L, Paszat L, Rodin D, Trebinjac S, Fong C, Rakovitch E. The Association Between Surgical Axillary Staging, Adjuvant Treatment Use and Survival in Older Women with Early Stage Breast Cancer: A Population-Based Study. Ann Surg Oncol. 2023 Jul;30(7):3901-3912. doi: 10.1245/s10434-023-13274-0. Epub 2023 Mar 14. PMID: 36917335.

4. Castelo M, Hansen BE, Paszat L, Baxter NN, Scheer AS. Omission of Axillary Staging and Survival in Elderly Women With Early Stage Breast Cancer: A Population-Based Cohort Study. Ann Surg Open. 2022 Apr 25;3(2):e159. doi: 10.1097/AS9.0000000000000159. PMID: 37601604; PMCID: PMC10431311.

5. Wang T, Bredbeck BC, Sinco B, Shubeck S, Baskin AS, Skolarus T, Dossett LA. Variations in Persistent Use of Low-Value Breast Cancer Surgery. JAMA Surg. 2021 Apr 1;156(4):353-362. doi: 10.1001/jamasurg.2020.6942. PMID: 33533894; PMCID: PMC7859877..

Population-based and prospective

Systematic reviews and expert perspectives 

These articles synthesize the existing evidence or offer expert commentary on the changing role of lymph node testing. 

Articles - 

1.Li Q, Xu H, Bao B, Xie Y, Guo S, Gao Z, Chen S, Sun J, Zhu L, Wang J. Predicting sentinel lymph node metastasis in breast cancer: a study based on the SEER database. Clin Exp Med. 2025 Mar 13;25(1):82. doi: 10.1007/s10238-025-01591-5. PMID: 40080204; PMCID: PMC11906503.

2. Morrow M. Sentinel-Lymph-Node Biopsy in Early-Stage Breast Cancer - Is It Obsolete? N Engl J Med. 2025 Mar 13;392(11):1134-1136. doi: 10.1056/NEJMe2414899. Epub 2024 Dec 12. PMID: 39665673.

3. Kaviani A, Bourque JM, Farazmand B, Salmon RJ. Beyond the Trials: Real-World Considerations for Sentinel Lymph Node Biopsy Omission in Early Breast Cancer. J Clin Oncol. 2025 Dec;43(34):3636-3638. doi: 10.1200/JCO-25-01630. Epub 2025 Oct 13. PMID: 41082696.

4. Daly GR, Dowling GP, Said M, Qasem Y, Hembrecht S, Calpin GG, AlRawashdeh MM, Hill ADK. Impact of Sentinel Lymph Node Biopsy on Management of Older Women With Clinically Node-Negative, Early-Stage, ER+/HER2-, Invasive Breast Cancer: A Systematic Review and Meta-Analysis. Clin Breast Cancer. 2024 Dec;24(8):e681-e688.e1. doi: 10.1016/j.clbc.2024.07.012. Epub 2024 Aug 8. PMID: 39214843.

5. Liang S, Hallet J, Simpson JS, Tricco AC, Scheer AS. Omission of axillary staging in elderly patients with early stage breast cancer impacts regional control but not survival: A systematic review and meta-analysis. J Geriatr Oncol. 2017 Mar;8(2):140-147. doi: 10.1016/j.jgo.2016.12.003. Epub 2016 Dec 13. PMID: 27986500.

Systematic reviews and expert prespectives
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Radiation treatment

Radiation treatment (RT)

Omission of radiotherapy trials 

Articles - 

1.Kunkler IH, Williams LJ, Jack WJL, Cameron DA, Dixon JM. Breast-Conserving Surgery with or without Irradiation in Early Breast Cancer. N Engl J Med. 2023 Feb 16;388(7):585-594. doi: 10.1056/NEJMoa2207586. PMID: 36791159.

2. Blamey RW, Bates T, Chetty U, Duffy SW, Ellis IO, George D, Mallon E, Mitchell MJ, Monypenny I, Morgan DA, Macmillan RD, Patnick J, Pinder SE. Radiotherapy or tamoxifen after conserving surgery for breast cancers of excellent prognosis: British Association of Surgical Oncology (BASO) II trial. Eur J Cancer. 2013 Jul;49(10):2294-302. doi: 10.1016/j.ejca.2013.02.031. Epub 2013 Mar 21. PMID: 23523089.

3. Hughes KS, Schnaper LA, Bellon JR, Cirrincione CT, Berry DA, McCormick B, Muss HB, Smith BL, Hudis CA, Winer EP, Wood WC. 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 Jul 1;31(19):2382-7. doi: 10.1200/JCO.2012.45.2615. Epub 2013 May 20. PMID: 23690420; PMCID: PMC3691356.

4. Pötter R, Gnant M, Kwasny W, Tausch C, Handl-Zeller L, Pakisch B, Taucher S, Hammer J, Luschin-Ebengreuth G, Schmid M, Sedlmayer F, Stierer M, Reiner G, Kapp K, Hofbauer F, Rottenfusser A, Pöstlberger S, Haider K, Draxler W, Jakesz R; Austrian Breast and Colorectal Cancer Study Group. Lumpectomy plus tamoxifen or anastrozole with or without whole breast irradiation in women with favorable early breast cancer. Int J Radiat Oncol Biol Phys. 2007 Jun 1;68(2):334-40. doi: 10.1016/j.ijrobp.2006.12.045. Epub 2007 Mar 23. PMID: 17363187.

Omission of radiotherapy

Radiotherapy observational studies

Articles - 

1. Sperk E, Lemanski C, Neumaier C, Lauer J, Siefert V, Völker R, Lindner C, Niehoff P, Tallet AR, Racadot S, Petit A, Pazos M, Le-Blanc Onfroy M, Martin E, Reuter C, Hermann RM, Pohl F, Friedrichs K, Würschmidt F, Pigorsch S, Kolberg HC, Graf H, Brunner TB, Malter W, Park-Simon TW, Brucker C, Fleckenstein J, Petersen C, Tuschy B, Wilken EE, Büttner S, Sütterlin M, Flyger H, Wenz F. Intraoperative radiotherapy in elderly patients with breast cancer: long-term follow-up results of the prospective phase II trial TARGIT-E. BMC Cancer. 2025 Dec 4;25(1):1862. doi: 10.1186/s12885-025-15289-0. PMID: 41345599; PMCID: PMC12690916.

2. Karlsson P, Fyles A, Chang SL, Arrick B, Baehner FL, Malmström P, Fernö M, Holmberg E, Sjöström M, Liu FF, Cameron DA, Williams LJ, Bartlett JMS, Dunlop J, Caldwell J, Loane JF, Mallon E, Piper T, Kunkler I, Feng FY, Speers CW, Pierce LJ, Bennett JP, Taylor KJ. Validation of a breast cancer assay for radiotherapy omission: an individual participant data meta-analysis. J Natl Cancer Inst. 2025 Mar 1;117(3):486-495. doi: 10.1093/jnci/djae262. PMID: 39423142; PMCID: PMC11884857.

3. Palmér S, Valachis A, Lindman H, Smith DR, Wickberg Å, Killander F, Bjöhle J, Einbeigi Z, Nilsson G, Ahlgren J, Villman K. Omission of postoperative radiotherapy after breast-conserving surgery in low-risk breast cancer. J Natl Cancer Inst. 2025 Jun 1;117(6):1125-1133. doi: 10.1093/jnci/djae315. PMID: 39656805; PMCID: PMC12145905.

4. Jagsi R, Griffith KA, Harris EE, Wright JL, Recht A, Taghian AG, Lee L, Moran MS, Small W Jr, Johnstone C, Rahimi A, Freedman G, Muzaffar M, Haffty B, Horst K, Powell SN, Sharp J, Sabel M, Schott A, El-Tamer M. Omission of Radiotherapy After Breast-Conserving Surgery for Women With Breast Cancer With Low Clinical and Genomic Risk: 5-Year Outcomes of IDEA. J Clin Oncol. 2024 Feb 1;42(4):390-398. doi: 10.1200/JCO.23.02270. Epub 2023 Dec 7. PMID: 38060195; PMCID: PMC11846025.

5.Stafford L, Sinclair M, Butow P, Hughes J, Park A, Gilham L, Rose A, Mann GB. Quality of Life Outcomes Associated With Optimization of Treatment by Omitting Radiotherapy in Early Breast Cancer. Clin Breast Cancer. 2024 Jul;24(5):447-456.e2. doi: 10.1016/j.clbc.2024.03.002. Epub 2024 Mar 6. PMID: 38548516.

6. Stafford L, Sinclair M, Butow P, Hughes J, Park A, Gilham L, Rose A, Mann GB. Is de-escalation of treatment by omission of radiotherapy associated with fear of cancer recurrence in women with early breast cancer? An exploratory study. Breast Cancer Res Treat. 2023 Oct;201(3):367-376. doi: 10.1007/s10549-023-07039-2. Epub 2023 Jul 22. PMID: 37480383; PMCID: PMC10460737.

7. Wu N, Tan Q, Su X, Yuan Y, Hou L, Li J. Adjuvant radiation therapy for older women with early-stage breast cancer: a propensity-matched SEER analysis. Clin Transl Oncol. 2023 Feb;25(2):523-534. doi: 10.1007/s12094-022-02967-9. Epub 2022 Oct 13. PMID: 36227413; PMCID: PMC9873780.

8.Whelan TJ, Smith S, Parpia S, Fyles AW, Bane A, Liu FF, Rakovitch E, Chang L, Stevens C, Bowen J, Provencher S, Théberge V, Mulligan AM, Kos Z, Akra MA, Voduc KD, Hijal T, Dayes IS, Pond G, Wright JR, Nielsen TO, Levine MN; LUMINA Study Investigators. Omitting Radiotherapy after Breast-Conserving Surgery in Luminal A Breast Cancer. N Engl J Med. 2023 Aug 17;389(7):612-619. doi: 10.1056/NEJMoa2302344. PMID: 37585627.

9. Lui G, Hassett MJ, Tramontano AC, Uno H, Punglia RS. Regional Disparities in the Use and Delivery of Adjuvant Radiation Therapy after Lumpectomy for Breast Cancer in the Medicare Population. Adv Radiat Oncol. 2022 Jul 19;7(6):101017. doi: 10.1016/j.adro.2022.101017. PMID: 36420195; PMCID: PMC9677192.

10. Downs-Canner S, Zabor EC, Wind T, Cobovic A, McCormick B, Morrow M, Heerdt A. Radiation Therapy After Breast-Conserving Surgery in Women 70 Years of Age and Older: How Wisely Do We Choose? Ann Surg Oncol. 2019 Apr;26(4):969-975. doi: 10.1245/s10434-018-07151-4. Epub 2019 Feb 8. PMID: 30737670; PMCID: PMC6613396.

Observation or single arm trials

Accelerated and partial-breast irradiation (APBI/Hypofractionation)

Studies testing accelerated and partial breast irradiation

and other alternatives for radiation treatment.

Articles - 

1. Kim DH, Théberge V, Parpia S, Kong I, Provencher S, Yassa M, Perera F, Lavertu S, Rousseau P, Lee J, Karam I, Schneider K, Levine MN, Whelan TJ; OPAR Study Investigators. OPAR: A Randomized Trial of Partial Breast Irradiation in Five Fractions Once Daily for Early Breast Cancer. J Clin Oncol. 2025 Feb 10;43(5):505-512. doi: 10.1200/JCO.24.00600. Epub 2024 Oct 8. PMID: 39378393.

2. Meattini I, Marrazzo L, Saieva C, Desideri I, Scotti V, Simontacchi G, Bonomo P, Greto D, Mangoni M, Scoccianti S, Lucidi S, Paoletti L, Fambrini M, Bernini M, Sanchez L, Orzalesi L, Nori J, Bianchi S, Pallotta S, Livi L. Accelerated Partial-Breast Irradiation Compared With Whole-Breast Irradiation for Early Breast Cancer: Long-Term Results of the Randomized Phase III APBI-IMRT-Florence Trial. J Clin Oncol. 2020 Dec 10;38(35):4175-4183. doi: 10.1200/JCO.20.00650. Epub 2020 Aug 24. PMID: 32840419.

3.Murray Brunt A, Haviland JS, Wheatley DA, Sydenham MA, Alhasso A, Bloomfield DJ, Chan C, Churn M, Cleator S, Coles CE, Goodman A, Harnett A, Hopwood P, Kirby AM, Kirwan CC, Morris C, Nabi Z, Sawyer E, Somaiah N, Stones L, Syndikus I, Bliss JM, Yarnold JR; FAST-Forward Trial Management Group. Hypofractionated breast radiotherapy for 1 week versus 3 weeks (FAST-Forward): 5-year efficacy and late normal tissue effects results from a multicentre, non-inferiority, randomised, phase 3 trial. Lancet. 2020 May 23;395(10237):1613-1626. doi: 10.1016/S0140-6736(20)30932-6. Epub 2020 Apr 28. PMID: 32580883; PMCID: PMC7262592.

4. Whelan TJ, Julian JA, Berrang TS, Kim DH, Germain I, Nichol AM, Akra M, Lavertu S, Germain F, Fyles A, Trotter T, Perera FE, Balkwill S, Chafe S, McGowan T, Muanza T, Beckham WA, Chua BH, Gu CS, Levine MN, Olivotto IA; RAPID Trial Investigators. External beam accelerated partial breast irradiation versus whole breast irradiation after breast conserving surgery in women with ductal carcinoma in situ and node-negative breast cancer (RAPID): a randomised controlled trial. Lancet. 2019 Dec 14;394(10215):2165-2172. doi: 10.1016/S0140-6736(19)32515-2. Epub 2019 Dec 5. PMID: 31813635.

5. Coles CE, Griffin CL, Kirby AM, Titley J, Agrawal RK, Alhasso A, Bhattacharya IS, Brunt AM, Ciurlionis L, Chan C, Donovan EM, Emson MA, Harnett AN, Haviland JS, Hopwood P, Jefford ML, Kaggwa R, Sawyer EJ, Syndikus I, Tsang YM, Wheatley DA, Wilcox M, Yarnold JR, Bliss JM; IMPORT Trialists. Partial-breast radiotherapy after breast conservation surgery for patients with early breast cancer (UK IMPORT LOW trial): 5-year results from a multicentre, randomised, controlled, phase 3, non-inferiority trial. Lancet. 2017 Sep 9;390(10099):1048-1060. doi: 10.1016/S0140-6736(17)31145-5. Epub 2017 Aug 2. PMID: 28779963; PMCID: PMC5594247.

APBI / Hypofractionation
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Radiation versus endocrine therapy

Studies comparing radiation treatment alone vs. endocrine therapy alone after breast conserving surgery in older women with

hormone receptor-positive tumors early-stage breast cancers.

Radiation versus endocrine therapy

Articles - 

1. Joseph K, Ademola A, Zebak J, Singh A, Zuo H, Warkentin H, Abraham A, Gabos Z, Tankel K, Chafe S, King K. Adjuvant radiotherapy alone, an effective treatment option for early-stage low- risk breast cancer in women over 50: results from a population based cohort study using a Canadian provincial database. Radiother Oncol. 2025 Dec;213:111175. doi: 10.1016/j.radonc.2025.111175. Epub 2025 Sep 29. PMID: 41033355.

2.Meattini I, De Santis MC, Visani L, Scorsetti M, Fozza A, Meduri B, De Rose F, Bonzano E, Prisco A, Masiello V, La Rocca E, Spoto R, Becherini C, Blandino G, Moscetti L, Colciago RR, Audisio RA, Brain E, Caini S, Hamaker M, Kaidar-Person O, Lambertini M, Marrazzo L, Saieva C, Spanic T, Strnad V, Wheelwright S, Poortmans PMP, Livi L; EUROPA Trial Investigators. Single-modality endocrine therapy versus radiotherapy after breast-conserving surgery in women aged 70 years and older with luminal A-like early breast cancer (EUROPA): a preplanned interim analysis of a phase 3, non-inferiority, randomised trial. Lancet Oncol. 2025 Jan;26(1):37-50. doi: 10.1016/S1470-2045(24)00661-2. Epub 2024 Dec 12. PMID: 39675376.

3. Tringale KR, Berger ER, Sevilimedu V, Wen HY, Gillespie EF, Mueller BA, McCormick B, Xu AJ, Cuaron JJ, Cahlon O, Khan AJ, Powell SN, Morrow M, Heerdt AS, Braunstein LZ. Breast conservation among older patients with early-stage breast cancer: Locoregional recurrence following adjuvant radiation or hormonal therapy. Cancer. 2021 Jun 1;127(11):1749-1757. doi: 10.1002/cncr.33422. Epub 2021 Jan 26. PMID: 33496354; PMCID: PMC8113065.

4. Savard MF, Alzahrani MJ, Saunders D, Chang L, Arnaout A, Ng TL, Brackstone M, Vandermeer L, Hsu T, Awan AA, Cole K, Larocque G, Clemons M. Experiences and Perceptions of Older Adults with Lower-Risk Hormone Receptor-Positive Breast Cancer about Adjuvant Radiotherapy and Endocrine Therapy: A Patient Survey. Curr Oncol. 2021 Dec 8;28(6):5215-5226. doi: 10.3390/curroncol28060436. PMID: 34940075; PMCID: PMC8700141.

5. Taylor LJ, Steiman JS, Anderson B, Schumacher JR, Wilke LG, Greenberg CC, Neuman HB. Does persistent use of radiation in women > 70 years of age with early-stage breast cancer reflect tailored patient-centered care? Breast Cancer Res Treat. 2020 Apr;180(3):801-807. doi: 10.1007/s10549-020-05579-5. Epub 2020 Mar 3. PMID: 32125557; PMCID: PMC7474974.

6. Winzer KJ, Sauerbrei W, Braun M, Liersch T, Dunst J, Guski H, Schumacher M; German Breast Cancer Study Group (GBSG). Radiation therapy and tamoxifen after breast-conserving surgery: updated results of a 2 x 2 randomised clinical trial in patients with low risk of recurrence. Eur J Cancer. 2010 Jan;46(1):95-101. doi: 10.1016/j.ejca.2009.10.007. PMID: 19879131.

7. Fisher B, Bryant J, Dignam JJ, Wickerham DL, Mamounas EP, Fisher ER, Margolese RG, Nesbitt L, Paik S, Pisansky TM, Wolmark N; National Surgical Adjuvant Breast and Bowel Project. Tamoxifen, radiation therapy, or both for prevention of ipsilateral breast tumor recurrence after lumpectomy in women with invasive breast cancers of one centimeter or less. J Clin Oncol. 2002 Oct 15;20(20):4141-9. doi: 10.1200/JCO.2002.11.101. PMID: 12377957.

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Endocrine therapy

The experience and outcomes of endocrine therapy among older women with hormone-receptor positive early-stage breast cancer. 

Endocrine therapy
Primary endocrine therapy (PET)
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Primary endocrine therapy (PET)

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Systematic reviews and studies that compare Primary Endocrine

Therapy (PET) with primary surgery or surgery plus endocrine therapy.  

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Abstract Blue Waves

SDM POSSIBBLE 

SDMPOSSIBLE@bidmc.harvard.edu

617-754-1458

© 2025 by Beth Israel Deaconess Medical Center (BIDMC)

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