Clinical Trials That Have Informed the Modern Management of Breast Cancer

Fisher B. Jeong J.H. Anderson S. et al.

Twenty-Five-Year Follow-up of a Randomized Trial Comparing Radical Mastectomy, Total Mastectomy, and Total Mastectomy Followed by Irradiation.

N Engl J Med. 347: 567-575

Long-term follow-up of the first breast conservation trial: Guy’ wide excision study.

Breast Edinb Scotl. 9: 5-8

Randomized Controlled Trials in Surgical Oncology.

Surg Oncol Clin N Am. 21: 449-466

The Radium Treatment of Primary Carcinoma of the Breast ∗Read 25th November 1930.

Edinb Med J. 38: T19-T36Veronesi U. Saccozzi R. Del Vecchio M. et al.

Comparing Radical Mastectomy with Quadrantectomy, Axillary Dissection, and Radiotherapy in Patients with Small Cancers of the Breast.

N Engl J Med. 305: 6-11Veronesi U. Cascinelli N. Mariani L. et al.

Twenty-Year Follow-up of a Randomized Study Comparing Breast-Conserving Surgery with Radical Mastectomy for Early Breast Cancer.

N Engl J Med. 347: 1227-1232

Review of Breast Cancer Clinical Trials Conducted by the National Surgical Adjuvant Breast Project - ClinicalKey.

() ()Sarrazin D. Lê M.G. Arriagada R. et al.

Ten-year results of a randomized trial comparing a conservative treatment to mastectomy in early breast cancer.

Radiother Oncol J Eur Soc Ther Radiol Oncol. 14: 177-184Fisher B. Anderson S. Bryant J. et al.

Twenty-Year Follow-up of a Randomized Trial Comparing Total Mastectomy, Lumpectomy, and Lumpectomy plus Irradiation for the Treatment of Invasive Breast Cancer.

N Engl J Med. 347: 1233-1241Fisher B. Anderson S. Redmond C.K. et al.

Reanalysis and Results after 12 Years of Follow-up in a Randomized Clinical Trial Comparing Total Mastectomy with Lumpectomy with or without Irradiation in the Treatment of Breast Cancer.

N Engl J Med. 333: 1456-1461Litière S. Werutsky G. Fentiman I.S. et al.

Breast conserving therapy versus mastectomy for stage I-II breast cancer: 20 year follow-up of the EORTC 10801 phase 3 randomised trial.

Lancet Oncol. 13: 412-419Jacobson J.A. Danforth D.N. Cowan K.H. et al.

Ten-year results of a comparison of conservation with mastectomy in the treatment of stage I and II breast cancer.

N Engl J Med. 332: 907-911Poggi M.M. Danforth D.N. Sciuto L.C. et al.

Eighteen-year results in the treatment of early breast carcinoma with mastectomy versus breast conservation therapy: the National Cancer Institute Randomized Trial.

Cancer. 98: 697-702Blichert-Toft M. Rose C. Andersen J.A. et al.

Danish randomized trial comparing breast conservation therapy with mastectomy: six years of life-table analysis. Danish Breast Cancer Cooperative Group.

J Natl Cancer Inst Monogr. 11: 19-25

Effects of Radiotherapy and Surgery in Early Breast Cancer — An Overview of the Randomized Trials | NEJM.

() ()Liljegren G. Holmberg L. Bergh J. et al.

10-Year results after sector resection with or without postoperative radiotherapy for stage I breast cancer: a randomized trial.

J Clin Oncol. 17: 2326-2333Clark R.M. McCulloch P.B. Levine M.N. et al.

Randomized clinical trial to assess the effectiveness of breast irradiation following lumpectomy and axillary dissection for node-negative breast cancer.

J Natl Cancer Inst. 84: 683-689Clark R.M. Whelan T. Levine M. et al.

Randomized Clinical Trial of Breast Irradiation Following Lumpectomy and Axillary Dissection for Node-Negative Breast Cancer: an Update.

JNCI J Natl Cancer Inst. 88: 1659-1664Veronesi U. Marubini E. Mariani L. et al.

Radiotherapy after breast-conserving surgery in small breast carcinoma: long-term results of a randomized trial.

Ann Oncol. 12: 997-1003Hughes K.S. Schnaper L.A. Berry D. et al.

Lumpectomy plus Tamoxifen with or without Irradiation in Women 70 Years of Age or Older with Early Breast Cancer.

N Engl J Med. 351: 971-977Hughes K.S. Schnaper L.A. Bellon J.R. 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. 31: 2382-2387Kunkler I.H. Williams L.J. Jack W.J.L. et al.

PRIME II investigators. Breast-conserving surgery with or without irradiation in women aged 65 years or older with early breast cancer (PRIME II): a randomised controlled trial.

Lancet Oncol. 16: 266-273Fisher B. Costantino J. Redmond C. et al.

Lumpectomy Compared with Lumpectomy and Radiation Therapy for the Treatment of Intraductal Breast Cancer.

N Engl J Med. 328: 1581-1586Fisher B. Dignam J. Wolmark N. et al.

Tamoxifen in treatment of intraductal breast cancer: National Surgical Adjuvant Breast and Bowel Project B-24 randomised controlled trial.

Lancet Lond Engl. 353: 1993-2000Fisher B. Bryant J. Dignam J.J. et al.

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. 20: 4141-4149Moran M.S. Schnitt S.J. Giuliano A.E. et al.

SSO-ASTRO Consensus Guideline on Margins for Breast-Conserving Surgery with Whole Breast Irradiation in Stage I and II Invasive Breast Cancer.

Int J Radiat Oncol Biol Phys. 88: 553-564

Guidelines Detail. NCCN.

() ()Houssami N. Macaskill P. Luke Marinovich M. et al.

The Association of Surgical Margins and Local Recurrence in Women with Early-Stage Invasive Breast Cancer Treated with Breast-Conserving Therapy: A Meta-Analysis.

Ann Surg Oncol. 21: 717-730Morrow M. Van Zee K.J. Solin L.J. et al.

Society of Surgical Oncology-American Society for Radiation Oncology-American Society of Clinical Oncology Consensus Guideline on Margins for Breast-Conserving Surgery With Whole-Breast Irradiation in Ductal Carcinoma In Situ.

J Clin Oncol. 34: 4040-4046Wapnir I.L. Dignam J.J. Fisher B. et al.

Long-term outcomes of invasive ipsilateral breast tumor recurrences after lumpectomy in NSABP B-17 and B-24 randomized clinical trials for DCIS.

J Natl Cancer Inst. 103: 478-488Houghton J. George W.D. Cuzick J. et al.

Radiotherapy and tamoxifen in women with completely excised ductal carcinoma in situ of the breast in the UK, Australia, and New Zealand: randomised controlled trial.

Lancet Lond Engl. 362: 95-102Julien J.P. Bijker N. Fentiman I.S. et al.

Radiotherapy in breast-conserving treatment for ductal carcinoma in situ: first results of the EORTC randomised phase III trial 10853. EORTC Breast Cancer Cooperative Group and EORTC Radiotherapy Group.

Lancet Lond Engl. 355: 528-533Emdin S.O. Granstrand B. Ringberg A. et al.

SweDCIS: Radiotherapy after sector resection for ductal carcinoma in situ of the breast. Results of a randomised trial in a population offered mammography screening.

Acta Oncol Stockh Swed. 45: 536-543Krag D.N. Anderson S.J. Julian T.B. et al.

Technical outcomes of sentinel-lymph-node resection and conventional axillary-lymph-node dissection in patients with clinically node-negative breast cancer: results from the NSABP B-32 randomised phase III trial.

Lancet Oncol. 8: 881-888Krag D.N. Anderson S.J. Julian T.B. et al.

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. 11: 927-933Zavagno G. De Salvo G.L. Scalco G. et al.

A Randomized clinical trial on sentinel lymph node biopsy versus axillary lymph node dissection in breast cancer: results of the Sentinella/GIVOM trial.

Ann Surg. 247: 207-213Veronesi U. Paganelli G. Viale G. et al.

Sentinel-lymph-node biopsy as a staging procedure in breast cancer: update of a randomised controlled study.

Lancet Oncol. 7: 983-990Veronesi U. Viale G. Paganelli G. et al.

Sentinel lymph node biopsy in breast cancer: ten-year results of a randomized controlled study.

Ann Surg. 251: 595-600Canavese G. Catturich A. Vecchio C. et al.

Sentinel node biopsy compared with complete axillary dissection for staging early breast cancer with clinically negative lymph nodes: results of randomized trial.

Ann Oncol. 20: 1001-1007Wilke L.G. McCall L.M. Posther K.E. et al.

Surgical complications associated with sentinel lymph node biopsy: results from a prospective international cooperative group trial.

Ann Surg Oncol. 13: 491-500Galimberti V. Cole B.F. Zurrida S. et al.

Axillary dissection versus no axillary dissection in patients with sentinel-node micrometastases (IBCSG 23-01): A phase 3 randomised controlled trial.

Lancet Oncol. 14: 297-305Giuliano A.E. Hunt K.K. Ballman K.V. et al.

Axillary Dissection vs No Axillary Dissection in Women With Invasive Breast Cancer and Sentinel Node Metastasis: A Randomized Clinical Trial.

JAMA. 305: 569-575Giuliano A.E. Ballman K.V. McCall L. 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. 318: 918-926Donker M. van Tienhoven G. Straver M.E. 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. 15: 1303-1310Sávolt Á. Péley G. Polgár C. et al.

Eight-year follow up result of the OTOASOR trial: The Optimal Treatment Of the Axilla - Surgery Or Radiotherapy after positive sentinel lymph node biopsy in early-stage breast cancer: A randomized, single centre, phase III, non-inferiority trial.

Eur J Surg Oncol. 43: 672-679Whelan T.J. Olivotto I.A. Parulekar W.R. et al.

Regional Nodal Irradiation in Early-Stage Breast Cancer.

N Engl J Med. 373: 307-316Katz M.S. McCall L. Ballman K. et al.

Nomogram-based estimate of axillary nodal involvement in ACOSOG Z0011 (Alliance): validation and association with radiation protocol variations.

Breast Cancer Res Treat. 180: 429-436Boughey J.C. Suman V.J. Mittendorf E.A. et al.

Sentinel lymph node surgery after neoadjuvant chemotherapy in patients with node-positive breast cancer: the ACOSOG Z1071 (Alliance) clinical trial.

JAMA. 310: 1455-1461Caudle A.S. Yang W.T. Krishnamurthy S. et al.

Improved Axillary Evaluation Following Neoadjuvant Therapy for Patients With Node-Positive Breast Cancer Using Selective Evaluation of Clipped Nodes: Implementation of Targeted Axillary Dissection.

J Clin Oncol. 34: 1072-1078Kuehn T. Bauerfeind I. Fehm T. et al.

Sentinel-lymph-node biopsy in patients with breast cancer before and after neoadjuvant chemotherapy (SENTINA): a prospective, multicentre cohort study.

Lancet Oncol. 14: 609-618Boileau J.F. Poirier B. Basik M. et al.

Sentinel Node Biopsy After Neoadjuvant Chemotherapy in Biopsy-Proven Node-Positive Breast Cancer: The SN FNAC Study.

J Clin Oncol. 33: 258-264Classe J.M. Loaec C. Gimbergues P. et al.

Sentinel lymph node biopsy without axillary lymphadenectomy after neoadjuvant chemotherapy is accurate and safe for selected patients: the GANEA 2 study.

Breast Cancer Res Treat. 173: 343-352Boughey J.C. Ballman K.V. McCall L.M. et al.

Tumor Biology and Response to Chemotherapy Impact Breast Cancer-Specific Survival in Node-Positive Breast Cancer Patients Treated with Neoadjuvant Chemotherapy: Long-term Follow-up from ACOSOG Z1071 (Alliance).

Ann Surg. 266: 667-676Samiei S. Simons J.M. Engelen S.M.E. 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. 156: e210891de Boniface J. Frisell J. Andersson Y. et al.

Survival and axillary recurrence following sentinel node-positive breast cancer without completion axillary lymph node dissection: the randomized controlled SENOMAC trial.

BMC Cancer. 17: 379

Alliance for Clinical Trials in Oncology. A Randomized Phase III Trial Comparing Axillary Lymph Node Dissection to Axillary Radiation in Breast Cancer Patients (CT1-3 N1) Who Have Positive Sentinel Lymph Node Disease After Neoadjuvant Chemotherapy. clinicaltrials.gov; 2022.

() ()Fisher B. Ravdin R.G. Ausman R.K. et al.

Surgical adjuvant chemotherapy in cancer of the breast: results of a decade of cooperative investigation.

Ann Surg. 168: 337-356Bonadonna G. Valagussa P. Moliterni A. et al.

Adjuvant cyclophosphamide, methotrexate, and fluorouracil in node-positive breast cancer: the results of 20 years of follow-up.

N Engl J Med. 332: 901-906Fisher B. Dignam J. Mamounas E.P. et al.

Sequential methotrexate and fluorouracil for the treatment of node-negative breast cancer patients with estrogen receptor-negative tumors: eight-year results from National Surgical Adjuvant Breast and Bowel Project (NSABP) B-13 and first report of findings from NSABP B-19 comparing methotrexate and fluorouracil with conventional cyclophosphamide, methotrexate, and fluorouracil.

J Clin Oncol. 14: 1982-1992Early 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 Lond Engl. 393: 1440-1452Anampa J. Makower D. Sparano J.A.

Progress in adjuvant chemotherapy for breast cancer: an overview.

BMC Med. 13: 195Perez E.A. Romond E.H. Suman V.J. 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. 32: 3744-3752Romond E.H. Perez E.A. Bryant J. et al.

Trastuzumab plus Adjuvant Chemotherapy for Operable HER2-Positive Breast Cancer.

N Engl J Med. 353: 1673-1684Cameron D. Piccart-Gebhart M.J. Gelber R.D. 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 Lond Engl. 389: 1195-1205von Minckwitz G. Procter M. de Azambuja E. et al.

Adjuvant Pertuzumab and Trastuzumab in Early HER2-Positive Breast Cancer.

N Engl J Med. 377: 122-131Hurvitz S.A. Gelmon K.A. Tolaney S.M.

Optimal Management of Early and Advanced HER2 Breast Cancer.

Am Soc Clin Oncol Educ Book Am Soc Clin Oncol Annu Meet. 37: 76-92Fisher B. Bryant J. Wolmark N. et al.

Effect of preoperative chemotherapy on the outcome of women with operable breast cancer.

J Clin Oncol. 16: 2672-2685Rastogi P. Anderson S.J. Bear H.D. et al.

Preoperative chemotherapy: updates of National Surgical Adjuvant Breast and Bowel Project Protocols B-18 and B-27.

J Clin Oncol. 26: 778-785Mamounas E.P. Anderson S.J. Dignam J.J. et al.

Predictors of Locoregional Recurrence After Neoadjuvant Chemotherapy: Results From Combined Analysis of National Surgical Adjuvant Breast and Bowel Project B-18 and B-27.

J Clin Oncol. 30: 3960-3966Gianni L. Pienkowski T. Im Y.H. et al.

5-year analysis of neoadjuvant pertuzumab and trastuzumab in patients with locally advanced, inflammatory, or early-stage HER2-positive breast cancer (NeoSphere): a multicentre, open-label, phase 2 randomised trial.

Lancet Oncol. 17: 791-800Schneeweiss A. Chia S. Hickish T. et al.

Long-term efficacy analysis of the randomised, phase II TRYPHAENA cardiac safety study: Evaluating pertuzumab and trastuzumab plus standard neoadjuvant anthracycline-containing and anthracycline-free chemotherapy regimens in patients with HER2-positive early breast cancer.

Eur J Cancer Oxf Engl 1990. 89: 27-35Leon-Ferre R.A. Hieken T.J. Boughey J.C.

The Landmark Series: Neoadjuvant Chemotherapy for Triple-Negative and HER2-Positive Breast Cancer.

Ann Surg Oncol. 28: 2111-2119Schmid P. Cortes J. Pusztai L. et al.

Pembrolizumab for Early Triple-Negative Breast Cancer.

N Engl J Med. 382: 810-821

An Update on Randomized Clinical Trials in Breast Cancer.

Surg Oncol Clin N Am. 26: 587-620Rugo H.S. Olopade O.I. DeMichele A. et al.

Adaptive Randomization of Veliparib–Carboplatin Treatment in Breast Cancer.

N Engl J Med. https://doi.org/10.1056/NEJMoa1513749Masuda N. Lee S.J. Ohtani S. et al.

Adjuvant Capecitabine for Breast Cancer after Preoperative Chemotherapy.

N Engl J Med. 376: 2147-2159

M.D. Anderson Cancer Center. Multicenter Trial for Eliminating Breast Cancer Surgery or Radiotherapy in Exceptional Responders to Neoadjuvant Systemic Therapy. clinicaltrials.gov; 2021.

() ()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 Lond Engl. 365: 1687-1717Fisher B. Dignam J. Bryant J. et al.

Five versus more than five years of tamoxifen therapy for breast cancer patients with negative lymph nodes and estrogen receptor-positive tumors.

J Natl Cancer Inst. 88: 1529-1542Fisher B. Dignam J. Emir B. et al.

Tamoxifen and Chemotherapy for Lymph Node-Negative, Estrogen Receptor-Positive Breast Cancer.

JNCI J Natl Cancer Inst. 89: 1673-1682Mouridsen H. Gershanovich M. Sun Y. et al.

Phase III study of letrozole versus tamoxifen as first-line therapy of advanced breast cancer in postmenopausal women: analysis of survival and update of efficacy from the International Letrozole Breast Cancer Group.

J Clin Oncol. 21: 2101-2109Mouridsen H. Gershanovich M. Sun Y. et al.

Superior efficacy of letrozole versus tamoxifen as first-line therapy for postmenopausal women with advanced breast cancer: results of a phase III study of the International Letrozole Breast Cancer Group.

J Clin Oncol. 19: 2596-2606Goss P.E. Ingle J.N. Martino S. et al.

Randomized trial of letrozole following tamoxifen as extended adjuvant therapy in receptor-positive breast cancer: updated findings from NCIC CTG MA.17.

J Natl Cancer Inst. 97: 1262-1271Burstein H.J. Lacchetti C. Anderson H. et al.

Adjuvant Endocrine Therapy for Women With Hormone Receptor-Positive Breast Cancer: ASCO Clinical Practice Guideline Focused Update.

J Clin Oncol. 37: 423-438Burstein H.J. Lacchetti C. Anderson H. et al.

Adjuvant Endocrine Therapy for Women With Hormone Receptor-Positive Breast Cancer: American Society of Clinical Oncology Clinical Practice Guideline Update on Ovarian Suppression.

J Clin Oncol. 34: 1689-1701Ellis M.J. Suman V.J. Hoog J. 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. 29: 2342-2349Sparano J.A. Gray R.J. Makower D.F. et al.

Adjuvant Chemotherapy Guided by a 21-Gene Expression Assay in Breast Cancer.

N Engl J Med. 379: 111-121

Postmenopausal Women with HR+/HER2– Early Breast Cancer, 1–3 Positive Nodes, and a Low Risk of Recurrence Can Safely Forego Chemotherapy.

Oncologist. 26: S11-S12Kalinsky K. Barlow W.E. Gralow J.R. et al.

21-Gene Assay to Inform Chemotherapy Benefit in Node-Positive Breast Cancer.

N Engl J Med. 385: 2336-2347Cardoso F. van’t Veer L.J. Bogaerts J. et al.

70-Gene Signature as an Aid to Treatment Decisions in Early-Stage Breast Cancer.

N Engl J Med. 375: 717-729Piccart M. van ’t Veer L.J. Poncet C. 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. 22: 476-488

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