Clinical Trials in Breast Cancer

The Results of Operations for the Cure of Cancer of the Breast Performed at the Johns Hopkins Hospital from June, 1889, to January, 1894.

Ann Surg. 20: 497-555

Results of Operations at the Johns Hopkins Hospital for Cancer of the Breast: Performed at the Johns Hopkins Hospital from 1889 to 1931.

Ann Surg. 95: 336-400Fisher B. Redmond C. Fisher E.R.

The contribution of recent NSABP clinical trials of primary breast cancer therapy to an understanding of tumor biology--an overview of findings.

Cancer. 46: 1009-1025

Transmigration of lymph nodes by tumor cells.

Science. 152: 1397-1398

Experimental evidence in support of the dormant tumor cell.

Science. 130: 918-919

The interrelationship of hematogenous and lymphatic tumor cell dissemination.

Surg Gynecol Obstet. 122: 791-798Fisher B. Montague E. Redmond C. et al.

Comparison of radical mastectomy with alternative treatments for primary breast cancer. A first report of results from a prospective randomized clinical trial.

Cancer. 39: 2827-2839Fisher B. Redmond C. Fisher E.R. et al.

Ten-year results of a randomized clinical trial comparing radical mastectomy and total mastectomy with or without radiation.

N Engl J Med. 312: 674-681Fisher 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: 567-575Fisher 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. 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: 1581-1586National Comprehensive Cancer Network

Clinical Practice Guidelines in Oncology: Breast Cancer (version 4.2022).

Litière 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: 412-419van Maaren M.C. de Munck L. de Bock G.H. et al.

10 year survival after breast-conserving surgery plus radiotherapy compared with mastectomy in early breast cancer in the Netherlands: a population-based study.

Lancet Oncol. 17: 1158-1170Hartmann-Johnsen O.J. Kåresen R. Schlichting E. et al.

Survival is Better After Breast Conserving Therapy than Mastectomy for Early Stage Breast Cancer: A Registry-Based Follow-up Study of Norwegian Women Primary Operated Between 1998 and 2008.

Ann Surg Oncol. 22: 3836-3845Veronesi 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: 1227-1232Fortin A. Larochelle M. Laverdière J. et al.

Local failure is responsible for the decrease in survival for patients with breast cancer treated with conservative surgery and postoperative radiotherapy.

J Clin Oncol. 17: 101-109Darby S. McGale P. Correa C. et al.

Effect of radiotherapy after breast-conserving surgery on 10-year recurrence and 15-year breast cancer death: meta-analysis of individual patient data for 10,801 women in 17 randomised trials.

Lancet. 378: 1707-1716Poortmans P.M.P. Arenas M. Livi L.

Over-irradiation.

Breast. 31: 295-302Mittendorf E.A. Buchholz T.A. Tucker S.L. et al.

Impact of chemotherapy sequencing on local-regional failure risk in breast cancer patients undergoing breast-conserving therapy.

Ann Surg. 257: 173-179McCormick B. Winter K. Hudis C. et al.

RTOG 9804: a prospective randomized trial for good-risk ductal carcinoma in situ comparing radiotherapy with observation.

J Clin Oncol Mar. 33: 709-715Erbas B. Provenzano E. Armes J. et al.

The natural history of ductal carcinoma in situ of the breast: a review.

Breast Cancer Res Treat. 97: 135-144Hwang E.S. Hyslop T. Lynch T. et al.

The COMET (Comparison of Operative versus Monitoring and Endocrine Therapy) trial: a phase III randomised controlled clinical trial for low-risk ductal carcinoma in situ (DCIS).

BMJ Open. 9: e026797Francis A. Thomas J. Fallowfield L. et al.

Addressing overtreatment of screen detected DCIS; the LORIS trial.

Eur J Cancer. 51: 2296-2303Elshof L.E. Tryfonidis K. Slaets L. et al.

Feasibility of a prospective, randomised, open-label, international multicentre, phase III, non-inferiority trial to assess the safety of active surveillance for low risk ductal carcinoma in situ - The LORD study.

Eur J Cancer. 51: 1497-1510Kanbayashi C. Thompson A.M. Hwang E.-S.S. et al.

The international collaboration of active surveillance trials for low-risk DCIS (LORIS, LORD, COMET, LORETTA).

J Clin Oncol. 37: TPS603Fleissig A. Fallowfield L.J. Langridge C.I. et al.

Post-operative arm morbidity and quality of life. Results of the ALMANAC randomised trial comparing sentinel node biopsy with standard axillary treatment in the management of patients with early breast cancer.

Breast Cancer Res Treat. 95: 279-293Lucci A. McCall L.M. Beitsch P.D. et al.

Surgical complications associated with sentinel lymph node dissection (SLND) plus axillary lymph node dissection compared with SLND alone in the American College of Surgeons Oncology Group Trial Z0011.

J Clin Oncol. 25: 3657-3663Krag 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: 927-933Giuliano A.E. McCall L. Beitsch P. et al.

Locoregional recurrence after sentinel lymph node dissection with or without axillary dissection in patients with sentinel lymph node metastases: the American College of Surgeons Oncology Group Z0011 randomized trial.

Ann Surg Sep. 252 (): 426-432Giuliano 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. McCall L. et al.

Locoregional Recurrence After Sentinel Lymph Node Dissection With or Without Axillary Dissection in Patients With Sentinel Lymph Node Metastases: Long-term Follow-up From the American College of Surgeons Oncology Group (Alliance) ACOSOG Z0011 Randomized Trial.

Ann Surg Sep. 264: 413-420Galimberti 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: 297-305Donker 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: 1303-1310Weiss A. Mittendorf E.A. DeSnyder S.M. et al.

Expanding Implementation of ACOSOG Z0011 in Surgeon Practice.

Clin Breast Cancer. 18: 276-281Tseng J. Alban R.F. Siegel E. et al.

Changes in utilization of axillary dissection in women with invasive breast cancer and sentinel node metastasis after the ACOSOG Z0011 trial.

Breast J. 27: 216-221

Five Things Physicians and Patients Should Question 2016.

Hughes 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: 2382-2387Blair S.L. Tsai C. Tafra L.

ASBRS Great Debate: Sentinel Node Biopsy in Patients Over 70 Years of Age.

Ann Surg Oncol. 25: 2813-2817Boughey 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: 1455-1461Kuehn 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: 609-618Fisher C.S. Margenthaler J.A. Hunt K.K. et al.

The Landmark Series: Axillary Management in Breast Cancer.

Ann Surg Oncol Mar. 27: 724-729

NCT01901094: Comparison of axillary lymph node dissection with axillary radiation for patients with node-positive breast cancer treated with chemotherapy.

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NCT01872975: Standard or comprehensive radiation therapy in treating patients with early-stage breast cancer previously treated with chemotherapy and surgery.

Joshi S.C. Khan F.A. Pant I. et al.

Role of radiotherapy in early breast cancer: an overview.

Int J Health Sci (Qassim). 1: 259-264Overgaard M. Hansen P.S. Overgaard J. et al.

Postoperative radiotherapy in high-risk premenopausal women with breast cancer who receive adjuvant chemotherapy. Danish Breast Cancer Cooperative Group 82b Trial.

N Engl J Med. 337: 949-955Overgaard M. Jensen M.B. Overgaard J. et al.

Postoperative radiotherapy in high-risk postmenopausal breast-cancer patients given adjuvant tamoxifen: Danish Breast Cancer Cooperative Group DBCG 82c randomised trial.

Lancet. 353: 1641-1648Hughes 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: 971-977Kunkler I.H. Williams L.J. Jack W.J. et al.

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 Mar. 16: 266-273Gradishar W.J. Moran M.S. Abraham J. et al.

NCCN Guidelines® Insights: Breast Cancer, Version 4.2021: Featured Updates to the NCCN Guidelines.

J Natl Compr Cancer Netw. 19: 484-493Njeh C.F. Saunders M.W. Langton C.M.

Accelerated Partial Breast Irradiation (APBI): A review of available techniques.

Radiat Oncol. 5: 90Legorreta A.P. Liu X. Parker R.G.

Examining the use of breast-conserving treatment for women with breast cancer in a managed care environment.

Am J Clin Oncol. 23: 438-441Whelan T.J. Pignol J.-P. Levine M.N. et al.

Long-Term Results of Hypofractionated Radiation Therapy for Breast Cancer.

N Engl J Med. 362: 513-520Bentzen S.M. Agrawal R.K. Aird E.G. et al.

The UK Standardisation of Breast Radiotherapy (START) Trial B of radiotherapy hypofractionation for treatment of early breast cancer: a randomised trial.

Lancet Mar. 371: 1098-1107Bentzen S.M. Agrawal R.K. Aird E.G. et al.

The UK Standardisation of Breast Radiotherapy (START) Trial A of radiotherapy hypofractionation for treatment of early breast cancer: a randomised trial.

Lancet Oncol. 9: 331-341Tann A.W. Hatch S.S. Joyner M.M. et al.

Accelerated partial breast irradiation: Past, present, and future.

World J Clin Oncol. 7: 370-379Vicini F.A. Cecchini R.S. White J.R. et al.

Long-term primary results of accelerated partial breast irradiation after breast-conserving surgery for early-stage breast cancer: a randomised, phase 3, equivalence trial.

Lancet. 394: 2155-2164Vaidya J.S. Bulsara M. Baum M. et al.

Long term survival and local control outcomes from single dose targeted intraoperative radiotherapy during lumpectomy (TARGIT-IORT) for early breast cancer: TARGIT-A randomised clinical trial.

BMJ. 370: m2836Orecchia R. Veronesi U. Maisonneuve P. et al.

Intraoperative irradiation for early breast cancer (ELIOT): long-term recurrence and survival outcomes from a single-centre, randomised, phase 3 equivalence trial.

Lancet Oncol. 22: 597-608

Chemotherapy for early-stage breast cancer: a brief history.

Br J Cancer Sep. 101: S2-S5Hensing W. Santa-Maria C.A. Peterson L.L. et al.

Landmark trials in the medical oncology management of early stage breast cancer.

Semin Oncol. 47: 278-292Paik S. Tang G. Shak S. et al.

Gene Expression and Benefit of Chemotherapy in Women With Node-Negative, Estrogen Receptor–Positive Breast Cancer.

J Clin Oncol. 24: 3726-3734Sparano 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: 111-121Cardoso 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: 717-729Kalinsky 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: 2336-2347Xin L. Liu Y.H. Martin T.A. et al.

The Era of Multigene Panels Comes? The Clinical Utility of Oncotype DX and MammaPrint.

World J Oncol. 8: 34-40Bradley R. Braybrooke J. Gray R. et al.

Trastuzumab for early-stage, HER2-positive breast cancer: a meta-analysis of 13 864 women in seven randomised trials.

Lancet Oncol. 22: 1139-1150Krop I. Ismaila N. Andre F. et al.

Use of Biomarkers to Guide Decisions on Adjuvant Systemic Therapy for Women With Early-Stage Invasive Breast Cancer: American Society of Clinical Oncology Clinical Practice Guideline Focused Update.

J Clin Oncol. 35: 2838-2847Perez E.A. Romond E.H. Suman V.J. et al.

Four-year follow-up of trastuzumab plus adjuvant chemotherapy for operable human epidermal growth factor receptor 2-positive breast cancer: joint analysis of data from NCCTG N9831 and NSABP B-31.

J Clin Oncol. 29: 3366-3373Modi S. Ohtani S. Lee C. et al.

Abstract OT1-07-02: A phase 3, multicenter, randomized, open-label trial of [fam-] trastuzumab deruxtecan (T-DXd; DS-8201a) vs investigator’s choice in HER2-low breast cancer (DESTINY-Breast04).

Cancer Res. 80: OT1-07-02Fisher B. Brown A. Mamounas E. et al.

Effect of preoperative chemotherapy on local-regional disease in women with operable breast cancer: findings from National Surgical Adjuvant Breast and Bowel Project B-18.

J Clin Oncol. 15: 2483-2493

Landscape of neoadjuvant therapy for breast cancer.

Ann Surg Oncol. 22: 1408-1415JAvd Hage Velde CJHvd Julien J.-P. et al.

Preoperative Chemotherapy in Primary Operable Breast Cancer: Results From the European Organization for Research and Treatment of Cancer Trial 10902.

J Clin Oncol. 19: 4224-4237Wahba H.A. El-Hadaad H.A.

Current approaches in treatment of triple-negative breast cancer.

Cancer Biol Med. 12: 106-116Masuda N. Lee S.-J. Ohtani S. et al.

Adjuvant capecitabine for breast cancer after preoperative chemotherapy.

N Engl J Med. 376: 2147-2159Schmid P. Cortes J. Pusztai L. et al.

Pembrolizumab for early triple-negative breast cancer.

N Engl J Med. 382: 810-821

Clinical review on the management of hormone receptor–positive metastatic breast cancer.

JCO Oncol Pract. 21: 00384Chang Y.-C. Cheung C.H.A. Kuo Y.-L.

Tamoxifen Rechallenge Decreases Metastatic Potential but Increases Cell Viability and Clonogenicity in a Tamoxifen-Mediated Cytotoxicity-Resistant Subline of Human Breast MCF7 Cancer Cells. Original Research.

Frontiers in cell and developmental biology. 8https://doi.org/10.3389/fcell.2020.00485

Controlled trial of tamoxifen as adjuvant agent in management of early breast cancer: interim analysis at four years by nolvadex adjuvant trial organisation.

Lancet. 321: 257-261

Landmark trials in endocrine adjuvant therapy for breast carcinoma.

Cancer. 106: 975-981

Tamoxifen for early breast cancer: an overview of the randomised trials. Early Breast Cancer Trialists' Collaborative Group.

Lancet. 351: 1451-1467Lorizio W. Wu A.H. Beattie M.S. et al.

Clinical and biomarker predictors of side effects from tamoxifen.

Breast Cancer Res Treat. 132: 1107-1118Chumsri S. Howes T. Bao T. et al.

Aromatase, aromatase inhibitors, and breast cancer.

J Steroid Biochem Mol Biol. 125: 13-22Baum M. Budzar A.U. Cuzick J. et al.

Anastrozole alone or in combination with tamoxifen versus tamoxifen alone for adjuvant treatment of postmenopausal women with early breast cancer: first results of the ATAC randomised trial.

Lancet. 359: 2131-2139Sella T. Weiss A. Mittendorf E.A. et al.

Neoadjuvant Endocrine Therapy in Clinical Practice: A Review.

JAMA Oncol. 7: 1700-1708Eiermann W. Paepke S. Appfelstaedt J. et al.

Preoperative treatment of postmenopausal breast cancer patients with letrozole: A randomized double-blind multicenter study.

Ann Oncol. 12: 1527-1532Barchiesi G. Mazzotta M. Krasniqi E. et al.

Neoadjuvant Endocrine Therapy in Breast Cancer: Current Knowledge and Future Perspectives.

Int J Mol Sci. 16: 21

ClinicalTrials.gov. Fulvestrant and/or Anastrozole in Treating Postmenopausal Patients With Stage II-III Breast Cancer Undergoing Surgery.

Whitworth P. Beitsch P. Mislowsky A. et al.

Chemosensitivity and Endocrine Sensitivity in Clinical Luminal Breast Cancer Patients in the Prospective Neoadjuvant Breast Registry Symphony Trial (NBRST) Predicted by Molecular Subtyping.

Ann Surg Oncol. 24: 669-675

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