• L M van Roozendaal, M L G Vane, T van Dalen, J A van der Hage, StrobbeL J ALJADivision of Surgical Oncology, Canisius-Wilhelmina Hospital, Nijmegen, the Netherlands., L J Boersma, S C Linn, LobbesM B IMBIDepartment of Radiology and Nuclear Medicine, Maastricht University Medical Centre, Maastricht, the Netherlands., PoortmansP M PPMPDepartment of Radiation Oncology, Radboud University Medical Centre, Nijmegen, the Netherlands., Tjan-HeijnenV C GVCGGROW - School for Oncology and Developmental Biology, Maastricht University Medical Centre, Maastricht, the Netherlands.Division of Medical Oncology, Maastricht University Medical Centre, Maastricht, the Netherlands., Van de VijverK K B TKKBTDepartment of Pathology, Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital, Amsterdam, the Netherlands., J de Vries, A H Westenberg, KesselsA G HAGHDepartment of Clinical Epidemiology and Medical Technology Assessment, Maastricht University Medical Centre, Maastricht, the Netherlands., de WiltJ H WJHWDivision of Surgical Oncology, Radboud University Medical Centre, Nijmegen, the Netherlands., and M L Smidt.
• Division of Surgical Oncology, Maastricht University Medical Centre, P.O. Box 5800, 6202 AZ, Maastricht, The Netherlands.
• Bmc Cancer. 2017 Jul 1; 17 (1): 459.

BackgroundStudies showed that axillary lymph node dissection can be safely omitted in presence of positive sentinel lymph node(s) in breast cancer patients treated with breast conserving therapy. Since the outcome of the sentinel lymph node biopsy has no clinical consequence, the value of the procedure itself is being questioned. The aim of the BOOG 2013-08 trial is to investigate whether the sentinel lymph node biopsy can be safely omitted in clinically node negative breast cancer patients treated with breast conserving therapy.MethodsThe BOOG 2013-08 is a Dutch prospective non-inferiority randomized multicentre trial. Women with pathologically confirmed clinically node negative T1-2 invasive breast cancer undergoing breast conserving therapy will be randomized for sentinel lymph node biopsy versus no sentinel lymph node biopsy. Endpoints include regional recurrence after 5 (primary endpoint) and 10 years of follow-up, distant-disease free and overall survival, quality of life, morbidity and cost-effectiveness. Previous data indicate a 5-year regional recurrence free survival rate of 99% for the control arm and 96% for the study arm. In combination with a non-inferiority limit of 5% and probability of 0.8, this result in a sample size of 1.644 patients including a lost to follow-up rate of 10%. Primary and secondary endpoints will be reported after 5 and 10 years of follow-up.DiscussionIf the sentinel lymph node biopsy can be safely omitted in clinically node negative breast cancer patients undergoing breast conserving therapy, this study will cost-effectively lead to a decreased axillary morbidity rate and thereby improved quality of life with non-inferior regional control, distant-disease free survival and overall survival.Trial RegistrationThe BOOG 2013-08 study is registered in ClinicalTrials.gov since October 20, 2014, Identifier: NCT02271828. https://clinicaltrials.gov/ct2/show/NCT02271828.

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