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Randomized Controlled Trial
. 2017 Jul 1;17(1):459.
doi: 10.1186/s12885-017-3443-x.

Clinically node negative breast cancer patients undergoing breast conserving therapy, sentinel lymph node procedure versus follow-up: a Dutch randomized controlled multicentre trial (BOOG 2013-08)

L M van Roozendaal  1   2 , M L G Vane  3   4 , T van Dalen  5 , J A van der Hage  6 , L J A Strobbe  7 , L J Boersma  2   8 , S C Linn  9 , M B I Lobbes  10 , P M P Poortmans  11 , V C G Tjan-Heijnen  2   12 , K K B T Van de Vijver  13 , J de Vries  14 , A H Westenberg  15 , A G H Kessels  16 , J H W de Wilt  17 , M L Smidt  1   2
Affiliations
Randomized Controlled Trial

Clinically node negative breast cancer patients undergoing breast conserving therapy, sentinel lymph node procedure versus follow-up: a Dutch randomized controlled multicentre trial (BOOG 2013-08)

L M van Roozendaal et al. BMC Cancer. .

Abstract

Background: Studies 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.

Methods: The 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.

Discussion: If 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 registration: The BOOG 2013-08 study is registered in ClinicalTrials.gov since October 20, 2014, Identifier: NCT02271828. https://clinicaltrials.gov/ct2/show/NCT02271828.

Keywords: Breast cancer; Breast conserving therapy; Breast neoplasms; Sentinel lymph node biopsy.

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Conflict of interest statement

Authors’ information

LvR is surgeon in training and received her PhD degree in surgical oncology at Maastricht University Medical Centre, MV is PhD candidate in surgical oncology at Maastricht University Medical Centre, AK is statistician at Maastricht University Medical Centre, TvD is surgical oncologist at Diakonessenhuis Hospital, JvdH is surgical oncologist at Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital, LS is surgical oncologist at Canisius-Wilhelmina Hospital, LB is radiation oncologist at Maastricht University Medical Centre (MAASTRO clinic), SL is professor in medical oncology at Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital, ML is breast radiologist at Maastricht University Medical Centre, PP is professor in radiation oncology at Radboud university medical centre, VTH is professor in medical oncology at Maastricht University Medical Centre, KVdV is pathologist at Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital, JdV is professor in quality of life in the medical setting at Tilburg University, AW is radiation oncologist at Arnhem Institute for Radiation Oncology, JdW is professor of surgical oncology at Radboud university medical centre, MS is surgical oncologist at Maastricht University Medical Centre.

Ethics approval and consent to participate

The study is conducted in accordance to the standards of Good Clinical Practice, in agreement with the Declaration of Helsinki and with Dutch law in general and with the Medical Research Involving Human Subjects Act (in Dutch: Wet Medisch-wetenschappelijk Onderzoek met mensen) in particular.

This study was approved by the medical ethics committee Stichting het Nederlands Kanker Instituut – Antoni van Leeuwenhoek ziekenhuis Amsterdam, the Netherlands (PTC15.0111/M14CNB).

The study will be performed in 35 participating centres, including 4 university medical centres. The Board of Directors approved initiation of the study in current participating centres that are open for accrual. The BOOG 2013–08 trial is registered at ClinicalTrials.gov (NCT02271828) [30].

All patients will be provided with written information in the form of a Patient Information Folder, including the study aims, randomization procedure, possible AEs, and their rights and responsibilities. Written informed consent must be obtained for all patients included in the study before they are randomized in the study.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

References

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