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Published in: BMC Cancer 1/2017

Open Access 01-12-2017 | Study protocol

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)

Authors: L. M. van Roozendaal, M. L. G. Vane, T. van Dalen, J. A. van der Hage, L. J. A. Strobbe, L. J. Boersma, S. C. Linn, M. B. I. Lobbes, P. M. P. Poortmans, V. C. G. Tjan-Heijnen, K. K. B. T. Van de Vijver, J. de Vries, A. H. Westenberg, A. G. H. Kessels, J. H. W. de Wilt, M. L. Smidt

Published in: BMC Cancer | Issue 1/2017

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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
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Metadata
Title
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)
Authors
L. M. van Roozendaal
M. L. G. Vane
T. van Dalen
J. A. van der Hage
L. J. A. Strobbe
L. J. Boersma
S. C. Linn
M. B. I. Lobbes
P. M. P. Poortmans
V. C. G. Tjan-Heijnen
K. K. B. T. Van de Vijver
J. de Vries
A. H. Westenberg
A. G. H. Kessels
J. H. W. de Wilt
M. L. Smidt
Publication date
01-12-2017
Publisher
BioMed Central
Published in
BMC Cancer / Issue 1/2017
Electronic ISSN: 1471-2407
DOI
https://doi.org/10.1186/s12885-017-3443-x

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