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Published in: BMC Cancer 1/2017

Open Access 01-12-2017 | Study protocol

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

Authors: Jana de Boniface, Jan Frisell, Yvette Andersson, Leif Bergkvist, Johan Ahlgren, Lisa Rydén, Roger Olofsson Bagge, Malin Sund, Hemming Johansson, Dan Lundstedt, on behalf of the SENOMAC Trialists’ Group

Published in: BMC Cancer | Issue 1/2017

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Abstract

Background

The role of axillary lymph node dissection (ALND) has increasingly been called into question among patients with positive sentinel lymph nodes. Two recent trials have failed to show a survival difference in sentinel node-positive breast cancer patients who were randomized either to undergo completion ALND or not. Neither of the trials, however, included breast cancer patients undergoing mastectomy or those with tumors larger than 5 cm, and power was debatable to show a small survival difference.

Methods

The prospective randomized SENOMAC trial includes clinically node-negative breast cancer patients with up to two macrometastases in their sentinel lymph node biopsy. Patients with T1-T3 tumors are eligible as well as patients prior to systemic neoadjuvant therapy. Both breast-conserving surgery and mastectomy, with or without breast reconstruction, are eligible interventions. Patients are randomized 1:1 to either undergo completion ALND or not by a web-based randomization tool. This trial is designed as a non-inferiority study with breast cancer-specific survival at 5 years as the primary endpoint. Target accrual is 3500 patients to achieve 80% power in being able to detect a potential 2.5% deterioration of the breast cancer-specific 5-year survival rate. Follow-up is by annual clinical examination and mammography during 5 years, and additional controls after 10 and 15 years. Secondary endpoints such as arm morbidity and health-related quality of life are measured by questionnaires at 1, 3 and 5 years.

Discussion

Several large subgroups of breast cancer patients, such as patients undergoing mastectomy or those with larger tumors, have not been included in key trials; however, the use of ALND is being questioned even in these groups without the support of high-quality evidence. Therefore, the SENOMAC Trial will investigate the need of completion ALND in case of limited spread to the sentinel lymph nodes not only in patients undergoing any breast surgery, but also in neoadjuvantly treated patients and patients with larger tumors.

Trial registration

NCT 02240472, retrospective registration date September 14, 2015 after trial initiation on January 31, 2015.
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Metadata
Title
Survival and axillary recurrence following sentinel node-positive breast cancer without completion axillary lymph node dissection: the randomized controlled SENOMAC trial
Authors
Jana de Boniface
Jan Frisell
Yvette Andersson
Leif Bergkvist
Johan Ahlgren
Lisa Rydén
Roger Olofsson Bagge
Malin Sund
Hemming Johansson
Dan Lundstedt
on behalf of the SENOMAC Trialists’ Group
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/s12885-017-3361-y

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