Cancer types
  • Breast
Title of study
Clinically node negative breast cancer patients undergoing breast conserving therapy: sentinel lymph node procedure versus follow-up
Version Number
Approval Date 
2, 5 July 2015
Short Title
Boog 2013-08
Study site
Principle Investigator
M.L. Smidt, J.H.W. de Wilt
Investigator Maastro
Prof. Dr. L. Boersma
Sponsor
KWF
Trial registry
Objectives 

• Primary objective: to investigate whether omitting the sentinel lymph node procedure is not inferior to the current axillary staging regimen in clinically node negative breast cancer patients undergoing breast conserving therapy, in terms of regional recurrence rate.
• Secondary objectives: to investigate whether omitting the sentinel lymph node procedure is not inferior to the current axillary staging regimen in clinically node negative breast cancer patients undergoing breast conserving therapy, in terms of distant-disease free survival, overall survival rate, the local recurrence rate and the occurrence of contralateral breast cancer. Other secondary objectives are the influence of omitting the sentinel lymph node procedure on the number of delayed axillary lymph node dissections, the axillary morbidity rate and quality of life.

Primary Endpoint 

Regional recurrence rate

Secondary Endpoints 

Regional recurrence free survival, number of delayed axillary lymph node dissections, distant-disease free survival, overall survival, local recurrence rate, other-regional recurrence rate, contralateral breast cancer rate, percentage difference in the administration of postoperative radiotherapy, axillary morbidity rate, quality of life