Omitting Sentinel Node Procedure in Breast Cancer Patients Undergoing Breast Conserving Therapy
Clinically Node Negative Breast Cancer Patients Undergoing Breast Conserving Therapy: Sentinel Lymph Node Procedure Versus Follow-Up.
2 other identifiers
interventional
1,644
1 country
22
Brief Summary
STUDY AIM To decrease the number of breast cancer patients receiving over treatment of the axilla, in order to positively influence the axillary morbidity rate and quality of life. PRIMARY OBJECTIVE To determine 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. HYPOTHESIS The sentinel lymph node procedure can be safely omitted in clinically node negative breast cancer patients undergoing breast conserving therapy. This will lead to a decreased axillary morbidity rate, with a non-inferior regional recurrence-, distant-disease free- and overall survival rates.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2015
Longer than P75 for not_applicable
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 20, 2014
CompletedFirst Posted
Study publicly available on registry
October 22, 2014
CompletedStudy Start
First participant enrolled
April 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2027
May 11, 2025
May 1, 2025
12.3 years
October 20, 2014
May 7, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Regional recurrence rate
Regional recurrence is defined as tumour recurrence and as residual tumour that became clinically apparent in ipsilateral axillary, infraclavicular and supraclavicular lymph nodes (pathologically proven).
Up to ten years
Study Arms (2)
Sentinel lymph node procedure
ACTIVE COMPARATORSentinel lymph node procedure according to the Dutch breast cancer guideline
No sentinel lymph node procedure
NO INTERVENTIONNo sentinel lymph node procedure
Interventions
Sentinel lymph node procedure according to the Dutch breast cancer guideline
Eligibility Criteria
You may qualify if:
- Female
- Aged 18 years or older
- Pathologically confirmed invasive breast carcinoma
- A clinical T1-2 tumor
- Will be treated with lumpectomy and whole breast radiotherapy
- Clinically node negative status: no signs of axillary lymph node metastases at physical examination and preoperative axillary ultrasound (or negative cyto-/histopathology)
- Written informed consent
You may not qualify if:
- Clinically node positive pre-operative
- Bilateral breast cancer
- Evidence of metastatic disease
- History of invasive breast cancer
- Previous treatment of the axilla with surgery or radiotherapy (except surgery for hidradenitis suppurativa or for other superficially located skin lesions, such as naevi)
- Pregnant or nursing
- Other prior malignancies within the past 5 years (except successfully treated basal cell and squamous cell skin cancer, carcinoma in situ of the cervix or carcinoma in situ of the ipsilateral or contralateral breast) or unsuccessfully treated malignancies \> 5 years before randomization
- Unable or unwilling to give informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Maastricht University Medical Centerlead
- Borstkanker Onderzoek Groepcollaborator
- Dutch Cancer Societycollaborator
- Maastricht Universitycollaborator
Study Sites (22)
Maastricht University Medical Centre+
Maastricht, Limburg, 6202 AZ, Netherlands
Jeroen Bosch ziekenhuis
's-Hertogenbosch, Netherlands
Flevoziekenhuis
Almere Stad, Netherlands
Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital
Amsterdam, Netherlands
Rijnstate
Arnhem, Netherlands
Amphia ziekenhuis
Breda, Netherlands
Deventer ziekenhuis
Deventer, Netherlands
Catharina ziekenhuis
Eindhoven, Netherlands
Maxima Medisch Centrum
Eindhoven, Netherlands
Groene Hart ziekenhuis
Gouda, Netherlands
UMC Groningen
Groningen, Netherlands
Spaarne Gasthuis
Haarlem, Netherlands
Alrijne
Leiden, Netherlands
St. Antonius ziekenhuis
Nieuwegein, Netherlands
Canisius-Wilhelmina ziekenhuis
Nijmegen, Netherlands
Radboud UMC
Nijmegen, Netherlands
Laurentius ziekenhuis
Roermond, Netherlands
Haga ziekenhuis
The Hague, Netherlands
Diakonessenhuis
Utrecht, Netherlands
UMC Utrecht
Utrecht, Netherlands
Zuwehofpoort ziekenhuis
Woerden, Netherlands
Isala Klinieken
Zwolle, Netherlands
Related Publications (2)
Wintraecken VM, van Roozendaal LM, Simons JM, de Vries J, van Kuijk SMJ, Vane MLG, van Dalen T, Sackey H, van der Hage JA, Strobbe LJA, Linn SC, Lobbes MBI, Poortmans PMP, Tjan-Heijnen VCG, van de Vijver KKBT, Westenberg HH, Dirksen CD, de Wilt JHW, Boersma LJ, Smidt ML. Three-year patient-reported outcomes of the BOOG 2013-08 RCT evaluating omission of sentinel lymph node biopsy in early-stage breast cancer patients treated with breast conserving surgery: Impact of personality traits on health-related quality of life. Br J Surg. 2025 Apr 30;112(5):znaf031. doi: 10.1093/bjs/znaf031.
PMID: 40365927DERIVEDvan Roozendaal LM, Vane MLG, van Dalen T, van der Hage JA, Strobbe LJA, Boersma LJ, Linn SC, Lobbes MBI, Poortmans PMP, Tjan-Heijnen VCG, Van de Vijver KKBT, de Vries J, Westenberg AH, Kessels AGH, de Wilt JHW, Smidt ML. 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). BMC Cancer. 2017 Jul 1;17(1):459. doi: 10.1186/s12885-017-3443-x.
PMID: 28668073DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marjolein L Smidt, MD, PhD
Maastricht University Medical Centre, Maastricht, the Netherlands
- PRINCIPAL INVESTIGATOR
Hans JW de Wilt, MD, PhD
Radboud University Medical Centre, Nijmegen, the Netherlands
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 20, 2014
First Posted
October 22, 2014
Study Start
April 1, 2015
Primary Completion (Estimated)
July 1, 2027
Study Completion (Estimated)
July 1, 2027
Last Updated
May 11, 2025
Record last verified: 2025-05