Clinical trial · Interventional
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.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sentinel lymph node procedure | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Sentinel lymph node procedure
- description
- Sentinel lymph node procedure according to the Dutch breast cancer guideline
- interventionNames
- Procedure: Sentinel lymph node procedure
- type
- NO_INTERVENTION
- label
- No sentinel lymph node procedure
- description
- No sentinel lymph node procedure
Primary outcomes (1)
- measure
- Regional recurrence rate
- timeFrame
- Up to ten years
- description
- 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).
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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
References
Publications (2)
- DERIVEDWintraecken 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 40365927
- DERIVEDvan 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 28668073