Clinical trial · Interventional
Omitting Completion Axillary Treatment in Sentinel Node Positive Breast Cancer Patients Undergoing a Mastectomy
The Value of Completion Axillary Treatment in Sentinel Node Positive Breast Cancer Patients Undergoing a Mastectomy. A Dutch Randomized Controlled Multicentre Trial.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): slow accrual rate
Summary
Brief summary (as posted)
STUDY AIM To decrease the number of breast cancer patients receiving overtreatment of the axilla, in order to positively influence the axillary morbidity rate and quality of life. PRIMARY OBJECTIVE To determine whether omitting completion axillary treatment is not inferior to the current axillary treatment regimen in sentinel node positive breast cancer patients undergoing a mastectomy, in terms of regional recurrence rate. HYPOTHESIS Completion axillary treatment can be safely omitted in sentinel node positive breast cancer patients undergoing a mastectomy. This will lead to a decreased axillary morbidity rate and to an increased quality of life, with non-inferior regional control, 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 |
|---|---|---|---|
| Completion axillary treatment | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Completion axillary treatment
- description
- Completion axillary treatment according to the Dutch breast cancer guideline
- interventionNames
- Procedure: Completion axillary treatment
- type
- NO_INTERVENTION
- label
- No completion axillary treatment
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 unilateral breast carcinoma * A clinical T1-2 tumour (including multifocal or multicentric breast cancer) * Will be or is treated with mastectomy * Clinically node negative: no signs of axillary lymph node metastases at physical examination and preoperative axillary ultrasound (or negative cyto-/histopathology) * Sentinel lymph node procedure and its pathologic evaluation should be performed according to the Dutch breast cancer guideline * pN1mi(sn) or pN1(sn): at least one and a maximum of three axillary sentinel lymph nodes containing micro- and/or macrometastases * Written informed consent Exclusion Criteria: * Clinically node positive pre-operative * Sentinel lymph nodes only containing isolated tumour cells (\<0.2 mm) * Solitary parasternal sentinel lymph node metastasis (pN1b) * Bilateral breast cancer * Irradical resection of primary tumour at time of randomization (applicable in case the mastectomy is performed before randomization) * 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 (1)
- DERIVEDvan Roozendaal LM, de Wilt JH, van Dalen T, van der Hage JA, Strobbe LJ, Boersma LJ, Linn SC, Lobbes MB, Poortmans PM, Tjan-Heijnen VC, Van de Vijver KK, de Vries J, Westenberg AH, Kessels AG, Smidt ML. The value of completion axillary treatment in sentinel node positive breast cancer patients undergoing a mastectomy: a Dutch randomized controlled multicentre trial (BOOG 2013-07). BMC Cancer. 2015 Sep 3;15:610. doi: 10.1186/s12885-015-1613-2. PMID 26335105