axillaire lymfekliermetastasen axillary lymph node metastases breast cancer nodal metastases
Conditions
Interventions
Patients in the experimental arm will not receive completion axillary
treatment. Patients in the control arm will undergo completion axillary
treatment according to the Dutch breast cancer guideline
Sponsors
Medisch Universitair Ziekenhuis Maastricht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Female - Aged 18 years or older - Pathologically confirmed invasive unilateral breast carcinoma - A clinical T1-2 tumour (* 5cm) (including multifocal or multicentric breast cancer) - Will be or is treated by mastectomy - Clinically node negative: no signs of axillary lymph node metastases at physical examination and preoperative axillary ultrasound (or negative cyto-/histopathology) - SLN 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
Exclusion criteria: - Clinically node positive pre-operative - Sentinel lymph nodes only containing isolated tumour cells (
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint: - Regionale recurrence rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints: - Distant-disease free survival - Overall survival - Number of delayed axillary lymph node dissections - Quality of life and axillary morbidity rate - Local recurrence rate - Other-regional recurrence rate - Contralateral breast cancer - Percentage difference in the administration of postoperative radiotherapy | — |
Countries
Netherlands
Outcome results
None listed