breast cancer sentinel lymph node metastases sentinel lymph nodes
Conditions
Interventions
Patients in the control arm will be treated with the sentinel lymph node
procedure according to the Dutch breast cancer guideline. Patients in the
experimental arm will not be treated with the senti
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 (
Exclusion criteria
Exclusion criteria: - Clinically node positive pre-operative - Bilateral breast cancer - Evidence of metastatic disease - History of invasive breast cancer - Previous treatment of the ipsilateral 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 malignancies that occurred more than five years before randomization, and 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 - Unable or unwilling to give informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint: - Regional recurrence rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints: - Distant-disease free survival - Overall survival - Delayed axillary treatment - Local recurrence rate - Other-regional recurrence rate - Contralateral breast cancer rate - Percentage difference in the administration of (neo)adjuvant systemic therapy - Quality of life and axillary morbidity rate - Cost-effectiveness | — |
Countries
Netherlands
Outcome results
None listed