Clinically node negative breast cancer patients undergoing breast conserving therapy: Sentinel lymph node procedure versus follow-up. A Dutch randomized controlled multicentre trial.

Phase 3

Completed

Conditions: breast cancer
sentinel lymph node metastases
sentinel lymph nodes
10006291
10006295

Registration Number: NL-OMON54499

Lead Sponsor: Medisch Universitair Ziekenhuis Maastricht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 1730

Inclusion Criteria

- Female
- Aged 18 years or older
- Pathologically confirmed invasive unilateral breast carcinoma
- A clinical T1-2 tumour (<= 5cm)
- Will be treated with lumpectomy followed by 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 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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary endpoint:<br /><br>- Regional recurrence rate</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints:<br /><br>- Distant-disease free survival<br /><br>- Overall survival<br /><br>- Delayed axillary treatment<br /><br>- Local recurrence rate<br /><br>- Other-regional recurrence rate<br /><br>- Contralateral breast cancer rate<br /><br>- Percentage difference in the administration of (neo)adjuvant systemic therapy<br /><br>- Quality of life and axillary morbidity rate<br /><br>- Cost-effectiveness</p><br>