The value of completion axillary treatment in sentinel node positive breast cancer patients undergoing a mastectomy: a Dutch multicentre cohort study l

Phase 3

Completed

• Conditions: axillaire lymfekliermetastasen; axillary lymph node metastases; breast cancer; nodal metastases; 10006291; 10006295

• Registration Number: NL-OMON44960
• Lead Sponsor: Medisch Universitair Ziekenhuis Maastricht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 11 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 878

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

- Clinically node positive pre-operative
- Sentinel lymph nodes only containing isolated tumour cells (<0.2mm)
- Solitary parasternal sentinel lymph node metastasis (pN1b(sn))
- Bilateral breast cancer
- Irradical resection of primary tumour at time of inclusion (applicable in case the mastectomy is performed before inclusion)
- Evidence of metastatic disease
- History of invasive breast cancer
- Previous treatment of the axilla by 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 history of unsuccessfully treated malignancies
- 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>- Regionale 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>- Number of delayed axillary lymph node dissections<br /><br>- Quality of life and axillary morbidity rate<br /><br>- Local recurrence rate<br /><br>- Other-regional recurrence rate<br /><br>- Contralateral breast cancer<br /><br>- Percentage difference in the administration of postoperative radiotherapy</p><br>