Omitting Completion Axillary Treatment in Sentinel Node Positive Breast Cancer Patients Undergoing a Mastectomy

Study Overview
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Brief Summary
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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.

Official Title
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The Value of Completion Axillary Treatment in Sentinel Node Positive Breast Cancer Patients Undergoing a Mastectomy. A Dutch Randomized Controlled Multicentre Trial.

Conditions
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Breast Neoplasms

Intervention / Treatment
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* Procedure: Completion axillary treatment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Completion axillary treatment<br>Completion axillary treatment according to the Dutch breast cancer guideline | Procedure: Completion axillary treatment<br>* Completion axillary treatment according to the Dutch breast cancer guideline<br>|
| No Intervention: No completion axillary treatment<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Regional recurrence rate | 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). | up to ten years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sentinel lymph node metastasis, Completion axillary lymph node dissection, Axillary radiotherapy