Omitting Sentinel Node Procedure in Breast Cancer Patients Undergoing Breast Conserving Therapy

Study Overview
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Brief Summary
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STUDY AIM To decrease the number of breast cancer patients receiving over treatment of the axilla, in order to positively influence the axillary morbidity rate and quality of life. PRIMARY OBJECTIVE To determine whether omitting the sentinel lymph node procedure is not inferior to the current axillary staging regimen in clinically node negative breast cancer patients undergoing breast conserving therapy, in terms of regional recurrence rate. HYPOTHESIS The sentinel lymph node procedure can be safely omitted in clinically node negative breast cancer patients undergoing breast conserving therapy. This will lead to a decreased axillary morbidity rate, with a non-inferior regional recurrence-, distant-disease free- and overall survival rates.

Official Title
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Clinically Node Negative Breast Cancer Patients Undergoing Breast Conserving Therapy: Sentinel Lymph Node Procedure Versus Follow-Up.

Conditions
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Breast Neoplasms

Intervention / Treatment
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* Procedure: Sentinel lymph node procedure


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female Aged 18 years or older Pathologically confirmed invasive breast carcinoma A clinical T1-2 tumor Will be treated with lumpectomy and 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 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: Sentinel lymph node procedure<br>Sentinel lymph node procedure according to the Dutch breast cancer guideline | Procedure: Sentinel lymph node procedure<br>* Sentinel lymph node procedure according to the Dutch breast cancer guideline<br>|
| No Intervention: No sentinel lymph node procedure<br>No sentinel lymph node procedure | |

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 |