Omitting Sentinel Node Procedure in Breast Cancer Patients Undergoing Breast Conserving Therapy
- Conditions
- Breast Neoplasms
- Interventions
- Procedure: Sentinel lymph node procedure
- Registration Number
- NCT02271828
- Lead Sponsor
- Maastricht University Medical Center
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Female
- Target Recruitment
- 1644
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sentinel lymph node procedure Sentinel lymph node procedure Sentinel lymph node procedure according to the Dutch breast cancer guideline
- Primary Outcome Measures
Name Time Method Regional recurrence rate Up to ten years 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).
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (22)
Haga ziekenhuis
🇳🇱Den Haag, Netherlands
UMC Groningen
🇳🇱Groningen, Netherlands
Diakonessenhuis
🇳🇱Utrecht, Netherlands
Alrijne
🇳🇱Leiden, Netherlands
Jeroen Bosch ziekenhuis
🇳🇱Den Bosch, Netherlands
Maastricht University Medical Centre+
🇳🇱Maastricht, Limburg, Netherlands
Flevoziekenhuis
🇳🇱Almere, Netherlands
Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital
🇳🇱Amsterdam, Netherlands
Rijnstate
🇳🇱Arnhem, Netherlands
Amphia ziekenhuis
🇳🇱Breda, Netherlands
Deventer ziekenhuis
🇳🇱Deventer, Netherlands
Catharina ziekenhuis
🇳🇱Eindhoven, Netherlands
Maxima Medisch Centrum
🇳🇱Eindhoven, Netherlands
Groene Hart ziekenhuis
🇳🇱Gouda, Netherlands
Spaarne Gasthuis
🇳🇱Haarlem, Netherlands
St. Antonius ziekenhuis
🇳🇱Nieuwegein, Netherlands
Canisius-Wilhelmina ziekenhuis
🇳🇱Nijmegen, Netherlands
Radboud UMC
🇳🇱Nijmegen, Netherlands
Laurentius ziekenhuis
🇳🇱Roermond, Netherlands
UMC Utrecht
🇳🇱Utrecht, Netherlands
Zuwehofpoort ziekenhuis
🇳🇱Woerden, Netherlands
Isala Klinieken
🇳🇱Zwolle, Netherlands