Omitting Completion Axillary Treatment in Sentinel Node Positive Breast Cancer Patients Undergoing a Mastectomy
- Conditions
- Breast Neoplasms
- Interventions
- Procedure: Completion axillary treatment
- Registration Number
- NCT02112682
- Lead Sponsor
- Maastricht University Medical Center
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 52
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Completion axillary treatment Completion axillary treatment Completion axillary treatment 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 (30)
Martini Ziekenhuis
🇳🇱Groningen, Netherlands
Alrijne ziekenhuis
🇳🇱Leiden, Netherlands
Rijnstate
🇳🇱Arnhem, Netherlands
Tergooi
🇳🇱Hilversum, Netherlands
Amphia ziekenhuis
🇳🇱Breda, Netherlands
Meander Medisch Centrum
🇳🇱Amersfoort, Netherlands
Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital
🇳🇱Amsterdam, Netherlands
Flevoziekenhuis
🇳🇱Almere, Netherlands
Maastricht University Medical Centre+
🇳🇱Maastricht, Limburg, Netherlands
Gelre Ziekenhuizen
🇳🇱Apeldoorn, Netherlands
St. Elisabeth Ziekenhuis
🇳🇱Tilburg, Netherlands
Reinier de Graaf
🇳🇱Delft, Netherlands
Haga Ziekenhuis
🇳🇱Den Haag, Netherlands
Deventer Ziekenhuis
🇳🇱Deventer, Netherlands
Jeroen Bosch ziekenhuis
🇳🇱Den Bosch, Netherlands
Bronovo / Medisch Centrum Haaglanden
🇳🇱Den Haag, Netherlands
Catharina Ziekenhuis Eindhoven
🇳🇱Eindhoven, Netherlands
Groene Hart Ziekenhuis
🇳🇱Gouda, Netherlands
Medisch Spectrum Twente
🇳🇱Enschede, Netherlands
Zuyderland Medisch Centrum
🇳🇱Sittard, Netherlands
UMC Groningen
🇳🇱Groningen, Netherlands
St. Antonius Ziekenhuis
🇳🇱Nieuwegein, Netherlands
Canisius-Wilhelmina Ziekenhuis
🇳🇱Nijmegen, Netherlands
Radboud university medical center
🇳🇱Nijmegen, Netherlands
Laurentius Ziekenhuis
🇳🇱Roermond, Netherlands
Antonius Ziekenhuis
🇳🇱Sneek, Netherlands
Rivierenland
🇳🇱Tiel, Netherlands
Diakonessenhuis Utrecht
🇳🇱Utrecht, Netherlands
Isala Klinieken
🇳🇱Zwolle, Netherlands
Maxima Medisch Centrum
🇳🇱Veldhoven, Netherlands