Maastricht UMC+
M.L. Smidt, J.H.W. de Wilt
M.L. Smidt
mamma.research@mumc.nl
IKNL Clinical Trial Centre
Tel: +31 (0)88 234 65 00
E-mail: trialbureau@iknl.nl
n.a.
IKNL
Funding by KWF
September 2021: Sample size aangepast van 1647 naar 1730, noodzakelijk wegens 5% protocol violations.
A prospective non-inferiority randomized multicentre trial. Patient group: Women aged 18 years or older with pathologically confirmed unilateral cT1-2N0* invasive breast cancer about to undergo breast conserving surgery followed by radiotherapy of the breast. Randomization: Arm A – control arm: lumpectomy with sentinel lymph node procedure, followed by radiotherapy of the breast with or without completion axillary treatment according to the Dutch guideline. Arm B – study arm: lumpectomy without further axillary staging, followed by radiotherapy of the breast. Stratification: Patients will be stratified by: age (≤50, 50≤75, >75 years old), oestrogen receptor status (positive vs. negative), HER2neu status (amplified vs. not amplified), clinical tumour stage prior to any treatment (<3 cm vs. ≥3 cm), grading (grade I-II vs. III – according to Bloom-Richardson grading system), primary systemic therapy and participating centre.
Primary objective: The primary objective of this study is to investigate 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. Secondary objectives: Secondary objectives of this study are to investigate 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 distant-disease free survival, overall survival rate, the local recurrence rate and the occurrence of contralateral breast cancer. Other secondary objectives are the influence of omitting the sentinel lymph node procedure on the number of delayed axillary lymph node dissections, the axillary morbidity rate and quality of life.
Primary endpoint:
Regional recurrence rate.
Secondary endpoints:
Regional recurrence free survival, number of delayed axillary lymph node dissections, distant-disease free survival, overall survival, local recurrence rate, other-regional recurrence rate, contralateral breast cancer rate, percentage difference in the administration of postoperative radiotherapy, axillary morbidity rate, quality of life.
Inclusion criteria: 1. Female 2. Aged 18 years or older 3. Pathologically confirmed invasive unilateral breast carcinoma 4. A clinical T1-2 tumour (≤ 5cm) 5. Will be treated with lumpectomy followed by whole breast radiotherapy 6. Clinically node negative (cN0): no signs of axillary lymph node metastases at physical examination and a negative preoperative axillary ultrasound (or negative cyto-/histopathology) 7. Written informed consent Furthermore, primary systemic therapy is allowed if the patient has a clinical T1-2 tumour that is amenable to lumpectomy pre-systemic therapy. Exclusion criteria: 1. Clinically node positive pre-operative 2. Bilateral breast cancer 3. Evidence of metastatic disease 4. History of invasive breast cancer 5. Previous treatment of the axilla by surgery or radiotherapy (except surgery for hidradenitis suppurativa or for other superficially located skin lesions, such as naevi) 6. Pregnant or nursing 7. 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 8. Unable or unwilling to give informed consent
