|- candidate number||22881|
|- NTR Number||NTR5493|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||15-sep-2015|
|- Secondary IDs||NL49315.031.14 M14CAT|
|- Public Title||BOOG 2013-08: Clinically node negative breast cancer patients undergoing breast conserving therapy: Sentinel lymph node procedure versus follow-up.
|- Scientific Title||BOOG 2013-08: Clinically node negative breast cancer patients undergoing breast conserving therapy: Sentinel lymph node procedure versus follow-up.
|- 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 non-inferior regional control, distant-disease free survival and overall survival.|
|- Healt Condition(s) or Problem(s) studied||Breast cancer, Sentinel Lymph Node Biopsy (SLNB)|
|- Inclusion criteria||1. Female|
2. Aged 18 years or older
3. Pathologically confirmed invasive unilateral breast carcinoma
4. A clinical T1-2 tumour
5. Will be treated with lumpectomy and whole breast radiotherapy
6. Clinically node negative status: no signs of axillary lymph node metastases at physical examination and preoperative axillary ultrasound (or negative cyto-/histopathology)
7. Written informed consent
Primary systemic therapy is allowed if the patient has a clinical T1-2N0 status (initial stage) 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 ipsilateral axilla with 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 malignancies that occurred more than five years before randomization, and 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
8. Unable or unwilling to give informed consent
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-jun-2015|
|- planned closingdate|
|- Target number of participants||1644|
|- Interventions||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.
|- Primary outcome||Regional recurrence rate after 5- and 10 years of follow-up.|
|- Secondary outcome||Distant-disease free survival, overall survival, delayed axillary lymph node dissections, axillary morbidity, quality of life, local recurrence, contralateral breast cancer, and percentage difference in administered (neo)adjuvant systemic therapy after 5- and 10 years of follow-up.|
|- Timepoints||5- and 10 years.|
|- Trial web site||www.boogstudycenter.nl|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| |
|- CONTACT for SCIENTIFIC QUERIES|| |
|- Sponsor/Initiator ||KWF Kankerbestrijding, CZ, health insurance company, ZonMw: The Netherlands Organization for Health Research and Development|
(Source(s) of Monetary or Material Support)
|KWF Kankerbestrijding, CZ zorgverzekeringen, ZON-MW, The Netherlands Organization for Health Research and Development|
|- Brief summary||Clinically T1-2N0 (tumour < 5 cm) invasive breast cancer about to undergo breast conserving surgery followed by radiotherapy of the breast are randomized for no sentinel lymph node procedure or sentinel lymph node procedure (standard care).
|- Main changes (audit trail)|
|- RECORD||15-sep-2015 - 5-jan-2016|