The goal of this clinical trial is to determine if the omission of sentinel lymph node biopsy is safe for early-stage breast cancer patients in our institution (Clinical Hospital Centre Rijeka). Targeted group are postmenopausal patients, older than 55 years, diagnosed with hormone-receptor-positive breast cancer, with primary tumour less than 3 cm and unaffected axilla on clinical exam and axillary ultrasound. The main questions we aim to answer are: * if this treatment de-escalation affects patient oncological outcomes (cancer recurrence)? * if this treatment de-escalation affects patient clinical outcomes (early and late complications related to axillary surgery)? * if this omission of pathological examination of sentinel lymph node affects recommendations on postoperative treatments (irradiation and systemic therapy)? Researchers will compare outcomes between participants submitted to sentinel lymph node biopsy and participants in whom the procedure is omitted to answer those questions. Participants will be asked to: * decide in which group they wish to participate * visit the clinic for checkups and tests once every 6 months in first two years and yearly thereafter up to 5 years
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
620
As sentinel lymph node biopsy is still a standard of care in early-stage breast cancer surgery, it represents the intervention in the standard of care arm
omission of sentinel lymph node biopsy is the intervention in the experimental arm
Clinical Hospital Centre Rijeka
Rijeka, Croatia
Isolated regional recurrence free survival
Isolated axillary lymph node recurrence free interval (time from surgery until axillary lymph node recurrence, provided that axillary recurrence is the first and only recurrence)
Time frame: 5 years
Disease free survival
Cancer recurrence-free interval (time from surgery until any recurrence)
Time frame: 5 years
Isolated regional recurrence rate
Rate of isolated recurrence in axillary lymph nodes
Time frame: 5 years
Any invasive recurrence rate
Overall recurrence rate (in breast, axillary lymph nodes or distant sites)
Time frame: 5 years
Rate of adjuvant chemotherapy recommendation in standard and experimental arm
Differences in adjuvant chemotherapy recommendation between standard and experimental arm.
Time frame: 5 years
Rate of adjuvant regional nodal irradiation in standard and experimental arm
Difference in regional nodal irradiation rate between standard and experimental arm
Time frame: 4 years
Rate of early postoperative complications in axilla in standard arm
Rate of haematoma, seroma and wound infection in axilla after SLNB
Time frame: 3 years (accrual period)
Rate of late complications of axillary surgery in standard arm
Rate of arm paraesthesia, decreased range of motions in shoulder and arm lymphedema
Time frame: 5 years
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