Omitting Sentinel Lymph Node Biopsy in Early-stage Breast Cancer
Conditions
Keywords
breast cancer, sentinel lymph node biopsy
Brief summary
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
Interventions
PROCEDUREsentinel lymph node biopsy
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
Sponsors
Clinical Hospital Center Rijeka
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
55 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* newly diagnosed hormone receptor positive, HER2 negative invasive breast cancer or DCIS with microinvasion, histologically confirmed, in postmenopausal patients older than 55 years, with primary tumour up to 3 cm and uninvolved axillary lymph nodes on clinical examination and on axillary ultrasound performed in Clinical Hospital Centre Rijeka. Patients should be eligible for breast conserving surgery and adjuvant whole breast irradiation.
Exclusion criteria
* Patients younger than 55 years of age and/or premenopausal, with cN1-3 status (confirmed cytologically or histologically), or with multiple suspicious lymph nodes on axillary ultrasound, regardless of cytological/histological confirmation. * Patients diagnosed with pure breast carcinoma in situ (DCIS) without focal invasion * Patients with tumour larger than 3 cm or with cT4 status, with de novo metastatic disease * Patients with a breast cancer of HER2+ or triple-negative immunophenotype * Patients who have received any type of neoadjuvant systemic therapy before surgery and those who have a previous personal history of invasive breast cancer * Patients with extensive multifocal or multicentric breast cancer, patients scheduled for mastectomy, partial breast irradiation or who refuse recommended adjuvant systemic oncological treatment * Patients who do not wish to participate in a clinical trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Isolated regional recurrence free survival | 5 years | 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) |
| Disease free survival | 5 years | Cancer recurrence-free interval (time from surgery until any recurrence) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of adjuvant chemotherapy recommendation in standard and experimental arm | 5 years | Differences in adjuvant chemotherapy recommendation between standard and experimental arm. |
| Rate of adjuvant regional nodal irradiation in standard and experimental arm | 4 years | Difference in regional nodal irradiation rate between standard and experimental arm |
| Isolated regional recurrence rate | 5 years | Rate of isolated recurrence in axillary lymph nodes |
| Rate of late complications of axillary surgery in standard arm | 5 years | Rate of arm paraesthesia, decreased range of motions in shoulder and arm lymphedema |
| Rate of early postoperative complications in axilla in standard arm | 3 years (accrual period) | Rate of haematoma, seroma and wound infection in axilla after SLNB |
| Any invasive recurrence rate | 5 years | Overall recurrence rate (in breast, axillary lymph nodes or distant sites) |
Countries
Croatia
Contacts
Primary ContactAna Car Peterko, MD, FEBS (breast surgery)
Backup ContactMarina Kosmat Tomaic, MD, general surgeon
Outcome results
None listed