An interventional study of sentinel lymph node biopsy and omission of sentinel lymph node biopsy in Omitting Sentinel Lymph Node Biopsy in Early-stage Breast Cancer, sponsored by Clinical Hospital Center Rijeka. Not yet recruiting at 1 site in Croatia. Open to female participants aged 55 Years and older. Per ClinicalTrials.gov, last updated 2025-08-01.
Sponsored by Clinical Hospital Center Rijeka · Not applicable, Interventional, and Treatment
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:
Participants will be asked to:
14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.
This study's planned enrollment of 620 is above the median of 72 across 10,896 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Clinical Hospital Center Rijeka is the lead sponsor of 20 studies on the registry; 9 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
HER2
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Sentinel lymph node biopsy will be omitted for all participants
Procedure: omission of sentinel lymph node biopsy
Standard of care treatment (SLNB) will be performed in all participants
Procedure: sentinel 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
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
Start is estimated for Sep 2025; primary completion for Sep 2033, 96 months later.
Of 2,661 non-industry interventional studies with no phase under Breast Neoplasms, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 66. This study's planned 96 months is above that.
Counting every sponsor, half of 2,771 studies reached it within 33 months; a quarter within 15 and three quarters within 66.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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Clinical Hospital Center Rijeka