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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental arm (NO-SLNB) | Experimental | Sentinel lymph node biopsy will be omitted for all participants |
|
| Standard of care (SLNB) | Active Comparator | Standard of care treatment (SLNB) will be performed in all participants |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sentinel lymph node biopsy | Procedure | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 5 years |
| Disease free survival | Cancer recurrence-free interval (time from surgery until any recurrence) | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Isolated regional recurrence rate | Rate of isolated recurrence in axillary lymph nodes | 5 years |
| Any invasive recurrence rate | Overall recurrence rate (in breast, axillary lymph nodes or distant sites) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ana Car Peterko, MD, FEBS (breast surgery) | Contact | 0038551658120 | anacarpeterko@gmail.com | |
| Marina Kosmat Tomaic, MD, general surgeon | Contact | 0038551658120 | marina.kosmat@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Hospital Centre Rijeka | Rijeka | 51000 | Croatia |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D021701 | Sentinel Lymph Node Biopsy |
| ID | Term |
|---|---|
| D001706 | Biopsy |
| D003581 | Cytodiagnosis |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
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| omission of sentinel lymph node biopsy | Procedure | omission of sentinel lymph node biopsy is the intervention in the experimental arm |
|
| 5 years |
| Rate of adjuvant chemotherapy recommendation in standard and experimental arm | Differences in adjuvant chemotherapy recommendation between standard and experimental arm. | 5 years |
| Rate of adjuvant regional nodal irradiation in standard and experimental arm | Difference in regional nodal irradiation rate between standard and experimental arm | 4 years |
| Rate of early postoperative complications in axilla in standard arm | Rate of haematoma, seroma and wound infection in axilla after SLNB | 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 | 5 years |
| D017437 |
| Skin and Connective Tissue Diseases |
| D019937 |
| Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D013048 | Specimen Handling |
| D003949 | Diagnostic Techniques, Surgical |
| D013514 | Surgical Procedures, Operative |
| D008197 | Lymph Node Excision |
| D008919 | Investigative Techniques |