Status:
ACTIVE_NOT_RECRUITING
Sentinel Node Biopsy in Breast Cancer: Omission of Axillary Clearance After Macrometastases. A Randomized Trial.
Lead Sponsor:
Karolinska Institutet
Collaborating Sponsors:
The Swedish Research Council
Swedish Cancer Foundation
Conditions:
Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Since the introduction of sentinel node biopsy in breast cancer, it has become clear that its use is reliable and reproducible. Today, it is clinical routine to not remove further lymph nodes from the...
Detailed Description
Details can be found on www.senomac.se
Eligibility Criteria
Inclusion
- Patients with invasive breast cancer (T1-T3)
- N0 on palpation
- Preoperative ultrasound performed
- Pathology report shows macrometastasis in 1-2 sentinel lymph nodes
- Patients undergo breast-conserving therapy or mastectomy
- The patient must have provided oral and written consent
- Age ≥ 18 years
Exclusion
- Metastases outside of the ipsilateral axilla
- Prior history of invasive breast cancer
- Pregnancy
- Bilateral breast cancer if one side meets exclusion criteria
- Medical contraindication for radiotherapy or systemic treatment
- Inability to absorb or understand the meaning of the study information; for example, through disability, inadequate language skills or dementia.
Key Trial Info
Start Date :
January 27 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2031
Estimated Enrollment :
2700 Patients enrolled
Trial Details
Trial ID
NCT02240472
Start Date
January 27 2015
End Date
December 31 2031
Last Update
March 4 2025
Active Locations (33)
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1
Sygehus Sonderjylland
Aabenraa, Denmark
2
Aalborg University Hospital
Aalborg, Denmark
3
Aarhus University Hospital
Aarhus, Denmark
4
Rigshospitalet
Copenhagen, Denmark