Sentinel Node Biopsy in Breast Cancner: Omission of Axillary Clearance After Micrometastasis
SENOMIC
Survival and Axillary Relapse in Breast Cancer Patients With Sentinel Node Micrometastases Who Have Not Undergone Completion Axillary Clearance - a National Cohort Study
1 other identifier
interventional
805
1 country
22
Brief Summary
Sentinel node (SN) biopsy in breast cancer has been demonstrated to be a reliable method, and several follow-up studies have shown that it is safe to refrain from completion axillary clearance (axillary lymph node dissection, ALND) in SN-negative patients. SN biopsy alone results in significantly less arm discomfort following the operation. However, as a surprisingly low frequency of axillary relapse has been observed in patients without any axillary intervention (neither SN biopsy nor axillary clearance), or without completion ALND after a positive SN biopsy, the importance of ALND is being questioned, even for patients with SN metastases. A large, randomized study (ISBCG23-1) was not able to show any differences in 5-year disease-free survival between patients with SN micrometastases who had undergone ALND and those who had not. This Swedish multicenter study will include patients with SN micrometastases. These women will not undergo ALND but will be registered in a study cohort. The patients will otherwise be treated in accordance with the national guidelines and will be clinically followed every year for five years, after 10 years and finally after 15 years. Hypothesis: To refrain from axillary clearance in breast cancer patients with sentinel node micrometastases does not impair survival.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable breast-cancer
Started Dec 2013
Longer than P75 for not_applicable breast-cancer
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2013
CompletedFirst Submitted
Initial submission to the registry
January 24, 2014
CompletedFirst Posted
Study publicly available on registry
January 30, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2022
CompletedMarch 10, 2023
March 1, 2023
9.1 years
January 24, 2014
March 8, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Disease-free survival
Five years
Secondary Outcomes (1)
Axillary recurrence rate
Five years
Other Outcomes (2)
Breast cancer-specific survival
Five years
Overall survival
Five years
Study Arms (1)
Omission of axillary clearance
EXPERIMENTALNo axillary lymph node dissection after sentinel node biopsy and sentinel node micrometastases
Interventions
Eligibility Criteria
You may qualify if:
- Patients with clinically node-negative, invasive breast cancer ≤ 5 cm (T1-T2)
- Histopathology results demonstrate SN micrometastases.
- Patients who undergo mastectomy (protocol change from April 2017 onwards)
- The patient must have given verbal and written consent.
You may not qualify if:
- Preoperatively diagnosed lymph node metastases.
- Sentinel node metastases \> 2 mm.
- Metastases beyond the ipsilateral axillary lymph nodes at the time of surgery.
- History of previous breast cancer.
- Pregnancy.
- Medical contraindication for systemic adjuvant therapy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Karolinska Institutetlead
- Centrallasarettet Västeråscollaborator
- Uppsala Universitycollaborator
Study Sites (22)
Sahlgrenska University Hospital
Gothenburg, Sweden
Helsingborgs Hospital
Helsingborg, Sweden
Kalmar Hospital
Kalmar, Sweden
Karlskrona Hospital
Karlskrona, Sweden
Kristianstad Hospital
Kristianstad, Sweden
Lidköping Hospital
Lidköping, Sweden
Linköping University Hospital
Linköping, Sweden
Lund and Malmö University Hospital
Lund, Sweden
Örebro University Hospital
Örebro, Sweden
Skövde Hospital
Skövde, Sweden
Karolinska University Hospital
Stockholm, 17176, Sweden
Capio St Görans Hospital
Stockholm, Sweden
Danderyds Hospital AB
Stockholm, Sweden
Southern General Hospital
Stockholm, Sweden
Sundsvall Hospital
Sundsvall, Sweden
Uddevalla Hospital
Uddevalla, Sweden
Umeå University Hospital
Umeå, Sweden
Akademiska Universitetssjukhuset
Uppsala, Sweden
Varberg Hospital
Varberg, Sweden
Växjö Hospital
Vaxjo, Sweden
Västmanlands Hospital
Västerås, Sweden
Västervik Hospital
Västervik, Sweden
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jana M de Boniface, MD, PhD
Karolinska Institutet
- PRINCIPAL INVESTIGATOR
Jan Frisell, Professor
Karolinska Institutet
- PRINCIPAL INVESTIGATOR
Leif Bergkvist, Professor
Uppsala University
- PRINCIPAL INVESTIGATOR
Yvette Andersson, MD, PhD
Västmanlands Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD
Study Record Dates
First Submitted
January 24, 2014
First Posted
January 30, 2014
Study Start
December 1, 2013
Primary Completion
December 31, 2022
Study Completion
December 31, 2022
Last Updated
March 10, 2023
Record last verified: 2023-03