Can we predict advanced lymph node disease and safely avoid sentinel lymph node biopsy in early breast cancer? A nationwide study using Swedish registry data
| ISRCTN | ISRCTN27020370 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN27020370 |
| Sponsor | Lund University |
| Funders | Lunds Universitet, The Governmental Funding of Clinical Research within the National Health Services ,Sweden, Vetenskapsrådet, Cancerfonden |
- Submission date
- 28/04/2026
- Registration date
- 28/04/2026
- Last edited
- 28/04/2026
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English summary of protocol
Background and study aims
Sentinel lymph node biopsy is a minor surgical procedure used to check whether breast cancer has spread to the lymph nodes in the armpit. Current guidelines suggest that some women with small, low-risk breast cancers may safely avoid this procedure. However, many patients still undergo sentinel lymph node biopsy because clinicians are concerned about missing more advanced lymph node disease, which can affect decisions about further treatment.
This study aims to develop and test a model to predict which patients have advanced lymph node disease (defined as cancer spread to four or more lymph nodes) without needing this procedure.
Who can participate?
This study includes women with early breast cancer recorded in the Swedish National Quality Registry for Breast Cancer. All participants are postmenopausal, aged 50 years or older, and have small, low-risk tumours. The cancer has not been found to have spread to the lymph nodes based on routine clinical assessment. These patients meet current guideline criteria for possibly avoiding sentinel lymph node biopsy.
What does the study involve?
This is a registry-based study using existing patient data. No new tests or treatments will be performed. Researchers will use information such as tumour size and other tumour and clinical characteristics to develop a prediction model. The data will be divided into two groups: one to develop the model and one to test how well it works.
What are the possible benefits and risks of participating?
There are no direct risks or benefits for the individuals included, as the study uses existing data only. The results may help improve future care by reducing unnecessary surgery and supporting more personalised treatment decisions.
Where is the study run from?
The study is conducted at Lund University and Skåne University Hospital in Sweden, using nationwide registry data.
When is the study starting and how long is it expected to run for?
The study uses data collected between January 2014 and December 2023. The analysis is ongoing and is expected to be completed in 2026.
Who is funding the study?
The study is funded by Swedish governmental funding of clinical research (ALF), the Swedish Research Council, Cancerfonden, and Lund University.
Who is the main contact?
Dr Ida Skarping, ida.skarping@med.lu.se
Contact information
Scientific, Principal investigator, Public
Lund University, Faculty of Medicine, Department of Clinical Sciences Lund, Box 118
Lund
221 00
Sweden
 ORCID ID |
0000-0002-1265-8649 |
|---|---|
| Phone | +46 (0)704585588 |
| ida.skarping@med.lu.se |
Study information
| Primary study design | Observational |
|---|---|
| Observational study design | Cohort study |
| Scientific title | Predicting advanced nodal disease (≥pN2) without sentinel lymph node biopsy in early breast cancer: a nationwide real-world data cohort study |
| Study objectives | To develop and validate a preoperative prediction model to estimate the individual probability of high nodal burden, defined as ≥pN2 disease, in patients with early breast cancer who meet American Society of Clinical Oncology (ASCO) criteria for omission of sentinel lymph node biopsy. |
| Ethics approval(s) |
Approved 06/05/2014, Swedish Ethical Review Authority (Etikprövningsmyndigheten, Box 2110, Uppsala, 750 02, Sweden; +46 (0)10-475 08 00; registrator@etikprovning.se), ref: 2024-02690-02 |
| Health condition(s) or problem(s) studied | High nodal burden (≥pN2, ≥4 positive axillary lymph nodes) early breast cancer |
| Intervention | This is a retrospective nationwide registry-based cohort study using data from the Swedish National Quality Registry for Breast Cancer. Eligible patients are women with early breast cancer diagnosed between 2014 and 2023 who meet criteria for possible omission of sentinel lymph node biopsy. The cohort will be divided into training and test sets based on year of diagnosis. Candidate clinical and tumour-related predictors available before or around surgery will be evaluated; no imaging or sentinel lymph node biopsy data. Alongside descriptive results, a prediction model will be developed and validated to estimate the probability of high nodal burden. |
| Intervention type | Other |
| Primary outcome measure(s) |
|
| Key secondary outcome measure(s) |
|
| Completion date | 20/04/2026 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Mixed |
| Lower age limit | 50 Years |
| Upper age limit | 100 Years |
| Sex | Female |
| Target sample size at registration | 59754 |
| Total final enrolment | 13211 |
| Key inclusion criteria | 1. Female sex 2. Invasive breast cancer 3. ≤2 cm 4. Clinically node negative 5. Postmenopausal status 6. Aged ≥50 years 7. Unifocal tumour 8. Invasive ductal carcinoma 9. Nottingham histological grade 1-2 10. Oestrogen receptor–positive tumour 11. Human epidermal growth factor receptor 2-negative tumour 12. Planned upfront breast surgery |
| Key exclusion criteria | 1. No data on endpoint variable 2. Age <50 years 3. Pre- or perimenopausal status 4. Tumour size T2–T4 5. Clinically node-positive disease 6. Distant metastatic disease 7. Multifocal disease 8. Non-invasive tumour 9. Not classified as no specific type histology 10. Nottingham histological grade 3 11. Oestrogen receptor–negative tumour 12. HER2-positive tumour |
| Date of first enrolment | 01/01/2014 |
| Date of final enrolment | 31/12/2023 |
Locations
Countries of recruitment
- Sweden
Study participating centres
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Statistical Analysis Plan | 28/04/2026 | No | No |
Additional files
- 49442_SAP.pdf
- Statistical Analysis Plan
Editorial Notes
28/04/2026: Study's existence confirmed by the Swedish Ethical Review Authority.
