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

Predicting advanced nodal disease (=pN2) without sentinel lymph node biopsy in early breast cancer: a nationwide real-world data cohort study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN27020370

Enrollment

59754

Registered

2026-04-28

Start date

2014-01-01

Completion date

Unknown

Last updated

2026-05-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

High nodal burden (=pN2, =4 positive axillary lymph nodes) early breast cancer Cancer

Interventions

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 b

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.

Eligibility

Sex/Gender

Female

Age

50 Years to 100 Years

Inclusion criteria

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

Exclusion criteria

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

Countries

Sweden

Contacts

Public ContactIda Skarping

ida.skarping@med.lu.se+46 (0)704585588

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: May 16, 2026