Clinically node-negative primary breast cancer Cancer Clinically node-negative primary malignant neoplasms of breast
Conditions
Interventions
Current intervention as of 31/08/2021:
Patients in this study are undergoing standard diagnostic work-up within the clinical pathway for breast cancer including a clinical examination, mammogram, ultr
Sponsors
Lund University
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 31/08/2021: 1. Invasive breast cancer 2. Clinically and ultrasound node-negative disease 3. Scheduled for primary surgery 4. Female _____ Previous inclusion criteria: 1. Invasive breast cancer 2. Clinically node-negative disease 3. Scheduled for primary surgery 4. Female
Exclusion criteria
Exclusion criteria: 1. Male 2. Previous ipsilateral breast or axillary surgery 3. Previous neoadjuvant therapy 4. Palpable axillary lymphadenopathy 5. No axillary staging
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 31/08/2021: Axillary nodal status stratified by stage N0, N1 and N2, determined from pre-operatively available clinicopathological data after surgery compared with the predictive N-status by the algorithms _____ Previous primary outcome measure: Axillary nodal status stratified by stage N0, N1 and N2, determined from pre-operatively available clinicopathological data after surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| False negative rate with negative predictive value of NPV max to 10% for prediction of N0, determined from sentinel node biopsy data after surgery | — |
Countries
Sweden
Outcome results
None listed