Clinical trial · Interventional
Avoiding Sentinel Lymph Node Biopsy in Breast Cancer Patients After Neoadjuvant Chemotherapy
Avoiding Sentinel Lymph Node Biopsy In Select Clinical Node Negative Breast Cancer Patients After Neoadjuvant Systemic Therapy: the ASICS Trial
NCT04225858CI-TRIAL-00042718ASICSnot yet recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study evaluates whether SLNB can safely be omitted in breast cancer patients with HER2+ or TN tumors who achieve a radiological complete response on MRI after neoadjuvant systemic therapy
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| HER2-positive Breast Cancer | HER2-Positive Breast Carcinoma | ALIAS | 0.90 |
| Sentinel Lymph Node | — | UNRESOLVED | — |
| Triple Negative Breast Cancer | Triple-Negative Breast Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Omission of sentinel lymph node biopsy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Omission of sentinel lymph node biopsy
- description
- No surgical axillary staging (i.e. sentinel lymph node biopsy) will be performed.
- interventionNames
- Procedure: Omission of sentinel lymph node biopsy
Primary outcomes (1)
- measure
- Axillary recurrence
- timeFrame
- at 5 years
- description
- To show that sentinel lymph node biopsy after neoadjuvant systemic therapy can be omitted in clinically node-negative HER2+ or TN breast cancer patients who achieve radiological complete response on MRI without compromising the 5 - year axillary recurrence rate (i.e, \< 6% axillary recurrences within 5 years).
Secondary outcomes (5)
- measure
- Breast cancer specific quality of life
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Women, aged ≥ 18 years * Invasive HER2+ (HR+/-) or TN breast cancer * Primary tumor (T), clinical stage T1-3 * Neoadjuvant systemic therapy (NST), at least 3 cycles * Tumor stage assessed with breast MRI before start NST * Clinically node-negative before start NST (no suspect ALNs on ultrasound and FGD-PET/CT, or negative cyto-/histopathology in case of suspect nodes) * MRI after or during NST shows radiologic complete response * Written and signed informed consent Exclusion Criteria: * Primary tumor (T) clinical stage T4 * Patients without ultrasound or FDG-PET/CT pre-NST * History of breast cancer ipsilateral breast * Synchronous contralateral breast cancer * Synchronous M1 disease
References
Publications (0)
Data not yet available
No reference posted for this study.