ASICS trial: Avoiding Sentinel lymph node biopsy In select Clinical node negative breast cancer patients after neoadjuvant Systemic therapy

ASICS trial: Avoiding Sentinel lymph node biopsy In select Clinical node negative breast cancer patients after neoadjuvant Systemic therapy - ASICS trial

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON48085

Enrollment

340

Registered

2019-11-22

Start date

2019-10-01

Completion date

Unknown

Last updated

2025-09-15

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

Conditions

Breast cancer

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: • Women, aged >= 18 years • Invasive HER2-positive (Hormone receptor +/-) or triple negative 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 axillary lymph nodes 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

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 metastatic disease

Design outcomes

Primary

Measure	Time frame
The primary endpoint is axillary recurrence after 5 years. Previous data indicate a 5-year axillary recurrence rate of 1-3% in cN0 patients who underwent NST. An upper margin of 5% axillary recurrences is considered an acceptable extent of clinical non-inferiority.	—

Secondary

Measure	Time frame
Secondary endpoints are quality of life (specifically axillary morbidity and level of cancer worry), recurrence free survival (RFS), distant metastasis-free survival, disease-specific survival and overall survival.	—

Countries

Netherlands

Outcome results