NCT04225858Not yet recruiting
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
Source: ClinicalTrials.gov · Last updated 13 Jan 2020 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 340 (estimated)
- First submitted
- 4 Dec 2019
- Start date
- Jan 2020
- Primary completion date
- Jan 2025
- Lead sponsor
- The Netherlands Cancer Institute
- Diseases
- Triple-negative breast cancer
- NCT number
- NCT04225858
What you commit to
- Study type: Interventional
- Planned participants: 340
- From Jan 2020 to the primary completion date, Jan 2025
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- History of breast cancer ipsilateral breast
- Synchronous contralateral breast cancer
- Synchronous M1 disease
Other
- Primary tumor (T) clinical stage T4
- Patients without ultrasound or FDG-PET/CT pre-NST
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.