Avoiding Sentinel Lymph Node Biopsy in Breast Cancer Patients After Neoadjuvant Chemotherapy (ASICS)

Netherlands Cancer Institute (NKI)

Status: Not yet enrolling

Conditions: Sentinel Lymph Node; Breast Cancer; HER2-positive Breast Cancer; Triple Negative Breast Cancer

Treatments: Procedure: Omission of sentinel lymph node biopsy

Study type: Interventional

Funder types: Other

Identifiers

NCT04225858

N19ASC

Details and patient eligibility

About

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

Full description

Axillary staging in clinically node negative (cN0) breast cancer patients with neoadjuvant systemic therapy (NST; i.e. chemo- and immunotherapy), is preferably performed with sentinel lymph node biopsy (SLNB) after NST. The probability of a tumor-positive SLNB post-NST is low. cN0 patients with Human Epidermal growth factor Receptor 2- positive (HER2+) or triple negative (TN) breast cancer who achieve radiologic complete response (rCR) of the breast on MRI, have the lowest probability of a tumor-positive SLNB post-NST (<3%). Omitting removal of axillary lymph nodes in clinically node negative patients does not increase the rate of distant metastases nor breast cancer mortality. Performing SLNB can cause short- and long-term morbidity, reducing quality of life. The additional value of performing SLNB in patients with a very low risk of tumor-positive axillary lymph nodes should be investigated.

Enrollment: 340 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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340 participants in 1 patient group

Omission of sentinel lymph node biopsy

Experimental group

Description:

No surgical axillary staging (i.e. sentinel lymph node biopsy) will be performed.

Treatment:

Procedure: Omission of sentinel lymph node biopsy